NCT07482293

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2025

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

January 13, 2025

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 28, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 28, 2025

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

March 16, 2026

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 19, 2026

Completed
Last Updated

March 24, 2026

Status Verified

December 1, 2024

Enrollment Period

11 months

First QC Date

March 16, 2026

Last Update Submit

March 20, 2026

Conditions

Oral Health Related Quality of Life (OHRQoL)

Keywords

OHIPoral health impact profilequality of lifeoral healthfrench versionOHIP 14OHIP 49

Outcome Measures

Primary Outcomes (1)

  • 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)

Study Arms (2)

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

OHIPOTHER

Self-administration of the OHIP-49

Control groupParodontisis group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Clermont-Ferrand

Clermont-Ferrand, 63000, France

Location

Study Officials

  • Sophie Doméjean

    CHU de Clermnt-Ferrand

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Model Details: 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).
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 16, 2026

First Posted

March 19, 2026

Study Start

January 13, 2025

Primary Completion

November 28, 2025

Study Completion

November 28, 2025

Last Updated

March 24, 2026

Record last verified: 2024-12

Locations

FR(1)