Ignite Creation Date:
2025-12-25 @ 2:52 AM
Ignite Modification Date:
2025-12-26 @ 1:33 AM
Study NCT ID:
NCT04845633
Status:
COMPLETED
Last Update Posted:
2021-08-12
First Post:
2021-04-11
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Effectiveness of Customized Handle Toothbrush
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003773', 'term': 'Dental Plaque'}, {'id': 'D004314', 'term': 'Down Syndrome'}], 'ancestors': [{'id': 'D003741', 'term': 'Dental Deposits'}, {'id': 'D014076', 'term': 'Tooth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D008607', 'term': 'Intellectual Disability'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D000015', 'term': 'Abnormalities, Multiple'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D025063', 'term': 'Chromosome Disorders'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'droubiline@gmail.com', 'phone': '00963966896989', 'title': 'Dr. Line Droubi', 'organization': 'Damascus University'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'Base line between normal children group and down children group can not be achieved easily, yet it can be compared later after a week and three weeks and give some valuable information.'}}, 'adverseEventsModule': {'timeFrame': 'Throw study completion.Plaque accumulation was evaluated at four times 1- Pre-brushing at baseline. 2- Post-brushing at baseline. 3- 1 week from baseline 4- 3 weeks from baseline .', 'description': 'Serious or other non-serious adverse events were not collected in the current trial.', 'eventGroups': [{'id': 'EG000', 'title': 'Healthy Children Using Toothbrush With Customized Handle', 'description': 'Evaluation of the Effectiveness of Customized Handle Toothbrush in Dental Plaque Control in Healthy Children: Healthy children will be given toothbrush with Customized Handle.Plaque scores in groups will be assess pre-brushing and post-brushing in baseline, a week, and after 3 weeks by using the Turesky Modification of the Quigley-Hein Plaque Index (TMQHPI) for both buccal and lingual surfaces', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 12, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Healthy Children Using Conventional Toothbrush', 'description': 'Evaluation of the Effectiveness of Conventional Toothbrush in Dental Plaque Control in Healthy Children: Healthy children will be given conventional toothbrush.Plaque scores in groups will be assess pre-brushing and post-brushing in baseline, a week, and after 3 weeks by using the Turesky Modification of the Quigley-Hein Plaque Index (TMQHPI) for both buccal and lingual surfaces', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 12, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Children With Down Syndrome Using Conventional Toothbrush', 'description': 'Evaluation of the Effectiveness of Conventional Toothbrush in Dental Plaque Control in Children with Down Syndrome: Children with Down syndrome will be given conventional toothbrush.Plaque scores in groups will be assess pre-brushing and post-brushing in baseline, a week, and after 3 week by using the Turesky Modification of the Quigley-Hein Plaque Index (TMQHPI) for both buccal and lingual surfaces', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 12, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Children With Down Syndrome Using Toothbrush With Customized Handle', 'description': 'Evaluation of the Effectiveness of Customized Handle Toothbrush in Dental Plaque Control in Children with Down Syndrome: Children with Down syndrome will be given toothbrush with Customized Handle.Plaque scores in groups will be assess pre-brushing and post-brushing in baseline, a week, and after 3 weeks by using the Turesky Modification of the Quigley-Hein Plaque Index (TMQHPI) for both buccal and lingual surfaces', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 12, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Clinical Plaque Evaluation of Healthy Children and Down Syndrome of Both Groups at the Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Healthy Children Using Toothbrush With Customized Handle', 'description': 'Evaluation of the Effectiveness of Customized Handle Toothbrush in Dental Plaque Control in Healthy Children: Healthy children will be given toothbrush with Customized Handle.Plaque scores in groups will be assess pre-brushing and post-brushing in baseline, a week, and after 3 weeks by using the Turesky Modification of the Quigley-Hein Plaque Index (TMQHPI) for both buccal and lingual surfaces'}, {'id': 'OG001', 'title': 'Healthy Children Using Conventional Toothbrush', 'description': 'Evaluation of the Effectiveness of Conventional Toothbrush in Dental Plaque Control in Healthy Children: Healthy children will be given conventional toothbrush.Plaque scores in groups will be assess pre-brushing and post-brushing in baseline, a week, and after 3 weeks by using the Turesky Modification of the Quigley-Hein Plaque Index (TMQHPI) for both buccal and lingual surfaces'}, {'id': 'OG002', 'title': 'Children With Down Syndrome Using Conventional Toothbrush', 'description': 'Evaluation of the Effectiveness of Conventional Toothbrush in Dental Plaque Control in Children with Down Syndrome: Children with Down syndrome will be given conventional toothbrush.Plaque scores in groups will be assess pre-brushing and post-brushing in baseline, a week, and after 3 week by using the Turesky Modification of the Quigley-Hein Plaque Index (TMQHPI) for both buccal and lingual surfaces'}, {'id': 'OG003', 'title': 'Children With Down Syndrome Using Toothbrush With Customized Handle', 'description': 'Evaluation of the Effectiveness of Customized Handle Toothbrush in Dental Plaque Control in Children with Down Syndrome: Children with Down syndrome will be given toothbrush with Customized Handle.Plaque scores in groups will be assess pre-brushing and post-brushing in baseline, a week, and after 3 weeks by using the Turesky Modification of the Quigley-Hein Plaque Index (TMQHPI) for both buccal and lingual surfaces'}], 'classes': [{'categories': [{'measurements': [{'value': '3.05', 'spread': '.48', 'groupId': 'OG000'}, {'value': '3.19', 'spread': '.5', 'groupId': 'OG001'}, {'value': '3.63', 'spread': '.29', 'groupId': 'OG002'}, {'value': '3.41', 'spread': '.25', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline: Pre-brushing', 'description': 'Plaque scores will be assessed with Turesky Modification of the Quigley-Hein Plaque Index (TMQHPI). Plaque will be detected using plaque disclosing agent. In this index the plaque is evaluated and revealed on the buccal and lingual non-restored surfaces of the teeth on a scale of 0 to 5. Where 0 means no plaque presence which is considered as a perfect state, 1 separated flecks of plaque at the cervical margin, 2 a thin continuous back of plaque (up to 1 mm) at the cervical margin, 3 a band of plaque wider than 1 mm but covering less than one-third of the side of the crown of the tooth, 4 plaque covering at least one-third but less than two-thirds of the side of crown of the tooth and finally 5 is considered as the worst state by plaque covering two-thirds or more of the side of the crown of the tooth. All teeth are assessed. The final outcome is determined by an index of the entire mouth by dividing the total score by the number of surfaces examined.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Clinical Plaque Evaluation of Healthy Children and Down Syndrome of Both Groups After Brushing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Healthy Children Using Conventional Toothbrush', 'description': 'Evaluation of the Effectiveness of Conventional Toothbrush in Dental Plaque Control in Healthy Children: Healthy children will be given conventional toothbrush.Plaque scores in groups will be assess pre-brushing and post-brushing in baseline, a week, and after 3 weeks by using the Turesky Modification of the Quigley-Hein Plaque Index (TMQHPI) for both buccal and lingual surfaces'}, {'id': 'OG001', 'title': 'Healthy Children Using Toothbrush With Customized Handle', 'description': 'Evaluation of the Effectiveness of Customized Handle Toothbrush in Dental Plaque Control in Healthy Children: Healthy children will be given toothbrush with Customized Handle.Plaque scores in groups will be assess pre-brushing and post-brushing in baseline, a week, and after 3 weeks by using the Turesky Modification of the Quigley-Hein Plaque Index (TMQHPI) for both buccal and lingual surfaces'}, {'id': 'OG002', 'title': 'Children With Down Syndrome Using Conventional Toothbrush', 'description': 'Evaluation of the Effectiveness of Conventional Toothbrush in Dental Plaque Control in Children with Down Syndrome: Children with Down syndrome will be given conventional toothbrush.Plaque scores in groups will be