Dental PlaqueNCT04845633
Effectiveness of Customized Handle Toothbrush
A study of Dental Plaque and Dental Prophylaxis, run by Damascus University at 1 site in Syria.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 9 years
- Conditions the study is for
- Dental Plaque, Dental Prophylaxis, Dental Care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteSyria
- Study dates
- 9 Apr 2021to 16 May 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 9 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Effectiveness of Customized Handle Toothbrush in Dental Plaque Control in Healthy Children and Children With Down Syndrome
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.
Read the 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
- Conditions
- Dental Plaque, Dental Prophylaxis, Dental Care
- Being tested
- 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
- Keywords
- Customized Handle Toothbrush, Dental Primary Prevention, Down Syndrome
- Medical subject headings
- Dental Plaque, Down Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Evaluation of the Effectiveness of Conventional Toothbrush in Dental Plaque Control in Healthy ChildrenOther
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
Evaluation of the Effectiveness of Customized Handle Toothbrush in Dental Plaque Control in Healthy ChildrenOther
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
Evaluation of the Effectiveness of Conventional Toothbrush in Dental Plaque Control in Children with Down SyndromeOther
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
Evaluation of the Effectiveness of Customized Handle Toothbrush in Dental Plaque Control in Children with Down SyndromeOther
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
| Study group | Role | What they receive |
|---|---|---|
| Healthy children using conventional toothbrush | Other | Not described Receives: Other: Evaluation of the Effectiveness of Conventional Toothbrush in Dental Plaque Control in Healthy Children |
| Healthy children using toothbrush with Customized Handle | Experimental | Not described Receives: Other: Evaluation of the Effectiveness of Customized Handle Toothbrush in Dental Plaque Control in Healthy Children |
| Children with Down syndrome using conventional toothbrush | Other | Not described Receives: Other: Evaluation of the Effectiveness of Conventional Toothbrush in Dental Plaque Control in Children with Down Syndrome |
| Children with Down syndrome using toothbrush with Customized Handle | Experimental | Not described Receives: Other: Evaluation of the Effectiveness of Customized Handle Toothbrush in Dental Plaque Control in Children with Down Syndrome |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline: Pre-brushing
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.
Measured: Post-brushing
Secondary outcomes (1)
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.
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2021
- Study start9 Apr 2021
- Primary completion14 May 2021
- Study completion16 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Dental PlaqueStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Damascus University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Line B Droubi, DDs, Principal investigator, MSc student in Pedodontics, University of DamascusMohannad G Laflouf, Phd, Study director, Professor of Pedodontics, Department of Pedodontics, University of Damascus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04845633
- Sponsor's protocol ID
- UDDS-Pedo-01-2021
- Status last verified
- Jun 2021
- First submitted
- 11 Apr 2021
- Last updated
- 12 Aug 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 12131899Kammers 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.
PubMed 26155573
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effectiveness of Customized Handle Toothbrush in Dental Plaque Control in Healthy Children and Children With Down Syndrome
- ClinicalTrials.gov ID
- NCT04845633
- Acronym / sponsor ID
- UDDS-Pedo-01-2021
- Conditions
- Dental Plaque, Dental Prophylaxis, Dental Care
- Keywords
- Customized Handle Toothbrush, Dental Primary Prevention, Down Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Damascus UniversityUniversity, hospital or other
- Study start
- 9 Apr 2021 (actual)
- Primary completion
- 14 May 2021 (actual)
- Study completion
- 16 May 2021 (actual)
- First posted
- 15 Apr 2021 (actual)
- Results
- Posted 12 Aug 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Healthy children using conventional toothbrush | Other | Other: Evaluation of the Effectiveness of Conventional Toothbrush in Dental Plaque Control in Healthy Children |
| Healthy children using toothbrush with Customized Handle | Experimental | Other: Evaluation of the Effectiveness of Customized Handle Toothbrush in Dental Plaque Control in Healthy Children |
| Children with Down syndrome using conventional toothbrush | Other | Other: Evaluation of the Effectiveness of Conventional Toothbrush in Dental Plaque Control in Children with Down Syndrome |
| Children with Down syndrome using toothbrush with Customized Handle | Experimental | Other: Evaluation of the Effectiveness of Customized Handle Toothbrush in Dental Plaque Control in Children with Down Syndrome |
Who may qualify
- Ages
- 6 to 9 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Evaluation of the Effectiveness of Conventional Toothbrush in Dental Plaque Control in Healthy ChildrenHealthy 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 | Other | Healthy children using conventional toothbrush |
| Evaluation of the Effectiveness of Customized Handle Toothbrush in Dental Plaque Control in Healthy ChildrenHealthy 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 | Other | Healthy children using toothbrush with Customized Handle |
| Evaluation of the Effectiveness of Conventional Toothbrush in Dental Plaque Control in Children with Down SyndromeChildren 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 | Other | Children with Down syndrome using conventional toothbrush |
| Evaluation of the Effectiveness of Customized Handle Toothbrush in Dental Plaque Control in Children with Down SyndromeChildren 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 | Other | Children with Down syndrome using toothbrush with Customized Handle |
Primary outcome
Clinical Plaque Evaluation of Healthy Children and Down Syndrome of Both Groups at the Baseline
Time frame: Baseline: Pre-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.
Clinical Plaque Evaluation of Healthy Children and Down Syndrome of Both Groups After Brushing
Time frame: Post-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.
1 secondary outcome
Clinical Plaque Evaluation of Healthy Children and Down Syndrome of Both Groups After a Week
Time frame: 1 week
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 12131899Reeson 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.
- Background: PubMed 26155573Kammers 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Line B Droubi, DDs principal investigator
MSc student in Pedodontics, University of Damascus
Mohannad G Laflouf, Phd study director
Professor of Pedodontics, Department of Pedodontics, University of Damascus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Dental Plaque and Dental Prophylaxis, run by Damascus University at 1 site in Syria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Syria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Aug 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Plaque Evaluation of Healthy Children and Down Syndrome of Both Groups at the Baseline (time frame: Baseline: Pre-brushing). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04845633, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2021.