Ignite Creation Date:
2025-12-25 @ 12:52 AM
Ignite Modification Date:
2026-01-24 @ 7:08 PM
Study NCT ID:
NCT02340767
Status:
COMPLETED
Last Update Posted:
2019-04-03
First Post:
2014-12-30
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Decision Aids for the Management of Suspicious Occlusal Caries Lesions
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003731', 'term': 'Dental Caries'}], 'ancestors': [{'id': 'D017001', 'term': 'Tooth Demineralization'}, {'id': 'D014076', 'term': 'Tooth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'smakhija@uab.edu', 'phone': '2059965298', 'title': 'Dr. Sonia Makhija', 'organization': 'National Dental PBRN'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'No Device Clinicians', 'description': 'The practitioners will not receive any additional training.', 'otherNumAtRisk': 28, 'deathsNumAtRisk': 28, 'otherNumAffected': 0, 'seriousNumAtRisk': 28, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Spectra Device Clinicians', 'description': "The practitioners in the Spectra Device Arm will be trained to the device according to the manufacturers' usual care for training. The training will consist of viewing the manufacturer's instructions for the device. Training will also consist of practitioners familiarizing themselves with the device through unsupervised clinical use with patients.\n\nSpectra Device: Spectra Caries detection device is used for study data collection recording the results of the dental examination and recording results of dental treatment.", 'otherNumAtRisk': 28, 'deathsNumAtRisk': 28, 'otherNumAffected': 0, 'seriousNumAtRisk': 28, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'DIAGNOdent Device Clinicians', 'description': "The practitioners in the DIAGNOdent Device Arm will be trained to the device according to the manufacturers' usual care for training. The training will consist of viewing the manufacturer's instructions for the device. Training will also consist of practitioners familiarizing themselves with the device through unsupervised clinical use with patients.\n\nDIAGNOdent: DIAGNOdent Caries detection device is used for study data collection recording the results of the dental examination and recording results of dental treatment.", 'otherNumAtRisk': 29, 'deathsNumAtRisk': 29, 'otherNumAffected': 0, 'seriousNumAtRisk': 29, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'No Device Patients (Pre-intervention and Post-intervention)', 'description': 'The total number of patients in these two phases is 1000 and 0/1000 were affected. These were 2 different sets of patients.', 'otherNumAtRisk': 1000, 'deathsNumAtRisk': 1000, 'otherNumAffected': 0, 'seriousNumAtRisk': 1000, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'Spectra Patients (Pre-intervention and Post-intervention)', 'description': 'The total number of patients in these two phases is 918 and 0/918 were affected. These were 2 different sets of patients.', 'otherNumAtRisk': 918, 'deathsNumAtRisk': 918, 'otherNumAffected': 0, 'seriousNumAtRisk': 918, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG005', 'title': 'DIAGNOdent Patients (Pre-intervention and Post-intervention)', 'description': 'The total number of patients in these two phases is 1057 and 0/1057 were affected. These were 2 different sets of patients.', 'otherNumAtRisk': 1057, 'deathsNumAtRisk': 1057, 'otherNumAffected': 0, 'seriousNumAtRisk': 1057, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Lesions That Received Invasive Treatment and the Number of Lesions Receiving Invasive Treatment That Extended Into Dentin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1500', 'groupId': 'OG000'}, {'value': '525', 'groupId': 'OG001'}, {'value': '444', 'groupId': 'OG002'}, {'value': '531', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'No Device Patients in Pre-intervention', 'description': 'The patients in pre-intervention are different than post-intervention.'}, {'id': 'OG001', 'title': 'No Device Patients Post-intervention', 'description': 'The patients in the pre-intervention stage are not the same as the post-intervention stage.'