Ignite Creation Date:
2025-12-25 @ 1:17 AM
Ignite Modification Date:
2025-12-25 @ 11:26 PM
Study NCT ID:
NCT05202093
Status:
COMPLETED
Last Update Posted:
2025-12-22
First Post:
2022-01-07
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Efficacy of Two Sonic Toothbrushes in Reducing Extrinsic Tooth Stain
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'hongchun_liu@vip.sina.com', 'phone': '86-13826189071', 'title': 'Dr. Hongchun Liu', 'organization': 'Sun Yat-sen University'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '8 weeks', 'eventGroups': [{'id': 'EG000', 'title': 'the Oclean Digital Visual Toothbrush (2.16 N·cm Torque)', 'description': 'Use the Oclean Digital Visual toothbrush (2.16 N·cm torque) to brush teeth twice daily for 8 weeks\n\nOclean electric toothbrush A: Use the Oclean Digital Visual toothbrush (2.16 N·cm torque) to brush teeth twice a day for 8 weeks', 'otherNumAtRisk': 43, 'deathsNumAtRisk': 43, 'otherNumAffected': 0, 'seriousNumAtRisk': 43, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'the Oclean Sonic Electric Toothbrush (1.96 N·cm Torque)', 'description': 'Use the Oclean Sonic Electric toothbrush (1.96 N·cm torque) to brush teeth twice daily for 8 week\n\nthe Oclean Sonic Electric toothbrush (1.96 N·cm torque): Use the Oclean Sonic Electric toothbrush (1.96 N·cm torque) to brush teeth twice a day for 8 weeks', 'otherNumAtRisk': 42, 'deathsNumAtRisk': 42, 'otherNumAffected': 0, 'seriousNumAtRisk': 42, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Manual Toothbrush', 'description': 'Use Oral-B manual toothbrush to brush teeth twice daily for 8 weeks\n\nOral-B manual toothbrush: Use Oral B manual toothbrush to brush teeth twice a day for 8 weeks', 'otherNumAtRisk': 41, 'deathsNumAtRisk': 41, 'otherNumAffected': 0, 'seriousNumAtRisk': 41, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Lobene Stain Index of Stain Intensity Scores 4 Weeks After Toothbrush Use', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'the Oclean Digital Visual Toothbrush (2.16 N·cm Torque)', 'description': 'Use the Oclean Digital Visual toothbrush (2.16 N·cm torque) to brush teeth twice daily for 8 weeks\n\nthe Oclean Digital Visual toothbrush (2.16 N·cm torque) : Use Oclean electric toothbrush A to brush teeth twice a day for 8 weeks'}, {'id': 'OG001', 'title': 'the Oclean Sonic Electric Toothbrush (1.96 N·cm Torque)', 'description': 'Use the Oclean Sonic Electric toothbrush (1.96 N·cm torque) to brush teeth twice daily for 8 week\n\nthe Oclean Sonic Electric toothbrush (1.96 N·cm torque): Use Oclean electric toothbrush B to brush teeth twice a day for 8 weeks'}, {'id': 'OG002', 'title': 'Manual Toothbrush', 'description': 'Use Oral-B manual toothbrush to brush teeth twice daily for 8 weeks\n\nOral B manual toothbrush: Use Oral B manual toothbrush to brush teeth twice a day for 8 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '0.89', 'spread': '0.48', 'groupId': 'OG000'}, {'value': '0.88', 'spread': '0.46', 'groupId': 'OG001'}, {'value': '1.13', 'spread': '0.55', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4 weeks after toothbrush use', 'description': 'Tooth stain of the anterior teeth was measured using the Lobene Stain Index. The index assesses the area and intensity of extrinsic tooth stain on the facial and lingual surfaces of the lower anterior teeth and the facial surfaces of the upper anterior teeth. Each evaluated tooth surface was divided into two anatomical regions: body and gingival. For each region, stain intensity was rated on a 0-3 ordinal scale with the following criteria: 0 = No stain; 1 = Light stain (yellow to light brown or gray); 2 = Moderate stain (medium brown); 3 = Heavy stain (dark brown to black).\n\nEach region(body and gingival) has a score range of 0-3 (minimum = 0, maximum = 3).\n\nThe mean Lobene stain intensity score was determined by summing the scores from all assessed regions of the tooth surfaces and dividing by the total number of regions evaluated.\n\nHigher scores (both subscale and mean score) indicate a worse outcome (i.e., more severe extrinsic tooth stain).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Lobene Stain Index of Stain Area Scores 4 Weeks After Toothbrush Use', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'the Oclean Digital Visual Toothbrush (2.16 N·cm Torque)', 'description': 'Use the Oclean Digital Visual toothbrush (2.16 N·cm torque) to brush teeth twice daily for 8 weeks\n\nthe Oclean Digital Visual toothbrush (2.16 N·cm torque): Use the Oclean Digital Visual toothbrush (2.16 N·cm torque) to brush teeth twice a day for 8 weeks'}, {'id': 'OG001', 'title': 'the Oclean Sonic Electric Toothbrush (1.96 N·cm Torque)', 'description': 'Use the Oclean Sonic Electric toothbrush (1.96 N·cm torque)to brush teeth twice daily for 8 week\n\nthe Oclean Sonic Electric toothbrush (1.96 N·cm torque): Use the Oclean Sonic Electric toothbrush (1.96 N·cm torque) to brush teeth twice a day for 8 weeks'}, {'id': 'OG002', 'title': 'Manual Toothbrush', 'description': 'Use Oral-B manual toothbrush to brush teeth twice daily for 8 weeks\n\nOral B manual toothbrush: Use Oral B manual toothbrush to brush teeth twice a day for 8 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '0.81', 'spread': '0.37', 'groupId': 'OG000'}, {'value': '0.81', 'spread': '0.43', 'groupId': 'OG001'}, {'value': '1.02', 'spread': '0.43', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4 weeks after toothbrush use', 'description': 'Tooth stain of the anterior teeth was measured using the Lobene Stain Index. The index assesses the area and intensity of extrinsic tooth stain on the facial and lingual surfaces of the lower anterior teeth and the facial surfaces of the upper anterior teeth. Each evaluated tooth surface was divided into two anatomical regions: body and gingival. For each region, the stain area score were assessed using 0-3 scale. 0= no stain detected; 1= stain covering up to 1/3 of the region; 2= stain covering \\>1/3 to 2/3 of the region; 3=stain covering \\>2/3 of the region.\n\nEach region (body and gingival) has a score range of 0-3 (minimum = 0, maximum = 3).\n\nThe mean Lobene stain area score was determined by summing the scores from all assessed regions of the tooth surfaces and dividing by the total number of regions evaluated.\n\nHigher scores (both subscale and mean score) indicate a worse outcome (i.e., more severe extrinsic tooth stain).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Lobene Stain Index of Stain Composite Scores 4 Weeks After Toothbrush Use', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'the Oclean Digital Visual Toothbrush (2.16 N·cm Torque)', 'description': 'Use the Oclean Digital Visual toothbrush (2.16 N·cm torque) to brush teeth twice daily for 8 weeks\n\nthe Oclean Digital Visual toothbrush (2.16 N·cm torque): Use the Oclean Digital Visual toothbrush (2.16 N·cm torque) to brush teeth twice a day for 8 weeks'}, {'id': 'OG001', 'title': 'the Oclean Sonic Electric Toothbrush (1.96 N·cm Torque)', 'description': 'Use the Oclean Sonic Electric toothbrush (1.96 N·cm torque) to brush teeth twice daily for 8 week\n\nthe Oclean Sonic Electric toothbrush (1.96 N·cm torque): Use the Oclean Sonic Electric toothbrush (1.96 N·cm torque)B to brush teeth twice a day for 8 weeks'}, {'id': 'OG002', 'title': 'Manual Toothbrush', 'description': 'Use Oral-B manual toothbrush to brush teeth twice daily for 8 weeks\n\nOral B manual toothbrush: Use Oral B manual toothbrush to brush teeth twice a day for 8 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '1.54', 'spread': '0.94', 'groupId': 'OG000'}, {'value': '1.5', 'spread': '0.96', 'groupId': 'OG001'}, {'value': '2.05', 'spread': '1.21', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4 weeks after toothbrush use', 'description': 'Tooth stain of the anterior teeth was measured using the Lobene Stain Index. The index assesses the area and intensity of extrinsic tooth stain on the facial and lingual surfaces of the lower anterior teeth and the facial surfaces of the upper anterior teeth. Each evaluated tooth surface was divided into two anatomical regions: body and gingival. For each region, a composite score is calculated by averaging the product of the intensity and extent scores.\n\nEach region (body and gingival) has a score range of 0-9 (minimum = 0, maximum = 9).\n\nThe mean Lobene stain composite score was determined by summing the scores from all assessed regions of the tooth surfaces and dividing by the total number of regions evaluated.\n\nHigher scores (both subscale and mean score) indicate a worse outcome (i.e., more severe extrinsic tooth stain).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Lobene Stain Index of Stain Intensity Scores 8 Weeks After Toothbrush Use', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'the Oclean Digital Visual Toothbrush (2.16 N·cm Torque)', 'description': 'Use the Oclean Digital Visual toothbrush (2.16 N·cm torque)to brush teeth twice daily for 8 weeks\n\nthe Oclean Digital Visual toothbrush (2.16 N·cm torque): Usethe Oclean Digital Visual toothbrush (2.16 N·cm torque) to brush teeth twice a day for 8 weeks'}, {'id': 'OG001', 'title': 'the Oclean Sonic Electric Toothbrush (1.96 N·cm Torque)', 'description': 'Use the Oclean Sonic Electric toothbrush (1.96 N·cm torque) to brush teeth twice daily for 8 week\n\nthe Oclean Sonic Electric toothbrush (1.96 N·cm torque): Use the Oclean Sonic Electric toothbrush (1.96 N·cm torque) to brush teeth twice a day for 8 weeks'}, {'id': 'OG002', 'title': 'Manual Toothbrush', 'description': 'Use Oral-B manual toothbrush to brush teeth twice daily for 8 weeks\n\nOral-B manual toothbrush: Use Oral B manual toothbrush to brush teeth twice a day for 8 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '0.78', 'spread': '0.41', 'groupId': 'OG000'}, {'value': '0.71', 'spread': '0.4', 'groupId': 'OG001'}, {'value': '1.01', 'spread': '0.52', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '8 weeks after toothbrush use', 'description': 'Tooth stain of the anterior teeth was measured using the Lobene Stain Index. The index assesses the area and intensity of extrinsic tooth stain on the facial and lingual surfaces of the lower anterior teeth and the facial surfaces of the upper anterior teeth. Each evaluated tooth surface was divided into two anatomical regions: body and gingival. For each region, stain intensity was rated on a 0-3 ordinal scale with the following criteria: 0 = No stain; 1 = Light stain (yellow to light brown or gray); 2 = Moderate stain (medium brown); 3 = Heavy stain (dark brown to black).\n\nEach region(body and gingival) has a score range of 0-3 (minimum = 0, maximum = 3).\n\nThe mean Lobene stain intensity score was determined by summing the scores from all assessed regions of the tooth surfaces and dividing by the total number of regions evaluated.\n\nHigher scores (both subscale and mean score) indicate a worse outcome (i.e., more severe extrinsic tooth stain).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Lobene Stain Index of Stain Area Scores 8 Weeks After Toothbrush Use', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'the Oclean Digital Visual Toothbrush (2.16 N·cm Torque)', 'description': 'Use the Oclean Digital Visual toothbrush (2.16 N·cm torque) to brush teeth twice daily for 8 weeks\n\nthe Oclean Digital Visual toothbrush (2.16 N·cm torque): Use the Oclean Digital Visual toothbrush (2.16 N·cm torque) to brush teeth twice a day for 8 weeks'}, {'id': 'OG001', 'title': 'the Oclean Sonic Electric Toothbrush (1.96 N·cm Torque)', 'description': 'Use the Oclean Sonic Electric toothbrush (1.96 N·cm torque) to brush teeth twice daily for 8 week\n\nthe Oclean Sonic Electric toothbrush (1.96 N·cm torque): Use the Oclean Sonic Electric toothbrush (1.96 N·cm torque) to brush teeth twice a day for 8 weeks'}, {'id': 'OG002', 'title': 'Manual Toothbrush', 'description': 'Use Oral-B manual toothbrush to brush teeth twice daily for 8 weeks\n\nOral-B manual toothbrush: Use Oral B manual toothbrush to brush teeth twice a day for 8 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '0.75', 'spread': '0.33', 'groupId': 'OG000'}, {'value': '0.74', 'spread': '0.42', 'groupId': 'OG001'}, {'value': '0.94', 'spread': '0.45', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '8 weeks after toothbrush use', 'description': 'Tooth stain of the anterior teeth was measured using the Lobene Stain Index. The index assesses the area and intensity of extrinsic tooth stain on the facial and lingual surfaces of the lower anterior teeth and the facial surfaces of the upper anterior teeth. Each evaluated tooth surface was divided into two anatomical regions: body and gingival. For each region, the stain area score were assessed using 0-3 scale. 0= no stain detected; 1= stain covering up to 1/3 of the region; 2= stain covering \\>1/3 to 2/3 of the region; 3=stain covering \\>2/3 of the region.\n\nEach region (body and gingival) has a score range of 0-3 (minimum = 0, maximum = 3).\n\nThe mean Lobene stain area score was determined by summing the scores from all assessed regions of the tooth surfaces and dividing by the total number of regions evaluated.\n\nHigher scores (both subscale and mean score) indicate a worse outcome (i.e., more severe extrinsic tooth stain).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Lobene Stain Index of Stain Composite Scores 8 Weeks After Toothbrush Use', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'the Oclean Digital Visual Toothbrush (2.16 N·cm Torque)', 'description': 'Use the Oclean Digital Visual toothbrush (2.16 N·cm torque) to brush teeth twice daily for 8 weeks\n\nthe Oclean Digital Visual toothbrush (2.16 N·cm torque): Use the Oclean Digital Visual toothbrush (2.16 N·cm torque) to brush teeth twice a day for 8 weeks'}, {'id': 'OG001', 'title': 'the Oclean Sonic Electric Toothbrush (1.96 N·cm Torque)', 'description': 'Use the Oclean Sonic Electric toothbrush (1.96 N·cm torque) to brush teeth twice daily for 8 week\n\nthe Oclean Sonic Electric toothbrush (1.96 N·cm torque): Use the Oclean Sonic Electric toothbrush (1.96 N·cm torque) to brush teeth twice a day for 8 weeks'}, {'id': 'OG002', 'title': 'Manual Toothbrush', 'description': 'Use Oral-B manual toothbrush to brush teeth twice daily for 8 weeks\n\nOral-B manual toothbrush: Use Oral B manual toothbrush to brush teeth twice a day for 8 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '1.37', 'spread': '0.87', 'groupId': 'OG000'}, {'value': '1.27', 'spread': '0.84', 'groupId': 'OG001'}, {'value': '1.88', 'spread': '1.21', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '8 weeks after toothbrush use', 'description': 'Tooth stain of the anterior teeth was measured using the Lobene Stain Index. The index assesses the area and intensity of extrinsic tooth stain on the facial and lingual surfaces of the lower anterior teeth and the facial surfaces of the upper anterior teeth. Each evaluated tooth surface was divided into two anatomical regions: body and gingival. For each region, a composite score is calculated by averaging the product of the intensity and extent scores.\n\nEach region (body and gingival) has a score range of 0-9 (minimum = 0, maximum = 9).\n\nThe mean Lobene stain composite score was determined by summing the scores from all assessed regions of the tooth surfaces and dividing by the total number of regions evaluated.\n\nHigher scores (both subscale and mean score) indicate a worse outcome (i.e., more severe extrinsic tooth stain).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'the Oclean Digital Visual Toothbrush (2.16 N·cm Torque)', 'description': 'Use the Oclean Digital Visual toothbrush (2.16 N·cm torque) to brush teeth twice daily for 8 weeks\n\nOclean electric toothbrush A: Use the Oclean Digital Visual toothbrush (2.16 N·cm torque)to brush teeth twice a day for 8 weeks'}, {'id': 'FG001', 'title': 'the Oclean Sonic Electric Toothbrush (1.96 N·cm Torque)', 'description': 'Use the Oclean Sonic Electric toothbrush (1.96 N·cm torque) to brush teeth twice daily for 8 week\n\nOclean electric toothbrush B: Usethe Oclean Sonic Electric toothbrush (1.96 N·cm torque) to brush teeth twice a day for 8 weeks'}, {'id': 'FG002', 'title': 'Manual Toothbrush', 'description': 'Use Oral-B manual toothbrush to brush teeth twice daily for 8 weeks\n\nOral-B manual toothbrush: Use Oral B manual toothbrush to brush teeth twice a day for 8 weeks'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '43'}, {'groupId': 'FG001', 'numSubjects': '43'}, {'groupId': 'FG002', 'numSubjects': '43'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '43'}, {'groupId': 'FG001', 'numSubjects': '42'}, {'groupId': 'FG002', 'numSubjects': '41'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '2'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}, {'value': '126', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'the Oclean Digital Visual Toothbrush (2.16 N·cm Torque)', 'description': 'Use the Oclean Digital Visual toothbrush (2.16 N·cm torque) to brush teeth twice daily for 8 weeks\n\nOclean the Oclean Digital Visual toothbrush (2.16 N·cm torque) : Use the Oclean Digital Visual toothbrush (2.16 N·cm torque) to brush teeth twice a day for 8 weeks'}, {'id': 'BG001', 'title': 'the Oclean Sonic Electric Toothbrush (1.96 N·cm Torque)', 'description': 'Use the Oclean Sonic Electric toothbrush (1.96 N·cm torque) to brush teeth twice daily for 8 week\n\nOclean the Oclean Sonic Electric toothbrush (1.96 N·cm torque): Use the Oclean Sonic Electric toothbrush (1.96 N·cm torque) to brush teeth twice a day for 8 weeks'}, {'id': 'BG002', 'title': 'Manual Toothbrush', 'description': 'Use Oral-B manual toothbrush to brush teeth twice daily for 8 weeks\n\nOral-B manual toothbrush: Use Oral B manual toothbrush to brush teeth twice a day for 8 weeks'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '43.02', 'spread': '8.87', 'groupId': 'BG000'}, {'value': '43.98', 'spread': '9.98', 'groupId': 'BG001'}, {'value': '44.15', 'spread': '8.28', 'groupId': 'BG002'}, {'value': '43.71', 'spread': '9.02', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}, {'value': '76', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}, {'value': '50', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Han', 'categories': [{'measurements': [{'value': '43', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}, {'value': '126', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Lobene Stain Index of Stain Intensity Scores', 'classes': [{'categories': [{'measurements': [{'value': '1.28', 'spread': '0.48', 'groupId': 'BG000'}, {'value': '1.28', 'spread': '0.57', 'groupId': 'BG001'}, {'value': '1.31', 'spread': '0.52', 'groupId': 'BG002'}, {'value': '1.29', 'spread': '0.52', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'Each tooth surface was divided into two regions: body and gingival. For each region, tooth stain intensity was rated on a 0-3 ordinal scale (minimum = 0, maximum = 3),using the Lobene Stain Index: 0 = No stain; 1 = Light stain (yellow to light brown or gray); 2 = Moderate stain (medium brown); 3 = Heavy stain (dark brown to black).\n\nThe mean Lobene stain intensity score was calculated by summing the scores from all assessed regions of the tooth surfaces and dividing by the total number of regions.\n\nHigher scores indicate a worse outcome (i.e., more severe extrinsic tooth stain).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Lobene Stain Index of Stain Area Scores', 'classes': [{'categories': [{'measurements': [{'value': '1.1', 'spread': '0.35', 'groupId': 'BG000'}, {'value': '1.13', 'spread': '0.43', 'groupId': 'BG001'}, {'value': '1.14', 'spread': '0.39', 'groupId': 'BG002'}, {'value': '1.12', 'spread': '0.39', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'Each tooth surface was divided into two regions: body and gingival. For each region, tooth stain area was rated on a 0-3 ordinal scale (minimum = 0, maximum = 3), using the Lobene Stain Index: 0= no stain detected; 1= stain covering up to 1/3 of the region; 2= stain covering \\>1/3 to 2/3 of the region; 3=stain covering \\>2/3 of the region.\n\nThe mean Lobene stain area score was calculated by summing the scores from all assessed regions of the tooth surfaces and dividing by the total number of regions.\n\nHigher scores indicate a worse outcome (i.e., more severe extrinsic tooth stain).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Lobene Stain Index of Stain Composite Scores', 'classes': [{'categories': [{'measurements': [{'value': '2.4', 'spread': '1.03', 'groupId': 'BG000'}, {'value': '2.35', 'spread': '1.24', 'groupId': 'BG001'}, {'value': '2.37', 'spread': '1.16', 'groupId': 'BG002'}, {'value': '2.37', 'spread': '1.13', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'Each tooth surface was divided into two regions: body and gingival. For each region, a composite score is calculated by averaging the product of the intensity and extent scores.\n\nEach subscale (body and gingival) has a range of 0-9 (minimum = 0, maximum = 9).\n\nThe mean Lobene stain composite score was determined by summing the scores from all assessed regions of the tooth surfaces and dividing by the total number of regions evaluated.\n\nHigher scores indicate a worse outcome (i.e., more severe extrinsic tooth stain).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-01-18', 'size': 114402, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-11-20T06:16', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 129}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-03-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2022-07-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-12-04', 'studyFirstSubmitDate': '2022-01-07', 'resultsFirstSubmitDate': '2025-11-20', 'studyFirstSubmitQcDate': '2022-01-07', 'lastUpdatePostDateStruct': {'date': '2025-12-22', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2025-12-04', 'studyFirstPostDateStruct': {'date': '2022-01-21', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-12-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2022-07-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Lobene Stain Index of Stain Intensity Scores 4 Weeks After Toothbrush Use', 'timeFrame': '4 weeks after toothbrush use', 'description': 'Tooth stain of the anterior teeth was measured using the Lobene Stain Index. The index assesses the area and intensity of extrinsic tooth stain on the facial and lingual surfaces of the lower anterior teeth and the facial surfaces of the upper anterior teeth. Each evaluated tooth surface was divided into two anatomical regions: body and gingival. For each region, stain intensity was rated on a 0-3 ordinal scale with the following criteria: 0 = No stain; 1 = Light stain (yellow to light brown or gray); 2 = Moderate stain (medium brown); 3 = Heavy stain (dark brown to black).\n\nEach region(body and gingival) has a score range of 0-3 (minimum = 0, maximum = 3).\n\nThe mean Lobene stain intensity score was determined by summing the scores from all assessed regions of the tooth surfaces and dividing by the total number of regions evaluated.\n\nHigher scores (both subscale and mean score) indicate a worse outcome (i.e., more severe extrinsic tooth stain).'}, {'measure': 'Lobene Stain Index of Stain Area Scores 4 Weeks After Toothbrush Use', 'timeFrame': '4 weeks after toothbrush use', 'description': 'Tooth stain of the anterior teeth was measured using the Lobene Stain Index. The index assesses the area and intensity of extrinsic tooth stain on the facial and lingual surfaces of the lower anterior teeth and the facial surfaces of the upper anterior teeth. Each evaluated tooth surface was divided into two anatomical regions: body and gingival. For each region, the stain area score were assessed using 0-3 scale. 0= no stain detected; 1= stain covering up to 1/3 of the region; 2= stain covering \\>1/3 to 2/3 of the region; 3=stain covering \\>2/3 of the region.\n\nEach region (body and gingival) has a score range of 0-3 (minimum = 0, maximum = 3).\n\nThe mean Lobene stain area score was determined by summing the scores from all assessed regions of the tooth surfaces and dividing by the total number of regions evaluated.\n\nHigher scores (both subscale and mean score) indicate a worse outcome (i.e., more severe extrinsic tooth stain).'}, {'measure': 'Lobene Stain Index of Stain Composite Scores 4 Weeks After Toothbrush Use', 'timeFrame': '4 weeks after toothbrush use', 'description': 'Tooth stain of the anterior teeth was measured using the Lobene Stain Index. The index assesses the area and intensity of extrinsic tooth stain on the facial and lingual surfaces of the lower anterior teeth and the facial surfaces of the upper anterior teeth. Each evaluated tooth surface was divided into two anatomical regions: body and gingival. For each region, a composite score is calculated by averaging the product of the intensity and extent scores.\n\nEach region (body and gingival) has a score range of 0-9 (minimum = 0, maximum = 9).\n\nThe mean Lobene stain composite score was determined by summing the scores from all assessed regions of the tooth surfaces and dividing by the total number of regions evaluated.\n\nHigher scores (both subscale and mean score) indicate a worse outcome (i.e., more severe extrinsic tooth stain).'}, {'measure': 'Lobene Stain Index of Stain Intensity Scores 8 Weeks After Toothbrush Use', 'timeFrame': '8 weeks after toothbrush use', 'description': 'Tooth stain of the anterior teeth was measured using the Lobene Stain Index. The index assesses the area and intensity of extrinsic tooth stain on the facial and lingual surfaces of the lower anterior teeth and the facial surfaces of the upper anterior teeth. Each evaluated tooth surface was divided into two anatomical regions: body and gingival. For each region, stain intensity was rated on a 0-3 ordinal scale with the following criteria: 0 = No stain; 1 = Light stain (yellow to light brown or gray); 2 = Moderate stain (medium brown); 3 = Heavy stain (dark brown to black).