MedDataX Logo

Oral Health-related Quality of Life (OHRQoL) in Patients With Inflammatory Bowel Disease (IBD)

NCT ID: NCT05096897

Last Updated: 2025-12-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

138 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-01-05

Study Completion Date

2023-12-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Inflammatory Bowel Diseases Periodontitis Dental Caries Tooth Loss

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Crohn disease Ulcerative Colitis oral diseases Oral health-related quality of life self-questionnaire

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

IBD patients

Self-administrated questionnaires

Intervention Type OTHER

GOHAI, IBD-Q, IBD-disk

Non-IBD patients (irritable bowel syndrome)

Self-administrated questionnaires

Intervention Type OTHER

GOHAI, IBD-Q, IBD-disk

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Self-administrated questionnaires

GOHAI, IBD-Q, IBD-disk

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Adults ≥ 18 years of age
* With Crohn's disease or ulcerative colitis
* Able to understand and answer the questions asked

Exclusion Criteria

* Unable to understand and/or answer questions
* Not willing to participate in the study
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University Hospital, Lille

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Kevimy AGOSSA

Role: STUDY_CHAIR

University Hospital, Lille

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

CHU Lille service odontologie

Lille, , France

Site Status

Countries

Review the countries where the study has at least one active or historical site.

France

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2021-A01875-36

Identifier Type: OTHER

Identifier Source: secondary_id

2021_0464

Identifier Type: -

Identifier Source: org_study_id