- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07460271
Goal Attainment-Based Parent Education for ECC Prevention (GAT-ECC)
Assessing the Effectiveness of Parent Education on the Prevention of Early Childhood Caries Based on Goal Attainment Theory
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Early childhood caries (ECC) is a common dental health problem affecting children under the age of three, which can lead to pain, infection, and long-term oral health issues. Parental knowledge and behaviors play a critical role in the prevention of ECC, as early habits significantly influence children's oral health outcomes. This study aims to evaluate the effectiveness of structured parent education in improving parental knowledge and oral hygiene practices, and in reducing ECC incidence in young children.
This randomized controlled trial will include two groups: an experimental group receiving structured oral health education and a control group receiving standard care. A total of 100 parents with children aged 0-3 years who meet the inclusion criteria will be recruited at the Rize University Faculty of Dentistry, Department of Pedodontics. Participants will be randomly assigned to either group using a simple randomization method via an online randomization tool.
Eligible participants include parents of healthy children without chronic diseases, special care needs, or mental/communication disorders. Participants must be able to read, write, and speak Turkish. Parents who do not meet these criteria will be excluded.
The intervention consists of educational sessions on oral hygiene practices, diet, fluoride use, and early detection of dental caries. Parents in the control group will receive routine information and standard dental care without structured education. Primary outcomes include changes in parental knowledge scores and ECC incidence in children. Secondary outcomes include improvements in oral hygiene behaviors and adherence to preventive practices.
Data will be collected through questionnaires, clinical examinations, and follow-up visits. Statistical analyses will compare outcomes between the experimental and control groups to determine the effectiveness of the parent education program.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
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Centre
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Rize, Centre, Turkey (Türkiye), 53020
- Karadeniz Technical University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Parents of children aged 0-3 years
- Ability to read, write, and speak Turkish
- Willingness to participate and provide written informed consent
Exclusion Criteria:
- Parents of children with chronic diseases
- Parents of children with special care needs
- Parents unwilling to participate in the study
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Experimental group
Participants in this group receive structured parent education sessions, including oral hygiene training, diet counseling, and guidance on early childhood caries prevention.
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Participants in the experimental group receive structured parent education sessions covering oral hygiene practices, diet counseling, fluoride use, and strategies for early childhood caries prevention.
Sessions include interactive discussions, demonstrations, and take-home educational materials.
Other Names:
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No Intervention: Control group
Participants in this group receive standard care, including routine oral health information provided during regular clinic visits, without structured educational sessions.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Parental Knowledge Score
Time Frame: Baseline, 3 months
|
The Early Childhood Caries Prevention Knowledge and Behavior Questionnaire was used to assess parents' knowledge and practices regarding the prevention of early childhood caries (ECC). The questionnaire was developed by the research team based on a review of the relevant literature and King's purposive data collection approach. It consists of 26 items evaluating parental knowledge and behaviors related to oral hygiene practices, dietary habits, fluoride use, dental visit timing, and risk factors for ECC. Each correct response receives 1 point, and incorrect or "do not know" responses receive 0 points. The total score ranges from 0 to 26. Higher scores indicate greater parental knowledge and more appropriate oral health behaviors related to the prevention of early childhood caries. The reliability of the questionnaire was assessed using Cronbach's alpha, which was found to be 0.727, indicating acceptable internal consistency. |
Baseline, 3 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Serpil Boran, MSc, Karadeniz Technical University, Graduate School of Health Sciences
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TDK-2025-16367 (Other Grant/Funding Number: KTU Scientific Research Projects Coordination Office)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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