assess pre-brushing and post-brushing in baseline, a week, and after 3 week by using the Turesky Modification of the Quigley-Hein Plaque Index (TMQHPI) for both buccal and lingual surfaces'}, {'id': 'OG003', 'title': 'Children With Down Syndrome Using Toothbrush With Customized Handle', 'description': 'Evaluation of the Effectiveness of Customized Handle Toothbrush in Dental Plaque Control in Children with Down Syndrome: Children with Down syndrome will be given toothbrush with Customized Handle.Plaque scores in groups will be assess pre-brushing and post-brushing in baseline, a week, and after 3 weeks by using the Turesky Modification of the Quigley-Hein Plaque Index (TMQHPI) for both buccal and lingual surfaces'}], 'classes': [{'categories': [{'measurements': [{'value': '1.7', 'spread': '.68', 'groupId': 'OG000'}, {'value': '.96', 'spread': '.29', 'groupId': 'OG001'}, {'value': '2.69', 'spread': '.45', 'groupId': 'OG002'}, {'value': '.97', 'spread': '.35', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Post-brushing', 'description': 'Plaque scores will be assessed with Turesky Modification of the Quigley-Hein Plaque Index (TMQHPI). Plaque will be detected using plaque disclosing agent. In this index the plaque is evaluated and revealed on the buccal and lingual non-restored surfaces of the teeth on a scale of 0 to 5. Where 0 means no plaque presence which is considered as a perfect state, 1 separated flecks of plaque at the cervical margin, 2 a thin continuous back of plaque (up to 1 mm) at the cervical margin, 3 a band of plaque wider than 1 mm but covering less than one-third of the side of the crown of the tooth, 4 plaque covering at least one-third but less than two-thirds of the side of crown of the tooth and finally 5 is considered as the worst state by plaque covering two-thirds or more of the side of the crown of the tooth. All teeth are assessed. The final outcome is determined by an index of the entire mouth by dividing the total score by the number of surfaces examined.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Clinical Plaque Evaluation of Healthy Children and Down Syndrome of Both Groups After a Week', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Healthy Children Using Conventional Toothbrush', 'description': 'Evaluation of the Effectiveness of Conventional Toothbrush in Dental Plaque Control in Healthy Children: Healthy children will be given conventional toothbrush.Plaque scores in groups will be assess pre-brushing and post-brushing in baseline, a week, and after 3 weeks by using the Turesky Modification of the Quigley-Hein Plaque Index (TMQHPI) for both buccal and lingual surfaces'}, {'id': 'OG001', 'title': 'Healthy Children Using Toothbrush With Customized Handle', 'description': 'Evaluation of the Effectiveness of Customized Handle Toothbrush in Dental Plaque Control in Healthy Children: Healthy children will be given toothbrush with Customized Handle.Plaque scores in groups will be assess pre-brushing and post-brushing in baseline, a week, and after 3 weeks by using the Turesky Modification of the Quigley-Hein Plaque Index (TMQHPI) for both buccal and lingual surfaces'}, {'id': 'OG002', 'title': 'Children With Down Syndrome Using Conventional Toothbrush', 'description': 'Evaluation of the Effectiveness of Conventional Toothbrush in Dental Plaque Control in Children with Down Syndrome: Children with Down syndrome will be given conventional toothbrush.Plaque scores in groups will be assess pre-brushing and post-brushing in baseline, a week, and after 3 week by using the Turesky Modification of the Quigley-Hein Plaque Index (TMQHPI) for both buccal and lingual surfaces'}, {'id': 'OG003', 'title': 'Children With Down Syndrome Using Toothbrush With Customized Handle', 'description': 'Evaluation of the Effectiveness of Customized Handle Toothbrush in Dental Plaque Control in Children with Down Syndrome: Children with Down syndrome will be given toothbrush with Customized Handle.Plaque scores in groups will be assess pre-brushing and post-brushing in baseline, a week, and after 3 weeks by using the Turesky Modification of the Quigley-Hein Plaque Index (TMQHPI) for both buccal and lingual surfaces'}], 'classes': [{'categories': [{'measurements': [{'value': '1.41', 'spread': '.39', 'groupId': 'OG000'}, {'value': '.38', 'spread': '.43', 'groupId': 'OG001'}, {'value': '2.23', 'spread': '.54', 'groupId': 'OG002'}, {'value': '.52', 'spread': '.21', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 week', 'description': 'Plaque scores will be assessed with Turesky Modification of the Quigley-Hein Plaque Index (TMQHPI). Plaque will be detected using plaque disclosing agent. In this index the plaque is evaluated and revealed on the buccal and lingual non-restored surfaces of the teeth on a scale of 0 to 5. Where 0 means no plaque presence which is considered as a perfect state, 1 separated flecks of plaque at the cervical margin, 2 a thin continuous back of plaque (up to 1 mm) at the cervical margin, 3 a band of plaque wider than 1 mm but covering less than one-third of the side of the crown of the tooth, 4 plaque covering at least one-third but less than two-thirds of the side of crown of the tooth and finally 5 is considered as the worst state by plaque covering two-thirds or more of the side of the crown of the tooth. All teeth are assessed. The final outcome is determined by an index of the entire mouth by dividing the total score by the number of surfaces examined.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'POST_HOC', 'title': 'Clinical Plaque Evaluation of Healthy Children and Down Syndrome of Both Groups After Three Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Healthy Children Using Toothbrush With Customized Handle', 'description': 'Evaluation of the Effectiveness of Customized Handle Toothbrush in Dental Plaque Control in Healthy Children: Healthy children will be given toothbrush with Customized Handle.Plaque scores in groups will be assess pre-brushing and post-brushing in baseline, a week, and after 3 weeks by using the Turesky Modification of the Quigley-Hein Plaque Index (TMQHPI) for both buccal and lingual surfaces'}, {'id': 'OG001', 'title': 'Healthy Children Using Conventional Toothbrush', 'description': 'Evaluation of the Effectiveness of Conventional Toothbrush in Dental Plaque Control in Healthy Children: Healthy children will be given conventional toothbrush.Plaque scores in groups will be assess pre-brushing and post-brushing in baseline, a week, and after 3 weeks by using the Turesky Modification of the Quigley-Hein Plaque Index (TMQHPI) for both buccal and lingual surfaces'}, {'id': 'OG002', 'title': 'Children With Down Syndrome Using Conventional Toothbrush', 'description': 'Evaluation of the Effectiveness of Conventional Toothbrush in Dental Plaque Control in Children with Down Syndrome: Children with Down syndrome will be given conventional toothbrush.Plaque scores in groups will be assess pre-brushing and post-brushing in baseline, a week, and after 3 week by using the Turesky Modification of the Quigley-Hein Plaque Index (TMQHPI) for both buccal and lingual surfaces'}, {'id': 'OG003', 'title': 'Children With Down Syndrome Using Toothbrush With Customized Handle', 'description': 'Evaluation of the Effectiveness of Customized Handle Toothbrush in Dental Plaque Control in Children with Down Syndrome: Children with Down syndrome will be given toothbrush with Customized Handle.Plaque scores in groups will be assess pre-brushing and post-brushing in baseline, a week, and after 3 weeks by using the Turesky Modification of the Quigley-Hein Plaque Index (TMQHPI) for both buccal and lingual surfaces'}], 'classes': [{'categories': [{'measurements': [{'value': '.14', 'spread': '.27', 'groupId': 'OG000'}, {'value': '1.21', 'spread': '.47', 'groupId': 'OG001'}, {'value': '1.91', 'spread': '.58', 'groupId': 'OG002'}, {'value': '.26', 'spread': '.1', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3 weeks', 'description': 'Plaque scores will be assessed with Turesky Modification of the Quigley-Hein Plaque Index (TMQHPI). Plaque will be detected using plaque disclosing agent. In this index the plaque is evaluated and revealed on the buccal and lingual non-restored surfaces of the teeth on a scale of 0 to 5. Where 0 means no plaque presence which is considered as a perfect state, 1 separated flecks of plaque at the cervical margin, 2 a thin continuous back of plaque (up to 1 mm) at the cervical margin, 3 a band of plaque wider than 1 mm but covering less than one-third of the side of the crown of the tooth, 4 plaque covering at least one-third but less than two-thirds of the side of crown of the tooth and finally 5 is considered as the worst state by plaque covering two-thirds or more of the side of the crown of the tooth. All teeth are assessed. The final outcome is determined by an index of the entire mouth by dividing the total score by the number of surfaces examined.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Healthy Children Using Toothbrush With Customized Handle', 'description': 'Evaluation of the Effectiveness of Customized Handle Toothbrush in Dental Plaque Control in Healthy Children: Healthy children will be given toothbrush with Customized Handle.Plaque scores in groups will be assess pre-brushing and post-brushing in baseline, a week, and after 3 weeks by using the Turesky Modification of the Quigley-Hein Plaque Index (TMQHPI) for both buccal and lingual surfaces'}, {'id': 'FG001', 'title': 'Healthy Children Using Conventional Toothbrush', 'description': 'Evaluation of the Effectiveness of Conventional Toothbrush in Dental Plaque Control in Healthy Children: Healthy children will be given conventional toothbrush.Plaque scores in groups will be assess pre-brushing and post-brushing in baseline, a week, and after 3 weeks by using the Turesky Modification of the Quigley-Hein Plaque Index (TMQHPI) for both buccal and lingual surfaces'}, {'id': 'FG002', 'title': 'Children With Down Syndrome Using Conventional Toothbrush', 'description': 'Evaluation of the Effectiveness of Conventional Toothbrush in Dental Plaque Control in Children with Down Syndrome: Children with Down syndrome will be given conventional toothbrush.Plaque scores in groups will be assess pre-brushing and post-brushing in baseline, a week, and after 3 week by using the Turesky Modification of the Quigley-Hein Plaque Index (TMQHPI) for both buccal and lingual surfaces'}, {'id': 'FG003', 'title': 'Children With Down Syndrome Using Toothbrush With Customized Handle', 'description': 'Evaluation of the Effectiveness of Customized Handle Toothbrush in Dental Plaque Control in Children with Down Syndrome: Children with Down syndrome will be given toothbrush with Customized Handle.Plaque scores in groups will be assess pre-brushing and post-brushing in baseline, a week, and after 3 weeks by using the Turesky Modification of the Quigley-Hein Plaque Index (TMQHPI) for both buccal and lingual surfaces'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '12'}, {'groupId': 'FG002', 'numSubjects': '12'}, {'groupId': 'FG003', 'numSubjects': '12'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '12'}, {'groupId': 'FG002', 'numSubjects': '12'}, {'groupId': 'FG003', 'numSubjects': '12'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}, {'value': '48', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Healthy Children Using Conventional Toothbrush', 'description': 'Evaluation of the Effectiveness of Conventional Toothbrush in Dental Plaque Control in Healthy Children: Healthy children will be given conventional toothbrush.Plaque scores in groups will be assess pre-brushing and post-brushing in baseline, a week, and after 3 weeks by using the Turesky Modification of the Quigley-Hein Plaque Index (TMQHPI) for both buccal and lingual surfaces'}, {'id': 'BG001', 'title': 'Healthy Children Using Toothbrush With Customized Handle', 'description': 'Evaluation of the Effectiveness of Customized Handle Toothbrush in Dental Plaque Control in Healthy Children: Healthy children will be given toothbrush with Customized Handle.Plaque scores in groups will be assess pre-brushing and post-brushing in baseline, a week, and after 3 weeks by using the Turesky Modification of the Quigley-Hein Plaque Index (TMQHPI) for both buccal and lingual surfaces'}, {'id': 'BG002', 'title': 'Children With Down Syndrome Using Conventional Toothbrush', 'description': 'Evaluation of the Effectiveness of Conventional Toothbrush in Dental Plaque Control in Children with Down Syndrome: Children with Down syndrome will be given conventional toothbrush.Plaque scores in groups will be assess pre-brushing and post-brushing in baseline, a week, and after 3 week by using the Turesky Modification of the Quigley-Hein Plaque Index (TMQHPI) for both buccal and lingual surfaces'}, {'id': 'BG003', 'title': 'Children With Down Syndrome Using Toothbrush With Customized Handle', 'description': 'Evaluation of the Effectiveness of Customized Handle Toothbrush in Dental Plaque Control in Children with Down Syndrome: Children with Down syndrome will be given toothbrush with Customized Handle.Plaque