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)

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.

Study Overview

• Status: Completed
• Conditions: Adolescent; Health Promotion; Dental Plaque; Cluster Randomized Trial; Oral Hygiene, Oral Health; Pakistan
• Intervention / Treatment: Behavioral: Smile Smarts

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.

• Study Type: Interventional
• Enrollment (Actual): 4055
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • Punjab Province
    • Sialkot, Punjab Province, Pakistan
      • District Sialkot

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Smile Smarts-PK; The intervention group is given the Smile Smarts-PK intervention. It is s a multi-theory, multicomponent oral health promotion intervention grounded in a multi-level theoretical framework integrating the Health Belief Model (HBM) and Social Cognitive Theory (SCT). In addition, the delivery strategy is viewed through an implementation science lens, implementation theory, to strengthen understanding not only of effectiveness but also of reach, adoption, fidelity, and future maintenance.	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.
No Intervention: Control group; Participants assigned to Arm 2 serve as the control group and do not receive any intervention during the study except for routine school activities

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oral Hygiene Status	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	12 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PLAQUE SCORE	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.	12 months
Observed toothbrushing performance	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.	12 months
Self-Reported Oral Hygiene Behaviors	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	12 months
Mothers' Knowledge, Attitudes, and Practices (KAP)	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).	12 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Implementation outcomes	Mixed methods (surveys, interviews, administrative data) to assess how well an intervention is adopted, delivered (fidelity), and sustained	12 months
Equity	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.	12 months
Acceptability, appropriateness, and feasibility	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.	12 months

Collaborators and Investigators

• Sponsor: Universiti Putra Malaysia
• Collaborators: University of Lahore
• Investigators: Principal Investigator: MUHAMMAD ARSHED, PhD, University of Lahore

Publications and helpful links

General Publications

• Halawany HS, Al Badr A, Al Sadhan S, Al Balkhi M, Al-Maflehi N, Abraham NB, Jacob V, Al Sherif G. Effectiveness of oral health education intervention among female primary school children in Riyadh, Saudi Arabia. Saudi Dent J. 2018 Jul;30(3):190-196. doi: 10.1016/j.sdentj.2018.04.001. Epub 2018 May 4.
• Wahengbam PP, Kshetrimayum N, Wahengbam BS, Nandkeoliar T, Lyngdoh D. Assessment of Oral Health Knowledge, Attitude and Self-Care Practice Among Adolescents - A State Wide Cross- Sectional Study in Manipur, North Eastern India. J Clin Diagn Res. 2016 Jun;10(6):ZC65-70. doi: 10.7860/JCDR/2016/20693.8002. Epub 2016 Jun 1.
• Carvalho AP, Moura MF, Costa FO, Cota LO. Correlations between different plaque indexes and bleeding on probing: A concurrent validity study. J Clin Exp Dent. 2023 Jan 1;15(1):e9-e16. doi: 10.4317/jced.60039. eCollection 2023 Jan.
• Hilgert LA, Leal SC, Bronkhorst EM, Frencken JE. Long-term Effect of Supervised Toothbrushing on Levels of Plaque and Gingival Bleeding Among Schoolchildren. Oral Health Prev Dent. 2017;15(6):537-542. doi: 10.3290/j.ohpd.a39593.
• Pine C, Adair P, Robinson L, Burnside G, Moynihan P, Wade W, Kistler J, Curnow M, Henderson M. The BBaRTS Healthy Teeth Behaviour Change Programme for preventing dental caries in primary school children: study protocol for a cluster randomised controlled trial. Trials. 2016 Feb 20;17(1):103. doi: 10.1186/s13063-016-1226-3.
• Florio FM, Dos Santos Klee L, Brandao Ramos AP, Ambrosano GMB, de Souza Fonseca Silva A. Use of Water by Schoolchildren: Impact of Indirectly Supervised Daily Toothbrushing-A Pilot Study. Int J Clin Pediatr Dent. 2020 Sep-Oct;13(5):513-517. doi: 10.5005/jp-journals-10005-1800.
• Salama FS, Al-Balkhi BK. Effectiveness of educational intervention of oral health for special needs on knowledge of dental students in Saudi Arabia. Disabil Health J. 2020 Jan;13(1):100789. doi: 10.1016/j.dhjo.2019.03.005. Epub 2019 Mar 19.
• Swe KK, Soe AK, Aung SH, Soe HZ. Effectiveness of oral health education on 8- to 10-year-old school children in rural areas of the Magway Region, Myanmar. BMC Oral Health. 2021 Jan 2;21(1):2. doi: 10.1186/s12903-020-01368-0.

Study record dates

Study Major Dates

• Study Start (Actual): July 25, 2024
• Primary Completion (Actual): June 24, 2025
• Study Completion (Actual): July 15, 2025

Study Registration Dates

• First Submitted: June 15, 2024
• First Submitted That Met QC Criteria: July 22, 2024
• First Posted (Actual): July 26, 2024

Study Record Updates

• Last Update Posted (Actual): April 16, 2026
• Last Update Submitted That Met QC Criteria: April 13, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Cluster randomized trial; School-based intervention; Oral health promotion; Adolescent health (LMICs); Equity-focused intervention
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Diseases; Dental Deposits; Dental Plaque
• Other Study ID Numbers: UOL (UOL/IREB/25/09/0051)

Plan for Individual participant data (IPD)

Study Data/Documents

1. Informed Consent Form
2. Informed Consent Form
3. Informed Consent Form

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No