Clinical trial NCT06910501: Comparative Effectiveness of Various Educational Approaches on Oral Hygiene
Official title: Comparative Effectiveness of Various Educational Approaches on Oral Hygiene in Pediatric Populations
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dental Caries
Dental Plaque
Lead sponsor: Ege University
Sponsor class: OTHER
First posted: 2025-04-04
Enrollment: 150
Sex: ALL
Minimum age (years): 5
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: PREVENTION

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:

Dental caries indices: Decayed, filled, missing teeth (dft/DMFT) and decayed, filled, missing surfaces (dfs/DMFS).

Plaque Index (PI): To assess the presence of dental plaque. Gingival Index (GI): To evaluate gingival inflammation. Participants were randomly assigned to one of the three intervention groups using a computer-generated block randomization method with a fixed block size of six to ensure balanced group allocation throughout the study.

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

Group 2: Education through a slide-based PowerPoint presentation, delivered on a tablet or projector (n=50).

Group 3: Use of the Brush DJ mobile application, which incorporates gamified elements such as music, timers, and oral hygiene tips to encourage brushing (n=50).

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

Follow-Up Assessments After three months, participants returned for a recall visit. Parents completed a follow-up questionnaire assessing changes in their child's oral hygiene behaviors. Clinical examinations were repeated to reassess the dental caries indices (dft/DMFT, dfs/DMFS), plaque index, and gingival index.

Parental Satisfaction Survey At the recall visit, parents were asked to complete a satisfaction survey to evaluate their perceptions of the educational interventions, including ease of use, engagement, and effectiveness in motivating their child. The Parental Satisfaction Survey consisting of four questions, scored out of 5 (1-5 points, from "strongly disagree" to "strongly agree") according to Likert scaling was performed on the parents.

Statistical Analysis All data were analyzed using SPSS software version 25.0 (IBM Corp., Armonk, NY, USA). Descriptive statistics were presented as means ± standard deviations for continuous variables and as frequencies and 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." modify this paragraph according to this review: Please remove all information pertaining to the results and conclusions of the study from the record. After the Protocol Section of a record has been registered, results information can be entered in the Results Section of the record by clicking on "Enter Results" on the Record Summary page. Information on how to enter results is provided on the Results Data Entry page (found in the Help menu on the PRS Home page). Please note that any relevant results-related citations can be added to the References module of the record's Protocol Section.

Eligibility criteria: 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.

Primary outcomes:
measure: Dental plaque index
timeFrame: 3 months
Secondary outcomes:
measure: Gingival index
timeFrame: 3 months
Other outcomes:
measure: Oral hygiene motivation
timeFrame: 3 months
Locations:
city: Izmir
country: Turkey
facility: Ege University
Study officials:
References: