Early Childhood Caries (ECC)GAT-ECCNCT07460271
Goal Attainment-Based Parent Education for ECC Prevention
A study testing Structured Parent Education in people with Early Childhood Caries (ECC), run by Karadeniz Technical University at 1 site in Turkey (Türkiye).
Trial summary
Preventing early childhood caries (ECC) requires improving parental knowledge and behavior, as parents play a critical role in establishing oral and dental health practices during early childhood. Read more about this study
- Who is it for?
- Ages 1 year to 3 yearsHealthy volunteers can take part
- Conditions the study is for
- Early Childhood Caries (ECC)
- What is being tested?
- Structured Parent Education
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2024to 28 Feb 2026
- 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 1 year to 3 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Parents of children aged 0-3 years
- Ability to read, write, and speak Turkish
- Willingness to participate and provide written informed consent
Who cannot join
- Parents of children with chronic diseases
- Parents of children with special care needs
- Parents unwilling to participate in the study
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Karadeniz Technical University
Rize, Centre, 53020
About this study
Official title: Assessing the Effectiveness of Parent Education on the Prevention of Early Childhood Caries Based on Goal Attainment Theory
Preventing early childhood caries (ECC) requires improving parental knowledge and behavior, as parents play a critical role in establishing oral and dental health practices during early childhood. This study aimed to evaluate the effectiveness of a parent-focused educational intervention, delivered within the nursing discipline and grounded in King's Theory of Goal Attainment, in preventing ECC. A pretest-posttest randomized controlled experimental design was employed. The study was conducted with 100 parents of children aged 0-3 years who presented for treatment at the Department of Pediatric Dentistry. Parents in the intervention group received ECC-prevention education supported by booklets, brochures, and videos.
Read the 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.
- Conditions
- Early Childhood Caries (ECC)
- Being tested
- Structured Parent Education
- Keywords
- Child, Primary Tooth Decay, Parents, Education, Knowledge, Behavior
- Medical subject headings
- Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Structured Parent EducationBehavioural
Also called Parent Education Program, Oral Health Training for Parents
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Participants in this group receive structured parent education sessions, including oral hygiene training, diet counseling, and guidance on early childhood caries prevention. Receives: Behavioral: Structured Parent Education |
| Control group | No intervention | Participants in this group receive standard care, including routine oral health information provided during regular clinic visits, without structured educational sessions. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Parental Knowledge Score
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.
Measured: Baseline, 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2026
- Study start1 Feb 2024
- Primary completion30 Sep 2025
- Study completion28 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Early Childhood Caries (ECC)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Parents of children aged 0-3 years are randomly assigned to either the experimental group, which receives structured oral health education, or the control group, which receives standard care. Outcomes include parental knowledge, oral hygiene behaviors, and incidence of early childhood caries in children.
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karadeniz Technical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Serpil Boran, Karadeniz Technical University
- Investigators
- Serpil Boran, MSc, Principal investigator, Karadeniz Technical University, Graduate School of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07460271
- Sponsor's protocol ID
- TDK-2025-16367
- Other IDs
- TDK-2025-16367
- Acronym
- GAT-ECC
- Status last verified
- Mar 2026
- First submitted
- 4 Mar 2026
- Last updated
- 10 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: De-identified individual participant data collected in this study will be made available for research purposes. Qualified researchers may request access, which will be provided through a secure data sharing process. The data will be accessible for up to 5 years after publication of the main study results, subject to ethical approval and data use agreements.
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Effectiveness of Parent Education on the Prevention of Early Childhood Caries Based on Goal Attainment Theory
- ClinicalTrials.gov ID
- NCT07460271
- Acronym / sponsor ID
- GAT-ECC / TDK-2025-16367
- Conditions
- Early Childhood Caries (ECC)
- Keywords
- Child, Primary Tooth Decay, Parents, Education, Knowledge, Behavior
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Karadeniz Technical UniversityUniversity, hospital or other
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- 30 Sep 2025 (actual)
- Study completion
- 28 Feb 2026 (actual)
- First posted
- 10 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Preventing early childhood caries (ECC) requires improving parental knowledge and behavior, as parents play a critical role in establishing oral and dental health practices during early childhood. This study aimed to evaluate the effectiveness of a parent-focused educational intervention, delivered within the nursing discipline and grounded in King's Theory of Goal Attainment, in preventing ECC. A pretest-posttest randomized controlled experimental design was employed. The study was conducted with 100 parents of children aged 0-3 years who presented for treatment at the Department of Pediatric Dentistry. Parents in the intervention group received ECC-prevention education supported by booklets, brochures, and videos.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Parents of children aged 0-3 years are randomly assigned to either the experimental group, which receives structured oral health education, or the control group, which receives standard care. Outcomes include parental knowledge, oral hygiene behaviors, and incidence of early childhood caries in children.
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Behavioral: Structured Parent EducationParticipants in this group receive structured parent education sessions, including oral hygiene training, diet counseling, and guidance on early childhood caries prevention. |
| Control group | No intervention | –Participants in this group receive standard care, including routine oral health information provided during regular clinic visits, without structured educational sessions. |
Who may qualify
- Ages
- 1 year to 3 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Parents of children aged 0-3 years
- Ability to read, write, and speak Turkish
- Willingness to participate and provide written informed consent
Key exclusion criteria (3 listed)
- Parents of children with chronic diseases
- Parents of children with special care needs
- Parents unwilling to participate in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Structured Parent EducationAlso: Parent Education Program, Oral Health Training for ParentsParticipants 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. | Behavioural | Experimental group |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2026.
- Individual participant dataSharing planned: No. De-identified individual participant data collected in this study will be made available for research purposes. Qualified researchers may request access, which will be provided through a secure data sharing process. The data will be accessible for up to 5 years after publication of the main study results, subject to ethical approval and data use agreements.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Serpil Boran, MSc principal investigator
Karadeniz Technical University, Graduate School of Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Structured Parent Education in people with Early Childhood Caries (ECC), run by Karadeniz Technical 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 3 inclusion and 3 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 10 Mar 2026. 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?
Parental Knowledge Score (time frame: Baseline, 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 10 Mar 2026.