Trial Outcomes & Findings for Effectiveness of Customized Handle Toothbrush (NCT NCT04845633)
NCT ID: NCT04845633
Last Updated: 2021-08-12
Results Overview
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.
COMPLETED
NA
48 participants
Baseline: Pre-brushing
2021-08-12
Participant Flow
Participant milestones
| Measure |
Healthy Children Using Toothbrush With Customized Handle
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
|
Healthy Children Using Conventional Toothbrush
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
|
Children With Down Syndrome Using Conventional Toothbrush
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
|
Children With Down Syndrome Using Toothbrush With Customized Handle
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
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
12
|
12
|
12
|
12
|
|
Overall Study
COMPLETED
|
12
|
12
|
12
|
12
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effectiveness of Customized Handle Toothbrush
Baseline characteristics by cohort
| Measure |
Healthy Children Using Conventional Toothbrush
n=12 Participants
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
|
Healthy Children Using Toothbrush With Customized Handle
n=12 Participants
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
|
Children With Down Syndrome Using Conventional Toothbrush
n=12 Participants
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
|
Children With Down Syndrome Using Toothbrush With Customized Handle
n=12 Participants
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
|
Total
n=48 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
7 years
STANDARD_DEVIATION .9 • n=99 Participants
|
7 years
STANDARD_DEVIATION .7 • n=107 Participants
|
7.7 years
STANDARD_DEVIATION .9 • n=206 Participants
|
7.4 years
STANDARD_DEVIATION 1.1 • n=7 Participants
|
7.2 years
STANDARD_DEVIATION .9 • n=31 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
7 Participants
n=7 Participants
|
26 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
5 Participants
n=7 Participants
|
22 Participants
n=31 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
12 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
12 Participants
n=7 Participants
|
48 Participants
n=31 Participants
|
PRIMARY outcome
Timeframe: Baseline: Pre-brushingPlaque 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.
Outcome measures
| Measure |
Children With Down Syndrome Using Toothbrush With Customized Handle
n=12 Participants
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
|
Healthy Children Using Conventional Toothbrush
n=12 Participants
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
|
Healthy Children Using Toothbrush With Customized Handle
n=12 Participants
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
|
Children With Down Syndrome Using Conventional Toothbrush
n=12 Participants
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
|
|---|---|---|---|---|
|
Clinical Plaque Evaluation of Healthy Children and Down Syndrome of Both Groups at the Baseline
|
3.41 score on a scale
Standard Deviation .25
|
3.05 score on a scale
Standard Deviation .48
|
3.19 score on a scale
Standard Deviation .5
|
3.63 score on a scale
Standard Deviation .29
|
PRIMARY outcome
Timeframe: Post-brushingPlaque 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.
Outcome measures
| Measure |
Children With Down Syndrome Using Toothbrush With Customized Handle
n=12 Participants
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
|
Healthy Children Using Conventional Toothbrush
n=12 Participants
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
|
Healthy Children Using Toothbrush With Customized Handle
n=12 Participants
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
|
Children With Down Syndrome Using Conventional Toothbrush
n=12 Participants
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
|
|---|---|---|---|---|
|
Clinical Plaque Evaluation of Healthy Children and Down Syndrome of Both Groups After Brushing
|
.97 score on a scale
Standard Deviation .35
|
1.7 score on a scale
Standard Deviation .68
|
.96 score on a scale
Standard Deviation .29
|
2.69 score on a scale
Standard Deviation .45
|
SECONDARY outcome
Timeframe: 1 weekPlaque 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.
Outcome measures
| Measure |
Children With Down Syndrome Using Toothbrush With Customized Handle
n=12 Participants
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
|
Healthy Children Using Conventional Toothbrush
n=12 Participants
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
|
Healthy Children Using Toothbrush With Customized Handle
n=12 Participants
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
|
Children With Down Syndrome Using Conventional Toothbrush
n=12 Participants
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
|
|---|---|---|---|---|
|
Clinical Plaque Evaluation of Healthy Children and Down Syndrome of Both Groups After a Week
|
.52 score on a scale
Standard Deviation .21
|
1.41 score on a scale
Standard Deviation .39
|
.38 score on a scale
Standard Deviation .43
|
2.23 score on a scale
Standard Deviation .54
|
POST_HOC outcome
Timeframe: 3 weeksPlaque 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.
Outcome measures
| Measure |
Children With Down Syndrome Using Toothbrush With Customized Handle
n=12 Participants
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
|
Healthy Children Using Conventional Toothbrush
n=12 Participants
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
|
Healthy Children Using Toothbrush With Customized Handle
n=12 Participants
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
|
Children With Down Syndrome Using Conventional Toothbrush
n=12 Participants
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
|
|---|---|---|---|---|
|
Clinical Plaque Evaluation of Healthy Children and Down Syndrome of Both Groups After Three Weeks
|
.26 score on a scale
Standard Deviation .1
|
.14 score on a scale
Standard Deviation .27
|
1.21 score on a scale
Standard Deviation .47
|
1.91 score on a scale
Standard Deviation .58
|
Adverse Events
Healthy Children Using Toothbrush With Customized Handle
Healthy Children Using Conventional Toothbrush
Children With Down Syndrome Using Conventional Toothbrush
Children With Down Syndrome Using Toothbrush With Customized Handle
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place