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NCT Number: NCT04380922

Prevalence of Periodontal Diseases in IBD

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

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Key information

Conditions

Inflammatory Bowel Diseases Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Intestinal Diseases Mouth Diseases Periodontal Diseases Stomatognathic Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Chu Reims

Reims, 51092, France

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Periodontal screening

Other

Periodontal data collection (PPD, REC, CAL)

Primary outcomes

  1. 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

  1. 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

  2. Oral mucosa dermatological manifestations secondary to IBD

    Time frame: Day 0

    Defined by WHO criteria (2013)

  3. Oral Health Quality of Life

    Time frame: Day 0

    GOHAI validated in French for general population -Tubert-Jeanin et al., 2003)

  4. Oral treatment need

    Time frame: Day 0

    Evaluated by ICDAS (International Caries Detection and Assessment Score) (Ismaïl et al., 2007)

Sponsors and collaborators

Lead sponsor

CHU de Reims

Other

Registry information

Official study title

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

Acronym: MICIMaP

Important dates

Study start
2020
Primary completion
2021
Study completion
2022
First posted
May 8, 2020
Registry last updated
Jun 13, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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