Ignite Creation Date:
2025-12-26 @ 12:16 PM
Ignite Modification Date:
2026-03-17 @ 3:30 AM
Study NCT ID:
NCT02207400
Status:
COMPLETED
Last Update Posted:
2018-07-31
First Post:
2014-07-21
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
To Evaluate Efficacy and Tolerability of Sodium Bicarbonate Toothpaste and Its Effect on Opportunistic or Resistant Organisms
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D017693', 'term': 'Sodium Bicarbonate'}, {'id': 'D012969', 'term': 'Sodium Fluoride'}], 'ancestors': [{'id': 'D001639', 'term': 'Bicarbonates'}, {'id': 'D002254', 'term': 'Carbonates'}, {'id': 'D002255', 'term': 'Carbonic Acid'}, {'id': 'D017554', 'term': 'Carbon Compounds, Inorganic'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}, {'id': 'D005459', 'term': 'Fluorides'}, {'id': 'D006858', 'term': 'Hydrofluoric Acid'}, {'id': 'D017611', 'term': 'Fluorine Compounds'}, {'id': 'D002327', 'term': 'Cariostatic Agents'}, {'id': 'D001697', 'term': 'Biomedical and Dental Materials'}, {'id': 'D008420', 'term': 'Manufactured Materials'}, {'id': 'D013676', 'term': 'Technology, Industry, and Agriculture'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '866-435-7343', 'title': 'GSK Response Center', 'organization': 'GlaxoSmithKline'}, 'certainAgreement': {'otherDetails': 'GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were collected throughout the study from the start of the washout period, until five days following last treatment.', 'eventGroups': [{'id': 'EG000', 'title': 'Sodium Bicarbonate and Sodium Fluoride Dentifrice', 'description': 'Experimental toothpaste containing sodium bicarbonate experimental dentifrice plus 1150 ppm fluoride as sodium fluoride', 'otherNumAtRisk': 123, 'otherNumAffected': 17, 'seriousNumAtRisk': 123, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Sodium Fluoride Dentifrice', 'description': 'Toothpaste containing 1100 ppm fluoride as sodium fluoride', 'otherNumAtRisk': 123, 'otherNumAffected': 14, 'seriousNumAtRisk': 123, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Cellulitis Orbital', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 123, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Lower Respiratory Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 123, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 123, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Acute sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 123, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'GASTROENTERITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 123, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'PHARYNGITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 123, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'PHARYNGITIS STREPTOCOCCAL', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 123, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'PULPITIS DENTAL', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 123, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'SINUSITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 123, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'STAPHYLOCOCCAL INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 123, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'TOOTH ABSCESS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 123, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'MOUTH INJURY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 123, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'TRAUMATIC ULCER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 123, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'ARTHROPOD BITE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 123, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'THERMAL BURN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 123, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'CHEILITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 123, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'SENSITIVITY OF TEETH', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 123, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'APHTHOUS STOMATITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 123, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'DIARRHOEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 123, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'GINGIVAL ULCERATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 123, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'MOUTH ULCERATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 123, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'TONGUE ULCERATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 123, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'HYPOTHYROIDISM', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 123, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'BURNING SENSATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 123, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'PULMONARY CONGESTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 123, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'INGROWING NAIL', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 123, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'GASTROENTERITIS VIRAL', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 123, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Gingival Bleeding Sites at 24 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '118', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sodium Bicarbonate and Sodium Fluoride Dentifrice', 'description': 'Experimental dentifrice containing sodium bicarbonate plus 1150 parts per million (ppm) fluoride as sodium fluoride'}, {'id': 'OG001', 'title': 'Sodium Fluoride Dentifrice', 'description': 'Toothpaste containing 1100 ppm fluoride as sodium fluoride'}], 'classes': [{'categories': [{'measurements': [{'value': '13.24', 'spread': '7.663', 'groupId': 'OG000'}, {'value': '24.90', 'spread': '9.044', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-11.612', 'ciLowerLimit': '-13.191', 'ciUpperLimit': '-10.033', 'estimateComment': 'Difference is Sodium Bicarbonate and Sodium Fluoride Dentifrice minus Sodium Fluoride Dentifrice such that a negative difference favors the first named treatment.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': '24 weeks', 'description': 'The Bleeding Index was performed by a single examiner using a color coded periodontal probe. The probe was engaged approximately 1 millimetre (mm) into the gingival crevice. A moderate pressure was used whilst sweeping from interproximal to interproximal along the sulcular epithelium. The BI scoring system used is as follows: 0= No bleeding after 30 seconds; 1= Bleeding upon probing after 30 seconds; 2= Immediate bleeding observed', 'unitOfMeasure': 'Number of bleeding sites', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population defined as those participants who had received study treatment and had at least one post-baseline efficacy measurement.'}, {'type': 'PRIMARY', 'title': 'Modified Gingival Index (MGI) at 24 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '118', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sodium Bicarbonate and Sodium Fluoride Dentifrice', 'description': 'Experimental dentifrice containing sodium bicarbonate plus 1150 ppm fluoride as sodium fluoride'}, {'id': 'OG001', 'title': 'Sodium Fluoride Dentifrice', 'description': 'Toothpaste containing 1100 ppm fluoride as sodium fluoride'}], 'classes': [{'categories': [{'measurements': [{'value': '1.26', 'spread': '0.505', 'groupId': 'OG000'}, {'value': '1.93', 'spread': '0.408', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.652', 'ciLowerLimit': '-0.738', 'ciUpperLimit': '-0.566', 'estimateComment': 'Difference is Sodium Bicarbonate and Sodium Fluoride Dentifrice minus Sodium Fluoride Dentifrice such that a negative difference favors the first named treatment.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': '24 weeks', 'description': 'MGI was assessed on facial and lingual surfaces at two sites on each tooth (papillae and margin). The scoring of the MGI was performed under dental office conditions using a standard dental light for illuminating the oral cavity. Compressed air, water and mouth mirrors were available to each examiner. This procedure was performed by a single examiner. The MGI scoring system is as follows: 0 = absence of inflammation; 1 = mild inflammation; slight change in color, little change in color; little change in texture of any portion of the marginal or papillary gingival unit; 2 = mild inflammation; criteria as above but involving the entire marginal or papillar gingival units; 3= moderate inflammation; glazing, redness, edema, and/ or hypertrophy of the marginal or papillary gingival unit; 4 = severe inflammation; marked redness, edema and/or hypertrophy of the marginal or papillary gingival unit, spontaneous bleeding, congestion, or ulceration', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population defined as those participants who had received study treatment and had at least one post-baseline efficacy measurement.'}, {'type': 'SECONDARY', 'title': 'Number of Gingival Bleeding Sites at 6 and 12 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '118', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sodium Bicarbonate and Sodium Fluoride Dentifrice', 'description': 'Experimental dentifrice containing sodium bicarbonate plus 1150 ppm fluoride as sodium fluoride'}, {'id': 'OG001', 'title': 'Sodium Fluoride Dentifrice', 'description': 'Toothpaste containing 1100 ppm fluoride as sodium fluoride'}], 'classes': [{'title': 'Number of Bleeding Sites at Baseline', 'categories': [{'measurements': [{'value': '29.76', 'spread': '8.238', 'groupId': 'OG000'}, {'value': '29.05', 'spread': '8.390', 'groupId': 'OG001'}]}]}, {'title': 'Number of Bleeding Sites at 6 weeks', 'categories': [{'measurements': [{'value': '12.26', 'spread': '9.339', 'groupId': 'OG000'}, {'value': '23.23', 'spread': '10.993', 'groupId': 'OG001'}]}]}, {'title': 'Number of Bleeding Sites at 12 weeks', 'categories': [{'measurements': [{'value': '15.73', 'spread': '7.632', 'groupId': 'OG000'}, {'value': '23.86', 'spread': '9.265', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 6 and 12 weeks', 'description': 'BI was performed by a single examiner using a color coded periodontal probe. The probe was engaged approximately 1mm into the gingival crevice. A moderate pressure was used whilst sweeping from interproximal to interproximal along the sulcular epithelium. The BI scoring system used is as follows: 0= No bleeding after 30 seconds; 1= Bleeding upon probing after 30 seconds; 2= Immediate bleeding observed', 'unitOfMeasure': 'Number of bleeding sites', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population defined as those participants who had received study treatment and had at least one post-baseline efficacy measurement.'}, {'type': 'SECONDARY', 'title': 'Modified Gingival Index (MGI)) at 6 and 12 Weeks.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '118', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sodium Bicarbonate and Sodium Fluoride Dentifrice', 'description': 'Experimental dentifrice containing sodium bicarbonate plus 1150 ppm fluoride as sodium fluoride'}, {'id': 'OG001', 'title': 'Sodium Fluoride Dentifrice', 'description': 'Toothpaste containing 1100 ppm fluoride as sodium fluoride'}], 'classes': [{'title': 'MGI at 6 weeks', 'categories': [{'measurements': [{'value': '1.50', 'spread': '0.567', 'groupId': 'OG000'}, {'value': '1.96', 'spread': '0.427', 'groupId': 'OG001'}]}]}, {'title': 'MGI at 12 weeks', 'categories': [{'measurements': [{'value': '1.50', 'spread': '0.536', 'groupId': 'OG000'}, {'value': '1.94', 'spread': '0.464', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 and 12 weeks', 'description': 'MGI was assessed on facial and lingual surfaces at two sites on each tooth (papillae and margin). The scoring of the MGI was performed under dental office conditions using a standard dental light for illuminating the oral cavity. Compressed air, water and mouth mirrors were available to each examiner. This procedure was performed by a single examiner. The MGI scoring system is as follows: 0 = absence of inflammation; 1 = mild inflammation; slight change in color, little change in color; little change in texture of any portion of the marginal or papillary gingival unit; 2 = mild inflammation; criteria as above but involving the entire marginal or papillar gingival units; 3= moderate inflammation; glazing, redness, edema, and/ or hypertrophy of the marginal or papillary gingival unit; 4 = severe inflammation; marked redness, edema and/or hypertrophy of the marginal or papillary gingival unit, spontaneous bleeding, congestion, or ulceration', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population defined as those participants who had received study treatment and had at least one post-baseline efficacy measurement.'}, {'type': 'SECONDARY', 'title': 'Bleeding Index (BI) at 6, 12 and 24 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '118', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sodium Bicarbonate and Sodium Fluoride Dentifrice', 'description': 'Experimental dentifrice containing sodium bicarbonate plus 1150 ppm fluoride as sodium fluoride'}, {'id': 'OG001', 'title': 'Sodium Fluoride Dentifrice', 'description': 'Toothpaste containing 1100 ppm fluoride as sodium fluoride'}], 'classes': [{'title': 'BI Score Score at 6 weeks', 'categories': [{'measurements': [{'value': '0.15', 'spread': '0.133', 'groupId': 'OG000'}, {'value': '0.30', 'spread': '0.172', 'groupId': 'OG001'}]}]}, {'title': 'BI Score Score at 12 weeks', 'categories': [{'measurements': [{'value': '0.19', 'spread': '0.112', 'groupId': 'OG000'}, {'value': '0.28', 'spread': '0.135', 'groupId': 'OG001'}]}]}, {'title': 'BI Score Score at 24 weeks', 'categories': [{'measurements': [{'value': '0.17', 'spread': '0.116', 'groupId': 'OG000'}, {'value': '0.31', 'spread': '0.159', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6, 12 and 24 weeks', 'description': 'BI was performed by a single examiner using a color coded periodontal probe. The probe was engaged approximately 1mm into the gingival crevice. A moderate pressure was used whilst sweeping from interproximal to interproximal along the sulcular epithelium. The BI scoring system used is as follows: 0= No bleeding after 30 seconds; 1= Bleeding upon probing after 30 seconds; 2= Immediate bleeding observed', 'unitOfMeasure': 'Units on a Scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population defined as those participants who had received study treatment and had at least one post-baseline efficacy measurement.'}, {'type': 'SECONDARY', 'title': 'Plaque Control (Overall and Interproximal Dental Plaque Scores) at 6, 12 and 24 Weeks.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '118', 'groupId': 'OG000'}, {'value': '112', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sodium Bicarbonate and Sodium Fluoride Dentifrice', 'description': 'Experimental toothpaste containing sodium bicarbonate experimental dentifrice plus 1150 ppm fluoride as sodium fluoride'}, {'id': 'OG001', 'title': 'Sodium Fluoride Dentifrice', 'description': 'Toothpaste containing 1100 ppm fluoride as sodium fluoride'}], 'classes': [{'title': 'Overall Plaque Score at 6 weeks', 'categories': [{'measurements': [{'value': '2.56', 'spread': '0.536', 'groupId': 'OG000'}, {'value': '3.01', 'spread': '0.411', 'groupId': 'OG001'}]}]}, {'title': 'Overall Plaque Score at 12 weeks', 'categories': [{'measurements': [{'value': '2.54', 'spread': '0.495', 'groupId': 'OG000'}, {'value': '2.90', 'spread': '0.374', 'groupId': 'OG001'}]}]}, {'title': 'Overall Plaque Score at 24 weeks', 'categories': [{'measurements': [{'value': '2.47', 'spread': '0.437', 'groupId': 'OG000'}, {'value': '2.92', 'spread': '0.399', 'groupId': 'OG001'}]}]}, {'title': 'Interproximal Plaque Score at 6 weeks', 'categories': [{'measurements': [{'value': '2.78', 'spread': '0.492', 'groupId': 'OG000'}, {'value': '3.19', 'spread': '0.351', 'groupId': 'OG001'}]}]}, {'title': 'Interproximal Plaque Score at 12 weeks', 'categories': [{'measurements': [{'value': '2.76', 'spread': '0.437', 'groupId': 'OG000'}, {'value': '3.10', 'spread': '0.311', 'groupId': 'OG001'}]}]}, {'title': 'Interproximal Plaque Score at 24 weeks', 'categories': [{'measurements': [{'value': '2.71', 'spread': '0.390', 'groupId': 'OG000'}, {'value': '3.11', 'spread': '0.336', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6, 12 and 24 weeks', 'description': 'The dental examiner had used the Turesky Modification of the Quigley Hein Index to assess plaque on all gradable teeth. Interproximal Dental Plaque Scores were analyzed in the same way as for Overall scores but just based on mesiofacial, facial, distofacial, mesiolingual, lingual and distolingual surfaces. Dental Plaque (Quigley-Hein, Turesky Modification Index) Units on a scale 0 to 5: 0= No plaque; 1= Slight flecks of plaque at the cervical margin of the tooth; 2= A thin continuous band of plaque (1 mm or smaller) at the cervical margin of the tooth; 3= A band of plaque wider than 1 mm but covering less than 1/3 of the crown of the tooth; 4= Plaque covering at least 1/3 but less than 2/3 of the crown of the tooth; 5= Plaque covering 2/3 or more of the crown of the tooth.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population defined as those participants who had received study treatment and had at least one post-baseline efficacy measurement.'}, {'type': 'SECONDARY', 'title': 'Bacterial Count at Baseline, After 6, 12, 24 and 32 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '118', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sodium Bicarbonate and Sodium Fluoride Dentifrice', 'description': 'Experimental toothpaste containing sodium bicarbonate experimental dentifrice plus 1150 ppm)fluoride as sodium fluoride'}, {'id': 'OG001', 'title': 'Sodium Fluoride Dentifrice', 'description': 'Toothpaste containing 1100 ppm fluoride as sodium fluoride'}], 'classes': [{'title': 'Staph Count at Baseline (n=24, 26)', 'categories': [{'measurements': [{'value': '0.2', 'spread': '0.82', 'groupId': 'OG000'}, {'value': '0.2', 'spread': '0.86', 