Translation and Validation of the Arabic Version of the O... | NCT05751902

Studies
Translation and Validation of the Arabic Version of the OHIP Questionnaire

NCT05751902

Sponsor

Future University in Egypt

Status

Unknown status

Last Update Posted

Jan 30, 2024Actual

Enrollment

254Estimated

Phase

Not provided

Conditions

Oral Health
Surveys and Questionnaires

Interventions

Arabic version of OHIP questionnaire

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2024

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 15, 2022Actual

Primary Completion Date

Jan 28, 2024Estimated

Completion Date

Jan 30, 2024Estimated

First Submitted Date

Feb 21, 2023

First Submission Date that Met QC Criteria

Feb 21, 2023

First Posted Date

Mar 2, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 27, 2024

Last Update Posted Date

Jan 30, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Medhat Sameh Abdelaziz, Assistant Lecturer of Prosthodontics, Future University in EgyptPrincipal Investigator

Lead Sponsor

Future University in EgyptOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

254Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Arabic version of OHIP questionnaire	Other	Translated Arabic version of Oral Health Impact Profile questionnaire

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Reliability and validity	Reliability of Translated Arabic version of OHIP questionnaire using internal consistency	3 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

any participant fluent in Arabic language and having a removable prosthesis.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Future University in Egypt	Recruiting	Cairo		111111	Egypt

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided