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Dental CariesNCT06910501

Comparative Effectiveness of Various Educational Approaches on Oral Hygiene

A study testing Traditional oral hygiene instruction, Digital slide-based education and Brush DJ mobile appliaction in people with Dental Caries and Dental Plaque, run by Ege University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 5 to 12 yearsHealthy volunteers can take part
Conditions the study is for
Dental Caries, Dental Plaque
What is being tested?
Traditional oral hygiene instruction, Digital slide-based education and Brush DJ mobile appliaction
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
150 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Jun 2024to 1 Oct 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 5 to 12 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Ege University

    Izmir, 35040

Other trials in Turkey (Türkiye)

About this study

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

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.

Read more

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.

Read the 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.

Being tested
Traditional oral hygiene instruction, Digital slide-based education, Brush DJ mobile appliaction
Medical subject headings
Dental Caries, Dental Plaque

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Traditional oral hygiene instructionOther

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

  • Digital slide-based educationOther

    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.

  • Brush DJ mobile appliactionOther

    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.

Study groups in NCT06910501
Study groupRoleWhat they receive
Individualized oral hygiene instruction using a toothbrush and modelExperimentalTraditional Method: Individualized oral hygiene instruction using a toothbrush and model (n=50).
Receives: Other: Traditional oral hygiene instruction
Education through a slide-based PowerPoint presentationExperimentalDigital Slide-Based Education: Education through a slide-based PowerPoint presentation (n=50).
Receives: Other: Digital slide-based education
Use of the Brush DJ mobile applicationExperimentalMobile 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).
Receives: Other: Brush DJ mobile appliaction

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 3 months

Secondary outcomes (1)
  1. Gingival index

    After three months, participants returned for a recall visit. Clinical examinations were repeated to reassess the gingival index. Gingival index 0: Healthy gums.

    Gingival index 1: Mild discolouration and oedematous gingiva. No bleeding on probing.

    Gingival index 2: Red, oedematous and shiny gingiva. There is bleeding on probing.

    Gingival index 3: Red, oedematous and ulcerated gingiva. There is spontaneous bleeding.

    Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Apr 2025
  2. Study start1 Jun 2024
  3. Primary completion1 Jul 2024
  4. Study completion1 Oct 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
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.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
150 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06910501
Sponsor's protocol ID
Ege U. Ethical Com. 21-3.1T/49
Status last verified
Mar 2025
First submitted
20 Mar 2025
Last updated
4 Apr 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Individual Participant Data (IPD) Sharing Statement: De-identified individual participant data (IPD) collected during the study, including questionnaire responses, clinical indices (dft/DMFT, dfs/DMFS, Plaque Index, Gingival Index), and follow-up assessments, will be shared with other researchers upon request. Data Availability: The IPD will be made available after publication of the study results, for up to five years. Access Criteria: Researchers must submit a formal request outlining the purpose of the data use, and approval will be subject to ethical considerations and institutional guidelines. Data Sharing Mechanism: Data will be shared through a secure institutional repository or via direct communication with the principal investigator. Restrictions: Personally identifiable information will not be shared, and data use must comply with ethical and legal regulations governing research data privacy.

Questions about this trial

What is this clinical trial studying?

A study testing Traditional oral hygiene instruction, Digital slide-based education and Brush DJ mobile appliaction in people with Dental Caries and Dental Plaque, run by Ege University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dental plaque index (time frame: 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2025.

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