Comparative Effectiveness of Various Educational Approaches on Oral Hygiene in Pediatric Populations
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Ege University
- Enrollment
- 150
- Locations
- 1
- Primary Endpoint
- Dental plaque index
Study Overview
Brief Summary
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.
Detailed Description
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:
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Single (Outcomes Assessor)
Masking Description
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.
Eligibility Criteria
- Ages
- 5 Years to 12 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •No systemic diseases No ongoing orthodontic treatment Patients and their parents willing to participate in the study.
Exclusion Criteria
- •Children with special healthcare needs Children who did not accept to participate in the study.
Arms & Interventions
Individualized oral hygiene instruction using a toothbrush and model
Traditional Method: Individualized oral hygiene instruction using a toothbrush and model (n=50).
Intervention: Traditional oral hygiene instruction (Other)
Education through a slide-based PowerPoint presentation
Digital Slide-Based Education: Education through a slide-based PowerPoint presentation (n=50).
Intervention: Digital slide-based education (Other)
Use of the Brush DJ mobile application
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).
Intervention: Brush DJ mobile appliaction (Other)
Outcomes
Primary Outcomes
Dental plaque index
Time Frame: 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.
Secondary Outcomes
- Gingival index(3 months)
Investigators
Dilsah Cogulu
Prof.Dr.-Head of Pediatric Dentistry Department
Ege University