Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 9:25 PM
Ignite Modification Date:
2025-12-24 @ 9:25 PM
NCT ID:
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)
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.
Study:
NCT07055932
Study Brief:
Protocol Section:
NCT07055932