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NCT05096897 Clinical Trial

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

Inflammatory Bowel Diseases Clinical Trial

— OQal-MICI  

Official title:
Self-rated Oral Health and Factors Associated With Oral Health-related Quality of Life (OHRQoL) in Patients With Inflammatory Bowel Disease (IBD)

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT05096897
Other study ID # 2021_0464
Secondary ID 2021-A01875-36
Status Not yet recruiting
Phase
First received
Last updated
Start date November 2022
Est. completion date November 2023

Study information
Verified date April 2022
Source University Hospital, Lille
Contact Kevimy AGOSSA
Phone 0320445962
Email DRS@chru-lille.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical 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). 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

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 122
Est. completion date November 2023
Est. primary completion date November 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Self-administrated questionnaires
GOHAI, IBD-Q, IBD-disk

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
University Hospital, Lille

Outcome
Type Measure Description Time frame Safety issue
Primary GOHAI score Baseline (One time only on the day of the consultation )
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