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Periodontal DiseasesISBOHE-PDNCT07055932

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

A study testing "Interactive Oral Health Education Program" in people with Periodontal Diseases, run by Al-Quds University at 1 site in Palestinian Territories.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 15 to 16 yearsHealthy volunteers can take part
Conditions the study is for
Periodontal Diseases
What is being tested?
"Interactive Oral Health Education Program"
Could I receive a placebo?
No, everyone receives an active treatment
How many people
946 participants
Where
1 sitePalestinian Territories
Study dates
1 Mar 2024to 30 May 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 15 to 16 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Palestinian Territories1 site

  • Faculty of Public Health, Al-Quds University

    Abū Dīs, Jerusalem Governorate, 00972

Other trials in Palestinian Territories

About this study

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

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:

Read more
  • 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)
Read the detailed description

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.

Being tested
"Interactive Oral Health Education Program"
Keywords
interactive school-based education
Medical subject headings
Periodontal Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • "Interactive Oral Health Education Program"Behavioural

    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"

Study groups in NCT07055932
Study groupRoleWhat they receive
Intervention Group - Interactive Oral Health EducationExperimentalParticipants 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.
Receives: Behavioral: "Interactive Oral Health Education Program"
Control Group - Single Oral Hygiene SessionNo interventionParticipants 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    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.

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

Secondary outcomes (4)

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

    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

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

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

    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.

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

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

    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.

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

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

    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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Jul 2025
  2. Study start1 Mar 2024
  3. Primary completion1 Apr 2024
  4. Study completion30 May 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
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.
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
946 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07055932
Sponsor's protocol ID
REF.13/24
Acronym
ISBOHE-PD
Status last verified
May 2025
First submitted
12 Jun 2025
Last updated
9 Jul 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: The de-identified individual participant data (IPD) that underlie the results reported in this interventional study (including demographic variables, clinical measurements, and outcome assessments) will be made available beginning one year after publication for researchers who provide a methodologically sound proposal. Data will be shared via a public repository (e.g., Dryad) with a digital object identifier (DOI) to ensure persistent access. Interested investigators should contact the corresponding author (sura.kazlak@yahoo.com) to request data and submit a brief research proposal. Data will be provided under a data-use agreement prohibiting participants' re-identification and further sharing without permission.

Questions about this trial

What is this clinical trial studying?

A study testing "Interactive Oral Health Education Program" in people with Periodontal Diseases, run by Al-Quds University at 1 site in Palestinian Territories.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Palestinian Territories. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Mean Community Periodontal Index of Treatment Needs (CPITN) Score (time frame: Baseline (prior to intervention) and two months post-intervention). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07055932.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2025.

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