Prevalence of Periodontal Diseases in IBD (MICIMaP)

June 10, 2022 updated by: CHU de Reims

Prevalence of Periodontal Diseases in Inflammatory Bowel Diseases : a Pilot-study

Periodontal diseases are highly prevalent inflammatory diseases. It is now well known that they are correlated with numerous systemic diseases as : diabetes, chronic obstructive pulmonary disease, metabolic syndrome or rheumatoid arthritis. Recently, periodontal diseases have been correlated with inflammatory bowel diseases (IBD). IBD include two types, Crohn's disease and Ulcerative Colitis. It could be a significant risk factor for the pathogenesis of periodontal disease. These diseases present common features : a high prevalence worldwide, multifactorial pathogenies with common mechanisms. To date, no study has linked activity of IBD and periodontal diseases. The authors hypotheses that the prevalence of periodontal diseases could be increased in patient presenting an active IBD

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The present study explores the prevalence of periodontal diseases regarding to the activity status of IBD (active versus non-active).

Diseases activity will be assessed by HBI (Crohn's disease) or partial Mayo score (Ulcerative Colitis) associated with fecal calprotectin and/or CRP and/or inflammatory/ulcerative lesions.

Periodontal diseases (periodontitis and gingivitis) will be diagnosed according to the international classification of periodontal diseases (Chicago 2017) and based on the decision-making algorithms by Tonetti and Sanz. A periodontal screening, socio-demographic data and clinical data will be collected. Then, oral mucosa dermatological manifestations relative to IBD, treatment need (ICDAS) and quality of life related to oral health (GOHAI) will be evaluated. These data will be collected by a periodontist.

The principal hypothesis of this study is that the prevalence of periodontal diseases could be increased in patient presenting an active IBD.

The primary objective is to evaluate if patients presenting active IBD present more stage III and IV periodontal diseases than non-active IBD ones.

The second objectives are :

  • to compare periodontal diseases, gingivitis and oral mucosa dermatological manifestations rates according to the diseases activity, the IBD type and the treatment used to treat IBD,
  • to compare oral treatment need according to the activity and the type of IBD,
  • to compare quality of life related to oral health according to the activity and the type of IBD

Study Type

Observational

Enrollment (Actual)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Reims, France, 51092
        • CHU Reims

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients consulting for the management of Crohn's disease or Ulcerative colitis

Description

Inclusion Criteria:

Patients

  • consulting Gastroenterology departments in the university hospital of Reims or Amiens-Picardie for the management of Crohn's disease or Ulcerative colitis
  • signed informed consent form
  • affiliated to the French Social Security system

Exclusion Criteria:

Patients presenting:

  • a medical history likely to compromise protocol (psychiatric disorders, other inflammatory diseases, antibiotics, NSAIDs within the last 3 months)
  • Diabetes
  • Inflammatory rheumatism
  • Cancer or radiotherapy up to5 years before inclusion
  • X-ray therapy in the area of interest
  • Pregnancy or Breastfeeding
  • Eating disorders
  • Patients under legal protection, trusteeship or guardianship

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Active IBD

Active Inflammatory Bowel Diseases defined as :

For Crohn's disease :

  • Harvey Bradshaw Index ≥ 4
  • Associated with fecal calprotectin rate > 250 µg/g within 3 months OR CRP ≥ 6mg /L OR the presence of ulcerative and/or inflammatory lesions in endoscopy or in imaging within 3 months For Ulcerative colitis
  • Partial Mayo score ≥ 2
  • Associated with fecal calprotectin rate > 250 µg/g within 3 months OR CRP ≥ 6mg /L OR the presence of ulcerative and/or inflammatory lesions in endoscopy within 3 months
Other: Periodontal screening
Periodontal data collection (PPD, REC, CAL)
Non-active IBD
Non-active Inflammatory Bowel Diseases
Other: Periodontal screening
Periodontal data collection (PPD, REC, CAL)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prevalence of Periodontal Disease
Time Frame: Day 0
Periodontal Disease will be diagnosed according to the new classification of periodontal diseases (Chicago, 2017) and defined by the decision-making algorithms (Tonetti and Sanz, 2019). Diagnosis will be based on Buccal or lingual Clinical attachment level (CAL), Recession (REC) and Periodontal Pocket Depths (PPD) measurement.
Day 0

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gingivitis
Time Frame: Day 0
Gingivitis will be diagnosed according to the new classification of periodontal diseases (Chicago, 2017) and defined by the decision-making algorithms (Tonetti and Sanz, 2019). Bleeding On Probing (BOP) higher than 10% is considered as a Gingivitis
Day 0
Oral mucosa dermatological manifestations secondary to IBD
Time Frame: Day 0
Defined by WHO criteria (2013)
Day 0
Oral Health Quality of Life
Time Frame: Day 0
GOHAI validated in French for general population -Tubert-Jeanin et al., 2003)
Day 0
Oral treatment need
Time Frame: Day 0
Evaluated by ICDAS (International Caries Detection and Assessment Score) (Ismaïl et al., 2007)
Day 0

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CHU de Reims

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

June 19, 2020

Primary Completion (ACTUAL)

July 30, 2021

Study Completion (ACTUAL)

June 10, 2022

Study Registration Dates

First Submitted

May 5, 2020

First Submitted That Met QC Criteria

May 5, 2020

First Posted (ACTUAL)

May 8, 2020

Study Record Updates

Last Update Posted (ACTUAL)

June 13, 2022

Last Update Submitted That Met QC Criteria

June 10, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PO20062*

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe