Evaluating the Impact of Novel Oral Health Promotion Program "SEHAT" Among Adolescents in Pakistan's Resource-Constrained Settings: A Cluster Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 1,500
- 试验地点
- 1
- 主要终点
- Plaque Score
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 11 Years 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
- •Diverse socioeconomic backgrounds
- •Students with parental and personal informed consent to participate in the trial
排除标准
- •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.
研究组 & 干预措施
Virtual SEHAT Intervention
A structured oral health promotion session delivered virtually using interactive sessions designed to improve oral health knowledge and behaviors.
干预措施: SEHAT Virtual Oral Health Education (Behavioral)
Conventional Oral Health Education
Face-to-face classroom-based oral health education session using standardized content.
干预措施: Conventional Oral Health Education (Behavioral)
Control Group
Participants receive no intervention during study period. Intervention: Leave blank
结局指标
主要结局
Plaque Score
时间窗: 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
时间窗: 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).
次要结局
未报告次要终点
研究者
Sadia Musharraf
Assistant Professor, Department of Periodontology
Shifa College of Dentistry