NCT07536958

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:

  1. 1.Does the SEHAT program improve toothbrushing behavior and oral hygiene?
  2. 2.Does the SEHAT program reduce plaque and gingival scores among adolescents?
  3. 3.Does the program improve oral health knowledge and awareness?
  4. 4.Take part in either the virtual SEHAT session or conventional in-person oral health education, or receive no intervention (control)
  5. 5.Watch structured 30-minute sessions delivered via Zoom (virtual group) or classroom instruction (conventional group)
  6. 6.Participate in follow-up assessments to measure plaque, gingival indices, and oral health knowledge and behaviors.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,500

participants targeted

Target at P75+ for not_applicable

Timeline
16mo left

Started Apr 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress7%
Apr 2026Sep 2027

Study Start

First participant enrolled

April 1, 2026

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

April 11, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 17, 2026

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2027

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2027

Last Updated

April 22, 2026

Status Verified

April 1, 2026

Enrollment Period

1.3 years

First QC Date

April 11, 2026

Last Update Submit

April 17, 2026

Conditions

Keywords

Oral HygieneOral Health EducationAdolescentsPlaque ScoreGingival IndexOral Health PromotionDigital HealthDistant EducationTelehealth

Outcome Measures

Primary Outcomes (1)

  • Silness-Löe Plaque Index

    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).

    Baseline and follow-up assessments at 3, 6, and 12 months

Study Arms (3)

Virtual SEHAT Intervention

EXPERIMENTAL

A structured oral health promotion session delivered virtually using interactive sessions designed to improve oral health knowledge and behaviors.

Behavioral: SEHAT Virtual Oral Health Education

Conventional Oral Health Education

ACTIVE COMPARATOR

Face-to-face classroom-based oral health education session using standardized content.

Behavioral: Conventional Oral Health Education

Control Group

NO INTERVENTION

Participants receive no intervention during study period. Intervention: Leave blank

Interventions

Face-to-face classroom-based oral health education using standardized content.

Conventional Oral Health Education

A structured oral health promotion program delivered virtually using interactive sessions designed to improve oral health knowledge and behaviors.

Virtual SEHAT Intervention

Eligibility Criteria

Age11 Years - 15 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Public Schools, Rawalpindi, Pakistan

Rawalpindi, 34178, Pakistan

Location

Study Officials

  • Sadia Musharraf, BDS, MCPS, PhD (Candidate)

    Shifa College of Dentistry, Shifa Tameer e Millat University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sadia Musharraf, BDS, MCPS, PhD (Candidate)

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: This is a cluster randomized, parallel-assignment trial in which school grades (clusters) are randomly assigned to one of three groups: the virtual SEHAT intervention, conventional in-person oral health education, or a control group receiving no intervention. Each cluster receives only the assigned intervention, and outcomes will be compared between groups to evaluate the effectiveness of the interventions on oral health behaviors, knowledge, attitude and clinical measures such as plaque and gingival indices.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor, Department of Periodontology

Study Record Dates

First Submitted

April 11, 2026

First Posted

April 17, 2026

Study Start

April 1, 2026

Primary Completion (Estimated)

August 1, 2027

Study Completion (Estimated)

September 1, 2027

Last Updated

April 22, 2026

Record last verified: 2026-04

Locations