Ignite Creation Date:
2025-12-24 @ 5:01 PM
Ignite Modification Date:
2025-12-24 @ 5:01 PM
Study NCT ID:
NCT04390750
Status:
COMPLETED
Last Update Posted:
2025-12-09
First Post:
2020-05-14
Is Possible Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Care Partner Assisted Intervention to Improve Oral Health of Individuals With Mild Dementia
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003704', 'term': 'Dementia'}, {'id': 'D010510', 'term': 'Periodontal Diseases'}], 'ancestors': [{'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'bw75@nyu.edu', 'phone': '12129925951', 'title': 'Bei Wu', 'organization': 'New York University'}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'We were unable to meet target accrual which may have limited the ability to detect statistically significant differences across arms, primarily due to the following barriers: reduced frequency of patient visits to clinics during the COVID-19 pandemic, which limited in-person recruitment and establishing relationships with non-affiliated hospitals and organizations.'}}, 'adverseEventsModule': {'timeFrame': 'Up to 6 months from Enrollment Date', 'description': 'Subjects were monitored for adverse events over a 6-month period, beginning at enrollment and continuing through the last study visit.', 'eventGroups': [{'id': 'EG000', 'title': 'Treatment Group 1', 'description': "Treatment Group 1 will receive a standard educational booklet, a clinical oral health evaluation and a smart electronic toothbrush with no instruction on oral hygiene technique. The study coordinator will download the toothbrush data for data collection. The dental hygienist will observe the participant's normal toothbrushing technique, interdental cleaning procedures and the cleaning of partial dentures. No instruction is provided. The hygienist will provide basic instruction on proper use of the smart electronic toothbrush.", 'otherNumAtRisk': 20, 'deathsNumAtRisk': 20, 'otherNumAffected': 1, 'seriousNumAtRisk': 20, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Treatment Group 2', 'description': 'Treatment Group 2 will receive a standard educational booklet, a smart electronic toothbrush, a clinical oral health evaluation with tailored instruction on oral hygiene technique and care partner coaching. The study coordinator will download the toothbrush data for data collection. The dental hygienist and interventionist will work together to fulfill the following intervention components: tailored instruction and coaching.', 'otherNumAtRisk': 20, 'deathsNumAtRisk': 20, 'otherNumAffected': 2, 'seriousNumAtRisk': 20, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Control Group', 'description': "The Control group will receive a standard educational booklet and a clinical oral health evaluation with no instruction on oral hygiene technique. The dental hygienist will observe the participant's normal toothbrushing technique, interdental cleaning procedures and the cleaning of partial dentures. No instruction is provided.", 'otherNumAtRisk': 20, 'deathsNumAtRisk': 20, 'otherNumAffected': 0, 'seriousNumAtRisk': 20, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Gum Soreness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Tissue Trauma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Plaque Index', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Group 1', 'description': "Treatment Group 1 will receive a standard educational booklet, a clinical oral health evaluation and a smart electronic toothbrush with no instruction on oral hygiene technique. The study coordinator will download the toothbrush data for data collection. The dental hygienist will observe the participant's normal toothbrushing technique, interdental cleaning procedures and the cleaning of partial dentures. No instruction is provided. The hygienist will provide basic instruction on proper use of the smart electronic toothbrush."}, {'id': 'OG001', 'title': 'Treatment Group 2', 'description': 'Treatment Group 2 will receive a standard educational booklet, a smart electronic toothbrush, a clinical oral health evaluation with tailored instruction on oral hygiene technique and care partner coaching. The study coordinator will download the toothbrush data for data collection. The dental hygienist and interventionist will work together to fulfill the following intervention components: tailored instruction and coaching.'}, {'id': 'OG002', 'title': 'Control Group', 'description': "The Control group will receive a standard educational booklet and a clinical oral health evaluation with no instruction on oral hygiene technique. The dental hygienist will observe the participant's normal toothbrushing technique, interdental cleaning procedures and the cleaning of partial dentures. No instruction is provided."}], 'classes': [{'categories': [{'measurements': [{'value': '0.55', 'spread': '0.36', 'groupId': 'OG000'}, {'value': '0.41', 'spread': '0.25', 'groupId': 'OG001'}, {'value': '0.48', 'spread': '0.32', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.939', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Interaction coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.00', 'ciLowerLimit': '-0.11', 'ciUpperLimit': '0.11', 'groupDescription': 'A linear mixed effects model including an arm-by-time interaction was used to estimate between-arm differences in change in plaque levels at the primary endpoint of 3 months.', 'statisticalMethod': 'Linear mixed effects model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Linear mixed effects model with arm-by-time interaction.', 'nonInferiorityComment': 'The effect estimate reflects the adjusted difference in change from baseline on plaque levels between Treatment Group 1 and Control at 3 months.'}, {'pValue': '0.103', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Interaction coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.09', 'ciLowerLimit': '-0.21', 'ciUpperLimit': '0.02', 'groupDescription': 'A linear mixed effects model including an arm-by-time interaction was used to estimate between-arm differences in change in plaque levels at the primary endpoint of 3 months.', 'statisticalMethod': 'Linear mixed effects model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Linear mixed effects model with arm-by-time interaction.', 'nonInferiorityComment': 'The effect estimate reflects the adjusted difference in change from baseline on plaque levels between Treatment Group 2 and Control at 3 months.'}], 'paramType': 'MEAN', 'timeFrame': '3 months', 'description': 'UNC Modified Green and Vermillion Oral Hygiene Index. Plaque was measured per tooth, 0 = No plaque, 1 = Plaque covers \\<1/3 tooth, 2 = Plaque covers \\>=1/3 but \\<2/3 tooth and 3 = Plaque covers \\>=2/3 tooth. The index values were calculated as the proportion of sites with plaque deposits on at least less than 1/3 of crown. The index value is the proportion of sites with plaque deposits. Higher index values indicate higher levels of plaque.', 'unitOfMeasure': 'Proportion of sites with plaque deposits', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '6 participants were withdrawn after the baseline visit, and 1 participant did not complete assessment at 3 months.'}, {'type': 'PRIMARY', 'title': 'Gingival Index', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Group 1', 'description': "Treatment Group 1 will receive a standard educational booklet, a clinical oral health evaluation and a smart electronic toothbrush with no instruction on oral hygiene technique. The study coordinator will download the toothbrush data for data collection. The dental hygienist will observe the participant's normal toothbrushing technique, interdental cleaning procedures and the cleaning of partial dentures. No instruction is provided. The hygienist will provide basic instruction on proper use of the smart electronic toothbrush."}, {'id': 'OG001', 'title': 'Treatment Group 2', 'description': 'Treatment Group 2 will receive a standard educational booklet, a smart electronic toothbrush, a clinical oral health evaluation with tailored instruction on oral hygiene technique and care partner coaching. The study coordinator will download the toothbrush data for data collection. The dental hygienist and interventionist will work together to fulfill the following intervention components: tailored instruction and coaching.'}, {'id': 'OG002', 'title': 'Control Group', 'description': "The Control group will receive a standard educational booklet and a clinical oral health evaluation with no instruction on oral hygiene technique. The dental hygienist will observe the participant's normal toothbrushing technique, interdental cleaning procedures and the cleaning of partial dentures. No instruction is provided."