Oral Health-related Quality of Life (OHRQoL) in Patients... | NCT05096897

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

NCT05096897

Sponsor

University Hospital, Lille

Status

Completed

Last Update Posted

Dec 26, 2025Actual

Enrollment

138Actual

Phase

Not provided

Conditions

Inflammatory Bowel Diseases
Periodontitis
Dental Caries
Tooth Loss

Interventions

Self-administrated questionnaires

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2021-A01875-36	Other Identifier	ID-RCB number, ANSM

Status Module

Record Verification Date

Apr 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 5, 2023Actual

Primary Completion Date

Dec 1, 2023Actual

Completion Date

Dec 1, 2023Actual

First Submitted Date

Oct 14, 2021

First Submission Date that Met QC Criteria

Oct 14, 2021

First Posted Date

Oct 27, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 18, 2025

Last Update Posted Date

Dec 26, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

138Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
IBD patients			Other: Self-administrated questionnaires
Non-IBD patients (irritable bowel syndrome)			Other: Self-administrated questionnaires

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Self-administrated questionnaires	Other	GOHAI, IBD-Q, IBD-disk	IBD patients Non-IBD patients (irritable bowel syndrome)

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

outpatients of the Service of Gastroenterology of the CHU of Amiens

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Kevimy AGOSSA	University Hospital, Lille	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CHU Lille service odontologie		Lille			France

Condition Browse Module

MeSH Terms

ID	Term
D015212	Inflammatory Bowel Diseases
D010518	Periodontitis
D003731	Dental Caries
D016388	Tooth Loss
D003424	Crohn Disease
D003093	Colitis, Ulcerative

Ancestor Terms

ID	Term
D005759	Gastroenteritis
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases
D007410	Intestinal Diseases

Browse Leaves

Not provided

Browse Branches

Not provided