Validation of the Arabic Version of the Caries Questionnaire

Dental Caries in Children Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04882852
• Other study ID #: Validation study
• Status: Completed
• Start date: December 15, 2019
• Est. completion date: February 25, 2021

Study information

• Verified date: May 2021
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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 .

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 .

Recruitment information / eligibility

• Status: Completed
• Enrollment: 234
• Est. completion date: February 25, 2021
• Est. primary completion date: December 29, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 5 Years to 16 Years

Eligibility

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

Related Conditions & MeSH terms

• Dental Caries
• Dental Caries in Children

Locations

Country	Name	City	State
Egypt	faculty of dentistry, Cairo university , Egypt	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	validation of Arabic version CARIES-QC questionnaire	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	Testing reliability of the Arabic version of CARIES-QC questionnaire	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