}], 'classes': [{'categories': [{'measurements': [{'value': '0.61', 'spread': '0.39', 'groupId': 'OG000'}, {'value': '0.37', 'spread': '0.39', 'groupId': 'OG001'}, {'value': '0.47', 'spread': '0.42', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.995', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Interaction coefficient', 'ciPctValue': '95', 'paramValue': '0.00', 'ciLowerLimit': '-0.16', 'ciUpperLimit': '0.16', 'groupDescription': 'A linear mixed effects model including an arm-by-time interaction was used to estimate between-arm differences in change in gingival inflammation at the primary endpoint of 3 months.', 'statisticalMethod': 'Linear mixed effects model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Linear mixed effects model with arm-by-time interaction.', 'nonInferiorityComment': 'The effect estimate reflects the adjusted difference in change from baseline on gingival inflammation between Treatment Group 1 and Control at 3 months.'}, {'pValue': '0.132', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Interaction coefficient', 'ciPctValue': '95', 'paramValue': '-0.12', 'ciLowerLimit': '-0.28', 'ciUpperLimit': '0.04', 'groupDescription': 'A linear mixed effects model including an arm-by-time interaction was used to estimate between-arm differences in change in gingival inflammation at the primary endpoint of 3 months.', 'statisticalMethod': 'Linear mixed effects model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Linear mixed effects model with arm-by-time interaction.', 'nonInferiorityComment': 'The effect estimate reflects the adjusted difference in change from baseline on gingival inflammation between Treatment Group 2 and Control at 3 months.'}], 'paramType': 'MEAN', 'timeFrame': '3 months', 'description': 'UNC Modified Loe and Silness Gingival Index Gingival inflammation is evaluated per tooth, classified as 0 = Normal gingiva, 1 = Mild inflammation, no bleeding on probing, 2 = Moderate inflammation, bleeding on probing, 3 = Severe inflammation, tendency to spontaneous bleeding. Index values were calculated as the proportion of sites with at least some mild inflammation. The index value is the proportion of sites with inflammation. Higher index values indicate greater gingival inflammation.', 'unitOfMeasure': 'Proportion of sites with inflammation.', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '6 participants were withdrawn after the baseline visit, and 1 participant did not complete assessment at 3 months.'}, {'type': 'PRIMARY', 'title': 'Plaque Index', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Group 1', 'description': "Treatment Group 1 will receive a standard educational booklet, a clinical oral health evaluation and a smart electronic toothbrush with no instruction on oral hygiene technique. The study coordinator will download the toothbrush data for data collection. The dental hygienist will observe the participant's normal toothbrushing technique, interdental cleaning procedures and the cleaning of partial dentures. No instruction is provided. The hygienist will provide basic instruction on proper use of the smart electronic toothbrush."}, {'id': 'OG001', 'title': 'Treatment Group 2', 'description': 'Treatment Group 2 will receive a standard educational booklet, a smart electronic toothbrush, a clinical oral health evaluation with tailored instruction on oral hygiene technique and care partner coaching. The study coordinator will download the toothbrush data for data collection. The dental hygienist and interventionist will work together to fulfill the following intervention components: tailored instruction and coaching.'}, {'id': 'OG002', 'title': 'Control Group', 'description': "The Control group will receive a standard educational booklet and a clinical oral health evaluation with no instruction on oral hygiene technique. The dental hygienist will observe the participant's normal toothbrushing technique, interdental cleaning procedures and the cleaning of partial dentures. No instruction is provided."}], 'classes': [{'categories': [{'measurements': [{'value': '0.55', 'spread': '0.35', 'groupId': 'OG000'}, {'value': '0.45', 'spread': '0.28', 'groupId': 'OG001'}, {'value': '0.53', 'spread': '0.30', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.402', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Interaction coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.05', 'ciLowerLimit': '-0.16', 'ciUpperLimit': '0.06', 'groupDescription': 'A linear mixed effects model including an arm-by-time interaction was used to estimate between-arm differences in change in plaque levels at the secondary endpoint of 6 months.', 'statisticalMethod': 'Linear mixed effects model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Linear mixed effects model with arm-by-time interaction.', 'nonInferiorityComment': 'The effect estimate reflects the adjusted difference in change from baseline on plaque levels between Treatment Group 1 and Control at 6 months.'}, {'pValue': '0.072', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Interaction coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.10', 'ciLowerLimit': '-0.21', 'ciUpperLimit': '0.01', 'groupDescription': 'A linear mixed effects model including an arm-by-time interaction was used to estimate between-arm differences in change in plaque levels at the secondary endpoint of 6 months.', 'statisticalMethod': 'Linear mixed effects model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Linear mixed effects model with arm-by-time interaction.', 'nonInferiorityComment': 'The effect estimate reflects the adjusted difference in change from baseline on plaque levels between Treatment Group 2 and Control at 6 months.'}], 'paramType': 'MEAN', 'timeFrame': '6 months', 'description': 'UNC Modified Green and Vermillion Oral Hygiene Index. Plaque was measured per tooth, 0 = No plaque, 1 = Plaque covers \\<1/3 tooth, 2 = Plaque covers \\>=1/3 but \\<2/3 tooth and 3 = Plaque covers \\>=2/3 tooth. The index values were calculated as the proportion of sites with plaque deposits on at least less than 1/3 of crown. The index value is the proportion of sites with plaque deposits. Higher index values indicate higher levels of plaque.', 'unitOfMeasure': 'Proportion of sites with plaque deposits', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '6 participants were withdrawn after the baseline visit.'}, {'type': 'PRIMARY', 'title': 'Gingival Index', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Group 1', 'description': "Treatment Group 1 will receive a standard educational booklet, a clinical oral health evaluation and a smart electronic toothbrush with no instruction on oral hygiene technique. The study coordinator will download the toothbrush data for data collection. The dental hygienist will observe the participant's normal toothbrushing technique, interdental cleaning procedures and the cleaning of partial dentures. No instruction is provided. The hygienist will provide basic instruction on proper use of the smart electronic toothbrush."}, {'id': 'OG001', 'title': 'Treatment Group 2', 'description': 'Treatment Group 2 will receive a standard educational booklet, a smart electronic toothbrush, a clinical oral health evaluation with tailored instruction on oral hygiene technique and care partner coaching. The study coordinator will download the toothbrush data for data collection. The dental hygienist and interventionist will work together to fulfill the following intervention components: tailored instruction and coaching.'}, {'id': 'OG002', 'title': 'Control Group', 'description': "The Control group will receive a standard educational booklet and a clinical oral health evaluation with no instruction on oral hygiene technique. The dental hygienist will observe the participant's normal toothbrushing technique, interdental cleaning procedures and the cleaning of partial dentures. No instruction is provided."}], 'classes': [{'categories': [{'measurements': [{'value': '0.58', 'spread': '0.39', 'groupId': 'OG000'}, {'value': '0.43', 'spread': '0.35', 'groupId': 'OG001'}, {'value': '0.63', 'spread': '0.41', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.014', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Interaction coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.20', 'ciLowerLimit': '-0.36', 'ciUpperLimit': '-0.04', 'groupDescription': 'A linear mixed effects model including an arm-by-time interaction was used to estimate between-arm differences in change in gingival inflammation at the secondary endpoint of 6 months.', 'statisticalMethod': 'Linear mixed effects model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Linear mixed effects model with arm-by-time interaction.', 'nonInferiorityComment': 'The effect estimate reflects the adjusted difference in change from baseline on gingival inflammation between Treatment Group 1 and Control at 6 months.'