NCT06525090

Brief Summary

Oral problems are a common occurrence among school-age children. In order to develop effective oral health interventions and services, it is essential to determine children's oral health behaviours using an internationally accepted standardised instrument that is child-friendly. However, no instrument currently exists to measure oral health according to the Theory of Planned Behaviour (TPB) in Turkish school-aged children. The aim of this study was to investigate the psychometric properties of the Oral Health Questionnaire, which includes the components of the theory of planned behavior such as attitude toward children's oral health, subjective norm, perceived behavioral control, and self-efficacy, for the Turkish population

Trial Health

87
On Track

Trial Health Score

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

Enrollment
298

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2021

Shorter than P25 for all trials

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2021

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

July 23, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 29, 2024

Completed
Last Updated

July 29, 2024

Status Verified

July 1, 2024

Enrollment Period

5 months

First QC Date

July 23, 2024

Last Update Submit

July 24, 2024

Conditions

Keywords

validityreliabilityoral health

Outcome Measures

Primary Outcomes (2)

  • reliability

    To measure stability of the test over time by Turkish Version of Child-Friendly Oral Health Questionnaire. Turkish Version of Child-Friendly Oral Health Questionnaireis filled with two week interval.

    2 months

  • validity

    To test in order to establish the correlation among the proposed instrument and instruments that had already been translated and validated. factor analysis was done.

    6 months

Study Arms (1)

298 school children aged 9-10 years

298 school children aged 9-10 years.

Other: no intervention-child-administered questionnaires

Interventions

The implementation of the research was started after getting approval from Mugla Sıtkı Kocman University Health Sciences Ethics Committee and TR Ministry of National Education Research, Competition and Social Activity. The purpose of the study was explained by the researchers to the administrators of the schools where the study was conducted and planning was made with the school administration. The data were collected in 15-20 minutes from the students who agreed to participate in the study during the course hours deemed appropriate by the administration. The purpose of the study and how to fill in the measurement tools was explained to the students, and it was stated that the research data would be kept confidential and used only by the researcher. The self-administered questionnaires were filled out on the paper. Verbal consent was obtained from the students participating in the study and written informed consent was obtained from their parents.

298 school children aged 9-10 years

Eligibility Criteria

Age9 Years - 10 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

The population of the study consisted of 5077 primary school students studying in 12 primary schools in the center of Fethiye in the 2020-2021 academic year. The study population comprised students in the third class of all primary schools in the centre of Fethiye. It is well-established that the sample size in validity and reliability studies should be at least 3-10 times the number of items.\[11\] To ensure the homogeneous distribution of students, the stratified random sampling method was used. In the sample determined by the stratified random sampling method, the number of students per school was determined and the students in the schools were stratified according to their classes, and data were collected from a total of 298 students

You may qualify if:

  • Third-class students of central primary schools affiliated with the Directorate of National Education in Fethiye,
  • Those without any communication barrier
  • Those with reading and writing skills who can answer questionnaires
  • Families who agreed to participate in the study and students who volunteered

You may not qualify if:

  • Students and the parents who did not agree to participate in the study or who wanted to leave the study after it started were excluded from the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

12 Primary Schools

Fethiye, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Tooth DiseasesMouth Diseases

Condition Hierarchy (Ancestors)

Stomatognathic Diseases

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

July 23, 2024

First Posted

July 29, 2024

Study Start

May 1, 2021

Primary Completion

October 1, 2021

Study Completion

December 31, 2021

Last Updated

July 29, 2024

Record last verified: 2024-07

Locations