Effectiveness of Customized Handle Toothbrush

NCT04845633 | Completed Results

• 1 other identifier: UDDS-Pedo-01-2021
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Dental Plaque; Dental Prophylaxis; Dental Care

Keywords

Customized Handle Toothbrush; Dental Primary Prevention; Down Syndrome

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Post-brushing

Secondary Outcomes (1)

• Clinical Plaque Evaluation of Healthy Children and Down Syndrome of Both Groups After a Week

  1 week

Study Arms (4)

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

Interventions

Evaluation of the Effectiveness of Conventional Toothbrush in Dental Plaque Control in Healthy Children OTHER

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 conventional toothbrush

Evaluation of the Effectiveness of Customized Handle Toothbrush in Dental Plaque Control in Healthy Children OTHER

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 toothbrush with Customized Handle

Evaluation of the Effectiveness of Conventional Toothbrush in Dental Plaque Control in Children with Down Syndrome OTHER

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 conventional toothbrush

Evaluation of the Effectiveness of Customized Handle Toothbrush in Dental Plaque Control in Children with Down Syndrome OTHER

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

Children with Down syndrome using toothbrush with Customized Handle

Eligibility Criteria

• Age: 6 Years - 9 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Damascus University: lead

Study Sites (1)

Damascus University

Damascus, 30621, Syria

Location

Related Publications (2)

• 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: 12131899 BACKGROUND

• 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.

  PMID: 26155573 BACKGROUND

MeSH Terms

Conditions

Dental Plaque; Down Syndrome

Condition Hierarchy (Ancestors)

Dental Deposits; Tooth Diseases; Stomatognathic Diseases; Intellectual Disability; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Abnormalities, Multiple; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Chromosome Disorders; Genetic Diseases, Inborn

Limitations and Caveats

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.

Results Point of Contact

• Title: Dr. Line Droubi
• Organization: Damascus University

droubiline@gmail.com

00963966896989

Study Officials

• Line B Droubi, DDs

  MSc student in Pedodontics, University of Damascus

  PRINCIPAL INVESTIGATOR

• Mohannad G Laflouf, Phd

  Professor of Pedodontics, Department of Pedodontics, University of Damascus

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 11, 2021
• First Posted: April 15, 2021
• Study Start: April 9, 2021
• Primary Completion: May 14, 2021
• Study Completion: May 16, 2021
• Last Updated: August 12, 2021
• Results First Posted: August 12, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

SY (1)