Interactive School-Based Oral Health Education Program to Reduce Periodontal Disease in Palestinian Adolescents

NCT ID: NCT07055932

Last Updated: 2025-07-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

946 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-01

Study Completion Date

2024-05-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The goal of this intervention study was to evaluate the effectiveness of a two-month interactive school-based oral health education program in reducing periodontal disease and improving oral health behaviors among 15-year-old schoolchildren in Nablus, Palestine.

The study was guided by the following hypotheses:

* The interactive education program would lead to a significant reduction in Community Periodontal Index for Treatment Needs (CPITN) and Simplified Oral Hygiene Index (S-OHI) scores.
* The program would result in significant improvements in oral hygiene practices, dietary habits, and smoking behaviors compared to standard oral health education.

Researchers compared students who received six interactive oral health sessions over two months to those who received a single standard oral health lecture, to determine whether the intervention group experienced greater improvements in periodontal status and self-reported health behaviors.

Participants:

* Completed self-administered questionnaire assessing oral hygiene practices, dietary habits, and smoking behaviors
* Underwent clinical periodontal examinations using CPITN and S-OHI indices
* Participated in oral health education sessions (intervention group only)

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

This completed clinical trial evaluated the effectiveness of an interactive, school-based oral health education program in improving periodontal health and associated behaviors among 9th-grade students in Nablus City, Palestine. The study employed a double-blind, pre-test/post-test experimental design involving 946 students (536 intervention, 410 control) from 15 schools selected through stratified random sampling.

Baseline data collection occurred in March 2024 and included clinical assessments using the Community Periodontal Index for Treatment Needs (CPITN) and Simplified Oral Hygiene Index (S-OHI), along with a validated 47-item questionnaire measuring oral hygiene practices, dietary habits, and smoking behaviors. Following randomization by school, the intervention group received six interactive oral health education sessions, while the control group attended one standard lecture. Follow-up assessments took place two months later.

Two levels of blinding were implemented: participants were unaware of group assignment, and outcome assessors were blinded during clinical evaluations. The educational program combined audiovisual materials, live demonstrations, group discussions, and hands-on practice focused on oral anatomy, prevention and treatment of periodontal disease, smoking harms, and nutrition.

Primary outcomes included changes in CPITN and S-OHI scores. Secondary outcomes addressed self-reported improvements in oral hygiene, dietary behaviors, and smoking habits. Data analysis was performed using SPSS version 25.0, with paired and independent t-tests applied to evaluate within- and between-group differences.

The findings indicated significant improvements in the intervention group across all primary and secondary outcomes. These results support the program's effectiveness in enhancing periodontal health and related behaviors among adolescents through interactive, school-based education.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Periodontal Diseases

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

In this parallel-assignment design, eligible ninth-grade students are randomized by school into either the interactive oral health education arm (intervention group) or the standard lecture arm (one educational session) (control group). Each participant remains in their assigned group for the full two-month intervention period, with no crossover between arms. Outcomes are assessed at baseline and two months post-intervention to compare changes in periodontal and oral hygiene indices and oral hygiene, dietary, and smoking behaviors between the two fixed groups.
Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors
Blinding was applied at the participant and outcome assessor levels. Participants were not informed of their group allocation, and assessors conducting data collection were blinded to reduce assessment bias. The educator administering the intervention was not blinded, as this was not operationally feasible.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Intervention Group - Interactive Oral Health Education

Participants in this arm receive an interactive oral health education program consisting of six sessions delivered over two months (one session every 10 days). Each session lasts 30-45 minutes and includes interactive lectures, visual presentations (PowerPoint slides and photographs), and anatomical models (tooth and gum replicas). Practical components involve live demonstrations of cleaning techniques (tooth brushing and flossing), group discussions, and educational puzzles. The aim is to strengthen participants' knowledge and hands-on practice of oral and periodontal hygiene habits, as well as to raise awareness of risks related to smoking and dietary factors.

Group Type EXPERIMENTAL

"Interactive Oral Health Education Program"

Intervention Type BEHAVIORAL

The interactive program in this study is distinguished by its multi-modal, hands-on approach and its sustained, bi-weekly delivery over two months, whereas most other school-based interventions rely on a single lecture or short-term animation. Specifically, our program:

Combines interactive lectures with live demonstrations (brushing/flossing on models), group discussions, and educational puzzles to reinforce learning through active participation rather than passive listening.

Uses anatomical tooth-and-gum replicas alongside PowerPoint slides and photographs to bridge theory and practice within each 30-45-minute session.

Addresses periodontal risk factors (e.g., smoking, diet) in dedicated sessions, integrating behavioural change techniques (e.g., problem-solving brainstorming, personalized feedback) rather than focusing solely on plaque removal.

Is delivered in six sessions (one every 10 days) to maximize retention and allow for iterative skill practice, unlike brief "brush-along"

Control Group - Single Oral Hygiene Session

Participants in this arm receive a single oral hygiene session at the beginning of the study. This session provides a straightforward explanation of tooth brushing and flossing techniques, without any additional interactive components or ongoing follow-up. The purpose is to measure improvements resulting from the interactive education compared to one-time standard care.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

"Interactive Oral Health Education Program"

The interactive program in this study is distinguished by its multi-modal, hands-on approach and its sustained, bi-weekly delivery over two months, whereas most other school-based interventions rely on a single lecture or short-term animation. Specifically, our program:

Combines interactive lectures with live demonstrations (brushing/flossing on models), group discussions, and educational puzzles to reinforce learning through active participation rather than passive listening.

Uses anatomical tooth-and-gum replicas alongside PowerPoint slides and photographs to bridge theory and practice within each 30-45-minute session.

Addresses periodontal risk factors (e.g., smoking, diet) in dedicated sessions, integrating behavioural change techniques (e.g., problem-solving brainstorming, personalized feedback) rather than focusing solely on plaque removal.

Is delivered in six sessions (one every 10 days) to maximize retention and allow for iterative skill practice, unlike brief "brush-along"

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Adolescents enrolled in 9th grade at one of the selected governmental or private schools in Nablus City during the 2023-2024 academic year
* Age approximately 15 years (index age for adolescence as defined by the World Health Organization)
* Willingness to participate and availability for both baseline and two-month follow-up assessments
* Provision of written informed consent by a parent or legal guardian, and written assent by the student
* Ability to complete the study questionnaire and undergo clinical periodontal and oral hygiene examinations

Exclusion Criteria

* Students who were absent from school for medical or other reasons at the time of baseline screening
* Inability or unwillingness to comply with study procedures (e.g., not completing the questionnaire, refusing periodontal examination)
* Refusal to provide either parental/guardian consent or student assent
Minimum Eligible Age

15 Years

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Al-Quds University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Faculty of Public Health, Al-Quds University

Abū Dīs, Jerusalem Governorate, Palestinian Territories

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Palestinian Territories

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Study Documents

Access uploaded study-related documents such as protocols, statistical analysis plans, or lay summaries.

Document Type: Study Protocol

View Document

Related Links

Access external resources that provide additional context or updates about the study.

https://theses.gla.ac.uk/1017/

Rice R. (2009). The effectiveness of computer-based interactive oral health education. MSc Thesis, Faculty of Medicine, University of Glasgow. Full text and appendices (e.g., questionnaires, intervention modules) available.

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

REF.13/24

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

The Treatment of Periodontal Diseases
NCT01318928 UNKNOWN PHASE4
Oral Health Among Children
NCT03791632 COMPLETED NA