Translation and Validation of the Arabic Version of the OHIP Questionnaire

• Sponsor: Future University in Egypt (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05751902
• Collaborator: (none)
• Enrollment: 254
• Locations: 2
• Anticipated Duration (Months): 3
• Patients Per Site: 127
• Patients Per Site Per Month: 43

Study Details

Study Description

Brief Summary

OHIP questionnaire was originally developed in English and in order to make use of this tool to measure the oral health-related quality of life of elderly Arabic populations, A translation is necessary. Also, validation of the translated instrument is very important. As people living in middle east are mainly influenced by the Arabic culture, which differs significantly from the Western culture where the OHIP questionnaire was first developed.

254 participants having removable prosthesis will be asked to complete translated Arabic version of OHIP questionnaire for validation.

Condition or Disease	Intervention/Treatment	Phase
Oral Health; Surveys and Questionnaires	Other: Arabic version of OHIP questionnaire

Study Design

• Study Type: Observational
• Anticipated Enrollment: 254 participants
• Observational Model: Other
• Time Perspective: Cross-Sectional
• Official Title: Translation and Validation of the Arabic Version of the Oral Health Impact Profile Questionnaire
• Actual Study Start Date: Dec 15, 2022
• Anticipated Primary Completion Date: Mar 7, 2023
• Anticipated Study Completion Date: Mar 15, 2023

Outcome Measures

Primary Outcome Measures

1. Reliability and validity [3 months]

   Reliability of Translated Arabic version of OHIP questionnaire using internal consistency

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Patients having removable partial denture in the last year

• Native Arabic patients

Exclusion Criteria:

• Patients non familiar with Arabic language

• patients with mental or perception problems

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Future University in Egypt	Cairo		Egypt	111111
2	Future University in Egypt	Cairo		Egypt

Sponsors and Collaborators

• Future University in Egypt

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Medhat Sameh Abdelaziz, Assistant Lecturer of Prosthodontics, Future University in Egypt
• ClinicalTrials.gov Identifier: NCT05751902
• Other Study ID Numbers: FUE.REC (1)/1-2023
• First Posted: Mar 2, 2023
• Last Update Posted: Mar 2, 2023
• Last Verified: Feb 1, 2023

• 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

Study Results

No Results Posted as of Mar 2, 2023