}, {'id': 'OG002', 'title': 'Spectra Patients Post-intervention', 'description': 'The patients in the pre-intervention stage are not the same as the post-intervention stage'}, {'id': 'OG003', 'title': 'DIAGNOdent Patients Post-intervention', 'description': 'The patients in the pre-intervention stage are not the same as the post-intervention stage'}], 'classes': [{'title': 'Invasive (yes/no) : Yes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1500', 'groupId': 'OG000'}, {'value': '525', 'groupId': 'OG001'}, {'value': '444', 'groupId': 'OG002'}, {'value': '531', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '603', 'groupId': 'OG000'}, {'value': '246', 'groupId': 'OG001'}, {'value': '213', 'groupId': 'OG002'}, {'value': '248', 'groupId': 'OG003'}]}]}, {'title': 'Invasive (yes/no) : No', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1500', 'groupId': 'OG000'}, {'value': '525', 'groupId': 'OG001'}, {'value': '444', 'groupId': 'OG002'}, {'value': '531', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '885', 'groupId': 'OG000'}, {'value': '277', 'groupId': 'OG001'}, {'value': '226', 'groupId': 'OG002'}, {'value': '276', 'groupId': 'OG003'}]}]}, {'title': 'Extended into dentin : Yes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '566', 'groupId': 'OG000'}, {'value': '227', 'groupId': 'OG001'}, {'value': '207', 'groupId': 'OG002'}, {'value': '221', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '349', 'groupId': 'OG000'}, {'value': '151', 'groupId': 'OG001'}, {'value': '133', 'groupId': 'OG002'}, {'value': '144', 'groupId': 'OG003'}]}]}, {'title': 'Extended into dentin : No', 'denoms': [{'units': 'Participants', 'counts': [{'value': '566', 'groupId': 'OG000'}, {'value': '525', 'groupId': 'OG001'}, {'value': '444', 'groupId': 'OG002'}, {'value': '531', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '217', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}, {'value': '74', 'groupId': 'OG002'}, {'value': '77', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Pre-intervention and post-intervention (one day visit)', 'description': 'There was one lesion/patient.', 'unitOfMeasure': 'lesions', 'reportingStatus': 'POSTED', 'populationDescription': 'Only the patients who received invasive treatment were analyzed for extension into dentin.Not all columns add up to the total N due to missing values.'}, {'type': 'SECONDARY', 'title': 'Number of Clinicians in Likelihood of Surgically Treating Lesions in Online Vignettes That Display Two Levels of Five Cues (Color, Surface Smoothness, Surface Luster, Caries Risk, and Device Reading (if Applicable) in Post-intervention', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'No Device Practitioners', 'description': 'The practitioners will not receive any additional training.'}, {'id': 'OG001', 'title': 'Spectra Device Practitioners', 'description': "The practitioners in the Spectra Device Arm will be trained to the device according to the manufacturers' usual care for training. The training will consist of viewing the manufacturer's instructions for the device. Training will also consist of practitioners familiarizing themselves with the device through unsupervised clinical use with patients.\n\nSpectra Device: Spectra Caries detection device is used for study data collection recording the results of the dental examination and recording results of dental treatment."}, {'id': 'OG002', 'title': 'DIAGNOdent Device Practitioners', 'description': "The practitioners in the DIAGNOdent Device Arm will be trained to the device according to the manufacturers' usual care for training. The training will consist of viewing the manufacturer's instructions for the device. Training will also consist of practitioners familiarizing themselves with the device through unsupervised clinical use with patients.\n\nDIAGNOdent: DIAGNOdent Caries detection device is used for study data collection recording the results of the dental examination and recording results of dental treatment."}], 'classes': [{'title': 'Luster', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}]}, {'title': 'Color', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}]}]}, {'title': 'Risk', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}]}]}, {'title': 'Feel of the lesion', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}]}, {'title': 'Device reading', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Post-intervention (dentists completed the vignettes one time)', 'description': "Clinicians' likelihood of treating surgical lesions depicted with brown verses black, smooth verses rough, shiny verses matte, in patients with high verses low caries risk, by post-intervention phases. The outcome measure will be to see what cues were used or treatment decisions in the post-intervention phase. Please note that more than one cue could be chosen, so values may add up to more than 100 percent. Participants in the no device group did not receive a device reading cue.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Clinicians in Likelihood of Surgically Treating Lesions in Online Vignettes That Display Two Levels of Four Cues (Color, Surface Smoothness, Surface Luster, and Caries Risk) in Pre-intervention', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'No Device Practitioners', 'description': 'The practitioners will not receive any additional training.'}], 'classes': [{'title': 'Luster', 'categories': [{'measurements': [{'value': '49', 'groupId': 'OG000'}]}]}, {'title': 'Color', 'categories': [{'measurements': [{'value': '40', 'groupId': 'OG000'}]}]}, {'title': 'Risk', 'categories': [{'measurements': [{'value': '29', 'groupId': 'OG000'}]}]}, {'title': 'Feel of the lesion', 'categories': [{'measurements': [{'value': '31', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Pre-intervention (dentists completed the vignettes one time)', 'description': "Clinicians' likelihood of treating surgical lesions depicted with brown verses black, smooth verses rough, shiny verses matte, in patients with high verses low caries risk, by post-intervention phases. The outcome measure will be to see what cues were used or treatment decisions in the pre-intervention phase. Please note that more than one cue could be chosen, so values may add to more than 100 percent of participants.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Pre-intervention the dentists were not randomized and had no device training and all dentists were combined'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'No Device Practitioners', 'description': 'The practitioners will not receive any additional training.'}, {'id': 'FG001', 'title': 'Spectra Device Practitioners', 'description': "The practitioners in the Spectra Device Arm will be trained to the device according to the manufacturers' usual care for training. The training will consist of viewing the manufacturer's instructions for the device. Training will also consist of practitioners familiarizing themselves with the device through unsupervised clinical use with patients.\n\nSpectra Device: Spectra Caries detection device is used for study data collection recording the results of the dental examination and recording results of dental treatment."}, {'id': 'FG002', 'title': 'DIAGNOdent Device Practitioners', 'description': "The practitioners in the DIAGNOdent Device Arm will be trained to the device according to the manufacturers' usual care for training. The training will consist of viewing the manufacturer's instructions for the device. Training will also consist of practitioners familiarizing themselves with the device through unsupervised clinical use with patients.\n\nDIAGNOdent: DIAGNOdent Caries detection device is used for study data collection recording the results of the dental examination and recording results of dental treatment."}, {'id': 'FG003', 'title': 'Pre-intervention Patients no Device', 'description': 'The patients in the pre-intervention group were not the same as the one in the post-intervention group. The clinicians were the same.'}, {'id': 'FG004', 'title': 'Pre-randomization Patients Spectra', 'description': 'The patients in the pre-intervention group were not the same as the one in the post-intervention group. The clinicians were the same.'}, {'id': 'FG005', 'title': 'Pre-randomization Patients DIANGOdent', 'description': 'The patients in the pre-intervention group were not the same as the one in the post-intervention group. The clinicians were the same.'}, {'id': 'FG006', 'title': 'Post-randomization Patients no Device', 'description': 'The patients in the pre-intervention group were not the same as the one in the post-intervention group. The clinicians were the same.'}, {'id': 'FG007', 'title': 'Post-randomization Patients Spectra', 'description': 'The patients in the pre-intervention group were not the same as the one in the post-intervention group. The clinicians were the same.'}, {'id': 'FG008', 'title': 'Post-randomization Patients DIAGNOdent', 'description': 'The patients in the pre-intervention group were not the same as the one in the post-intervention group. The clinicians were the same.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '28'}, {'groupId': 'FG001', 'numSubjects': '28'}, {'groupId': 'FG002', 'numSubjects': '29'}, {'groupId': 'FG003', 'numSubjects': '500'}, {'groupId': 'FG004', 'numSubjects': '474'}, {'groupId': 'FG005', 'numSubjects': '526'}, {'groupId': 'FG006', 'numSubjects': '525'}, {'groupId': 'FG007', 'numSubjects': '444'}, {'groupId': 'FG008', 'numSubjects': '531'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '28'}, {'groupId': 'FG001', 'numSubjects': '28'}, {'groupId': 'FG002', 'numSubjects': '29'}, {'groupId': 'FG003', 'numSubjects': '500'}, {'groupId': 'FG004', 'numSubjects': '474'}, {'groupId': 'FG005', 'numSubjects': '526'}, {'groupId': 'FG006', 'numSubjects': '525'}, {'groupId': 'FG007', 'numSubjects': '444'}, {'groupId': 'FG008', 'numSubjects': '531'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'The study had a pre-intervention phase, 108 clinicians (HS trained, consented, and met eligibility criterion) and 1500 patients enrolled. 85 clinicians met the enrollment threshold and were randomized.1500 patients were in the post-intervention phase.The pre- and post patients were not the same so the number analyzed for each group varies.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '500', 'groupId': 'BG000'}, {'value': '474', 'groupId': 'BG001'}, {'value': '526', 'groupId': 'BG002'}, {'value': '28', 'groupId': 'BG003'}, {'value': '28', 'groupId': 'BG004'}, {'value': '29', 'groupId': 'BG005'}, {'value': '525', 'groupId': 'BG006'}, {'value': '444', 'groupId': 'BG007'}, {'value': '531', 'groupId': 'BG008'}, {'value': '3085', 'groupId': 'BG009'}]}], 'groups': [{'id': 'BG000', 'title': 'No Device Patients Pre-intervention', 'description': "All pre-and post-intervention patients were different, which is why the numbers don't match. We place the pre-intervention patients into the arm their clinican was ultimately assigned to."}, {'id': 'BG001', 'title': 'Spectra Device Patients Pre-intervention', 'description': "All pre-and post-intervention patients were different, which is why the numbers don't match. We place the pre-intervention patients into the arm their clinican was ultimately assigned to."}, {'id': 'BG002', 'title': 'DIAGNOdent Device Patients Pre-intervention', 'description': "All pre-and post-intervention patients were different, which is why the numbers don't match. We place the pre-intervention patients into the arm their clinican was ultimately assigned to."}, {'id': 'BG003', 'title': 'No Device Clinicians', 'description': 'They received no device at randomization'}, {'id': 'BG004', 'title': 'Spectra Clinicians', 'description': "The practitioners in the Spectra Device Arm will be trained to the device according to the manufacturers' usual care for training. The training will consist of viewing the manufacturer's instructions for the device. Training will also consist of practitioners familiarizing themselves with the device through unsupervised clinical use with patients."}, {'id': 'BG005', 'title': 'DIAGNOdent Clinicians', 'description': "The practitioners in the DIAGNOdent Device Arm will be trained to the device according to the manufacturers' usual care for training. The training will consist of viewing the manufacturer's instructions for the device. Training will also consist of practitioners familiarizing themselves with the device through unsupervised clinical use with patients."}, {'id': 'BG006', 'title': 'No Device Patients Post-intervention'}, {'id': 'BG007', 'title': 'Spectra Device Patients Post-intervention'}, {'id': 'BG008', 'title': 'DIAGNOdent Device Patients Post-intervention'}, {'id': 'BG009', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'title': 'All patients and clinicians', 'categories': [{'measurements': [{'value': '32.3', 'spread': '17.5', 'groupId': 'BG000'}, {'value': '30.1', 'spread': '17.0', 'groupId': 'BG001'}, {'value': '34.7', 'spread': '17.3', 'groupId': 'BG002'}, {'value': 'NA', 'spread': 'NA', 'comment': 'This information was not collected on the clinicians, only patients', 'groupId': 'BG003'}, {'value': 'NA', 'spread': 'NA', 'comment': 'This information was not collected on the clinicians, only patients', 'groupId': 'BG004'}, {'value': 'NA', 'spread': 'NA', 'comment': 'This information was not collected on the clinicians, only patients', 'groupId': 'BG005'}, {'value': '37.2', 'spread': '19.2', 'groupId': 'BG006'}, {'value': '36.3', 'spread': '16.1', 'groupId': 'BG007'}, {'value': '34.7', 'spread': '16.8', 'groupId': 'BG008'}, {'value': '36.0', 'spread': '17.4', 'groupId': 'BG009'}]}]}], 'paramType': 'MEAN', 'description': 'The pre-intervention phase had 1500 patients and the post-intervention had 1500 patients. The pre-intervention patients are not the same as the patients in post-intervention. The clinicians were the same in both phases. Age was not reported for clinicians, only year of graduation. The race collected on the clinician was different as well. I have reported on the information we have collected.', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'title': 'All patients and clinicians', 'categories': [{'title': 'Female', 'measurements': [{'value': '303', 'groupId': 'BG000'}, {'value': '252', 'groupId': 'BG001'}, {'value': '328', 'groupId': 'BG002'}, {'value': '11', 'groupId': 'BG003'}, {'value': '10', 'groupId': 'BG004'}, {'value': '12', 'groupId': 'BG005'}, {'value': '297', 'groupId': 'BG006'}, {'value': '269', 'groupId': 'BG007'}, {'value': '302', 'groupId': 'BG008'}, {'value': '1784', 'groupId': 'BG009'}]}, {'title': 'Male', 'measurements': [{'value': '197', 'groupId': 'BG000'}, {'value': '222', 'groupId': 'BG001'}, {'value': '198', 'groupId': 'BG002'}, {'value': '17', 'groupId': 'BG003'}, {'value': '18', 'groupId': 'BG004'}, {'value': '17', 'groupId': 'BG005'}, {'value': '228', 'groupId': 'BG006'}, {'value': '175', 'groupId': 'BG007'}, {'value': '229', 'groupId': 'BG008'}, {'value': '1301', 'groupId': 'BG009'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'The pre-intervention patients were different than the post-intervention patients. Clinicians were the same.'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'title': 'Patients and Clinicians', 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '77', 'groupId': 'BG000'}, {'value': '73', 'groupId': 'BG001'}, {'value': '84', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '60', 'groupId': 'BG006'}, {'value': '20', 'groupId': 'BG007'}, {'value': '51', 'groupId': 'BG008'}, {'value': '366', 'groupId': 'BG009'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '395', 'groupId': 'BG000'}, {'value': '391', 'groupId': 'BG001'}, {'value': '417', 'groupId': 'BG002'}, {'value': '26', 'groupId': 'BG003'}, {'value': '26', 'groupId': 'BG004'}, {'value': '28', 'groupId': 'BG005'}, {'value': '443', 'groupId': 'BG006'}, {'value': '400', 'groupId': 'BG007'}, {'value': '450', 'groupId': 'BG008'}, {'value': '2576', 'groupId': 'BG009'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '22', 'groupId': 'BG006'}, {'value': '24', 'groupId': 'BG007'}, {'value': '30', 'groupId': 'BG008'}, {'value': '143', 'groupId': 'BG009'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Patients at the pre-intervention stage are not the same patients as post-randomization, which is why the numbers are different in both phases. Clinicians were the same.'}, {'title': 'Race (NIH/OMB)', 'classes': [{'title': 'Patients and Clinicians', 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '14', 'groupId': 'BG006'}, {'value': '15', 'groupId': 'BG007'}, {'value': '17', 'groupId': 'BG008'}, {'value': '66', 'groupId': 'BG009'}]}, {'title': 'Asian', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}, {'value': '6', 'groupId': 'BG005'}, {'value': '7', 'groupId': 'BG006'}, {'value': '1', 'groupId': 'BG007'}, {'value': '2', 'groupId': 'BG008'}, {'value': '81', 'groupId': 'BG009'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': 'NA', 'comment': 'This information was not collected on the clinicians, only patients', 'groupId': 'BG003'}, {'value': 'NA', 'comment': 'This information was not collected on the clinicians, only patients', 'groupId': 'BG004'}, {'value': 'NA', 'comment': 'This information was not collected on the clinicians, only patients', 'groupId': 'BG005'}, {'value': '4', 'groupId': 'BG006'}, {'value': '2', 'groupId': 'BG007'}, {'value': '1', 'groupId': 'BG008'}, {'value': 'NA', 'comment': 'Total not calculated because data are not available (NA) in one or more arms.', 'groupId': 'BG009'}]}, {'title': 'Black or African American', 'measurements': [{'value': '85', 'groupId': 'BG000'}, {'value': '72', 'groupId': 'BG001'}, {'value': '76', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}, {'value': '55', 'groupId': 'BG006'}, {'value': '66', 'groupId': 'BG007'}, {'value': '85', 'groupId': 'BG008'}, {'value': '445', 'groupId': 'BG009'}]}, {'title': 'White', 'measurements': [{'value': '353', 'groupId': 'BG000'}, {'value': '322', 'groupId': 'BG001'}, {'value': '378', 'groupId': 'BG002'}, {'value': '21', 'groupId': 'BG003'}, {'value': '20', 'groupId': 'BG004'}, {'value': '18', 'groupId': 'BG005'}, {'value': '407', 'groupId': 'BG006'}, {'value': '348', 'groupId': 'BG007'}, {'value': '388', 'groupId': 'BG008'}, {'value': '2255', 'groupId': 'BG009'}]}, {'title': 'More than one race', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': 'NA', 'comment': 'This information was not collected on the clinicians, only patients', 'groupId': 'BG003'}, {'value': 'NA', 'comment': 'This information was not collected on the clinicians, only patients', 'groupId': 'BG004'}, {'value': 'NA', 'comment': 'This information was not collected on the clinicians, only patients', 'groupId': 'BG005'}, {'value': '9', 'groupId': 'BG006'}, {'value': '4', 'groupId': 'BG007'}, {'value': '7', 'groupId': 'BG008'}, {'value': 'NA', 'comment': 'Total not calculated because data are not available (NA) in one or more arms.', 'groupId': 'BG009'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}, {'value': '29', 'groupId': 'BG006'}, {'value': '8', 'groupId': 'BG007'}, {'value': '31', 'groupId': 'BG008'}, {'value': '177', 'groupId': 'BG009'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'The patients at pre-intervention are not the same patients at post-intervention. We just placed them in the eventual categories. The clinicians were the same.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '500', 'groupId': 'BG000'}, {'value': '474', 'groupId': 'BG001'}, {'value': '526', 'groupId': 'BG002'}, {'value': '28', 'groupId': 'BG003'}, {'value': '28', 'groupId': 'BG004'}, {'value': '29', 'groupId': 'BG005'}, {'value': '525', 'groupId': 'BG006'}, {'value': '444', 'groupId': 'BG007'}, {'value': '531', 'groupId': 'BG008'}, {'value': '3085', 'groupId': 'BG009'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'patients and clinicians'}, {'title': 'Number of Patients and Clinicians', 'classes': [{'categories': [{'measurements': [{'value': '500', 'groupId': 'BG000'}, {'value': '474', 'groupId': 'BG001'}, {'value': '526', 'groupId': 'BG002'}, {'value': '28', 'groupId': 'BG003'}, {'value': '28', 'groupId': 'BG004'}, {'value': '29', 'groupId': 'BG005'}, {'value': '525', 'groupId': 'BG006'}, {'value': '444', 'groupId': 'BG007'}, {'value': '531', 'groupId': 'BG008'}, {'value': '3085', 'groupId': 'BG009'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'These were the patients in each arm for the pre-intervention and post-intervention. The pre-intervention patients were placed in their group that the clinician was ultimately randomized to. Clinicians were the same pre and post.'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 3085}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-07', 'completionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-04-01', 'studyFirstSubmitDate': '2014-12-30', 'resultsFirstSubmitDate': '2018-04-05', 'studyFirstSubmitQcDate': '2015-01-13', 'lastUpdatePostDateStruct': {'date': '2019-04-03', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-04-01', 'studyFirstPostDateStruct': {'date': '2015-01-19', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-04-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Lesions That Received Invasive Treatment and the Number of Lesions Receiving Invasive Treatment That Extended Into Dentin', 'timeFrame': 'Pre-intervention and post-intervention (one day visit)', 'description': 'There was one lesion/patient.'}], 'secondaryOutcomes': [{'measure': 'Number of Clinicians in Likelihood of Surgically Treating Lesions in Online Vignettes That Display Two Levels of Five Cues (Color, Surface Smoothness, Surface Luster, Caries Risk, and Device Reading (if Applicable) in Post-intervention', 'timeFrame': 'Post-intervention (dentists completed the vignettes one time)', 'description': "Clinicians' likelihood of treating surgical lesions depicted with brown verses black, smooth verses rough, shiny verses matte, in patients with high verses low caries risk, by post-intervention phases. The outcome measure will be to see what cues were used or treatment decisions in the post-intervention phase. Please note that more than one cue could be chosen, so values may add up to more than 100 percent. Participants in the no device group did not receive a device reading cue."}, {'measure': 'Number of Clinicians in Likelihood of Surgically Treating Lesions in Online Vignettes That Display Two Levels of Four Cues (Color, Surface Smoothness, Surface Luster, and Caries Risk) in Pre-intervention', 'timeFrame': 'Pre-intervention (dentists completed the vignettes one time)', 'description': "Clinicians' likelihood of treating surgical lesions depicted with brown verses black, smooth verses rough, shiny verses matte, in patients with high verses low caries risk, by post-intervention phases. The outcome measure will be to see what cues were used or treatment decisions in the pre-intervention phase. Please note that more than one cue could be chosen, so values may add to more than 100 percent of participants."}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Suspicious Occlusal Caries'], 'conditions': ['Dental Caries']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://NationalDentalPBRN.org', 'label': 'National Dental Practice-Based Research Network'}]}, 'descriptionModule': {'briefSummary': 'The study will determine whether clinicians who use a diagnostic device treat suspicious occlusal carious lesions (SOCL) surgically more often, with the same frequency, or less frequently, than dentists not relying on a diagnostic device. The study will also determine -- among those SOCLs that are opened -- whether the proportion of lesions that extend into the dentin when dentists are using a diagnostic device is more than, the same, or less than when no device is used.', 'detailedDescription': "The overall objectives of this study is to assess the contributions of diagnostic devices in clinicians' decision-making processes surrounding suspicious occlusal carious lesions (SOCL), an assessment that has not yet been attempted, despite the growing popularity of these devices. SOCLs can be defined as occlusal surface areas where visual, tactile, and radiographic signs are insufficient to definitively diagnose caries but where some of these signs are present.This study examines the use of two diagnostic devices on dental practitioners' identification and treatment of SOCLs.\n\nDuring a four-week pre-intervention period, 90 clinicians will collect and record descriptive and treatment information for the SOCLs they identify. Clinicians will then be randomized into one of 3 study arms: no diagnostic device, DIAGNOdent®, and Spectra®, and will collect and record similar information as the pre-intervention period for another six weeks, enrolling an additional 20 SOCLs. They will also complete diagnostic vignettes at the beginning and end of the study, as well as a post-study questionnaire on the utility of the devices, if assigned to a device arm. Analyses will examine differences in proportion of SOCLs treated surgically in the groups with and without the diagnostic device; and, for those treated surgically, differences in the proportions of SOCLs with extension into dentin. Differences in pre- and post-study responses on the vignettes will suggest which components of the decision-making process involved in SOCL identification and management have been modified by use of the diagnostic devices."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '6 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPractitioner: In order to be eligible to participate in this study, an individual must meet all of the following criteria:\n\n* Is enrolled in the National Dental Practice Based Research Network (National Dental PBRN);\n* Has completed an Enrollment Questionnaire;\n* Is a general or pediatric dentist who is licensed in the United States to treat patients and treats patients in the United States on a recurring basis;\n* Is trained and certified in Human Subjects Protection Training;\n* Has attended or viewed a National Dental PBRN orientation session or attended at least one annual regional meeting of practitioners or has attended a National Dental PBRN workshop at the International Association for Dental Research (IADR) or American Association for Dental Research (AADR).\n* Performs restorative dentistry routinely in their practices as reported on the enrollment questionnaire;\n* Has no clinical experience (no history of routine use in practice within the past one year) with either of the devices being used in the study and declares no conflict of interest with the corporations that produce DIAGNOdent® and Spectra®; and\n* Is able to complete the pre-and post-study vignettes online.\n\nPractice: If a practitioner is in a practice where they share an operatory (including a hygiene chair) only 1 dentist can be recruited from that practice.\n\nPatient: In order to be eligible to participate in this study, an individual with a SOCL must meet all of the following criteria:\n\n* Willing to provide consent according to regionally approved procedures and/or obtain parent/legal guardian permission as applicable;\n* Willing to comply with all study procedures; Is six years of age or older; and\n* Has not participated in the study previously. Patients will be enrolled only once throughout the study (this includes the pre-intervention and intervention phases for the pilot study and full study).\n\nTooth: In order to be eligible to be included in this study, a tooth with a SOCL must meet all of the following criteria:\n\n* Permanent tooth;\n* No radiographic evidence of caries into dentin based on available radiographs;\n* Caries into dentin is suspected due to roughness, surface opacities, or staining;\n* No symptoms of sensitivity to sweets, cold, air, etc.;\n* No restoration on the occlusal surface; and\n* No sealant on occlusal surface.\n\nExclusion Criteria:\n\n* Under the age of 6 years old\n* Primary Teeth\n* Evidence of Caries into dentin based on available radiographs\n* Sensitivity to sweets, cold, air etc.;\n* Restoration on the occlusal surface\n* Sealant on occlusal surface'}, 'identificationModule': {'nctId': 'NCT02340767', 'acronym': 'SOCL', 'briefTitle': 'Decision Aids for the Management of Suspicious Occlusal Caries Lesions', 'organization': {'class': 'NETWORK', 'fullName': 'The National Dental Practice-Based Research Network'}, 'officialTitle': 'Decision Aids for the Management of Suspicious Occlusal Caries Lesions', 'orgStudyIdInfo': {'id': '14-003-E'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'No Device Clinicians', 'description': 'The clinicians will not receive any additional training.'}, {'type': 'EXPERIMENTAL', 'label': 'Spectra Device Clinicians', 'description': "The clinicians in the Spectra Device Arm will be trained to the device according to the manufacturers' usual care for training. The training will consist of viewing the manufacturer's instructions for the device. Training will also consist of clinicians familiarizing themselves with the device through unsupervised clinical use with patients.", 'interventionNames': ['Device: Spectra Device']}, {'type': 'EXPERIMENTAL', 'label': 'DIAGNOdent Device Practitioners', 'description': "The clinicians in the DIAGNOdent Device Arm will be trained to the device according to the manufacturers' usual care for training. The training will consist of viewing the manufacturer's instructions for the device. Training will also consist of clinicians familiarizing themselves with the device through unsupervised clinical use with patients.", 'interventionNames': ['Device: DIAGNOdent']}], 'interventions': [{'name': 'Spectra Device', 'type': 'DEVICE', 'description': 'Spectra Caries detection device is used for study data collection recording the results of the dental examination and recording results of dental treatment.', 'armGroupLabels': ['Spectra Device Clinicians']}, {'name': 'DIAGNOdent', 'type': 'DEVICE', 'description': 'DIAGNOdent Caries detection device is used for study data collection recording the results of the dental examination and recording results of dental treatment.', 'armGroupLabels': ['DIAGNOdent Device Practitioners']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35294', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'University of Alabama at Birmingham', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '32610', 'city': 'Gainesville', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Florida', 'geoPoint': {'lat': 29.65163, 'lon': -82.32483}}, {'zip': '55445', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'HealthPartners Institute for Education and Research', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}, {'zip': '14620', 'city': 'Rochester', 'state': 'New York', 'country': 'United States', 'facility': 'University of Rochester', 'geoPoint': {'lat': 43.15478, 'lon': -77.61556}}, {'zip': '97227-1110', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Kaiser Permanente Center for Health Research', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'University of Texas Health Science Center at San Antonio', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}], 'overallOfficials': [{'name': 'Gregg H Gilbert, DDS, MBA', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Alabama at Birmingham'}, {'name': 'Sonia K Makhija, DDS, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Alabama at Birmingham'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The National Dental Practice-Based Research Network', 'class': 'NETWORK'}, 'collaborators': [{'name': 'Kaiser Permanente', 'class': 'OTHER'}, {'name': 'HealthPartners Institute', 'class': 'OTHER'}, {'name': 'The University of Texas Health Science Center at San Antonio', 'class': 'OTHER'}, {'name': 'University of Alabama at Birmingham', 'class': 'OTHER'}, {'name': 'University of Florida', 'class': 'OTHER'}, {'name': 'University of Rochester', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}