Comparative Effectiveness of Various Educational Approaches on Oral Hygiene

NCT06910501 | Completed

• 1 other identifier: Ege U. Ethical Com. 21-3.1T/49
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Dental Caries; Dental Plaque

Outcome Measures

Primary Outcomes (1)

• Dental plaque index

  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.

  3 months

Secondary Outcomes (1)

• Gingival index

  3 months

Other Outcomes (1)

• Oral hygiene motivation

  3 months

Study Arms (3)

Individualized oral hygiene instruction using a toothbrush and model

EXPERIMENTAL

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

Other: Traditional oral hygiene instruction

Education through a slide-based PowerPoint presentation

EXPERIMENTAL

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

Other: Digital slide-based education

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).

Other: Brush DJ mobile appliaction

Interventions

Traditional oral hygiene instruction OTHER

Individualized demonstration of proper toothbrushing techniques using a toothbrush and a dental model. Conducted by a trained dental professional.

Individualized oral hygiene instruction using a toothbrush and model

Digital slide-based education OTHER

Educational session using a PowerPoint presentation on a tablet or projector. The session includes visual aids to explain proper brushing techniques, the importance of oral hygiene, and the effects of poor dental care.

Education through a slide-based PowerPoint presentation

Brush DJ mobile appliaction OTHER

Children use the Brush DJ app, which includes gamified elements such as music, timers, and oral hygiene tips to encourage proper brushing habits. The app provides reminders and engaging content to maintain motivation.

Use of the Brush DJ mobile application

Eligibility Criteria

• Age: 5 Years - 12 Years
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Ege University: lead

Study Sites (1)

Ege University

Izmir, 35040, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Dental Caries; Dental Plaque

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases; Dental Deposits

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.Dr.-Head of Pediatric Dentistry Department

Model Details: This study is a randomized controlled trial designed to compare the effectiveness of traditional educational methods and a mobile application (Brush DJ) in promoting oral hygiene habits among healthy children aged 5-12 years.

Study Record Dates

• First Submitted: March 20, 2025
• First Posted: April 4, 2025
• Study Start: June 1, 2024
• Primary Completion: July 1, 2024
• Study Completion: October 1, 2024
• Last Updated: April 4, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: 20 March 2025-

Locations

TU (1)