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临床试验/NCT06910501
NCT06910501已完成不适用

Comparative Effectiveness of Various Educational Approaches on Oral Hygiene in Pediatric Populations

Ege University1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2024年6月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
150
试验地点
1
主要终点
Dental plaque index

研究概览

简要总结

Background: Dental caries constitutes a major global public health challenge, posing substantial burdens on both oral health outcomes and healthcare systems worldwide, with far-reaching implications for prevention, treatment, and economic resources. Regular tooth brushing is recognized as the most effective preventive measure against dental caries. However, motivating children to adopt and maintain proper oral hygiene behaviors remains a significant challenge. This study aims to evaluate and compare the effectiveness of traditional education methods and a mobile application in promoting oral hygiene habits among children.

Methods: The study included 150 children who attended routine dental examinations. Parents completed a baseline questionnaire to assess their child's oral hygiene habits. Baseline clinical measurements were recorded, including dental caries indices (dft/DMFT, dfs/DMFS), dental plaque, and gingival index scores. Participants were randomly allocated into three groups: Group-1: received individualized oral hygiene instruction using a model and toothbrush; Group-2: received slide-based oral hygiene education; and Group-3: utilized the Brush DJ mobile application. After three months, follow-up assessments were conducted, including a repeated parental questionnaire, clinical evaluations, and a parental satisfaction survey. Statistical analyses were performed using SPSS 25.0 with chi-square, Kruskal-Wallis, and Fisher's Exact tests.

Study Design: This prospective, randomized controlled study compared the effectiveness of traditional educational methods and a mobile application (Brush DJ) in promoting oral hygiene habits among 150 healthy children aged 5-12 years. Ethical approval was obtained from the institutional ethics committee (approval no.: 21-3.1T/49, date: March 18, 2021). Written informed consent was obtained from the parents of all participating children.

Study Population: Participants were recruited from routine dental examinations at Ege University Faculty of Dentistry, Department of Pediatric Dentistry. The sample size was determined through power analysis to ensure statistical significance. Inclusion criteria were children without systemic diseases, no ongoing orthodontic treatment, and willingness to participate. Children with special healthcare needs or those unwilling to participate were excluded.

Baseline Assessments: At baseline, parents completed a structured questionnaire on their child's oral hygiene habits, including frequency and duration of tooth brushing, parental supervision, and fluoride toothpaste use. Clinical oral examinations were conducted under standardized conditions.

The following indices were recorded:

Dental caries indices: dft/DMFT and dfs/DMFS.

Plaque Index (PI): To assess dental plaque presence.

Gingival Index (GI): To evaluate gingival inflammation.

Participants were randomly assigned to one of three groups using block randomization (block size: six):

Group 1: Individualized oral hygiene instruction using a toothbrush and model (n=50).

Group 2: Slide-based education via PowerPoint on a tablet or projector (n=50).

Group 3: Use of the Brush DJ mobile application, incorporating gamification elements such as music, timers, and oral hygiene tips (n=50).

Each intervention was delivered individually to children and their parents by a trained dental professional.

Follow-Up Assessments: After three months, participants attended a recall visit, during which parents completed a follow-up questionnaire. Clinical examinations were repeated to reassess dft/DMFT, dfs/DMFS, plaque index, and gingival index scores.

Parental Satisfaction Survey: Parents evaluated the educational interventions based on ease of use, engagement, and effectiveness in motivating their child. A four-question Likert-scale (1-5 points) parental satisfaction survey was administered.

Statistical Analysis: Data were analyzed using SPSS 25.0 (IBM Corp., Armonk, NY, USA). Descriptive statistics were presented as means ± standard deviations for continuous variables and as frequencies/percentages for categorical variables. The chi-square test, Kruskal-Wallis test, and Fisher's Exact test were used to assess differences between groups. A p-value of <0.05 was considered statistically significant.

详细描述

Detailed Description:

Study Design This prospective, randomized controlled study was conducted to compare the effectiveness of traditional educational methods and a mobile application (Brush DJ) in promoting oral hygiene habits among 150 (75 girls, 75 boys) healthy children aged 5-12 years. Ethical approval was obtained from the institutional ethics committee prior to the commencement of the study (approval no.: 21-3.1T/49, date: March 18, 2021). Written informed consent was obtained from the parents of all participating children.

Study Population A total of 150 healthy children aged 5-12 years were recruited from those attending routine dental examinations at Ege University Faculty of Dentistry Department of Pediatric Dentistry. The sample size of 150 participants was determined based on a power analysis to ensure adequate statistical power for detecting significant differences between the educational interventions, considering an expected effect size. Inclusion criteria included children with no systemic diseases, no ongoing orthodontic treatment, and patients and their parents willing to participate in the study. Children with special healthcare needs and who did not accept to participate in the study were excluded.

Baseline Assessments At baseline, parents completed an eleven-question structured questionnaire designed to assess their child's oral hygiene habits, including the frequency and duration of tooth brushing, supervision by parents, and use of fluoride toothpaste. Clinical oral examinations were conducted by a single calibrated examiner under standardized conditions.

The following indices were recorded by a calibrated examiner:

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
Single (Outcomes Assessor)

盲法说明

Due to the nature of the intervention, participants and the dental professional delivering the interventions were not blinded. However, the examiner (outcomes assessor) conducting clinical assessments was blinded to the intervention groups to minimize bias.

入排标准

年龄范围
5 Years 至 12 Years(Child)
性别
All
接受健康志愿者
是

入选标准

  • •No systemic diseases No ongoing orthodontic treatment Patients and their parents willing to participate in the study.

排除标准

  • •Children with special healthcare needs Children who did not accept to participate in the study.

研究组 & 干预措施

Individualized oral hygiene instruction using a toothbrush and model

Experimental

Traditional Method: Individualized oral hygiene instruction using a toothbrush and model (n=50).

干预措施: Traditional oral hygiene instruction (Other)

Education through a slide-based PowerPoint presentation

Experimental

Digital Slide-Based Education: Education through a slide-based PowerPoint presentation (n=50).

干预措施: Digital slide-based education (Other)

Use of the Brush DJ mobile application

Experimental

Mobile Application - Brush DJ: Use of the Brush DJ mobile application, which includes gamified elements such as music, timers, and oral hygiene tips to encourage brushing (n=50).

干预措施: Brush DJ mobile appliaction (Other)

结局指标

主要结局

Dental plaque index

时间窗: 3 months

After three months, participants returned for a recall visit. Clinical examinations were repeated to reassess the plaque index. Plaque index 0: No plaque is in the area adjacent to the gingiva. Plaque index 1: There is a plaque in the form of a thin film on the gingival margin. Plaque index 2: There is a visible plaque in the gingival pocket and gingival margin. Plaque index 3: There is a dense plaque in the gingival pocket and on the gingival margin.

次要结局

  • Gingival index(3 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dilsah Cogulu

Prof.Dr.-Head of Pediatric Dentistry Department

Ege University

研究点 (1)

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