NCT06910501

Comparative Effectiveness of Various Educational Approaches on Oral Hygiene

Completed NA Last updated 4 April 2025

What this trial tests

NA trial testing Traditional oral hygiene instruction in Dental Caries in 150 participants. Completed in 1 October 2024.

Timeline

1 June 2024

Primary endpoint
1 July 2024

1 October 2024

Quick facts

Lead sponsor	Ege University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	prevention
Enrollment	150
Start date	1 June 2024
Primary completion	1 July 2024
Estimated completion	1 October 2024
Sites	1 location across Turkey (Türkiye)

Drugs / interventions tested

• Traditional oral hygiene instruction
• Digital slide-based education
• Brush DJ mobile appliaction

Conditions studied

• Dental Caries — all drugs for Dental Caries →
• Dental Plaque — all drugs for Dental Plaque →

Sponsor

Ege University

Who can join

Adults 5 to 12, any sex, with Dental Caries or Dental Plaque. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.