NCT07055932

Brief 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. 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)

Trial Health

87
On Track

Trial Health Score

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

Enrollment
946

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

March 1, 2024

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2024

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

June 12, 2025

Completed
27 days until next milestone

First Posted

Study publicly available on registry

July 9, 2025

Completed
Last Updated

July 9, 2025

Status Verified

May 1, 2025

Enrollment Period

1 month

First QC Date

June 12, 2025

Last Update Submit

July 4, 2025

Conditions

Keywords

interactive school-based education

Outcome Measures

Primary Outcomes (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.

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

Secondary Outcomes (4)

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

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

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

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

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

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

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

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

Study Arms (2)

Intervention Group - Interactive Oral Health Education

EXPERIMENTAL

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.

Behavioral: "Interactive Oral Health Education Program"

Control Group - Single Oral Hygiene Session

NO INTERVENTION

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.

Interventions

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 Group - Interactive Oral Health Education

Eligibility Criteria

Age15 Years - 16 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Public Health, Al-Quds University

Abū Dīs, Jerusalem Governorate, 00972, Palestinian Territories

Location

Related Links

MeSH Terms

Conditions

Periodontal Diseases

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
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.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 12, 2025

First Posted

July 9, 2025

Study Start

March 1, 2024

Primary Completion

April 1, 2024

Study Completion

May 30, 2024

Last Updated

July 9, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
IPD will be released 12 months after publication of results and remain available for 5 years thereafter.

Available IPD Datasets

Study Protocol Access

Locations