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Completed

NCT Number: NCT06523712

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

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.

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Key information

Conditions

Dental Plaque Adolescent Cluster Randomized Trial Dental Deposits Health Promotion Oral Hygiene, Oral Health Pakistan Stomatognathic Diseases Tooth Diseases

Age range

10 year–15 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

District Sialkot

Sialkot, Punjab Province, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age between 10 to 15 years. Enrollment at one of the selected schools.
  • Consent obtained from parents or legal guardians for participation in the study.

Exclusion criteria

  • Children and their parents who did not give assent and consent to participate in the study.
  • Children with severe oral health issues require immediate medical attention.
  • Children with special needs affecting their ability to participate in the oral health education interventions.

Treatment and study plan

Smile Smarts

Behavioral

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.

Primary outcomes

  1. Oral Hygiene Status

    Time frame: 12 month

    The change in the Simplified Oral Hygiene Index (OHI-S) from baseline to 12 months served as the primary endpoint. The OHI-S scores debris and calculus on six index surfaces (scores 0-3 each), with the summed component means creating an overall score ranging from 0 (good hygiene) to 6 (poor hygiene). Scores were categorized as good (0.0-1.2), fair (1.3-3.0), or poor (3.1-6.0). The primary analysis focused on the change in mean OHI-S score at both the individual and cluster levels

Secondary outcomes

  1. PLAQUE SCORE

    Time frame: 12 months

    The secondary outcome is Plaque score will be measured using the Silness and Löe plaque index. This index scores the thickness of dental plaque at the gingival margin. The scoring range is from 0 to 3, with 0 indicating no plaque and 3 indicating a high amount of plaque accumulation.

  2. Observed toothbrushing performance

    Time frame: 12 months

    The change in toothbrushing performance from baseline to 12 months was assessed using a validated 12-item checklist. Each item was scored from 0 (poor) to 2 (good), yielding a total score of 0-24, categorized as poor (0-11), fair (12-17), or good (18-24). Analysis focused on changes in mean scores and the proportion of children in each category.

  3. Self-Reported Oral Hygiene Behaviors

    Time frame: 12 months

    Changes in self-reported oral hygiene behaviors from baseline to 12 months were measured using a validated 12-item questionnaire covering brushing frequency and fluoride use. Total scores ranged from 0 to 24, with classifications of poor (0-11), fair (12-17), or good

  4. Mothers' Knowledge, Attitudes, and Practices (KAP)

    Time frame: 12 months

    The third secondary outcome was the assessment of change in mothers' knowledge, attitudes, and practices (KAP) related to oral hygiene from baseline to 12 months. Data were collected using standardized Likert-scale and multiple-choice items. Response formats, including true/false, Likert scales, and multiple-choice questions, were standardized to allow calculation of summary scores: knowledge (% correct), attitudes (mean Likert score), and practices (categorical frequencies).

Other outcomes

  1. Implementation outcomes

    Time frame: 12 months

    Mixed methods (surveys, interviews, administrative data) to assess how well an intervention is adopted, delivered (fidelity), and sustained

  2. Equity

    Time frame: 12 months

    Equity was assessed across PROGRESS-Plus-informed dimensions through prespecified interaction analyses and by comparing changes in outcome gaps between more and less advantaged groups.

  3. Acceptability, appropriateness, and feasibility

    Time frame: 12 months

    Acceptability, appropriateness, and feasibility were assessed using the validated 4-item AIM, IAM, and FIM scales (each scored on a 5-point Likert scale from 1=strongly disagree to 5=strongly agree), with higher scores indicating more favourable implementation outcomes.

Sponsors and collaborators

Lead sponsor

Universiti Putra Malaysia

Other

Collaborators

  • University of Lahore

Registry information

Official study title

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)

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jul 26, 2024
Registry last updated
Apr 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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