Clinical trial NCT04882852: Validation of the Arabic Version of the Caries Questionnaire
Official title: Validation of the Arabic Version of the Caries Specific Measure of Quality of Life Questionnaire for Children
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dental Caries in Children
Keywords: CARIES-QC ,validity ,reliability, Arabic, dental caries
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2021-05-12
Enrollment: 234
Sex: ALL
Minimum age (years): 5
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Healthy children with active dental caries ranging in age from 5-16 year

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 .

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 .

Eligibility criteria: 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

Primary outcomes:
measure: validation of Arabic version CARIES-QC questionnaire
timeFrame: 1 year
Secondary outcomes:
measure: Testing reliability of the Arabic version of CARIES-QC questionnaire
timeFrame: 1 year
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: faculty of dentistry, Cairo university , Egypt
Study officials:
affiliation: Cairo University
name: Yasmin Mohamed, lecturer
role: PRINCIPAL_INVESTIGATOR
References: