Validation of a French Version of the OHIP - Oral Health Impact Profile (OHIP)

March 20, 2026 updated by: University Hospital, Clermont-Ferrand
The primary objective of this study is therefore to propose and validate a French-language (France) version of the OHIP (49 questions) (OHIP-fr-49: long version), and the secondary objective is to validate a shortened version, OHIP-fr-14.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

When patients are admitted to the study center, if they are seeking periodontal treatment, they may be asked to participate in the study. The control group consists of patients meeting inclusion and exclusion criteria and agreeing to participate. Participants will complete the questionnaire during their visit (test). The same questionnaire will be re-administrated 15 days later to the first 50 patients in each group.

Study Type

Interventional

Enrollment (Actual)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Clermont-Ferrand, France, 63000
        • CHU de Clermont-Ferrand

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients aged 18 years or older
  • Native French speakers
  • Able to read and complete a questionnaire
  • Willing to take part in a study assessing perceived oral health

Periodontitis group: patients with periodontitis requiring specific treatment

Control group: patients with at least 25 natural teeth and not suffering from periodontitis.

Exclusion Criteria:

  • Pregnant or breastfeeding patients;
  • Patients under guardianship, curatorship, or judicial protection
  • Patients deprived of their liberty
  • Patients participating in another clinical trial.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Control group
Patients with at least 25 natural teeth and not suffering from periodontitis.
Other: OHIP
Self-administration of the OHIP-49
Other: Parodontisis group
Patients with periodontitis requiring specific treatment.
Other: OHIP
Self-administration of the OHIP-49

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Questionnaire OHIP-fr
Time Frame: Baseline ; 15 days (if applicable)
Self administration of Oral Health Impact Profile questionnaire. The total score ranges from 0 to 196 (OHIP-49), with higher scores indicating worse oral health-related quality of life.
Baseline ; 15 days (if applicable)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Clermont-Ferrand

Investigators

  • Principal Investigator: Sophie Doméjean, CHU de Clermnt-Ferrand

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 13, 2025

Primary Completion (Actual)

November 28, 2025

Study Completion (Actual)

November 28, 2025

Study Registration Dates

First Submitted

March 16, 2026

First Submitted That Met QC Criteria

March 16, 2026

First Posted (Actual)

March 19, 2026

Study Record Updates

Last Update Posted (Actual)

March 24, 2026

Last Update Submitted That Met QC Criteria

March 20, 2026

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • RNI 2024 DOMEJEAN 2
  • ANSM (Other Identifier: 2025-A02921-48)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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