scores in groups will be assess pre-brushing and post-brushing in baseline, a week, and after 3 weeks by using the Turesky Modification of the Quigley-Hein Plaque Index (TMQHPI) for both buccal and lingual surfaces'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '7', 'spread': '.9', 'groupId': 'BG000'}, {'value': '7', 'spread': '.7', 'groupId': 'BG001'}, {'value': '7.7', 'spread': '.9', 'groupId': 'BG002'}, {'value': '7.4', 'spread': '1.1', 'groupId': 'BG003'}, {'value': '7.2', 'spread': '.9', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}, {'value': '26', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '22', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'White', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}, {'value': '48', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-07-19', 'size': 485640, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-07-20T14:33', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 48}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-04-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-06', 'completionDateStruct': {'date': '2021-05-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-07-20', 'studyFirstSubmitDate': '2021-04-11', 'resultsFirstSubmitDate': '2021-05-29', 'studyFirstSubmitQcDate': '2021-04-11', 'lastUpdatePostDateStruct': {'date': '2021-08-12', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-07-20', 'studyFirstPostDateStruct': {'date': '2021-04-15', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2021-08-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-05-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical Plaque Evaluation of Healthy Children and Down Syndrome of Both Groups at the Baseline', 'timeFrame': 'Baseline: Pre-brushing', 'description': 'Plaque scores will be assessed with Turesky Modification of the Quigley-Hein Plaque Index (TMQHPI). Plaque will be detected using plaque disclosing agent. In this index the plaque is evaluated and revealed on the buccal and lingual non-restored surfaces of the teeth on a scale of 0 to 5. Where 0 means no plaque presence which is considered as a perfect state, 1 separated flecks of plaque at the cervical margin, 2 a thin continuous back of plaque (up to 1 mm) at the cervical margin, 3 a band of plaque wider than 1 mm but covering less than one-third of the side of the crown of the tooth, 4 plaque covering at least one-third but less than two-thirds of the side of crown of the tooth and finally 5 is considered as the worst state by plaque covering two-thirds or more of the side of the crown of the tooth. All teeth are assessed. The final outcome is determined by an index of the entire mouth by dividing the total score by the number of surfaces examined.'}, {'measure': 'Clinical Plaque Evaluation of Healthy Children and Down Syndrome of Both Groups After Brushing', 'timeFrame': 'Post-brushing', 'description': 'Plaque scores will be assessed with Turesky Modification of the Quigley-Hein Plaque Index (TMQHPI). Plaque will be detected using plaque disclosing agent. In this index the plaque is evaluated and revealed on the buccal and lingual non-restored surfaces of the teeth on a scale of 0 to 5. Where 0 means no plaque presence which is considered as a perfect state, 1 separated flecks of plaque at the cervical margin, 2 a thin continuous back of plaque (up to 1 mm) at the cervical margin, 3 a band of plaque wider than 1 mm but covering less than one-third of the side of the crown of the tooth, 4 plaque covering at least one-third but less than two-thirds of the side of crown of the tooth and finally 5 is considered as the worst state by plaque covering two-thirds or more of the side of the crown of the tooth. All teeth are assessed. The final outcome is determined by an index of the entire mouth by dividing the total score by the number of surfaces examined.'}], 'secondaryOutcomes': [{'measure': 'Clinical Plaque Evaluation of Healthy Children and Down Syndrome of Both Groups After a Week', 'timeFrame': '1 week', 'description': 'Plaque scores will be assessed with Turesky Modification of the Quigley-Hein Plaque Index (TMQHPI). Plaque will be detected using plaque disclosing agent. In this index the plaque is evaluated and revealed on the buccal and lingual non-restored surfaces of the teeth on a scale of 0 to 5. Where 0 means no plaque presence which is considered as a perfect state, 1 separated flecks of plaque at the cervical margin, 2 a thin continuous back of plaque (up to 1 mm) at the cervical margin, 3 a band of plaque wider than 1 mm but covering less than one-third of the side of the crown of the tooth, 4 plaque covering at least one-third but less than two-thirds of the side of crown of the tooth and finally 5 is considered as the worst state by plaque covering two-thirds or more of the side of the crown of the tooth. All teeth are assessed. The final outcome is determined by an index of the entire mouth by dividing the total score by the number of surfaces examined.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Customized Handle Toothbrush', 'Dental Primary Prevention', 'Down Syndrome'], 'conditions': ['Dental Plaque', 'Dental Prophylaxis', 'Dental Care']}, 'referencesModule': {'references': [{'pmid': '12131899', 'type': 'BACKGROUND', 'citation': 'Reeson MG, Jepson NJ. Customizing the size of toothbrush handles for patients with restricted hand and finger movement. J Prosthet Dent. 2002 Jun;87(6):700. doi: 10.1067/mpr.2002.120840. No abstract available.'}, {'pmid': '26155573', 'type': 'BACKGROUND', 'citation': 'Kammers AC, Zanetti AL, Lacerda TE, Aroca JP, Camilotti V, Mendonca MJ. Toothbrush Handles Individually Adapted for Use by Elderly Patients to Reduce Biofilm on Complete Dentures: A Pilot Study. J Clin Diagn Res. 2015 May;9(5):ZC94-7. doi: 10.7860/JCDR/2015/11261.5975. Epub 2015 May 1.'}]}, 'descriptionModule': {'briefSummary': 'People with special needs suffer from many difficulties, including mental, physical or motor, which increase the difficulty of obtaining good oral health.\n\nTherefore, some adjustments must be made to help these patients maintain oral health.\n\nThe aim of the current research is to modify the traditional toothbrush grip by manufacturing a Customized Handle of every young child or people with special needs to improve oral health for those patients by relying on themselves with an effectively way.', 'detailedDescription': "Participants will be examined to ensure that the participants have met the sample entry criteria, then the participants will be randomly assigned to four groups each one according to a group:\n\n1. A group of healthy children using conventional toothbrush (12 children).\n2. A group of healthy children using toothbrush with Customized Handle (12 children).\n3. A group of children with Down syndrome using conventional toothbrush (12 children).\n4. A group of children with Down syndrome using toothbrush with Customized Handle (12 children).\n\nSecondly,\n\n1. Researcher will take an impression of the child hand grasp silicon impression material.\n2. Researcher will scan the impression with a model scanner and copy it to the computer, then convert it -through a specialized program- to a 3D analog.\n3. The program will print the digital analog via the 3D printer using Poly Lactic Acid compound and convert it into a model similar to the patient hand grasp, this model has a place to put the toothbrush.\n\nThird, Brushing instructions:\n\n1. The researcher will teach the participants how to brush by using (tell-show -do) technique.\n2. The brushing method that will be used is the modified Stillman technique.\n3. Brushing duration must be at least 3 minutes.\n4. The brushing must be twice a day.\n5. The amount of toothpaste is pea size.\n\nFinally, Mechanism of examination and follow up:\n\nAfter apply the plaque disclosing solution on the teeth with a bond brush, the plaque will be evaluated with Turesky Modification Quigley-Hein Plaque Index, checking on the buccal and lingual surfaces of all the teeth existing in the participant's mouth.\n\nThe participants will be observed in the same day, before and after brushing, and after one week and three weeks"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '9 Years', 'minimumAge': '6 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion criteria:\n\n* Ages between 6-9 years old.\n* Participant must have at least 10 teeth free from dental caries on both buccal and lingual surfaces of the teeth.\n* TMQHPI is at least 2.\n* Cooperative participant (Positive according to Frankel's behavioral rating scale).\n* Parents' consent.\n* Participant with down syndrome must have been diagnosed by specialist.\n\nExclusion criteria:\n\n* Children undergoing orthodontic treatment.\n* Allergic to any of the toothpaste ingredient used the study.