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Toothbrushing Program in Saudi Arabia "TOPS"

NCT05512156 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 588

Last updated 2025-04-27

No results posted yet for this study

Summary

Project summary

Introduction: Dental caries is a major oral health problem worldwide and is a particular public health challenge in Saudi Arabia. Dental caries cause pain, infection, and negatively impact quality of life. As part of population oral health improvement efforts in Saudi Arabia, this project aims to evaluate the effectiveness of a supervised toothbrushing programme in kindergartens.

Aim: The aim of this project is to conduct a trial to assess the effectiveness of a supervised toothbrushing programme in kindergartens in Riyadh, Saudi Arabia .

Methods: A cluster randomized controlled trial study will be undertaken in which the effectiveness of the daily supervised toothbrushing programme intervention running for two academic years will be randomly allocated to a sample of kindergartens in Riyadh and compared against treatment as usual which will be an annual oral health awareness visit in the control group of kindergartens over and above community water fluoridation. Effectiveness will be measured and delivered in terms of preventing dental caries in children when compared with children in the treatment as usual control group receiving the same level of community water fluoridation, but not the toothbrushing program intervention.

All children in all kindergartens (both intervention and control groups) will have a dental examination (via trained and calibrated dental teams recording dental caries levels via dmft index) at baseline before intervention commences and at two academic years. In addition, questionnaires on behaviours and quality of life. In addition, process monitoring, and cost analysis surveys will be distributed.

Research Questions:

* Can such a supervised toothbrushing programme in kindergartens be effective at reducing the development of dental caries by 6 years of age?
* Can a supervised toothbrushing programme in kindergartens in Saudi Arabia be established and implemented?

Conditions

  • Dental Caries in Children

Interventions

OTHER

Supervised Toothbrushing

* Recruitment, consent, and Questionnaires (Behaviors, Quality of Live, Cost Analysis) distribution. * Inclusion \& Exclusion Criteria Applied * Baseline Dental examination * Toothbrushes \& Toothpastes Home and school use packs delivery-Colgate (six pack per child a year- child soft toothbrush with a1450ppm fluoridated toothpaste)) * Supervised teachers training * Three months intervals monitoring visits * "12months" Follow up and Questionnaires (Behaviours) distribution * Endpoint dental Examination and Questionnaires (Behaviours, Quality of Live, Cost Analysis) distribution

Sponsors & Collaborators

  • Ministry of Health, Saudi Arabia

    collaborator OTHER_GOV

  • University of Glasgow

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
42 Months
Max Age
66 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-09-18
Primary Completion
2024-09-12
Completion
2024-12-30

Countries

  • Saudi Arabia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05512156 on ClinicalTrials.gov