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CompletedNCT06525090Updated Jul 29, 2024

Turkish Version of Child-Friendly Oral Health Questionnaire

An observational study in Tooth Diseases and Oral Disease, sponsored by Muğla Sıtkı Koçman University. Completed at 1 site in Turkey. Open to participants aged 9 Years to 10 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-07-29.

Sponsored by Muğla Sıtkı Koçman University · Observational

Study type
Observational
Model
Other
Time perspective
Cross-sectional
Enrollment
298
Ages
9 Years to 10 Years
Sex
All
01

Study 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

Read the detailed description

The Oral Health Questionnaire was used as the data collection tool in the study. It was developed by Davison et al. (2017) as a child-friendly scale consisting of 57 questions in a 5-point Likert type based on the TPB [6]. The scale consists of three parts. The first part consists of questions to obtain sociodemographic information (items 1-9), and the second part consists of questions to determine the behavioral characteristics of the individual toward tooth brushing. Tooth brushing behaviors are evaluated based on the individual's statements. The last part of the scale consists of questions to determine direct and indirect measures of beliefs based on the theory of planned behavior. We used the Pictorial rating Likert scales as original.

The translation is the first step in the adaptation process. After the scale was translated into Turkish, a common Turkish version was developed by the researchers through group work. The Turkish version of the scale was translated into English by a different linguist who is an expert in both Turkish and English. To determine the content validity of the scale whose language validity was completed, it was submitted to the opinions of 10 faculty members, including pediatric nursing, public health nursing, and pedodontics experts. After receiving expert opinions, it is recommended to administer the scale to a group of approximately 20-30 individuals who have similar characteristics with the study subjects for pilot study. For the language validity of the scale, the translation-back translation technique was used, and for content validity, I-CVI and S-CVI were used Davis technique. According to Davis technique, each item of the scale was evaluated by ten faculty members who are experts in the field by choosing one of the four rating options from 1 (not relevant) to 4 (highly relevant). Item Content Validity Index (I-CVI) for each item was obtained by dividing the number of experts who chose option (3) or (4) when evaluating each item and dividing by the total number of experts. The intraclass correlation coefficient was used to evaluate the expert opinions for the content validity of the scale. Regarding reliability, the Cronbach alpha reliability coefficient was used to evaluate the internal consistency of the scale and its sub-dimensions, and Pearson product-moment correlation was used to compare item-total score correlations. Correlation and regression analysis were conducted for predictive validity. While the sample size was analyzed with Kaiser-Meyer-Olkin, its suitability for factor analysis was tested with Bartlett's Test of Sphericity, factor analysis, and principal component analysis. CFA was used to determine whether the items and subscales explained the original scale structure. CFA were performed on the same sample, the general sample was randomly split. The model verification of the comparative fit index (CFI) was conducted based on the chi-square test, degree of freedom, root mean square error of approximation (RMSEA), goodness of fit index (GFI), and normal fit index (NFI)

02

Conditions studied

  • Tooth Diseases
  • Oral Disease

Keywords

  • validity
  • reliability
  • oral health
03

In context

Tooth Diseases

79 studies on the registry are indexed under Tooth Diseases; 11 are open to participants now.

This study's enrollment of 298 is above the median of 224 across 16 observational studies indexed under Tooth Diseases.

Browse Tooth Diseases studies →

Lead sponsor

Muğla Sıtkı Koçman University is the lead sponsor of 114 studies on the registry; 19 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
9 Years to 10 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability 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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Observational model
Other
Time perspective
Cross-sectional
Enrollment
298 participants (actual)
Patient registry
No

Groups and cohorts

  • 298 school children aged 9-10 years

    298 school children aged 9-10 years.

    Other: no intervention-child-administered questionnaires

Interventions

  • Otherno intervention-child-administered questionnaires

    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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 2 months

  2. 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.

    Time frame: 6 months

07

Study locations

1 site
  • 12 Primary Schools
    Fethiye, Turkey
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 29, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06525090
Collaborators
recep kara, özgül Cartı Dörterler, gülay manav
Responsible party
Gonca Karayagiz Muslu (Associate Professor, Muğla Sıtkı Koçman University) — Principal investigator
First posted
Jul 29, 2024
Start date
May 1, 2021
Primary completion
Oct 1, 2021
Completion
Dec 31, 2021
Last update
Jul 29, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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