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Completed

NCT Number: NCT07055932

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

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)

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Key information

Conditions

Periodontal Diseases Mouth Diseases Stomatognathic Diseases

Age range

15 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Public Health, Al-Quds University

Abū Dīs, Jerusalem Governorate, 00972, Palestinian Territories

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

"Interactive Oral Health Education Program"

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"

Primary outcomes

  1. Change in Mean Community Periodontal Index of Treatment Needs (CPITN) Score

    Time frame: Baseline (prior to intervention) and two months post-intervention

    Change in Mean Community Periodontal Index of Treatment Needs (CPITN) Score The outcome is defined as the mean difference in the Community Periodontal Index of Treatment Needs (CPITN) score between baseline and two months post-intervention. The CPITN is a standardised index developed by the World Health Organisation to assess periodontal status. Scores were recorded using a WHO periodontal probe across six index teeth (teeth 16, 11, 26, 36, 31, and 46), and the mean score per participant was calculated.

    The Community Periodontal Index of Treatment Needs scale ranges from 0 to 4, where:

    • 0 = Healthy gingiva
    • 1 = Bleeding on probing
    • 2 = Presence of calculus
    • 3 = Shallow periodontal pockets (4-5 mm)
    • 4 = Deep periodontal pockets (6 mm or more) Higher scores indicate worse periodontal health.

Secondary outcomes

  1. Mean Difference in Simplified Oral Hygiene Index (S-OHI) Score Pre- and Post-Intervention

    Time frame: From baseline (March 2024) to two months post-intervention (May 2024)

    Change in Mean Simplified Oral Hygiene Index (S-OHI) Score The outcome is defined as the mean difference in the Simplified Oral Hygiene Index (S-OHI) score between baseline and two months post-intervention. The S-OHI is a standardized tool developed by Greene and Vermillion to assess oral hygiene status through the presence of debris and calculus on specific index teeth (11, 16, 26, 31, 36, and 46).

    Each tooth surface was scored separately for debris and calculus, using a scale from 0 to 3 for each component. These scores were combined and averaged across examined surfaces to yield a final index score per participant.

    The total S-OHI score ranges from 0 to 6, where:

    • 0 = no debris
    • 1= debris on one-third of the tooth surface
    • 2=debris on two-thirds of the tooth surface
    • 3=debris on the all-tooth surface

  2. Change in Mean Oral Hygiene Practices Score from Baseline to Two Months Post-Intervention

    Time frame: Baseline (March 2024) and 2 months post-intervention (May 2024)

    This outcome measures the change in oral hygiene practices using a composite score derived from questionnaire responses. Items assessed included brushing frequency, duration, technique, toothbrush type, and replacement frequency. Each item was scored on a scale from 0 to 3. Higher scores indicate more frequent and correct practices. The outcome is calculated as the mean difference between baseline and two months post-intervention.

  3. Change in Mean Dietary Habits Score from Baseline to Two Months Post-Intervention

    Time frame: Baseline (March 2024) and two months post-intervention (May 2024)

    This outcome evaluates changes in dietary habits using a questionnaire-based composite score. Items covered breakfast frequency and intake of nutritious versus non-nutritious foods. Responses were coded into a continuous diet score, with higher scores reflecting healthier eating patterns. The outcome is defined as the mean difference between baseline and two months post-intervention.

  4. Change in Mean Smoking Behaviors Score from Baseline to Two Months Post-Intervention

    Time frame: Baseline (March 2024) and two months post-intervention (May 2024)

    This outcome assesses changes in smoking-related behavior through a composite score. Questionnaire items included cigarette smoking frequency (times/week), number of cigarettes per day, and water-pipe use frequency. Responses were recoded so that higher scores reflect healthier behaviors (i.e., less frequent or no smoking). The mean score difference was calculated between baseline and post-intervention.

Sponsors and collaborators

Lead sponsor

Al-Quds University

Other

Registry information

Official study title

Effectiveness of an Interactive School-Based Oral Health Education Program in Reducing Periodontal Disease Among Palestinian Adolescents: A Double-Blinded Intervention Study

Acronym: ISBOHE-PD

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jul 9, 2025
Registry last updated
Jul 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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