Effectiveness of Customized Handle Toothbrush
Primary Purpose
Dental Plaque, Dental Prophylaxis, Dental Care
Status
Completed
Phase
Not Applicable
Locations
Syrian Arab Republic
Study Type
Interventional
Intervention
Evaluation of the Effectiveness of Conventional Toothbrush in Dental Plaque Control in Healthy Children
Evaluation of the Effectiveness of Customized Handle Toothbrush in Dental Plaque Control in Healthy Children
Evaluation of the Effectiveness of Conventional Toothbrush in Dental Plaque Control in Children with Down Syndrome
Evaluation of the Effectiveness of Customized Handle Toothbrush in Dental Plaque Control in Children with Down Syndrome
Sponsored by
About this trial
This is an interventional prevention trial for Dental Plaque focused on measuring Customized Handle Toothbrush, Dental Primary Prevention, Down Syndrome
Eligibility Criteria
Inclusion criteria:
- Ages between 6-9 years old.
- Participant must have at least 10 teeth free from dental caries on both buccal and lingual surfaces of the teeth.
- TMQHPI is at least 2.
- Cooperative participant (Positive according to Frankel's behavioral rating scale).
- Parents' consent.
- Participant with down syndrome must have been diagnosed by specialist.
Exclusion criteria:
- Children undergoing orthodontic treatment.
- Allergic to any of the toothpaste ingredient used the study.
- Participant used any toothbrush other than the conventional brush before.
- Healthy children Participant with systemic diseases
- Excluding children with Down syndrome who suffer from chronic weakness such as epilepsy or taking medications continuously.
Sites / Locations
- Damascus University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Other
Experimental
Other
Experimental
Arm Label
Healthy children using conventional toothbrush
Healthy children using toothbrush with Customized Handle
Children with Down syndrome using conventional toothbrush
Children with Down syndrome using toothbrush with Customized Handle
Arm Description
Outcomes
Primary Outcome Measures
Clinical Plaque Evaluation of Healthy Children and Down Syndrome of Both Groups at the Baseline
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.
Clinical Plaque Evaluation of Healthy Children and Down Syndrome of Both Groups After Brushing
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.
Secondary Outcome Measures
Clinical Plaque Evaluation of Healthy Children and Down Syndrome of Both Groups After a Week
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04845633
Brief Title
Effectiveness of Customized Handle Toothbrush
Official Title
Evaluation of the Effectiveness of Customized Handle Toothbrush in Dental Plaque Control in Healthy Children and Children With Down Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
April 9, 2021 (Actual)
Primary Completion Date
May 14, 2021 (Actual)
Study Completion Date
May 16, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Damascus University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
People with special needs suffer from many difficulties, including mental, physical or motor, which increase the difficulty of obtaining good oral health.
Therefore, some adjustments must be made to help these patients maintain oral health.
The 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.
Detailed Description
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:
A group of healthy children using conventional toothbrush (12 children).
A group of healthy children using toothbrush with Customized Handle (12 children).
A group of children with Down syndrome using conventional toothbrush (12 children).
A group of children with Down syndrome using toothbrush with Customized Handle (12 children).
Secondly,
Researcher will take an impression of the child hand grasp silicon impression material.
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.
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.
Third, Brushing instructions:
The researcher will teach the participants how to brush by using (tell-show -do) technique.
The brushing method that will be used is the modified Stillman technique.
Brushing duration must be at least 3 minutes.
The brushing must be twice a day.
The amount of toothpaste is pea size.
Finally, Mechanism of examination and follow up:
After 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.
The participants will be observed in the same day, before and after brushing, and after one week and three weeks
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Plaque, Dental Prophylaxis, Dental Care
Keywords
Customized Handle Toothbrush, Dental Primary Prevention, Down Syndrome
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
48 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Healthy children using conventional toothbrush
Arm Type
Other
Arm Title
Healthy children using toothbrush with Customized Handle
Arm Type
Experimental
Arm Title
Children with Down syndrome using conventional toothbrush
Arm Type
Other
Arm Title
Children with Down syndrome using toothbrush with Customized Handle
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Evaluation of the Effectiveness of Conventional Toothbrush in Dental Plaque Control in Healthy Children
Intervention 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
Intervention Type
Other
Intervention Name(s)
Evaluation of the Effectiveness of Customized Handle Toothbrush in Dental Plaque Control in Healthy Children
Intervention 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
Intervention Type
Other
Intervention Name(s)
Evaluation of the Effectiveness of Conventional Toothbrush in Dental Plaque Control in Children with Down Syndrome
Intervention 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
Intervention Type
Other
Intervention Name(s)
Evaluation of the Effectiveness of Customized Handle Toothbrush in Dental Plaque Control in Children with Down Syndrome
Intervention 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
Primary Outcome Measure Information:
Title
Clinical Plaque Evaluation of Healthy Children and Down Syndrome of Both Groups at the Baseline
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.
Time Frame
Baseline: Pre-brushing
Title
Clinical Plaque Evaluation of Healthy Children and Down Syndrome of Both Groups After 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.
Time Frame
Post-brushing
Secondary Outcome Measure Information:
Title
Clinical Plaque Evaluation of Healthy Children and Down Syndrome of Both Groups After a 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.
Time Frame
1 week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
9 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria:
Ages between 6-9 years old.
Participant must have at least 10 teeth free from dental caries on both buccal and lingual surfaces of the teeth.
TMQHPI is at least 2.
Cooperative participant (Positive according to Frankel's behavioral rating scale).
Parents' consent.
Participant with down syndrome must have been diagnosed by specialist.
Exclusion criteria:
Children undergoing orthodontic treatment.
Allergic to any of the toothpaste ingredient used the study.
Participant used any toothbrush other than the conventional brush before.
Healthy children Participant with systemic diseases
Excluding children with Down syndrome who suffer from chronic weakness such as epilepsy or taking medications continuously.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Line B Droubi, DDs
Organizational Affiliation
MSc student in Pedodontics, University of Damascus
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mohannad G Laflouf, Phd
Organizational Affiliation
Professor of Pedodontics, Department of Pedodontics, University of Damascus
Official's Role
Study Director
Facility Information:
Facility Name
Damascus University
City
Damascus
ZIP/Postal Code
30621
Country
Syrian Arab Republic
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
12131899
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.
Results Reference
background
PubMed Identifier
26155573
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.
Results Reference
background
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Effectiveness of Customized Handle Toothbrush
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