- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04882852
Validation of the Arabic Version of the Caries Questionnaire
Validation of the Arabic Version of the Caries Specific Measure of Quality of Life Questionnaire for Children
Study Overview
Status
Conditions
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
Enrollment (Actual)
Contacts and Locations
Study Locations
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Cairo, Egypt, 11311
- faculty of dentistry, Cairo university , Egypt
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Child in age from 5-16 years .
- Child with active caries
- Child speaks Arabic.
Exclusion Criteria:
- Child with dental traumatic injuries .
- Child has oral mucosal diseases.
- Child has cleft lip and or palate .
- Child having severe medical or mental conditions.
- Child who cannot understand the question even with help
Study Plan
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 |
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validation of Arabic version CARIES-QC questionnaire
Time Frame: 1 year
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cross-cultural validity and convergent validity were performed to test validity .
The confirmatory factor analysis (CFA) was used to assess the cross- cultural validity.
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1 year
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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
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1 year
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Yasmin Mohamed, lecturer, Cairo University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Validation study
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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