'groupId': 'OG001'}]}]}, {'title': 'Steph Count at 6 weeks (n=24, 26)', 'categories': [{'measurements': [{'value': '0.1', 'spread': '0.34', 'groupId': 'OG000'}, {'value': '0', 'spread': '0.20', 'groupId': 'OG001'}]}]}, {'title': 'Steph Count at 12 weeks (n=24, 26)', 'categories': [{'measurements': [{'value': '1.8', 'spread': '7.10', 'groupId': 'OG000'}, {'value': '3.2', 'spread': '15.47', 'groupId': 'OG001'}]}]}, {'title': 'Steph Count at 24 weeks (n=23, 25)', 'categories': [{'measurements': [{'value': '0.6', 'spread': '1.59', 'groupId': 'OG000'}, {'value': '0.2', 'spread': '0.37', 'groupId': 'OG001'}]}]}, {'title': 'Steph Count at 32 weeks (n=21, 21)', 'categories': [{'measurements': [{'value': '0.2', 'spread': '0.51', 'groupId': 'OG000'}, {'value': '0.1', 'spread': '0.36', 'groupId': 'OG001'}]}]}, {'title': 'Yeast Count at Baseline (n=24, 26)', 'categories': [{'measurements': [{'value': '203.4', 'spread': '842.28', 'groupId': 'OG000'}, {'value': '647.8', 'spread': '2958.78', 'groupId': 'OG001'}]}]}, {'title': 'Yeast Count at 6 weeks (n=23, 26)', 'categories': [{'measurements': [{'value': '287.3', 'spread': '1014.31', 'groupId': 'OG000'}, {'value': '784.3', 'spread': '1796.75', 'groupId': 'OG001'}]}]}, {'title': 'Yeast Count at 12 weeks (n=24, 25)', 'categories': [{'measurements': [{'value': '668.9', 'spread': '812.81', 'groupId': 'OG000'}, {'value': '411.3', 'spread': '906.19', 'groupId': 'OG001'}]}]}, {'title': 'Yeast Count at 24 weeks (n=17, 22)', 'categories': [{'measurements': [{'value': '1479.6', 'spread': '1165.48', 'groupId': 'OG000'}, {'value': '1522.3', 'spread': '1008.13', 'groupId': 'OG001'}]}]}, {'title': 'Yeast Count at 32 weeks (n= 14, 14)', 'categories': [{'measurements': [{'value': '2743.5', 'spread': '2505.75', 'groupId': 'OG000'}, {'value': '1206.4', 'spread': '1008.34', 'groupId': 'OG001'}]}]}, {'title': 'Coliform count at Baseline (n= 24, 26)', 'categories': [{'measurements': [{'value': '3.9', 'spread': '8.82', 'groupId': 'OG000'}, {'value': '3.8', 'spread': '8.27', 'groupId': 'OG001'}]}]}, {'title': 'Coliform count at 6 weeks (n= 24, 26)', 'categories': [{'measurements': [{'value': '2.6', 'spread': '6.72', 'groupId': 'OG000'}, {'value': '5.7', 'spread': '20.05', 'groupId': 'OG001'}]}]}, {'title': 'Coliform count at 12 weeks (n= 24, 26)', 'categories': [{'measurements': [{'value': '10.9', 'spread': '14.65', 'groupId': 'OG000'}, {'value': '26.9', 'spread': '78.47', 'groupId': 'OG001'}]}]}, {'title': 'Coliform count at 24 weeks (n=23, 25)', 'categories': [{'measurements': [{'value': '8.1', 'spread': '16.86', 'groupId': 'OG000'}, {'value': '12.6', 'spread': '19.24', 'groupId': 'OG001'}]}]}, {'title': 'Coliform count at 32 weeks (n=21, 21)', 'categories': [{'measurements': [{'value': '10.9', 'spread': '16.17', 'groupId': 'OG000'}, {'value': '17.8', 'spread': '29.84', 'groupId': 'OG001'}]}]}, {'title': 'E. Coli count at Baseline (n=24, 26)', 'categories': [{'measurements': [{'value': '0', 'spread': '0', 'groupId': 'OG000'}, {'value': '0', 'spread': '0.20', 'groupId': 'OG001'}]}]}, {'title': 'E. Coli count at 6 weeks (n=24, 26)', 'categories': [{'measurements': [{'value': '0.1', 'spread': '0.28', 'groupId': 'OG000'}, {'value': '0', 'spread': '0.20', 'groupId': 'OG001'}]}]}, {'title': 'E. Coli count at 12 weeks (n=24, 26)', 'categories': [{'measurements': [{'value': '0.1', 'spread': '0.28', 'groupId': 'OG000'}, {'value': '0', 'spread': '0', 'groupId': 'OG001'}]}]}, {'title': 'E. Coli count at 24 weeks (n=23, 25)', 'categories': [{'measurements': [{'value': '0.3', 'spread': '1.25', 'groupId': 'OG000'}, {'value': '0.2', 'spread': '0.55', 'groupId': 'OG001'}]}]}, {'title': 'E. Coli count at 32 weeks (n=21, 21)', 'categories': [{'measurements': [{'value': '0.6', 'spread': '1.29', 'groupId': 'OG000'}, {'value': '0', 'spread': '0.22', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 6, 12, 24 and 32 weeks', 'description': "Microbiological samples were collected at baseline, 6 weeks, 12 weeks, 24 weeks and 32 weeks. Plaque was harvested from contra-lateral 1st molar teeth, where no restorations are present, using a sterile paper point. The paper point was immersed into 4 ml of Calgon Ringer's solution in a sterile bijou and kept on ice until they can be taken to the laboratory for processing (within 24 hours).", 'unitOfMeasure': 'colony forming units per sample', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population defined as those participants who had received study treatment and had at least one post-baseline efficacy measurement.