\n\nEach region(body and gingival) has a score range of 0-3 (minimum = 0, maximum = 3).\n\nThe mean Lobene stain intensity score was determined by summing the scores from all assessed regions of the tooth surfaces and dividing by the total number of regions evaluated.\n\nHigher scores (both subscale and mean score) indicate a worse outcome (i.e., more severe extrinsic tooth stain).'}, {'measure': 'Lobene Stain Index of Stain Area Scores 8 Weeks After Toothbrush Use', 'timeFrame': '8 weeks after toothbrush use', 'description': 'Tooth stain of the anterior teeth was measured using the Lobene Stain Index. The index assesses the area and intensity of extrinsic tooth stain on the facial and lingual surfaces of the lower anterior teeth and the facial surfaces of the upper anterior teeth. Each evaluated tooth surface was divided into two anatomical regions: body and gingival. For each region, the stain area score were assessed using 0-3 scale. 0= no stain detected; 1= stain covering up to 1/3 of the region; 2= stain covering \\>1/3 to 2/3 of the region; 3=stain covering \\>2/3 of the region.\n\nEach region (body and gingival) has a score range of 0-3 (minimum = 0, maximum = 3).\n\nThe mean Lobene stain area score was determined by summing the scores from all assessed regions of the tooth surfaces and dividing by the total number of regions evaluated.\n\nHigher scores (both subscale and mean score) indicate a worse outcome (i.e., more severe extrinsic tooth stain).'}, {'measure': 'Lobene Stain Index of Stain Composite Scores 8 Weeks After Toothbrush Use', 'timeFrame': '8 weeks after toothbrush use', 'description': 'Tooth stain of the anterior teeth was measured using the Lobene Stain Index. The index assesses the area and intensity of extrinsic tooth stain on the facial and lingual surfaces of the lower anterior teeth and the facial surfaces of the upper anterior teeth. Each evaluated tooth surface was divided into two anatomical regions: body and gingival. For each region, a composite score is calculated by averaging the product of the intensity and extent scores.\n\nEach region (body and gingival) has a score range of 0-9 (minimum = 0, maximum = 9).\n\nThe mean Lobene stain composite score was determined by summing the scores from all assessed regions of the tooth surfaces and dividing by the total number of regions evaluated.\n\nHigher scores (both subscale and mean score) indicate a worse outcome (i.e., more severe extrinsic tooth stain).'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Controlled Clinical Trial', 'Electric Toothbrush'], 'conditions': ['Tooth Bleaching']}, 'descriptionModule': {'briefSummary': 'The objective of the present study was to compare the effects of reduction of extrinsic stains between 2 commercially available Oclean sonic toothbrushes in comparison with an Oral-B manual toothbrush.', 'detailedDescription': "Extrinsic tooth stain, especially on anterior teeth, is a common aesthetic issue that affect smile and self-confidence. Epidemiological studies show that dissatisfaction with tooth color impacts approximately 20% to 60% of various population groups. In a Chinese urban sample, 52.6% reported dissatisfaction with tooth color. Patients often express a desire to achieve whiter teeth, as it improves smile aesthetics, attractiveness and quality of life. It also promotes overall oral health and well-being.\n\nMechanical tooth cleaning through brushing remains the most effective approach for daily oral hygiene, effectively removing plaque and stain to maintain oral health, irrespective of the use of dentifrice. The effectiveness of manual toothbrush is predominantly influenced by users' brushing habits and their compliance with professional recommendations.\n\nThe electric toothbrush was first introduced in Switzerland in 1954. It was designed to simulate and enhance manual brushing motions, thereby potentially offering an improved cleaning experience. Modern electric toothbrushes feature integrated timers, pressure sensors, multiple brushing modes, and Bluetooth-enabled apps to enhance brushing duration and quality. The Oclean Digital Visual toothbrush and Oclean Sonic Electric toothbrush, developed by a Shenzhen-based Chinese company, exemplify these innovations. Both sonic toothbrushes feature silent motor technology to reduce noise, avoid resonant frequencies to lessen facial discomfort, and provide real-time pressure feedback to prevent excessive brushing force. Together, these enhancements ensure a quieter, smoother, and more comfortable brushing experience. While both models share core manufacturing parameters, the Oclean Digital Visual toothbrush provides a higher driving torque (2.16 N.cm) than the Oclean Sonic Electric toothbrush (1.96 N.cm)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'The inclusion criteria were: 1) aged 18-70 years; 2) good general health; 3) ability to attend all scheduled visits over the 8-week study period; 4) possession of more than 20 natural permanent teeth, excluding third molars, which are free of crowns or extensive restorative materials; 5) at least 12 anterior teeth suitable for scoring (i.e., free of crowns, veneers, large restorations, trauma, or non-vital pulp); 6) a whole-mouth mean Lobene stain composite score greater than 1.\n\nExclusion criteria included: 1) severe oral or systemic diseases; 2) advanced periodontal diseases; 3) pregnancy or lactation; 4) dental fluorosis or tetracycline staining; 5) orthodontic appliances or partial removable dentures; 6) participation in other clinical trials; 7) professional prophylaxis within 3 months or tooth whitening within 6 months; and 8) known allergy to study products.'}, 'identificationModule': {'nctId': 'NCT05202093', 'briefTitle': 'Efficacy of Two Sonic Toothbrushes in Reducing Extrinsic Tooth Stain', 'organization': {'class': 'OTHER', 'fullName': 'Sun Yat-sen University'}, 'officialTitle': 'Efficacy of Two Sonic Toothbrushes in Reducing Extrinsic Tooth Stain: An 8-week Randomized Clinical Trial', 'orgStudyIdInfo': {'id': 'Whitening sonic toothbrush'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'the Oclean Digital Visual toothbrush (2.16 N·cm torque)', 'description': 'Use the Oclean Digital Visual toothbrush (2.16 N·cm torque) to brush teeth twice daily for 8 weeks', 'interventionNames': ['Device: the Oclean Digital Visual toothbrush (2.16 N·cm torque)']}, {'type': 'EXPERIMENTAL', 'label': 'the Oclean Sonic Electric toothbrush (1.96 N·cm torque)', 'description': 'Use the Oclean Sonic Electric toothbrush (1.96 N·cm torque) to brush teeth twice daily for 8 week', 'interventionNames': ['Device: the Oclean Sonic Electric toothbrush (1.96 N·cm torque)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Manual toothbrush', 'description': 'Use Oral-B manual toothbrush to brush teeth twice daily for 8 weeks', 'interventionNames': ['Device: Oral B manual toothbrush']}], 'interventions': [{'name': 'the Oclean Digital Visual toothbrush (2.16 N·cm torque)', 'type': 'DEVICE', 'description': 'Use the Oclean Digital Visual toothbrush (2.16 N·cm torque) to brush teeth twice a day for 8 weeks', 'armGroupLabels': ['the Oclean Digital Visual toothbrush (2.16 N·cm torque)']}, {'name': 'Oral B manual toothbrush', 'type': 'DEVICE', 'description': 'Use Oral B manual toothbrush to brush teeth twice a day for 8 weeks', 'armGroupLabels': ['Manual toothbrush']}, {'name': 'the Oclean Sonic Electric toothbrush (1.96 N·cm torque)', 'type': 'DEVICE', 'description': 'Use the Oclean Sonic Electric toothbrush (1.96 N·cm torque) to brush teeth twice a day for 8 weeks', 'armGroupLabels': ['the Oclean Sonic Electric toothbrush (1.96 N·cm torque)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '510055', 'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'facility': 'Hongchun Liu', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}], 'overallOfficials': [{'name': 'Hongchun Liu', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Guanghua School of Stomatology, Sun Yat-sen University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sun Yat-sen University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Liu Hongchun', 'investigatorAffiliation': 'Hospital of Stomatology, Sun Yat-Sen University'}}}}