}, {'pValue': '0.005', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Interaction coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.23', 'ciLowerLimit': '-0.39', 'ciUpperLimit': '-0.07', 'groupDescription': 'A linear mixed effects model including an arm-by-time interaction was used to estimate between-arm differences in change in gingival inflammation at the secondary endpoint of 6 months.', 'statisticalMethod': 'Linear mixed effects model.', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Linear mixed effects model with arm-by-time interaction.', 'nonInferiorityComment': 'The effect estimate reflects the adjusted difference in change from baseline on gingival inflammation between Treatment Group 2 and Control at 6 months.'}], 'paramType': 'MEAN', 'timeFrame': '6 months', 'description': 'UNC Modified Loe and Silness Gingival Index Gingival inflammation is evaluated per tooth, classified as 0 = Normal gingiva, 1 = Mild inflammation, no bleeding on probing, 2 = Moderate inflammation, bleeding on probing, 3 = Severe inflammation, tendency to spontaneous bleeding. Index values were calculated as the proportion of sites with at least some mild inflammation. The index value is the proportion of sites with inflammation. Higher index values indicate greater gingival inflammation.', 'unitOfMeasure': 'Proportion of sites with inflammation.', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '6 participants were withdrawn after the baseline visit.'}, {'type': 'SECONDARY', 'title': 'Frequency of Toothbrushing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Group 1', 'description': "Treatment Group 1 will receive a standard educational booklet, a clinical oral health evaluation and a smart electronic toothbrush with no instruction on oral hygiene technique. The study coordinator will download the toothbrush data for data collection. The dental hygienist will observe the participant's normal toothbrushing technique, interdental cleaning procedures and the cleaning of partial dentures. No instruction is provided. The hygienist will provide basic instruction on proper use of the smart electronic toothbrush."}, {'id': 'OG001', 'title': 'Treatment Group 2', 'description': 'Treatment Group 2 will receive a standard educational booklet, a smart electronic toothbrush, a clinical oral health evaluation with tailored instruction on oral hygiene technique and care partner coaching. The study coordinator will download the toothbrush data for data collection. The dental hygienist and interventionist will work together to fulfill the following intervention components: tailored instruction and coaching.'}, {'id': 'OG002', 'title': 'Control Group', 'description': "The Control group will receive a standard educational booklet and a clinical oral health evaluation with no instruction on oral hygiene technique. The dental hygienist will observe the participant's normal toothbrushing technique, interdental cleaning procedures and the cleaning of partial dentures. No instruction is provided."}], 'classes': [{'categories': [{'title': '< Twice a week', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}, {'title': '>= Twice a week', 'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '3 months', 'description': "Participants' frequency toothbrushing Categorical variable with the following response types: 'Less than Twice a Day' or 'Twice a Day or more'.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '6 participants were withdrawn after the baseline visit, and 1 participant did not complete assessment at 3 months.'}, {'type': 'SECONDARY', 'title': 'Frequency of Toothbrushing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Group 1', 'description': "Treatment Group 1 will receive a standard educational booklet, a clinical oral health evaluation and a smart electronic toothbrush with no instruction on oral hygiene technique. The study coordinator will download the toothbrush data for data collection. The dental hygienist will observe the participant's normal toothbrushing technique, interdental cleaning procedures and the cleaning of partial dentures. No instruction is provided. The hygienist will provide basic instruction on proper use of the smart electronic toothbrush."}, {'id': 'OG001', 'title': 'Treatment Group 2', 'description': 'Treatment Group 2 will receive a standard educational booklet, a smart electronic toothbrush, a clinical oral health evaluation with tailored instruction on oral hygiene technique and care partner coaching. The study coordinator will download the toothbrush data for data collection. The dental hygienist and interventionist will work together to fulfill the following intervention components: tailored instruction and coaching.'}, {'id': 'OG002', 'title': 'Control Group', 'description': "The Control group will receive a standard educational booklet and a clinical oral health evaluation with no instruction on oral hygiene technique. The dental hygienist will observe the participant's normal toothbrushing technique, interdental cleaning procedures and the cleaning of partial dentures. No instruction is provided."}], 'classes': [{'categories': [{'title': '< Twice a week', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}, {'title': '>= Twice a week', 'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '6 months', 'description': "Participants' frequency toothbrushing Categorical variable with the following response types: 'Less than Twice a Day' or 'Twice a Day or more'.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '6 participants were withdrawn after the baseline visit.'}, {'type': 'SECONDARY', 'title': 'Duration of Toothbrushing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Group 1', 'description': "Treatment Group 1 will receive a standard educational booklet, a clinical oral health evaluation and a smart electronic toothbrush with no instruction on oral hygiene technique. The study coordinator will download the toothbrush data for data collection. The dental hygienist will observe the participant's normal toothbrushing technique, interdental cleaning procedures and the cleaning of partial dentures. No instruction is provided. The hygienist will provide basic instruction on proper use of the smart electronic toothbrush."}, {'id': 'OG001', 'title': 'Treatment Group 2', 'description': 'Treatment Group 2 will receive a standard educational booklet, a smart electronic toothbrush, a clinical oral health evaluation with tailored instruction on oral hygiene technique and care partner coaching. The study coordinator will download the toothbrush data for data collection. The dental hygienist and interventionist will work together to fulfill the following intervention components: tailored instruction and coaching.'}, {'id': 'OG002', 'title': 'Control Group', 'description': "The Control group will receive a standard educational booklet and a clinical oral health evaluation with no instruction on oral hygiene technique. The dental hygienist will observe the participant's normal toothbrushing technique, interdental cleaning procedures and the cleaning of partial dentures. No instruction is provided."}], 'classes': [{'categories': [{'title': '>= 2 min', 'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}, {'title': '>= 1 min & < 2 min', 'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}, {'title': '< 1min', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}, {'title': 'Unknown', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '3 months', 'description': "Participants' duration of toothbrushing. Reported by the dental hygienist. Categorical variable consisting of 3 response types (\\< 1minute; \\> 1 minute \\& \\< 2minute; \\> 2 minute per toothbrushing session).", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '6 participants were withdrawn after the baseline visit, and 1 participant did not complete assessment at 3 months.'}, {'type': 'SECONDARY', 'title': 'Duration of Toothbrushing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Group 1', 'description': "Treatment Group 1 will receive a standard educational booklet, a clinical oral health evaluation and a smart electronic toothbrush with no instruction on oral hygiene technique. The study coordinator will download the toothbrush data for data collection. The dental hygienist will observe the participant's normal toothbrushing technique, interdental cleaning procedures and the cleaning of partial dentures. No instruction is provided. The hygienist will provide basic instruction on proper use of the smart electronic toothbrush."}, {'id': 'OG001', 'title': 'Treatment Group 2', 'description': 'Treatment Group 2 will receive a standard educational booklet, a smart electronic toothbrush, a clinical oral health evaluation with tailored instruction on oral hygiene technique and care partner coaching. The study coordinator will download the toothbrush data for data collection. The dental hygienist and interventionist will work together to fulfill the following intervention components: tailored instruction and coaching.'}, {'id': 'OG002', 'title': 'Control Group', 'description': "The Control group will receive a standard educational booklet and a clinical oral health evaluation with no instruction on oral hygiene technique. The dental hygienist will observe the participant's normal toothbrushing technique, interdental cleaning procedures and the cleaning of partial dentures. No instruction is provided."}], 'classes': [{'categories': [{'title': '>= 2 min', 'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}, {'title': '>= 1 min & < 2 min', 'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}, {'title': '< 1min', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}, {'title': 'Unknown', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '6 months', 'description': "Participants' duration of toothbrushing. Reported by the dental hygienist. Categorical variable consisting of 3 response types (\\< 1minute; \\> 1 minute \\& \\< 2minute; \\> 2 minute per toothbrushing session).", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '6 participants were withdrawn after the baseline visit.'}, {'type': 'SECONDARY', 'title': 'Frequency of Interdental Cleaning', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Group 1', 'description': "Treatment Group 1 will receive a standard educational booklet, a clinical oral health evaluation and a smart electronic toothbrush with no instruction on oral hygiene technique. The study coordinator will download the toothbrush data for data collection. The dental hygienist will observe the participant's normal toothbrushing technique, interdental cleaning procedures and the cleaning of partial dentures. No instruction is provided. The hygienist will provide basic instruction on proper use of the smart electronic toothbrush."}, {'id': 'OG001', 'title': 'Treatment Group 2', 'description': 'Treatment Group 2 will receive a standard educational booklet, a smart electronic toothbrush, a clinical oral health evaluation with tailored instruction on oral hygiene technique and care partner coaching. The study coordinator will download the toothbrush data for data collection. The dental hygienist and interventionist will work together to fulfill the following intervention components: tailored instruction and coaching.'}, {'id': 'OG002', 'title': 'Control Group', 'description': "The Control group will receive a standard educational booklet and a clinical oral health evaluation with no instruction on oral hygiene technique. The dental hygienist will observe the participant's normal toothbrushing technique, interdental cleaning procedures and the cleaning of partial dentures. No instruction is provided."}], 'classes': [{'categories': [{'title': 'Twice a day or more', 'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}, {'title': 'Once a day', 'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}, {'title': 'Several times a week', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}, {'title': 'Once or less than once a week', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}, {'title': 'Hardly ever', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}, {'title': 'Never', 'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '3 months', 'description': "Participants' frequency of interdental cleaning Collected via self-report via care partner. Categorical variable ranging from 'Never' to 'Twice a Day or More'.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '6 participants were withdrawn after the baseline visit, and 1 participant did not complete assessment at 3 months.'}, {'type': 'SECONDARY', 'title': 'Frequency of Interdental Cleaning', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Group 1', 'description': "Treatment Group 1 will receive a standard educational booklet, a clinical oral health evaluation and a smart electronic toothbrush with no instruction on oral hygiene technique. The study coordinator will download the toothbrush data for data collection. The dental hygienist will observe the participant's normal toothbrushing technique, interdental cleaning procedures and the cleaning of partial dentures. No instruction is provided. The hygienist will provide basic instruction on proper use of the smart electronic toothbrush."}, {'id': 'OG001', 'title': 'Treatment Group 2', 'description': 'Treatment Group 2 will receive a standard educational booklet, a smart electronic toothbrush, a clinical oral health evaluation with tailored instruction on oral hygiene technique and care partner coaching. The study coordinator will download the toothbrush data for data collection. The dental hygienist and interventionist will work together to fulfill the following intervention components: tailored instruction and coaching.'}, {'id': 'OG002', 'title': 'Control Group', 'description': "The Control group will receive a standard educational booklet and a clinical oral health evaluation with no instruction on oral hygiene technique. The dental hygienist will observe the participant's normal toothbrushing technique, interdental cleaning procedures and the cleaning of partial dentures. No instruction is provided."}], 'classes': [{'categories': [{'title': 'Twice a day or more', 'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}, {'title': 'Once a day', 'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}, {'title': 'Several times a week', 'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}, {'title': 'Once or less than once a week', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}, {'title': 'Hardly ever', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}, {'title': 'Never', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '6 months', 'description': "Participants' frequency of interdental cleaning. Collected via self-report via care partner. Categorical variable ranging from 'Never' to 'Twice a Day or More'.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '6 participants were withdrawn after the baseline visit.'}, {'type': 'SECONDARY', 'title': 'Interproximal Cleaning Technique', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Group 1', 'description': "Treatment Group 1 will receive a standard educational booklet, a clinical oral health evaluation and a smart electronic toothbrush with no instruction on oral hygiene technique. The study coordinator will download the toothbrush data for data collection. The dental hygienist will observe the participant's normal toothbrushing technique, interdental cleaning procedures and the cleaning of partial dentures. No instruction is provided. The hygienist will provide basic instruction on proper use of the smart electronic toothbrush."}, {'id': 'OG001', 'title': 'Treatment Group 2', 'description': 'Treatment Group 2 will receive a standard educational booklet, a smart electronic toothbrush, a clinical oral health evaluation with tailored instruction on oral hygiene technique and care partner coaching. The study coordinator will download the toothbrush data for data collection. The dental hygienist and interventionist will work together to fulfill the following intervention components: tailored instruction and coaching.'}, {'id': 'OG002', 'title': 'Control Group', 'description': "The Control group will receive a standard educational booklet and a clinical oral health evaluation with no instruction on oral hygiene technique. The dental hygienist will observe the participant's normal toothbrushing technique, interdental cleaning procedures and the cleaning of partial dentures. No instruction is provided."}], 'classes': [{'categories': [{'title': 'Less than optimal', 'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}, {'title': 'Optimal', 'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '3 months', 'description': "Participants' Interproximal Cleaning Technique Reported by the dental hygienist. Categorical variable, with the following response types: 'Less than Optimal' or 'Interproximal Surfaces Cleaned Using 'C' shape'.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '6 participants were withdrawn after the baseline visit, and 1 participant did not complete assessment at 3 months.'}, {'type': 'SECONDARY', 'title': 'Interproximal Cleaning Technique', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Group 1', 'description': "Treatment Group 1 will receive a standard educational booklet, a clinical oral health evaluation and a smart electronic toothbrush with no instruction on oral hygiene technique. The study coordinator will download the toothbrush data for data collection. The dental hygienist will observe the participant's normal toothbrushing technique, interdental cleaning procedures and the cleaning of partial dentures. No instruction is provided. The hygienist will provide basic instruction on proper use of the smart electronic toothbrush."}, {'id': 'OG001', 'title': 'Treatment Group 2', 'description': 'Treatment Group 2 will receive a standard educational booklet, a smart electronic toothbrush, a clinical oral health evaluation with tailored instruction on oral hygiene technique and care partner coaching. The study coordinator will download the toothbrush data for data collection. The dental hygienist and interventionist will work together to fulfill the following intervention components: tailored instruction and coaching.'}, {'id': 'OG002', 'title': 'Control Group', 'description': "The Control group will receive a standard educational booklet and a clinical oral health evaluation with no instruction on oral hygiene technique. The dental hygienist will observe the participant's normal toothbrushing technique, interdental cleaning procedures and the cleaning of partial dentures. No instruction is provided."}], 'classes': [{'categories': [{'title': 'Less than optimal', 'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}]}, {'title': 'Optimal', 'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '6 months', 'description': "Participants' Interproximal Cleaning Technique. Reported by the dental hygienist. Categorical variable, with the following response types: 'Less than Optimal' or 'Interproximal Surfaces Cleaned Using 'C' shape'.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '6 participants were withdrawn after the baseline visit.'}, {'type': 'SECONDARY', 'title': 'Oral Health Hygiene Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Group 1', 'description': "Treatment Group 1 will receive a standard educational booklet, a clinical oral health evaluation and a smart electronic toothbrush with no instruction on oral hygiene technique. The study coordinator will download the toothbrush data for data collection. The dental hygienist will observe the participant's normal toothbrushing technique, interdental cleaning procedures and the cleaning of partial dentures. No instruction is provided. The hygienist will provide basic instruction on proper use of the smart electronic toothbrush."}, {'id': 'OG001', 'title': 'Treatment Group 2', 'description': 'Treatment Group 2 will receive a standard educational booklet, a smart electronic toothbrush, a clinical oral health evaluation with tailored instruction on oral hygiene technique and care partner coaching. The study coordinator will download the toothbrush data for data collection. The dental hygienist and interventionist will work together to fulfill the following intervention components: tailored instruction and coaching.'}, {'id': 'OG002', 'title': 'Control Group', 'description': "The Control group will receive a standard educational booklet and a clinical oral health evaluation with no instruction on oral hygiene technique. The dental hygienist will observe the participant's normal toothbrushing technique, interdental cleaning procedures and the cleaning of partial dentures. No instruction is provided."}], 'classes': [{'categories': [{'measurements': [{'value': '1.83', 'spread': '0.67', 'groupId': 'OG000'}, {'value': '1.64', 'spread': '0.44', 'groupId': 'OG001'}, {'value': '1.78', 'spread': '0.45', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3 months', 'description': 'Participant Oral Hygiene Skills. Reported by the dental hygienist. Average score on the Oral Hygiene Assessment Sheet of Routine Care Questionnaire. Scores range from 1 to 3. Lower scores indicate higher oral health hygiene.', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '6 participants were withdrawn after the baseline visit, and 1 participant did not complete assessment at 3 months.'}, {'type': 'SECONDARY', 'title': 'Oral Health Hygiene Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Group 1', 'description': "Treatment Group 1 will receive a standard educational booklet, a clinical oral health evaluation and a smart electronic toothbrush with no instruction on oral hygiene technique. The study coordinator will download the toothbrush data for data collection. The dental hygienist will observe the participant's normal toothbrushing technique, interdental cleaning procedures and the cleaning of partial dentures. No instruction is provided. The hygienist will provide basic instruction on proper use of the smart electronic toothbrush."}, {'id': 'OG001', 'title': 'Treatment Group 2', 'description': 'Treatment Group 2 will receive a standard educational booklet, a smart electronic toothbrush, a clinical oral health evaluation with tailored instruction on oral hygiene technique and care partner coaching. The study coordinator will download the toothbrush data for data collection. The dental hygienist and interventionist will work together to fulfill the following intervention components: tailored instruction and coaching.'}, {'id': 'OG002', 'title': 'Control Group', 'description': "The Control group will receive a standard educational booklet and a clinical oral health evaluation with no instruction on oral hygiene technique. The dental hygienist will observe the participant's normal toothbrushing technique, interdental cleaning procedures and the cleaning of partial dentures. No instruction is provided."}], 'classes': [{'categories': [{'measurements': [{'value': '1.85', 'spread': '0.53', 'groupId': 'OG000'}, {'value': '1.58', 'spread': '0.46', 'groupId': 'OG001'}, {'value': '1.85', 'spread': '0.43', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 months', 'description': 'Participant Oral Hygiene Skills. Reported from dental hygienist. Average score on the Oral Hygiene Assessment Sheet of Routine Care Questionnaire. Scores on this scale range from 1 to 3. Lower scores indicate higher oral health hygiene.', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '6 participants were withdrawn after the baseline visit.'}, {'type': 'SECONDARY', 'title': 'Oral Health Knowledge Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Group 1', 'description': "Treatment Group 1 will receive a standard educational booklet, a clinical oral health evaluation and a smart electronic toothbrush with no instruction on oral hygiene technique. The study coordinator will download the toothbrush data for data collection. The dental hygienist will observe the participant's normal toothbrushing technique, interdental cleaning procedures and the cleaning of partial dentures. No instruction is provided. The hygienist will provide basic instruction on proper use of the smart electronic toothbrush."}, {'id': 'OG001', 'title': 'Treatment Group 2', 'description': 'Treatment Group 2 will receive a standard educational booklet, a smart electronic toothbrush, a clinical oral health evaluation with tailored instruction on oral hygiene technique and care partner coaching. The study coordinator will download the toothbrush data for data collection. The dental hygienist and interventionist will work together to fulfill the following intervention components: tailored instruction and coaching.'}, {'id': 'OG002', 'title': 'Control Group', 'description': "The Control group will receive a standard educational booklet and a clinical oral health evaluation with no instruction on oral hygiene technique. The dental hygienist will observe the participant's normal toothbrushing technique, interdental cleaning procedures and the cleaning of partial dentures. No instruction is provided."}], 'classes': [{'categories': [{'measurements': [{'value': '0.71', 'spread': '0.20', 'groupId': 'OG000'}, {'value': '0.81', 'spread': '0.12', 'groupId': 'OG001'}, {'value': '0.73', 'spread': '0.17', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3 months', 'description': 'Participant Oral Health Knowledge Score Scores were calculated as the proportion of correct responses on the Modified Oral Health Knowledge section of the Study Participant Questionnaire. Higher scores indicate greater oral health knowledge. Range is 0-1.', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '6 participants were withdrawn after the baseline visit, and 1 participant did not complete assessment at 3 months.'}, {'type': 'SECONDARY', 'title': 'Oral Health Knowledge Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Group 1', 'description': "Treatment Group 1 will receive a standard educational booklet, a clinical oral health evaluation and a smart electronic toothbrush with no instruction on oral hygiene technique. The study coordinator will download the toothbrush data for data collection. The dental hygienist will observe the participant's normal toothbrushing technique, interdental cleaning procedures and the cleaning of partial dentures. No instruction is provided. The hygienist will provide basic instruction on proper use of the smart electronic toothbrush."}, {'id': 'OG001', 'title': 'Treatment Group 2', 'description': 'Treatment Group 2 will receive a standard educational booklet, a smart electronic toothbrush, a clinical oral health evaluation with tailored instruction on oral hygiene technique and care partner coaching. The study coordinator will download the toothbrush data for data collection. The dental hygienist and interventionist will work together to fulfill the following intervention components: tailored instruction and coaching.'}, {'id': 'OG002', 'title': 'Control Group', 'description': "The Control group will receive a standard educational booklet and a clinical oral health evaluation with no instruction on oral hygiene technique. The dental hygienist will observe the participant's normal toothbrushing technique, interdental cleaning procedures and the cleaning of partial dentures. No instruction is provided."}], 'classes': [{'categories': [{'measurements': [{'value': '0.65', 'spread': '0.24', 'groupId': 'OG000'}, {'value': '0.76', 'spread': '0.19', 'groupId': 'OG001'}, {'value': '0.68', 'spread': '0.15', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 months', 'description': 'Participant Oral Health Knowledge Score Scores were calculated as the proportion of correct responses on the Modified Oral Health Knowledge section of the Study Participant Questionnaire. Higher scores indicate greater oral health knowledge. Range is 0-1.', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '6 participants were withdrawn after the baseline visit.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Treatment Group 1', 'description': "Treatment Group 1 will receive a standard educational booklet, a clinical oral health evaluation and a smart electronic toothbrush with no instruction on oral hygiene technique. The study coordinator will download the toothbrush data for data collection. The dental hygienist will observe the participant's normal toothbrushing technique, interdental cleaning procedures and the cleaning of partial dentures. No instruction is provided. The hygienist will provide basic instruction on proper use of the smart electronic toothbrush."}, {'id': 'FG001', 'title': 'Treatment Group 2', 'description': 'Treatment Group 2 will receive a standard educational booklet, a smart electronic toothbrush, a clinical oral health evaluation with tailored instruction on oral hygiene technique and care partner coaching. The study coordinator will download the toothbrush data for data collection. The dental hygienist and interventionist will work together to fulfill the following intervention components: tailored instruction and coaching.'}, {'id': 'FG002', 'title': 'Control Group', 'description': "The Control group will receive a standard educational booklet and a clinical oral health evaluation with no instruction on oral hygiene technique. The dental hygienist will observe the participant's normal toothbrushing technique, interdental cleaning procedures and the cleaning of partial dentures. No instruction is provided."}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '20'}, {'groupId': 'FG002', 'numSubjects': '20'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '17'}, {'groupId': 'FG002', 'numSubjects': '19'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Participants were recruited through the NYU ADRC, Duke Memory Disorders Clinic, and Montefiore CEAD. At NYU and CEAD, potential participants were identified from upcoming appointments, informed about the study by staff, and screened by phone. CEAD collaborators also partnered with community organizations to reach diverse populations. At Duke, participants were identified via electronic medical records, sent a letter, and contacted by a coordinator for phone screening.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}, {'value': '60', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Treatment Group 1', 'description': "Treatment Group 1 will receive a standard educational booklet, a clinical oral health evaluation and a smart electronic toothbrush with no instruction on oral hygiene technique. The study coordinator will download the toothbrush data for data collection. The dental hygienist will observe the participant's normal toothbrushing technique, interdental cleaning procedures and the cleaning of partial dentures. No instruction is provided. The hygienist will provide basic instruction on proper use of the smart electronic toothbrush."}, {'id': 'BG001', 'title': 'Treatment Group 2', 'description': 'Treatment Group 2 will receive a standard educational booklet, a smart electronic toothbrush, a clinical oral health evaluation with tailored instruction on oral hygiene technique and care partner coaching. The study coordinator will download the toothbrush data for data collection. The dental hygienist and interventionist will work together to fulfill the following intervention components: tailored instruction and coaching.'}, {'id': 'BG002', 'title': 'Control Group', 'description': "The Control group will receive a standard educational booklet and a clinical oral health evaluation with no instruction on oral hygiene technique. The dental hygienist will observe the participant's normal toothbrushing technique, interdental cleaning procedures and the cleaning of partial dentures. No instruction is provided."}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '75.05', 'spread': '6.61', 'groupId': 'BG000'}, {'value': '74.65', 'spread': '6.43', 'groupId': 'BG001'}, {'value': '76.35', 'spread': '6.77', 'groupId': 'BG002'}, {'value': '75.35', 'spread': '6.53', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '27', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '33', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Race/ethnicity', 'categories': [{'title': 'Hispanic', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}]}, {'title': 'Non-Hispanic Black', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '11', 'groupId': 'BG003'}]}, {'title': 'Non-Hispanic White', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}, {'value': '45', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Plaque Index', 'classes': [{'categories': [{'measurements': [{'value': '0.62', 'spread': '0.32', 'groupId': 'BG000'}, {'value': '0.60', 'spread': '0.25', 'groupId': 'BG001'}, {'value': '0.54', 'spread': '0.32', 'groupId': 'BG002'}, {'value': '0.59', 'spread': '0.31', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'UNC Modified Green and Vermillion Oral Hygiene Index. The index value is the proportion of sites with plaque deposits.', 'unitOfMeasure': 'Proportion of sites with plaque deposits', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Gingival Index', 'classes': [{'categories': [{'measurements': [{'value': '0.68', 'spread': '0.34', 'groupId': 'BG000'}, {'value': '0.59', 'spread': '0.38', 'groupId': 'BG001'}, {'value': '0.52', 'spread': '0.37', 'groupId': 'BG002'}, {'value': '0.60', 'spread': '0.36', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'UNC Modified Loe and Silness Gingival Index. The index value is the proportion of sites with inflammation.', 'unitOfMeasure': 'Proportion of sites with inflammation', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Frequency of Toothbrushing', 'classes': [{'categories': [{'title': '< Twice a day', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '22', 'groupId': 'BG003'}]}, {'title': '>= Twice a day', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '38', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Duration of Toothbrushing', 'classes': [{'categories': [{'title': '>= 2 minutes', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '18', 'groupId': 'BG003'}]}, {'title': '>= 1 min & < 2 minutes', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '26', 'groupId': 'BG003'}]}, {'title': '< 1 minute', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '16', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Frequency of interdental cleaning', 'classes': [{'categories': [{'title': 'Twice a day or more', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '16', 'groupId': 'BG003'}]}, {'title': 'Once a day', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}]}, {'title': 'Several times a week', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}]}, {'title': 'Once or less than once a week', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}]}, {'title': 'Hardly ever', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}]}, {'title': 'Never', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}]}, {'title': 'Unknown', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Interproximal cleaning technique', 'classes': [{'categories': [{'title': 'Less than optimal', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '45', 'groupId': 'BG003'}]}, {'title': 'Optimal', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '15', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Oral health knowledge score', 'classes': [{'categories': [{'measurements': [{'value': '0.66', 'spread': '0.19', 'groupId': 'BG000'}, {'value': '0.65', 'spread': '0.18', 'groupId': 'BG001'}, {'value': '0.68', 'spread': '0.15', 'groupId': 'BG002'}, {'value': '0.66', 'spread': '0.18', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Oral health hygiene score', 'classes': [{'categories': [{'measurements': [{'value': '2.18', 'spread': '0.41', 'groupId': 'BG000'}, {'value': '1.88', 'spread': '0.43', 'groupId': 'BG001'}, {'value': '1.82', 'spread': '0.53', 'groupId': 'BG002'}, {'value': '1.96', 'spread': '0.46', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2024-09-25', 'size': 883184, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-08-21T14:43', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '3 Groups - 2 Treatment Groups, 1 Control Group'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-10-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2024-03-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-12-02', 'studyFirstSubmitDate': '2020-05-14', 'resultsFirstSubmitDate': '2025-09-02', 'studyFirstSubmitQcDate': '2020-05-14', 'lastUpdatePostDateStruct': {'date': '2025-12-09', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2025-11-14', 'studyFirstPostDateStruct': {'date': '2020-05-18', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-11-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2024-03-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Plaque Index', 'timeFrame': '3 months', 'description': 'UNC Modified Green and Vermillion Oral Hygiene Index. Plaque was measured per tooth, 0 = No plaque, 1 = Plaque covers \\<1/3 tooth, 2 = Plaque covers \\>=1/3 but \\<2/3 tooth and 3 = Plaque covers \\>=2/3 tooth. The index values were calculated as the proportion of sites with plaque deposits on at least less than 1/3 of crown. The index value is the proportion of sites with plaque deposits. Higher index values indicate higher levels of plaque.'}, {'measure': 'Gingival Index', 'timeFrame': '3 months', 'description': 'UNC Modified Loe and Silness Gingival Index Gingival inflammation is evaluated per tooth, classified as 0 = Normal gingiva, 1 = Mild inflammation, no bleeding on probing, 2 = Moderate inflammation, bleeding on probing, 3 = Severe inflammation, tendency to spontaneous bleeding. Index values were calculated as the proportion of sites with at least some mild inflammation. The index value is the proportion of sites with inflammation. Higher index values indicate greater gingival inflammation.'}, {'measure': 'Plaque Index', 'timeFrame': '6 months', 'description': 'UNC Modified Green and Vermillion Oral Hygiene Index. Plaque was measured per tooth, 0 = No plaque, 1 = Plaque covers \\<1/3 tooth, 2 = Plaque covers \\>=1/3 but \\<2/3 tooth and 3 = Plaque covers \\>=2/3 tooth. The index values were calculated as the proportion of sites with plaque deposits on at least less than 1/3 of crown. The index value is the proportion of sites with plaque deposits. Higher index values indicate higher levels of plaque.'}, {'measure': 'Gingival Index', 'timeFrame': '6 months', 'description': 'UNC Modified Loe and Silness Gingival Index Gingival inflammation is evaluated per tooth, classified as 0 = Normal gingiva, 1 = Mild inflammation, no bleeding on probing, 2 = Moderate inflammation, bleeding on probing, 3 = Severe inflammation, tendency to spontaneous bleeding. Index values were calculated as the proportion of sites with at least some mild inflammation. The index value is the proportion of sites with inflammation. Higher index values indicate greater gingival inflammation.'}], 'secondaryOutcomes': [{'measure': 'Frequency of Toothbrushing', 'timeFrame': '3 months', 'description': "Participants' frequency toothbrushing Categorical variable with the following response types: 'Less than Twice a Day' or 'Twice a Day or more'."}, {'measure': 'Frequency of Toothbrushing', 'timeFrame': '6 months', 'description': "Participants' frequency toothbrushing Categorical variable with the following response types: 'Less than Twice a Day' or 'Twice a Day or more'."}, {'measure': 'Duration of Toothbrushing', 'timeFrame': '3 months', 'description': "Participants' duration of toothbrushing. Reported by the dental hygienist. Categorical variable consisting of 3 response types (\\< 1minute; \\> 1 minute \\& \\< 2minute; \\> 2 minute per toothbrushing session)."}, {'measure': 'Duration of Toothbrushing', 'timeFrame': '6 months', 'description': "Participants' duration of toothbrushing. Reported by the dental hygienist. Categorical variable consisting of 3 response types (\\< 1minute; \\> 1 minute \\& \\< 2minute; \\> 2 minute per toothbrushing session)."}, {'measure': 'Frequency of Interdental Cleaning', 'timeFrame': '3 months', 'description': "Participants' frequency of interdental cleaning Collected via self-report via care partner. Categorical variable ranging from 'Never' to 'Twice a Day or More'."}, {'measure': 'Frequency of Interdental Cleaning', 'timeFrame': '6 months', 'description': "Participants' frequency of interdental cleaning. Collected via self-report via care partner. Categorical variable ranging from 'Never' to 'Twice a Day or More'."}, {'measure': 'Interproximal Cleaning Technique', 'timeFrame': '3 months', 'description': "Participants' Interproximal Cleaning Technique Reported by the dental hygienist. Categorical variable, with the following response types: 'Less than Optimal' or 'Interproximal Surfaces Cleaned Using 'C' shape'."}, {'measure': 'Interproximal Cleaning Technique', 'timeFrame': '6 months', 'description': "Participants' Interproximal Cleaning Technique. Reported by the dental hygienist. Categorical variable, with the following response types: 'Less than Optimal' or 'Interproximal Surfaces Cleaned Using 'C' shape'."}, {'measure': 'Oral Health Hygiene Score', 'timeFrame': '3 months', 'description': 'Participant Oral Hygiene Skills. Reported by the dental hygienist. Average score on the Oral Hygiene Assessment Sheet of Routine Care Questionnaire. Scores range from 1 to 3. Lower scores indicate higher oral health hygiene.'}, {'measure': 'Oral Health Hygiene Score', 'timeFrame': '6 months', 'description': 'Participant Oral Hygiene Skills. Reported from dental hygienist. Average score on the Oral Hygiene Assessment Sheet of Routine Care Questionnaire. Scores on this scale range from 1 to 3. Lower scores indicate higher oral health hygiene.'}, {'measure': 'Oral Health Knowledge Score', 'timeFrame': '3 months', 'description': 'Participant Oral Health Knowledge Score Scores were calculated as the proportion of correct responses on the Modified Oral Health Knowledge section of the Study Participant Questionnaire. Higher scores indicate greater oral health knowledge. Range is 0-1.'}, {'measure': 'Oral Health Knowledge Score', 'timeFrame': '6 months', 'description': 'Participant Oral Health Knowledge Score Scores were calculated as the proportion of correct responses on the Modified Oral Health Knowledge section of the Study Participant Questionnaire. Higher scores indicate greater oral health knowledge. Range is 0-1.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['oral health', 'oral hygiene', 'dementia', 'care partner', 'periodontal disease'], 'conditions': ['Mild Dementia']}, 'referencesModule': {'references': [{'pmid': '35732396', 'type': 'DERIVED', 'citation': 'Wu B, Plassman BL, Poole P, Siamdoust S, Bunn M, Burwell B, Pei Y, Downey C, Gomes D, Kamer A, Yu G, Leak Bryant A, Anderson RA. Study protocol for a randomised controlled trial of a care partner assisted intervention to improve oral health of individuals with mild dementia. BMJ Open. 2022 Jun 22;12(6):e057099. doi: 10.1136/bmjopen-2021-057099.'