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Completed

NCT Number: NCT04882852

Validation of the Arabic Version of the Caries Questionnaire

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 .

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Key information

Age range

5 year–16 year

Sex eligibility

All sexes

Study type

Observational

Primary location

faculty of dentistry, Cairo university , Egypt

Cairo, 11311, Egypt

About this study

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 .

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2021
First posted
May 12, 2021
Registry last updated
May 12, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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