\n* Participant used any toothbrush other than the conventional brush before.\n* Healthy children Participant with systemic diseases\n* Excluding children with Down syndrome who suffer from chronic weakness such as epilepsy or taking medications continuously."}, 'identificationModule': {'nctId': 'NCT04845633', 'briefTitle': 'Effectiveness of Customized Handle Toothbrush', 'organization': {'class': 'OTHER', 'fullName': 'Damascus University'}, 'officialTitle': 'Evaluation of the Effectiveness of Customized Handle Toothbrush in Dental Plaque Control in Healthy Children and Children With Down Syndrome', 'orgStudyIdInfo': {'id': 'UDDS-Pedo-01-2021'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Healthy children using conventional toothbrush', 'interventionNames': ['Other: Evaluation of the Effectiveness of Conventional Toothbrush in Dental Plaque Control in Healthy Children']}, {'type': 'EXPERIMENTAL', 'label': 'Healthy children using toothbrush with Customized Handle', 'interventionNames': ['Other: Evaluation of the Effectiveness of Customized Handle Toothbrush in Dental Plaque Control in Healthy Children']}, {'type': 'OTHER', 'label': 'Children with Down syndrome using conventional toothbrush', 'interventionNames': ['Other: Evaluation of the Effectiveness of Conventional Toothbrush in Dental Plaque Control in Children with Down Syndrome']}, {'type': 'EXPERIMENTAL', 'label': 'Children with Down syndrome using toothbrush with Customized Handle', 'interventionNames': ['Other: Evaluation of the Effectiveness of Customized Handle Toothbrush in Dental Plaque Control in Children with Down Syndrome']}], 'interventions': [{'name': 'Evaluation of the Effectiveness of Conventional Toothbrush in Dental Plaque Control in Healthy Children', 'type': 'OTHER', 'description': 'Healthy children will be given conventional toothbrush.Plaque scores in groups will be assess pre-brushing and post-brushing in baseline, a week, and after 3 weeks by using the Turesky Modification of the Quigley-Hein Plaque Index (TMQHPI) for both buccal and lingual surfaces', 'armGroupLabels': ['Healthy children using conventional toothbrush']}, {'name': 'Evaluation of the Effectiveness of Customized Handle Toothbrush in Dental Plaque Control in Healthy Children', 'type': 'OTHER', 'description': 'Healthy children will be given toothbrush with Customized Handle.Plaque scores in groups will be assess pre-brushing and post-brushing in baseline, a week, and after 3 weeks by using the Turesky Modification of the Quigley-Hein Plaque Index (TMQHPI) for both buccal and lingual surfaces', 'armGroupLabels': ['Healthy children using toothbrush with Customized Handle']}, {'name': 'Evaluation of the Effectiveness of Conventional Toothbrush in Dental Plaque Control in Children with Down Syndrome', 'type': 'OTHER', 'description': 'Children with Down syndrome will be given conventional toothbrush.Plaque scores in groups will be assess pre-brushing and post-brushing in baseline, a week, and after 3 week by using the Turesky Modification of the Quigley-Hein Plaque Index (TMQHPI) for both buccal and lingual surfaces', 'armGroupLabels': ['Children with Down syndrome using conventional toothbrush']}, {'name': 'Evaluation of the Effectiveness of Customized Handle Toothbrush in Dental Plaque Control in Children with Down Syndrome', 'type': 'OTHER', 'description': 'Children with Down syndrome will be given toothbrush with Customized Handle.Plaque scores in groups will be assess pre-brushing and post-brushing in baseline, a week, and after 3 weeks by using the Turesky Modification of the Quigley-Hein Plaque Index (TMQHPI) for both buccal and lingual surfaces', 'armGroupLabels': ['Children with Down syndrome using toothbrush with Customized Handle']}]}, 'contactsLocationsModule': {'locations': [{'zip': '30621', 'city': 'Damascus', 'country': 'Syria', 'facility': 'Damascus University', 'geoPoint': {'lat': 33.5102, 'lon': 36.29128}}], 'overallOfficials': [{'name': 'Line B Droubi, DDs', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'MSc student in Pedodontics, University of Damascus'}, {'name': 'Mohannad G Laflouf, Phd', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Professor of Pedodontics, Department of Pedodontics, University of Damascus'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Damascus University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}