Evaluating the Impact of Novel Oral Health Promotion Program "SEHAT" Among Adolescents in Pakistan's Resource-Constrained Settings: A Cluster Randomized Trial
Phase: NA
Conditions: Oral Health Behavior Change
Sponsor: Shifa College of Dentistry

SEHAT Trial Study Protocol 
Official Title: 
Evaluating the Impact of Novel Oral Health Promotion Program “SEHAT” among 
Adolescents in Pakistan’s Resource-Constrained Settings – A Cluster Randomized Trial 
Document Type: 
Study Protocol 
Document Version / Date: 
Version 1.0 – April 10, 2026 
Principal Investigator: 
Dr. Sadia Musharraf  
BDS, MCPS, PhD (Candidate) 
Assistant Professor, Shifa College of Dentistry, Shifa Tameer e Millat University, 
Pakistan 
Confidentiality Statement: 
This document contains confidential information related to the SEHAT trial. It is 
intended solely for regulatory review and research purposes. Names of participants are 
not included. 
 
 

SEHAT Trial Study Protocol 
Official Title 
Evaluating the Impact of Novel Oral Health Promotion Program “SEHAT” among 
Adolescents in Pakistan’s Resource-Constrained Settings – A Cluster Randomized Trial. 
Background 
Oral diseases remain highly prevalent among adolescents in Pakistan. Digital and school-
based interventions may improve oral health literacy and behaviors, particularly in 
resource-constrained settings. 
Objectives 
1. To investigate the effectiveness of a Zoom-based oral health promotion 
intervention among adolescents in improving  
a. Knowledge about oral health 
b. Attitude towards oral health 
c. Behaviour identified as protective for oral health  
i. 
Toothbrushing twice daily with fluoridated toothpaste 
ii. 
Dietary habits with reduced consumption of sugary food and drinks 
2. To compare the impact of virtual oral health promotion intervention with a 
conventional in - person (positive control) and no intervention (negative control). 
Study Design 
Cluster randomized controlled trial with three arms: virtual intervention, conventional 
intervention, and control. 
Study Setting 
Public schools in Rawalpindi, Pakistan. 
Participants 
Adolescents aged 11–15 years enrolled in selected public schools. 
Sample Size 
A total sample of approximately 1,443 participants accounting for clustering and attrition. 
Randomization 
Grades will be randomized into three arms using block randomization. 
Intervention 
SEHAT virtual oral health education sessions delivered via telecommunication 
technology. Conventional arms will receive face-to-face sessions. Control groups will 
receive no intervention. 

Primary Outcome 
Change in plaque score from baseline to follow-up assessments. 
Secondary Outcomes 
Gingival index, oral health knowledge, attitude and toothbrushing behaviors. 
Data Collection 
Clinical examinations and structured questionnaires administered at baseline and follow-
ups. 
Statistical Analysis 
Mixed-effects models accounting for clustering will be used to compare outcomes 
between groups. 
Ethical Considerations 
Ethical approval obtained from Institutional Review Board. Informed consent will be 
obtained from participants and guardians. 
Timeline 
Baseline assessment, intervention delivery, and follow-ups up to 12 months.