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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Periodontitis; Inflammatory Bowel Diseases; Dental Caries; Tooth Loss
• Intervention / Treatment: Other: Self-administrated questionnaires

• Study Type: Observational
• Enrollment (Anticipated): 122

Contacts and Locations

• Study Contact: Name: Kevimy AGOSSA; Phone Number: +33 0320445962; Email: DRS@chru-lille.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

outpatients of the Service of Gastroenterology of the CHU of Amiens

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
IBD patients	Other: Self-administrated questionnaires; GOHAI, IBD-Q, IBD-disk
Non-IBD patients (irritable bowel syndrome)	Other: Self-administrated questionnaires; GOHAI, IBD-Q, IBD-disk

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
GOHAI score	Baseline (One time only on the day of the consultation )

Collaborators and Investigators

• Sponsor: University Hospital, Lille
• Investigators: Study Chair: Kevimy AGOSSA, University Hospital, Lille

Study record dates

Study Major Dates

• Study Start (Anticipated): November 1, 2022
• Primary Completion (Anticipated): November 1, 2023
• Study Completion (Anticipated): November 1, 2023

Study Registration Dates

• First Submitted: October 14, 2021
• First Submitted That Met QC Criteria: October 14, 2021
• First Posted (Actual): October 27, 2021

Study Record Updates

• Last Update Posted (Actual): April 5, 2022
• Last Update Submitted That Met QC Criteria: April 4, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: Ulcerative Colitis; Crohn disease; Oral health-related quality of life; oral diseases; self-questionnaire
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Tooth Demineralization; Tooth Diseases; Periodontitis; Inflammatory Bowel Diseases; Dental Caries; Intestinal Diseases; Tooth Loss
• Other Study ID Numbers: 2021_0464; 2021-A01875-36 (Other Identifier: ID-RCB number, ANSM)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No