Validation of the Arabic Version of the Caries Questionnaire

May 6, 2021 updated by: Yasmin Mohamed Yousry, Cairo University

Validation of the Arabic Version of the Caries Specific Measure of Quality of Life Questionnaire for Children

Arabic is one of the most spoken languages in the world; however, the CARIES-QC questionnaire which evaluate the effect of oral diseases and disorders on children's oral health-related quality of life has not yet been validated in Arabic speaking children. So the purpose of this study was to translate the CARIES-QC into Arabic and test the measurement properties of the Arabic version of the CARIES-QC for use in children with dental caries who speaks Arabic .

Study Overview

Status

Completed

Detailed Description

Dental caries is a major public health problem. It has been estimated that 621 million children in the world have untreated dental caries . Dental caries always manifests with significant pain, affecting oral health-related quality of life (OHRQoL) and well-being. Several measures were widely used to comprehensively evaluate the effect of oral diseases and disorders on children's OHRQoL. However, most of these measures were 'generic' measures, and they may fail to detect small, clinically important changes related to specific oral diseases. Gilchrist et al recently developed the Caries Impacts and Experiences Questionnaire for Children (CARIES-QC) in order to address this issue. Preliminary findings have confirmed that Caries Impacts and Experiences Questionnaire for Children measure had good reliability, validity, and responsiveness. However, The original CARIES-QC was an English measure; so appropriate translation and cultural adaptation should be done in order to be used in other culture and language.

Arabic is one of the most spoken languages in the world; however, the CARIES-QC has not yet been validated in Arabic speaking children. So the purpose of this study was to translate the CARIES-QC into Arabic and test the measurement properties of the Arabic version of the CARIES-QC for use in children with dental caries who speaks Arabic .

Study Type

Observational

Enrollment (Actual)

234

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Cairo, Egypt, 11311
        • faculty of dentistry, Cairo university , Egypt

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years to 16 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Healthy children with active dental caries ranging in age from 5-16 year

Description

Inclusion Criteria:

  1. Child in age from 5-16 years .
  2. Child with active caries
  3. Child speaks Arabic.

Exclusion Criteria:

  1. Child with dental traumatic injuries .
  2. Child has oral mucosal diseases.
  3. Child has cleft lip and or palate .
  4. Child having severe medical or mental conditions.
  5. Child who cannot understand the question even with help

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
validation of Arabic version CARIES-QC questionnaire
Time Frame: 1 year
cross-cultural validity and convergent validity were performed to test validity . The confirmatory factor analysis (CFA) was used to assess the cross- cultural validity.
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Testing reliability of the Arabic version of CARIES-QC questionnaire
Time Frame: 1 year
Two methods were used to evaluate the reliability of the scale. The internal consistency was investigated by Cronbach's alpha and inter-item correlation. To analyse the test-retest reliability, the intergroup correlation coefficient (ICC) was calculated
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Yasmin Mohamed, lecturer, Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 15, 2019

Primary Completion (Actual)

December 29, 2020

Study Completion (Actual)

February 25, 2021

Study Registration Dates

First Submitted

May 3, 2021

First Submitted That Met QC Criteria

May 6, 2021

First Posted (Actual)

May 12, 2021

Study Record Updates

Last Update Posted (Actual)

May 12, 2021

Last Update Submitted That Met QC Criteria

May 6, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • Validation study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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