Oral Health Related Quality of Life (OHRQoL)OHIPNCT07482293
Validation of a French Version of the OHIP - Oral Health Impact Profile
A study testing OHIP in people with Oral Health Related Quality of Life (OHRQoL), run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oral Health Related Quality of Life (OHRQoL)
- What is being tested?
- OHIP
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- 13 Jan 2025to 28 Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Pregnant or breastfeeding patients;
- Patients under guardianship, curatorship, or judicial protection
- Patients deprived of their liberty
- Patients participating in another clinical trial.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Being tested
- OHIP
- Keywords
- OHIP, oral health impact profile, quality of life, oral health, french version, OHIP 14, OHIP 49
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OHIPOther
Self-administration of the OHIP-49
| Study group | Role | What they receive |
|---|---|---|
| Control group | Other | Patients with at least 25 natural teeth and not suffering from periodontitis. Receives: Other: OHIP |
| Parodontisis group | Other | Patients with periodontitis requiring specific treatment. Receives: Other: OHIP |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline ; 15 days (if applicable)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2026
- Study start13 Jan 2025
- Primary completion28 Nov 2025
- Study completion28 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral Health Related Quality of Life (OHRQoL)Studies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- 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).
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sophie Doméjean, Principal investigator, CHU de Clermnt-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07482293
- Sponsor's protocol ID
- RNI 2024 DOMEJEAN 2
- Other IDs
- ANSM
- Acronym
- OHIP
- Status last verified
- Dec 2024
- First submitted
- 16 Mar 2026
- Last updated
- 24 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of a French Version of the OHIP - Oral Health Impact Profile
- ClinicalTrials.gov ID
- NCT07482293
- Acronym / sponsor ID
- OHIP / RNI 2024 DOMEJEAN 2
- Keywords
- OHIP, oral health impact profile, quality of life, oral health, french version, OHIP 14, OHIP 49
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- 13 Jan 2025 (actual)
- Primary completion
- 28 Nov 2025 (actual)
- Study completion
- 28 Nov 2025 (actual)
- First posted
- 19 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- 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).
| Arm | Type | Receives |
|---|---|---|
| Control group | Other | Other: OHIPPatients with at least 25 natural teeth and not suffering from periodontitis. |
| Parodontisis group | Other | Other: OHIPPatients with periodontitis requiring specific treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- Pregnant or breastfeeding patients;
- Patients under guardianship, curatorship, or judicial protection
- Patients deprived of their liberty
- Patients participating in another clinical trial.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OHIPSelf-administration of the OHIP-49 | Other | Control group, Parodontisis group |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sophie Doméjean principal investigator
CHU de Clermnt-Ferrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing OHIP in people with Oral Health Related Quality of Life (OHRQoL), run by University Hospital, Clermont-Ferrand at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Questionnaire OHIP-fr (time frame: Baseline ; 15 days (if applicable)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2026; AzTrials last refreshed its copy on 8 Nov 2026.