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

NCT06523712 | Completed DMC

• 1 other identifier: UOL
• Study Type: interventional
• Target: 4,055
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

School-based intervention; Oral health promotion; Adolescent health (LMICs); Equity-focused intervention; Cluster randomized trial

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• PLAQUE SCORE

  12 months

• Observed toothbrushing performance

  12 months

• Self-Reported Oral Hygiene Behaviors

  12 months

• Mothers' Knowledge, Attitudes, and Practices (KAP)

  12 months

Other Outcomes (3)

• Implementation outcomes

  12 months

• Equity

  12 months

• Acceptability, appropriateness, and feasibility

  12 months

Study Arms (2)

Smile Smarts-PK

EXPERIMENTAL

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

Control group

NO INTERVENTION

Participants assigned to Arm 2 serve as the control group and do not receive any intervention during the study except for routine school activities

Interventions

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.

Smile Smarts-PK

Eligibility Criteria

• Age: 10 Years - 15 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universiti Putra Malaysia: lead
• University of Lahore: collaborator

Study Sites (1)

District Sialkot

Sialkot, Punjab Province, Pakistan

Location

Related Publications (8)

• 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.

  PMID: 29942102 RESULT

• 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.

  PMID: 27504414 RESULT

• 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.

  PMID: 36755682 RESULT

• 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.

  PMID: 29319063 RESULT

• 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.

  PMID: 26897029 RESULT

• 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.

  PMID: 33623340 RESULT

• 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.

  PMID: 31495647 RESULT

• 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.

  PMID: 33388030 RESULT

MeSH Terms

Conditions

Dental Plaque

Condition Hierarchy (Ancestors)

Dental Deposits; Tooth Diseases; Stomatognathic Diseases

Study Officials

• MUHAMMAD ARSHED, PhD

  University of Lahore

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: In this study, masking, also known as blinding, refers to the practice of concealing the allocation of participants to intervention groups from outcome assessors and investigators involved in data collection and analysis. Masking helps minimize bias that could occur if those assessing the outcomes are aware of the participants' assigned interventions. In this case, both the outcome assessors and investigators are masked, meaning they are unaware of which participants received the interactive oral care lessons (experimental group) and which participants were in the control group.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD studentship

Model Details: 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.

Study Record Dates

• First Submitted: June 15, 2024
• First Posted: July 26, 2024
• Study Start: July 25, 2024
• Primary Completion: June 24, 2025
• Study Completion: July 15, 2025
• Last Updated: April 16, 2026

Record last verified: 2026-04

Locations

PA (1)