Effectiveness of Customized Handle Toothbrush

• ClinicalTrials.gov Identifier: NCT04845633
• Recruitment Status: Completed
• First Posted: April 15, 2021
• Results First Posted: August 12, 2021
• Last Update Posted: August 12, 2021
• Sponsor: Damascus University
• Information provided by (Responsible Party): Damascus University

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.

Condition or disease	Intervention/treatment	Phase
Dental Plaque; Dental Prophylaxis; Dental Care	Other: Evaluation of the Effectiveness of Conventional Toothbrush in Dental Plaque Control in Healthy Children; Other: Evaluation of the Effectiveness of Customized Handle Toothbrush in Dental Plaque Control in Healthy Children; Other: Evaluation of the Effectiveness of Conventional Toothbrush in Dental Plaque Control in Children with Down Syndrome; Other: Evaluation of the Effectiveness of Customized Handle Toothbrush in Dental Plaque Control in Children with Down Syndrome	Not Applicable

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:

1. A group of healthy children using conventional toothbrush (12 children).
2. A group of healthy children using toothbrush with Customized Handle (12 children).
3. A group of children with Down syndrome using conventional toothbrush (12 children).
4. A group of children with Down syndrome using toothbrush with Customized Handle (12 children).

Secondly,

1. Researcher will take an impression of the child hand grasp silicon impression material.
2. 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.
3. 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:

1. The researcher will teach the participants how to brush by using (tell-show -do) technique.
2. The brushing method that will be used is the modified Stillman technique.
3. Brushing duration must be at least 3 minutes.
4. The brushing must be twice a day.
5. 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

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 48 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Investigator, Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: Evaluation of the Effectiveness of Customized Handle Toothbrush in Dental Plaque Control in Healthy Children and Children With Down Syndrome
• Actual Study Start Date: April 9, 2021
• Actual Primary Completion Date: May 14, 2021
• Actual Study Completion Date: May 16, 2021

Arms and Interventions

Arm	Intervention/treatment
Healthy children using conventional toothbrush	Other: 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
Experimental: Healthy children using toothbrush with Customized Handle	Other: 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	Other: 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
Experimental: Children with Down syndrome using toothbrush with Customized Handle	Other: 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

Outcome Measures

Primary Outcome Measures :

1. 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.
2. 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.

Secondary Outcome Measures :

1. Clinical Plaque Evaluation of Healthy Children and Down Syndrome of Both Groups After a Week [ Time Frame: 1 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.

Eligibility Criteria

• Ages Eligible for Study: 6 Years to 9 Years (Child)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

Syrian Arab Republic

Damascus University

Damascus, Syrian Arab Republic, 30621

Sponsors and Collaborators

Damascus University

Investigators

• Principal Investigator: Line B Droubi, DDs; MSc student in Pedodontics, University of Damascus
• Study Director: Mohannad G Laflouf, Phd; Professor of Pedodontics, Department of Pedodontics, University of Damascus

  Study Documents (Full-Text)

Documents provided by Damascus University:

Study Protocol and Statistical Analysis Plan  [PDF] July 19, 2021

More Information

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.

Kammers AC, Zanetti AL, Lacerda TE, Aroca JP, Camilotti V, Mendonça 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.

• Responsible Party: Damascus University
• ClinicalTrials.gov Identifier: NCT04845633
• Other Study ID Numbers: UDDS-Pedo-01-2021
• First Posted: April 15, 2021
• Results First Posted: August 12, 2021
• Last Update Posted: August 12, 2021
• Last Verified: June 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Damascus University:

Customized Handle Toothbrush; Dental Primary Prevention; Down Syndrome

Additional relevant MeSH terms:

Dental Plaque; Dental Deposits; Tooth Diseases; Stomatognathic Diseases