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Clinical Trials/NCT04380922
NCT04380922CompletedNot Applicable

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

CHU de Reims1 site in 1 country60 target enrollmentStarted: June 19, 2020Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
60
Locations
1
Primary Endpoint
Prevalence of Periodontal Disease

Study Overview

Brief Summary

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

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.

Study Design

Study Type
Observational
Observational Model
Other
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to 70 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • 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)
  • 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

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • Gingivitis(Day 0)
  • Oral mucosa dermatological manifestations secondary to IBD(Day 0)
  • Oral treatment need(Day 0)
  • Oral Health Quality of Life(Day 0)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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