Effectiveness of an Interactive School-Based Oral Health Education Program in Reducing Periodontal Disease Among Palestinian Adolescents: A Double-Blinded Intervention Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 946
- 试验地点
- 2
- 主要终点
- Change in Mean Community Periodontal Index of Treatment Needs (CPITN) Score
研究概览
简要总结
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)
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 15 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: "Interactive Oral Health Education Program" (Behavioral)
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.
结局指标
主要结局
Change in Mean Community Periodontal Index of Treatment Needs (CPITN) Score
时间窗: 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.
Change in Mean Community Periodontal Index of Treatment Needs (CPITN) Score
时间窗: 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.
次要结局
- 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))
- 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))