Inflammatory Bowel DiseasesOQal-MICINCT05096897
Oral Health-related Quality of Life (OHRQoL) in Patients With Inflammatory Bowel Disease (IBD)
An observational study of Inflammatory Bowel Diseases and Periodontitis, run by University Hospital, Lille at 1 site in France.
Trial summary
IBD patients have a higher risk of oral diseases that affect the oral mucosa, the teeth and the tooth supporting tissues. These conditions are often associated with pain, bleeding and impaired masticatory function which may have an impact on the oral health-related quality of life (OHRQoL). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inflammatory Bowel Diseases, Periodontitis, Dental Caries
- What is being tested?
- Self-administrated questionnaires
- How many people
- 138 participants
- Where
- 1 siteFrance
- Study dates
- 5 Jan 2023to 1 Dec 2023
- Phase
- Observational
- 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
Study population: outpatients of the Service of Gastroenterology of the CHU of Amiens
Who may be able to join
- Adults ≥ 18 years of age
- With Crohn's disease or ulcerative colitis
- Able to understand and answer the questions asked
Who cannot join
- Unable to understand and/or answer questions
- Not willing to participate in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Self-rated Oral Health and Factors Associated With Oral Health-related Quality of Life (OHRQoL) in Patients With Inflammatory Bowel Disease (IBD)
IBD patients have a higher risk of oral diseases that affect the oral mucosa, the teeth and the tooth supporting tissues. These conditions are often associated with pain, bleeding and impaired masticatory function which may have an impact on the oral health-related quality of life (OHRQoL). However, few studies have investigated the self-evaluation of oral quality of life in IBD patients. The rare existing studies focus on very specific patients (elderly patients, patients with stomas) and do not use validated tools for the evaluation of OHRQoL. We also lack data on the effect of treatments such as immunosuppressants and type of IBD on OHRQoL. The aim of this study is to (i) compare oral quality of life in a cohort of IBD patients versus non-IBD patients and (ii) explore potential factors that influence oral quality of life in IBD
- Conditions
- Inflammatory Bowel Diseases, Periodontitis, Dental Caries, Tooth Loss
- Being tested
- Self-administrated questionnaires
- Keywords
- Crohn disease, Ulcerative Colitis, oral diseases, Oral health-related quality of life, self-questionnaire
- Medical subject headings
- Inflammatory Bowel Diseases, Periodontitis, Dental Caries, Tooth Loss, Crohn Disease, Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-administrated questionnairesOther
GOHAI, IBD-Q, IBD-disk
| Study group | Role | What they receive |
|---|---|---|
| IBD patients | Not described Receives: Other: Self-administrated questionnaires | |
| Non-IBD patients (irritable bowel syndrome) | Not described Receives: Other: Self-administrated questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
GOHAI score
Measured: Baseline (One time only on the day of the consultation )
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2021
- Study start5 Jan 2023
- Primary completion1 Dec 2023
- Study completion1 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory Bowel DiseasesStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 138 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kevimy AGOSSA, Study chair, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05096897
- Sponsor's protocol ID
- 2021_0464
- Other IDs
- 2021-A01875-36
- Acronym
- OQal-MICI
- Status last verified
- Apr 2022
- First submitted
- 14 Oct 2021
- Last updated
- 26 Dec 2025
- 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 26 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Self-rated Oral Health and Factors Associated With Oral Health-related Quality of Life (OHRQoL) in Patients With Inflammatory Bowel Disease (IBD)
- ClinicalTrials.gov ID
- NCT05096897
- Acronym / sponsor ID
- OQal-MICI / 2021_0464
- Conditions
- Inflammatory Bowel Diseases, Periodontitis, Dental Caries, Tooth Loss
- Keywords
- Crohn disease, Ulcerative Colitis, oral diseases, Oral health-related quality of life, self-questionnaire
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 138 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Study start
- 5 Jan 2023 (actual)
- Primary completion
- 1 Dec 2023 (actual)
- Study completion
- 1 Dec 2023 (actual)
- First posted
- 27 Oct 2021 (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.
IBD patients have a higher risk of oral diseases that affect the oral mucosa, the teeth and the tooth supporting tissues. These conditions are often associated with pain, bleeding and impaired masticatory function which may have an impact on the oral health-related quality of life (OHRQoL). However, few studies have investigated the self-evaluation of oral quality of life in IBD patients. The rare existing studies focus on very specific patients (elderly patients, patients with stomas) and do not use validated tools for the evaluation of OHRQoL. We also lack data on the effect of treatments such as immunosuppressants and type of IBD on OHRQoL. The aim of this study is to (i) compare oral quality of life in a cohort of IBD patients versus non-IBD patients and (ii) explore potential factors that influence oral quality of life in IBD
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IBD patients | – | Other: Self-administrated questionnaires |
| Non-IBD patients (irritable bowel syndrome) | – | Other: Self-administrated questionnaires |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- outpatients of the Service of Gastroenterology of the CHU of Amiens
Key inclusion criteria (3 listed)
- Adults ≥ 18 years of age
- With Crohn's disease or ulcerative colitis
- Able to understand and answer the questions asked
Key exclusion criteria (2 listed)
- Unable to understand and/or answer questions
- Not willing to participate in the study
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 |
|---|---|---|
| Self-administrated questionnairesGOHAI, IBD-Q, IBD-disk | Other | IBD patients, Non-IBD patients (irritable bowel syndrome) |
Primary outcome
GOHAI score
Time frame: Baseline (One time only on the day of the consultation )
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 26 Dec 2025.
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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.
Kevimy AGOSSA study chair
University Hospital, Lille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Inflammatory Bowel Diseases and Periodontitis, run by University Hospital, Lille 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 3 inclusion and 2 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 26 Dec 2025. 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?
GOHAI score (time frame: Baseline (One time only on the day of the consultation )). 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 26 Dec 2025.