}]}, 'descriptionModule': {'briefSummary': "Care Partner Assisted Intervention to Improve Oral Health for Individuals with Mild Dementia is a randomized control trial (RCT) based in New York City and North Carolina. The intervention includes both a tailored oral care plan and a behavioral component using the Adaptive Leadership Framework for Chronic Illness that the team introduced to manage symptoms associated with chronic conditions, such as dementia. Objective 1 is to evaluate the efficacy of an intervention to improve oral hygiene clinical outcomes (i.e. plaque index and gingival index) by improving oral hygiene behavior (i.e., frequency and duration of toothbrushing) and oral health skills among individuals with mild dementia. Objective 2A is to determine whether effects of the intervention on oral hygiene behavioral outcomes, are mediated by the following variables from the care partners' perspective: 1) oral care self-efficacy; 2) care partner self-efficacy; 3) use of cueing methods; 4) and FOCUSED Communication. Objective 2B is to determine whether effects of the intervention on oral hygiene clinical outcomes, are mediated by the following variables from the care partner's perspective: 1) oral care self-efficacy; 2) care partner's self-efficacy; 3) use of cueing methods; 4) and FOCUSED Communication. Objective 3A is to determine whether effects of the intervention on oral hygiene clinical outcomes are mediated by oral hygiene behavioral outcomes. Objective 3B is to determine whether effects of the intervention on oral hygiene clinical outcomes are mediated by the care partner's factors, which then mediate the oral hygiene behavioral outcomes on oral hygiene clinical outcomes. This innovative care partner-assisted oral care behavior intervention will assist participants and care partners in implementing a cooperative oral hygiene care plan to prevent deterioration of oral health, which in turn, will help the targeted population maintain independence in completing daily activities and quality of life for an extended period of time.", 'detailedDescription': 'Dyads that each consist of an individual with mild dementia and his/her care partner will be enrolled at two sites, Duke University in Durham, North Carolina and New York University in New York, New York. This is an unblinded, randomized trial to assess the acceptability and effectiveness of the oral health intervention among individuals with mild dementia (MD). The study will utilize qualitative and quantitative methods to learn about the oral health outcomes in individuals with mild dementia.\n\nThe study lasts 6 months. The first three months is the active intervention phase in which coaching and educational modules are delivered. The second three months is the maintenance period in which no coaching or educational modules are presented to participants. As a team, the study coordinator, the oral health evaluator (a dental hygienist), and the interventionist will conduct three visits with the participants and their care partners; baseline, 3-month (end of the active intervention phase), and 6-month (end of three-month maintenance phase).\n\nThe intervention protocol will include three groups; two treatment groups and one control group. All participants will receive oral health education material at the baseline visit. Treatment Group 1 and Treatment Group 2 will be given a smart electronic toothbrush. Only Treatment Group 2 will receive the in-home and telephone coaching throughout the duration of the study and will be instructed to record daily brushing habits. The coaching sessions include individualized instruction on oral hygiene technique, cueing strategy development, or oral hygiene monitoring and coaching. Treatment Group 1 and the Control Group will not receive the coaching sessions.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '60 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* a diagnosis of mild dementia\n* have at least 4 natural teeth\n* 60 years and older\n* living with an informal caregiver (i.e. care partner) who is age 18 or older and is willing to participate in the intervention\n* community-dwelling and physically able to brush own teeth\n* We will use the following guidelines to identify those with mild dementia: a) a diagnosis of dementia by a physician with dementia expertise within the past year, b) from medical records, a recent Montreal Cognitive Assessment (MoCA) score \\> 14 or a Mini-Mental Status Examination (MMSE) score \\> 16, and c) can follow 2 to 3-step commands\n\nExclusion Criteria:\n\n* unable to have an oral health evaluation\n* prescribed antibiotics prior to a regular dental visit\n* has sensory or physical problems that prevent participation in the intervention\n* has a terminal illness or behavioral or psychiatric disorder that would interfere with participation in the intervention\n* has a medical condition such as serious congenital heart conditions, previous infective endocarditis, prosthetic cardiac valves, and cardiac transplantation with cardiac valvulopathy that places him/her at greater risk of infection from the manipulation of the gums to measure the gingival index\n* has a medical condition that suppresses the immune system\n* has had a total joint replacement and has had an infection in the replaced joint\n* is at increased risk of bleeding due to bleeding disorder such as hemophilia or the use of anti-platelet therapy'}, 'identificationModule': {'nctId': 'NCT04390750', 'briefTitle': 'Care Partner Assisted Intervention to Improve Oral Health of Individuals With Mild Dementia', 'organization': {'class': 'OTHER', 'fullName': 'New York University'}, 'officialTitle': 'Care Partner Assisted Intervention to Improve Oral Health of Individuals With Mild Dementia', 'orgStudyIdInfo': {'id': '18-068-E'}, 'secondaryIdInfos': [{'id': 'U01DE027512', 'link': 'https://reporter.nih.gov/quickSearch/U01DE027512', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Treatment Group 1', 'description': "Treatment Group 1 will receive a standard educational booklet, a clinical oral health evaluation and a smart electronic toothbrush with no instruction on oral hygiene technique. The study coordinator will download the toothbrush data for data collection. The dental hygienist will observe the participant's normal toothbrushing technique, interdental cleaning procedures and the cleaning of partial dentures. No instruction is provided. The hygienist will provide basic instruction on proper use of the smart electronic toothbrush."}, {'type': 'EXPERIMENTAL', 'label': 'Treatment Group 2', 'description': 'Treatment Group 2 will receive a standard educational booklet, a smart electronic toothbrush, a clinical oral health evaluation with tailored instruction on oral hygiene technique and care partner coaching. The study coordinator will download the toothbrush data for data collection. The dental hygienist and interventionist will work together to fulfill the following intervention components: tailored instruction and coaching.', 'interventionNames': ['Behavioral: Care Partner-Assisted Intervention']}, {'type': 'NO_INTERVENTION', 'label': 'Control Group', 'description': "The Control group will receive a standard educational booklet and a clinical oral health evaluation with no instruction on oral hygiene technique. The dental hygienist will observe the participant's normal toothbrushing technique, interdental cleaning procedures and the cleaning of partial dentures. No instruction is provided."}], 'interventions': [{'name': 'Care Partner-Assisted Intervention', 'type': 'BEHAVIORAL', 'description': 'Tailored teaching and coaching', 'armGroupLabels': ['Treatment Group 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10010', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'New York City (Participants Homes)', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '27708', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'North Carolina (Participants Homes)', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}], 'overallOfficials': [{'name': 'Bei Wu, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'New York University'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ANALYTIC_CODE'], 'timeFrame': 'Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.', 'ipdSharing': 'YES', 'description': 'The de-identified individual participant data collected during the trial will be shared between 9 months and 36 months following article publication or as required by a condition of awards and agreements supporting the research, for researchers who provide a methodologically sound proposal. Data will be made available at https://www.icpsr.umich.edu/web/pages (Note: a specific link will be provided after the study is published/when the DOI is obtained.) The protocol, statistical analysis plan, and analytic code will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.', 'accessCriteria': 'Data will be made available at Clinicaltrials.gov and ICPSR (a specific link will be provided after the study is published/when the DOI is obtained).'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'New York University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Duke University', 'class': 'OTHER'}, {'name': 'University of North Carolina, Chapel Hill', 'class': 'OTHER'}, {'name': 'NYU Langone Health', 'class': 'OTHER'}, {'name': 'National Institute of Dental and Craniofacial Research (NIDCR)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}