Validation of a French Version of the OHIP - Oral Health... | NCT07482293

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

NCT07482293

Sponsor

University Hospital, Clermont-Ferrand

Status

Completed

Last Update Posted

Mar 24, 2026Actual

Enrollment

200Actual

Phase

Not Applicable

Conditions

Oral Health Related Quality of Life (OHRQoL)

Interventions

OHIP

Countries

France

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

ID	Type	Description	Link
ANSM	Other Identifier	2024-A01904-43

Status Module

Record Verification Date

Dec 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 13, 2025Actual

Primary Completion Date

Nov 28, 2025Actual

Completion Date

Nov 28, 2025Actual

First Submitted Date

Mar 16, 2026

First Submission Date that Met QC Criteria

Mar 16, 2026

First Posted Date

Mar 19, 2026Actual

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

Mar 20, 2026

Last Update Posted Date

Mar 24, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

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

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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

200Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Control group	Other	Patients with at least 25 natural teeth and not suffering from periodontitis.	Other: OHIP
Parodontisis group	Other	Patients with periodontitis requiring specific treatment.	Other: OHIP

Interventions

Name	Type	Description	Arm Group Labels	Other Names
OHIP	Other	Self-administration of the OHIP-49	Control group Parodontisis group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Questionnaire OHIP-fr	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)

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Sophie Doméjean	CHU de Clermnt-Ferrand	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CHU de Clermont-Ferrand		Clermont-Ferrand		63000	France

Intervention Model Description

All participants (n=200) will be asked to complete OHIP questionnaire at the end of their scheduled visit for periodontal treatment or follow-up.

The duration fullfilment is estimated at 10 minutes. The same questionnaire will be re-administered 15 days later at visit 2 (Retest), to one in two patients (n=100). If a second visit to the dental clinic is not necessary for the overall treatment plan, patients will be able to complete a paper questionnaire at home and return it by postal mail using a pre-stamped envelope or electronically (scanned questionnaire returned by e-mail).