SEHAT Virtual Oral Health Promotion for School Adolescent... | NCT07536958

Studies
SEHAT Virtual Oral Health Promotion for School Adolescents in Pakistan

NCT07536958

Sponsor

Shifa College of Dentistry

Status

Not yet recruiting

Last Update Posted

Apr 22, 2026Actual

Enrollment

1,500Estimated

Phase

Not Applicable

Conditions

Oral Health Behavior Change

Interventions

SEHAT Virtual Oral Health Education
Conventional Oral Health Education

Countries

Pakistan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Document Has No Statistical Analysis Plan (SAP)

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2026

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2026Estimated

Primary Completion Date

Aug 2027Estimated

Completion Date

Sep 2027Estimated

First Submitted Date

Apr 11, 2026

First Submission Date that Met QC Criteria

Apr 11, 2026

First Posted Date

Apr 17, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 17, 2026

Last Update Posted Date

Apr 22, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

1,500Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
SEHAT Virtual Oral Health Education	Behavioral	A structured oral health promotion program delivered virtually using interactive sessions designed to improve oral health knowledge and behaviors.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.
Diverse socioeconomic backgrounds
Students with parental and personal informed consent to participate in the trial

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

11 Years

Maximum Age

15 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Sadia Musharraf, BDS, MCPS, PhD (Candidate)	Contact	92 321 6127576		sadia.scd@stmu.edu.pk

Overall Officials

Name	Affiliation	Role
Sadia Musharraf, BDS, MCPS, PhD (Candidate)	Shifa College of Dentistry, Shifa Tameer e Millat University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Public Schools, Rawalpindi, Pakistan		Rawalpindi		34178	Pakistan

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Apr 10, 2026	Apr 11, 2026	Prot_000.pdf
SAP	No	Yes	No	Statistical Analysis Plan	Apr 10, 2026	Apr 11, 2026	SAP_001.pdf
ICF	No	No	Yes	Informed Consent Form	Apr 10, 2026	Apr 17, 2026	ICF_003.pdf

Intervention Model Description

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.