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Validation of the Arabic Version of the Caries Questionnaire

Sponsor
Cairo University (Other)
Overall Status
Completed
CT.gov ID
NCT04882852
Collaborator
(none)
234
Enrollment
1
Location
14.4
Actual Duration (Months)
16.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 .

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Actual Enrollment :
    234 participants
    Observational Model:
    Other
    Time Perspective:
    Cross-Sectional
    Official Title:
    Validation of the Arabic Version of the Caries Specific Measure of Quality of Life Questionnaire for Children
    Actual Study Start Date :
    Dec 15, 2019
    Actual Primary Completion Date :
    Dec 29, 2020
    Actual Study Completion Date :
    Feb 25, 2021

    Outcome Measures

    Primary Outcome Measures

    1. validation of Arabic version CARIES-QC questionnaire [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.

    Secondary Outcome Measures

    1. Testing reliability of the Arabic version of CARIES-QC questionnaire [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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    5 Years to 16 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 faculty of dentistry, Cairo university , Egypt Cairo Egypt 11311

    Sponsors and Collaborators

    • Cairo University

    Investigators

    • Principal Investigator: Yasmin Mohamed, lecturer, Cairo University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Yasmin Mohamed Yousry, Lecturer in pediatric dentistry and dental public health department , Cairo university, Cairo University
    ClinicalTrials.gov Identifier:
    NCT04882852
    Other Study ID Numbers:
    • Validation study
    First Posted:
    May 12, 2021
    Last Update Posted:
    May 12, 2021
    Last Verified:
    May 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Yasmin Mohamed Yousry, Lecturer in pediatric dentistry and dental public health department , Cairo university, Cairo University
    CARIES-QC ,validity ,reliability, Arabic, dental caries
    Additional relevant MeSH terms:
    Dental Caries

    Study Results

    No Results Posted as of May 12, 2021