NCT07460271

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2024

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2025

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2026

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

March 4, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 10, 2026

Completed
Last Updated

March 10, 2026

Status Verified

March 1, 2026

Enrollment Period

1.7 years

First QC Date

March 4, 2026

Last Update Submit

March 9, 2026

Conditions

Keywords

ChildPrimary Tooth DecayParentsEducationKnowledgeBehavior

Outcome Measures

Primary Outcomes (1)

  • 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.

    Baseline, 3 months

Study Arms (2)

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.

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.

Interventions

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.

Also known as: Parent Education Program, Oral Health Training for Parents
Experimental group

Eligibility Criteria

Age1 Year - 3 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Parents of children aged 0-3 years
  • Ability to read, write, and speak Turkish
  • Willingness to participate and provide written informed consent

You may not qualify if:

  • Parents of children with chronic diseases
  • Parents of children with special care needs
  • Parents unwilling to participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Karadeniz Technical University

Rize, Centre, 53020, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Behavior

Study Officials

  • Serpil Boran, MSc

    Karadeniz Technical University, Graduate School of Health Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
This is an open-label study. Both participants and investigators are aware of the group assignments, as the intervention involves structured parent education sessions.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ilknur Kahriman, Professor Dr., Registered Nurse

Study Record Dates

First Submitted

March 4, 2026

First Posted

March 10, 2026

Study Start

February 1, 2024

Primary Completion

September 30, 2025

Study Completion

February 28, 2026

Last Updated

March 10, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

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.

Locations