NCT04882852

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 .

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
234

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 15, 2019

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 29, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 25, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 3, 2021

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 12, 2021

Completed
Last Updated

May 12, 2021

Status Verified

May 1, 2021

Enrollment Period

1 year

First QC Date

May 3, 2021

Last Update Submit

May 6, 2021

Conditions

Keywords

CARIES-QC ,validity ,reliability, Arabic, dental caries

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Testing reliability of the Arabic version of CARIES-QC questionnaire

    1 year

Eligibility Criteria

Age5 Years - 16 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

Healthy children with active dental caries ranging in age from 5-16 year

You may qualify if:

  • Child in age from 5-16 years .
  • Child with active caries
  • Child speaks Arabic.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

faculty of dentistry, Cairo university , Egypt

Cairo, 11311, Egypt

Location

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth DemineralizationTooth DiseasesStomatognathic Diseases

Study Officials

  • Yasmin Mohamed, lecturer

    Cairo University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer in pediatric dentistry and dental public health department , Cairo university

Study Record Dates

First Submitted

May 3, 2021

First Posted

May 12, 2021

Study Start

December 15, 2019

Primary Completion

December 29, 2020

Study Completion

February 25, 2021

Last Updated

May 12, 2021

Record last verified: 2021-05

Locations