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Sodium Bicarbonate and Sodium Fluoride Dentifrice', 'description': 'Experimental toothpaste containing sodium bicarbonate experimental dentifrice plus 1150 parts per million (ppm) fluoride as sodium fluoride'}, {'id': 'FG001', 'title': 'Sodium Fluoride Dentifrice', 'description': 'Toothpaste containing 1100 ppm fluoride as sodium fluoride'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '123'}, {'groupId': 'FG001', 'numSubjects': '123'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '107'}, {'groupId': 'FG001', 'numSubjects': '109'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '14'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Positive Urine Pregnancy Test', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'The participants were recruited at a clinical site in the USA.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '123', 'groupId': 'BG000'}, {'value': '123', 'groupId': 'BG001'}, {'value': '246', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Sodium Bicarbonate and Sodium Fluoride Dentifrice', 'description': 'Experimental toothpaste containing sodium bicarbonate experimental dentifrice plus 1150 parts per million (ppm) fluoride as sodium fluoride'}, {'id': 'BG001', 'title': 'Sodium Fluoride Dentifrice', 'description': 'Toothpaste containing 1100 ppm fluoride as sodium fluoride'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '39.39', 'spread': '14.284', 'groupId': 'BG000'}, {'value': '37.77', 'spread': '12.615', 'groupId': 'BG001'}, {'value': '38.58', 'spread': '13.473', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '74', 'groupId': 'BG000'}, {'value': '78', 'groupId': 'BG001'}, {'value': '152', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '49', 'groupId': 'BG000'}, {'value': '45', 'groupId': 'BG001'}, {'value': '94', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 246}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-08-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-07', 'completionDateStruct': {'date': '2015-04-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-07-26', 'studyFirstSubmitDate': '2014-07-21', 'resultsFirstSubmitDate': '2015-12-21', 'studyFirstSubmitQcDate': '2014-07-31', 'lastUpdatePostDateStruct': {'date': '2018-07-31', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2016-06-13', 'studyFirstPostDateStruct': {'date': '2014-08-04', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-07-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-02-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Gingival Bleeding Sites at 24 Weeks', 'timeFrame': '24 weeks', 'description': 'The Bleeding Index was performed by a single examiner using a color coded periodontal probe. The probe was engaged approximately 1 millimetre (mm) into the gingival crevice. A moderate pressure was used whilst sweeping from interproximal to interproximal along the sulcular epithelium. The BI scoring system used is as follows: 0= No bleeding after 30 seconds; 1= Bleeding upon probing after 30 seconds; 2= Immediate bleeding observed'}, {'measure': 'Modified Gingival Index (MGI) at 24 Weeks', 'timeFrame': '24 weeks', 'description': 'MGI was assessed on facial and lingual surfaces at two sites on each tooth (papillae and margin). The scoring of the MGI was performed under dental office conditions using a standard dental light for illuminating the oral cavity. Compressed air, water and mouth mirrors were available to each examiner. This procedure was performed by a single examiner. The MGI scoring system is as follows: 0 = absence of inflammation; 1 = mild inflammation; slight change in color, little change in color; little change in texture of any portion of the marginal or papillary gingival unit; 2 = mild inflammation; criteria as above but involving the entire marginal or papillar gingival units; 3= moderate inflammation; glazing, redness, edema, and/ or hypertrophy of the marginal or papillary gingival unit; 4 = severe inflammation; marked redness, edema and/or hypertrophy of the marginal or papillary gingival unit, spontaneous bleeding, congestion, or ulceration'}], 'secondaryOutcomes': [{'measure': 'Number of Gingival Bleeding Sites at 6 and 12 Weeks', 'timeFrame': 'Baseline, 6 and 12 weeks', 'description': 'BI was performed by a single examiner using a color coded periodontal probe. The probe was engaged approximately 1mm into the gingival crevice. A moderate pressure was used whilst sweeping from interproximal to interproximal along the sulcular epithelium. The BI scoring system used is as follows: 0= No bleeding after 30 seconds; 1= Bleeding upon probing after 30 seconds; 2= Immediate bleeding observed'}, {'measure': 'Modified Gingival Index (MGI)) at 6 and 12 Weeks.', 'timeFrame': '6 and 12 weeks', 'description': 'MGI was assessed on facial and lingual surfaces at two sites on each tooth (papillae and margin). The scoring of the MGI was performed under dental office conditions using a standard dental light for illuminating the oral cavity. Compressed air, water and mouth mirrors were available to each examiner. This procedure was performed by a single examiner. The MGI scoring system is as follows: 0 = absence of inflammation; 1 = mild inflammation; slight change in color, little change in color; little change in texture of any portion of the marginal or papillary gingival unit; 2 = mild inflammation; criteria as above but involving the entire marginal or papillar gingival units; 3= moderate inflammation; glazing, redness, edema, and/ or hypertrophy of the marginal or papillary gingival unit; 4 = severe inflammation; marked redness, edema and/or hypertrophy of the marginal or papillary gingival unit, spontaneous bleeding, congestion, or ulceration'}, {'measure': 'Bleeding Index (BI) at 6, 12 and 24 Weeks', 'timeFrame': '6, 12 and 24 weeks', 'description': 'BI was performed by a single examiner using a color coded periodontal probe. The probe was engaged approximately 1mm into the gingival crevice. A moderate pressure was used whilst sweeping from interproximal to interproximal along the sulcular epithelium. The BI scoring system used is as follows: 0= No bleeding after 30 seconds; 1= Bleeding upon probing after 30 seconds; 2= Immediate bleeding observed'}, {'measure': 'Plaque Control (Overall and Interproximal Dental Plaque Scores) at 6, 12 and 24 Weeks.', 'timeFrame': '6, 12 and 24 weeks', 'description': 'The dental examiner had used the Turesky Modification of the Quigley Hein Index to assess plaque on all gradable teeth. Interproximal Dental Plaque Scores were analyzed in the same way as for Overall scores but just based on mesiofacial, facial, distofacial, mesiolingual, lingual and distolingual surfaces. Dental Plaque (Quigley-Hein, Turesky Modification Index) Units on a scale 0 to 5: 0= No plaque; 1= Slight flecks of plaque at the cervical margin of the tooth; 2= A thin continuous band of plaque (1 mm or smaller) at the cervical margin of the tooth; 3= A band of plaque wider than 1 mm but covering less than 1/3 of the crown of the tooth; 4= Plaque covering at least 1/3 but less than 2/3 of the crown of the tooth; 5= Plaque covering 2/3 or more of the crown of the tooth.'}, {'measure': 'Bacterial Count at Baseline, After 6, 12, 24 and 32 Weeks', 'timeFrame': 'Baseline, 6, 12, 24 and 32 weeks', 'description': "Microbiological samples were collected at baseline, 6 weeks, 12 weeks, 24 weeks and 32 weeks. Plaque was harvested from contra-lateral 1st molar teeth, where no restorations are present, using a sterile paper point. The paper point was immersed into 4 ml of Calgon Ringer's solution in a sterile bijou and kept on ice until they can be taken to the laboratory for processing (within 24 hours)."}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Oral Hygiene']}, 'referencesModule': {'references': [{'pmid': '29758155', 'type': 'DERIVED', 'citation': 'Jose A, Pratten J, Bosma ML, Milleman KR, Milleman JL, Wang N. Six-Month Evaluation of a Sodium Bicarbonate-Containing Toothpaste for Reduction of Established Gingivitis: A Randomized USA-Based Clinical Trial. J Clin Dent. 2018 Mar;29(1):33-39.'}]}, 'descriptionModule': {'briefSummary': 'This study will compare the Gingival Bleeding and Gingival Inflammation following twice daily use of a sodium bicarbonate experimental dentifrice compared to a 0% sodium bicarbonate toothpaste after 24 weeks of use. The study will be conducted at Salus Research, Inc. Participants will be recruited from their database and by use of an external recruitment agency', 'detailedDescription': 'This study will be a single-centre, examiner blind, two treatment, parallel group, stratified (by baseline number of bleeding sites smoking status and bacterial sampling) randomized clinical study. At the screening visit, following provision of written informed consent, eligible participants will be provided with a standard toothpaste and toothbrush for brushing once in at the clinic and for approximately one week use at home until the baseline visit. Participants will be asked to abstain from brushing over a 12 hour period prior to the Baseline visit. At the baseline visit an oral soft tissue (OST) assessment, Modified Gingival Index (MGI) and Bleeding Index (BI), and then dental plaque assessment will be performed. Participants will be stratified according to their baseline number of bleeding sites, smoking status and whether selected for bacterial sampling. Participants will be then randomized into one of two treatment groups. After using, their assigned treatment twice daily at home for 6 weeks (visit 3), 12 weeks (visit 4) and 24 weeks (visit 5), participants will return to the site with overnight plaque at approximately the same time of day as the Baseline visit if possible. Participants will undergo a full OST examination and the recording of any Adverse Events (AEs). Participants will then undergo MGI, BI followed by dental plaque assessment. Microbiological samples will be collected on a subset of 50 participants (Determined by first 50 participants randomized).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Good general health with (in the opinion of the investigator) no clinically significant and relevant abnormalities of medical history or oral/dental examination.\n* A minimum of 20 permanent gradable teeth\n* Moderate gingivitis present at the screening visit in the opinion of the investigator\n* A total of 20 bleeding sites or greater at baseline visit\n* Positive response to bleeding on brushing present at the screening visit\n\nExclusion Criteria:\n\n* Pregnant or breast feeding women\n* Tobacco chewers\n* Current or relevant history of any serious, severe or unstable physical or psychiatric illness or any other medical condition (e.g. Diabetes Mellitus) that would make the participant unlikely to fully complete the study or any that increases the risk to the participant or undermines the data validity.\n* Recent history (within the last year) of alcohol or other substance abuse\n* Participants requiring prophylactic antibiotic treatment prior to dental therapy\n* Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients\n* Have current active caries or any medical conditions which may directly influence gingival bleeding\n* Use of concomitant or any systemic medication that, in the opinion of the investigator, might interfere with the outcome of the study or have an effect on gingival conditions within 14 days of gingival examinations\n* Excessive calculus present that interferes with the probing examination for Gingival Bleeding Index\n* Participation in another clinical study or receipt of an investigational drug or oral care product within 30 days of the screening visit\n* An employee of the sponsor or the study site or members or their immediate family.'}, 'identificationModule': {'nctId': 'NCT02207400', 'briefTitle': 'To Evaluate Efficacy and Tolerability of Sodium Bicarbonate Toothpaste and Its Effect on Opportunistic or Resistant Organisms', 'organization': {'class': 'INDUSTRY', 'fullName': 'GlaxoSmithKline'}, 'officialTitle': 'A Six Month Clinical Study Based in the US to Evaluate the Efficacy and Tolerability of Sodium Bicarbonate Toothpaste and Its Effect on Opportunistic or Resistant Organisms', 'orgStudyIdInfo': {'id': '202193'}, 'secondaryIdInfos': [{'id': 'RH02434', 'type': 'OTHER', 'domain': 'GSK'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental Dentifrice', 'description': 'Participants were advised to brush their teeth with experimental dentifrice containing sodium bicarbonate plus 1150 parts per million (ppm) fluoride as sodium fluoride', 'interventionNames': ['Drug: Sodium bicarbonate and sodium fluoride']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Reference Dentifrice', 'description': 'Participants were advised to brush their teeth with reference dentifrice containing 1100ppm fluoride as sodium fluoride', 'interventionNames': ['Drug: Sodium fluoride']}], 'interventions': [{'name': 'Sodium bicarbonate and sodium fluoride', 'type': 'DRUG', 'description': 'Experimental toothpaste containing sodium bicarbonate experimental dentifrice plus 1150 parts per million (ppm) fluoride as sodium fluoride', 'armGroupLabels': ['Experimental Dentifrice']}, {'name': 'Sodium fluoride', 'type': 'DRUG', 'description': 'Comparator toothpaste containing 1100 ppm fluoride as sodium fluoride', 'armGroupLabels': ['Reference Dentifrice']}]}, 'contactsLocationsModule': {'locations': [{'zip': '46825', 'city': 'Fort Wayne', 'state': 'Indiana', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 41.1306, 'lon': -85.12886}}], 'overallOfficials': [{'name': 'GSK Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'GlaxoSmithKline'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'GlaxoSmithKline', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}