NCT06523712

A Scalable, Teacher-delivered, School-based Oral Health Intervention for Pakistani Lower Secondary Schoolchildren

A Scalable, Equity-focused, Teacher-delivered, School-based Oral Health Intervention for Pakistani Lower Secondary Schoolchildren: a Pragmatic Cluster-randomized Effectiveness-implementation Trial (Smile Smarts-PK)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 4,055 (actual)
• Sponsor: Universiti Putra Malaysia · Academic / Other
• Sex: All
• Age: 10 Years – 15 Years
• Healthy volunteers: Accepted

Summary

This was a pragmatic, two-arm, and parallel-group, superiority cluster-randomized controlled trial with 1:1 allocation of clusters (schools) to either the Smile Smarts-PK intervention arm or the control arm. The trial settings were lower secondary schools (classes 5-8) in the Punjab, Pakistan. Punjab is the most populous province of Pakistan; it has many public and low-cost private schools that serve lower- and middle-income communities.

Detailed description

Oral diseases are among the most common non-communicable conditions affecting children worldwide and disproportionately burden those in low- and middle-income countries. Robust evidence from pragmatic, theory-informed, school-based cluster-randomized trials in South Asia remains scarce. We evaluated the effectiveness of Smile Smarts-PK, a scalable teacher-delivered oral health intervention embedded within routine lower secondary school systems in Pakistan. Methods It is a parallel, pragmatic, school-level cluster-randomized controlled trial in 50 lower secondary schools in Pakistan. Schools were randomly assigned (1:1) to either the Smile Smarts-PK intervention or usual school practice. The intervention was teacher-delivered, integrated into routine academic schedules, and informed by the Health Belief Model. Primary outcomes at 12 months were clinical oral health indices: Debris Index-Simplified (DI-S), Calculus Index-Simplified (CI-S), Oral Hygiene Index-Simplified (OHI-S). Secondary outcomes included plaque index, children's oral health knowledge, observed and self-reported oral health behaviours, and maternal knowledge, attitudes, and practices. Analyses were by intention to treat using linear mixed-effects models accounting for clustering at the school level.

Conditions

• Dental Plaque
• Cluster Randomized Trial
• Adolescent
• Oral Hygiene, Oral Health
• Health Promotion
• Pakistan

Interventions

Type	Name	Description
BEHAVIORAL	Smile Smarts	The interactive oral health care lessons provided to participants in Arm 1 would involve activities and discussions aimed at changing behaviors such as tooth brushing frequency, brushing techniques, and the use of interdental aids. The intervention aims to educate and motivate participants to adopt and maintain optimal oral hygiene habits through behavioral change strategies.

Timeline

• Start date: 2024-07-25
• Primary completion: 2025-06-24
• Completion: 2025-07-15
• First posted: 2024-07-26
• Last updated: 2026-04-16

Locations

1 site across 1 country: Pakistan