Evaluating the Impact of Novel Oral Health Promotion Program "SEHAT" Among Adolescents in Pakistan's Resource-Constrained Settings: A Cluster Randomized Trial
Overview
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Shifa College of Dentistry
- Enrollment
- 1,500
- Locations
- 1
- Primary Endpoint
- Plaque Score
Overview
Brief Summary
The goal of this cluster-randomized trial is to learn if the SEHAT program works to improve oral health among school adolescents in Pakistan. It will also assess how the program affects oral health behaviors and knowledge. The main questions it aims to answer are:
- Does the SEHAT program improve toothbrushing behavior and oral hygiene?
- Does the SEHAT program reduce plaque and gingival scores among adolescents?
- Does the program improve oral health knowledge and awareness?
Researchers will compare the SEHAT virtual intervention with conventional oral health education and a control group to see which approach is most effective.
Participants will:
- Take part in either the virtual SEHAT session or conventional in-person oral health education, or receive no intervention (control)
- Watch structured 30-minute sessions delivered via Zoom (virtual group) or classroom instruction (conventional group)
- Participate in follow-up assessments to measure plaque, gingival indices, and oral health knowledge and behaviors.
Detailed Description
This study is a cluster randomized trial evaluating the effectiveness of the SEHAT (School-Based Education for Oral Health Awareness Using Advanced Telecommunication Technology) intervention among adolescents aged 11-14 years in public schools in Rawalpindi, Pakistan. The trial aims to improve oral health behaviors, knowledge, and clinical outcomes, including plaque and gingival scores.
Schools (clusters) will be randomly assigned to one of three groups: virtual SEHAT intervention, conventional in-person oral health education, or control (no intervention). The virtual intervention will deliver structured 30-minute sessions via Zoom, incorporating interactive elements, culturally relevant content, and reinforcement strategies, while the conventional group will receive the same content through face-to-face classroom instruction.
Outcome assessments will include clinical oral health measures (plaque and gingival indices) and self-reported oral health knowledge and behaviors, collected at baseline, post-intervention, and at follow-up timepoints to evaluate short- and medium-term effects. The study will also explore sustained engagement, feasibility, and acceptability of digital oral health education in resource-constrained school settings.
This trial addresses gaps in evidence regarding digital oral health interventions in low-resource settings, particularly for adolescents, and will provide data to guide scalable, culturally adapted, school-based oral health promotion strategies.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 11 Years to 15 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •For the Schools/grades:
- •Public high schools situated in the urban and rural areas of the Rawalpindi city, Punjab, Pakistan to account for the regional variations.
- •Single-gender schools housing classes 6th to 10th.
- •A minimum total enrollment of 300 - 500 students
- •A minimum of 30 students per section in the targeted grades (6th, 7th, and 8th).
- •The schools that sign an agreement to
- •Participate in the trial
- •Be randomized to any of the study arms
- •Assign the trial related tasks to the teachers. For study participants.
- •Currently enrolled students in 6th, 7th and 8th grades.
Exclusion Criteria
- •Students currently undergoing active orthodontic treatment.
- •Students with physical or cognitive impairments that prevent the use of digital interfaces.
- •Students with systemic medical conditions that manifest as oral health complications.
Arms & Interventions
Virtual SEHAT Intervention
A structured oral health promotion session delivered virtually using interactive sessions designed to improve oral health knowledge and behaviors.
Intervention: SEHAT Virtual Oral Health Education (Behavioral)
Conventional Oral Health Education
Face-to-face classroom-based oral health education session using standardized content.
Intervention: Conventional Oral Health Education (Behavioral)
Control Group
Participants receive no intervention during study period. Intervention: Leave blank
Outcomes
Primary Outcomes
Plaque Score
Time Frame: Baseline and follow-up assessments at 3, 6, and 12 months
Change in dental plaque levels measured using a standardized plaque index to assess oral hygiene status among adolescents.
Silness-Löe Plaque Index
Time Frame: Baseline and follow-up assessments at 3, 6, and 12 months
The index assigns a score from 0 to 3 based on the amount of plaque present on four surfaces of a tooth. 0 = No plaque in the gingival area. 3 = Abundance of plaque along the gingival margin. Higher scores indicate a worse outcome (greater accumulation of dental plaque).
Secondary Outcomes
No secondary outcomes reported
Investigators
Sadia Musharraf
Assistant Professor, Department of Periodontology
Shifa College of Dentistry