Prevalence of Periodontal Diseases in IBD

Inflammatory Bowel Diseases Clinical Trial

— MICIMaP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04380922
• Other study ID #: PO20062*
• Status: Completed
• Start date: June 19, 2020
• Est. completion date: June 10, 2022

Study information

• Verified date: June 2022
• Source: CHU de Reims
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: June 10, 2022
• Est. primary completion date: July 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Inflammatory Bowel Diseases
• Intestinal Diseases
• Periodontal Diseases

Intervention

Other:
• Periodontal screening
Periodontal data collection (PPD, REC, CAL)

Locations

Country	Name	City	State
France	Chu Reims	Reims

Sponsors (1)

Lead Sponsor	Collaborator
CHU de Reims

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of Periodontal Disease	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	Gingivitis	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
Secondary	Oral mucosa dermatological manifestations secondary to IBD	Defined by WHO criteria (2013)	Day 0
Secondary	Oral Health Quality of Life	GOHAI validated in French for general population -Tubert-Jeanin et al., 2003)	Day 0
Secondary	Oral treatment need	Evaluated by ICDAS (International Caries Detection and Assessment Score) (Ismaïl et al., 2007)	Day 0