Toothbrushing programme in Saudi Arabia 'TOPS': a study protocol for a cluster randomised controlled trial in...

Area of Science:

• Public Health
• Pediatric Dentistry
• Epidemiology

Background:

• Childhood dental caries is a significant global health issue, particularly in Saudi Arabia.
• Caries lead to pain, infection, and reduced quality of life for children.
• Oral health improvement efforts are crucial for Saudi Arabia's population.

Purpose of the Study:

• To evaluate the effectiveness of a supervised toothbrushing program in kindergartens.
• To assess the impact of the program on the prevalence and severity of dental caries in young children.
• To contribute to population oral health improvement strategies in Saudi Arabia.

Main Methods:

• Cluster randomized controlled trial involving 20 kindergartens in Riyadh over two academic years (2022-2024).
• Intervention group receives supervised toothbrushing; control group receives standard care (annual oral health awareness).
• Primary outcome: change in decayed, missing, and filled teeth (d3mft) index; secondary outcome: increase in affected teeth. Subgroup analyses planned.

Main Results:

• Data collection ongoing until September 2024.
• Sample size calculation requires 244 evaluable endpoints for 80% power.
• Questionnaires will gather data on behaviors, quality of life, process monitoring, and cost-effectiveness.

Conclusions:

• The study will provide evidence on the efficacy of supervised toothbrushing programs for preventing childhood dental caries in Saudi Arabia.
• Findings will inform public health policies and interventions for improving children's oral health.
• Results will be disseminated through scientific conferences and publications.