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NCT Number: NCT06245278

The Effect of Non-Surgical Periodontal Therapy on Inflammatory Bowel Disease

Inflammatory bowel disease (IBD) is a chronic and recurrent inflammatory disease of the gastrointestinal tract characterised by complex interactions between genetic susceptibility, environmental factors, microbiota and host immune response. It has two main forms, Crohn's disease (CD) and Ulcerative colitis (UC). The main mechanism of IBD pathogenesis is dysregulated host immune response to commensal microbiota and disruption of the balance of pro- and anti-inflammatory cytokines in genetically predisposed individuals. Periodontitis is a multifactorial inflammatory disease associated with dental biofilm resulting in the loss of periodontal supporting tissues and subsequently teeth. Although the occurrence of the disease depends on multifactorial factors, bacterial plaque is the primary etiological factor and various bacterial species found in plaque are responsible for initiating and maintaining the inflammatory and immune response in periodontal disease. Periodontal diseases are known to contribute to many systemic diseases/conditions or systemic disorders are known to affect periodontal disease. Although the relationship between IBD and periodontitis is based on the potential link between oral and intestinal microbiomes and host immunoinflammatory response, the pathological interactions between the two diseases have not yet been determined. From this point of view, the aim of our study was to investigate the effect of periodontal status on serum, saliva and gingival biomarkers (TIM-3, TNF-α, IL-6 and IL-17) in patients with IBD and to evaluate the relationship between these values and periodontal clinical parameters. This is the first study to examine TIM-3 levels in saliva, serum and gingival samples in patients with IBD and periodontitis with IBD.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Biruni University

Istanbul, 34025, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • To be between the ages of 18-65,
  • Having at least 8 teeth excluding wisdom teeth,
  • No periodontal treatment in the last 3 months,
  • Not having used antibiotics in the last 3 months,
  • Not being pregnant or breastfeeding,
  • The individuals to be included in the control group should not have any systemic disease that may change the periodontal status, and the individuals to be included in the experimental group should not have any systemic disease that may affect periodontal health except IBD.

Exclusion criteria

  • Under 18 years of age and over 65 years of age,
  • Having less than 8 teeth,
  • Having undergone periodontal treatment in the last 3 months,
  • Having used antibiotics in the last 3 months,
  • Being pregnant or breastfeeding,
  • Individuals to be included in the control group should have any systemic disease that may change the periodontal status, and individuals to be included in the test group should have any systemic disease that may affect periodontal health except IBD.

Treatment and study plan

ELISA (Enzyme-Linked ImmunoSorbent Assay)

Other

A total of 60 individuals, 15 with IBD and periodontitis, 15 with IBD and periodontal health, 15 with systemic health and periodontitis, and 15 with systemic and periodontal health, will be included in the study. At the beginning of the study, periodontal clinical measurements (gingival index, plaque index, probing depth, gingival recession, clinical attachment level, bleeding on probing) and serum, saliva and gingival samples will be obtained from all individuals. Individuals with periodontitis will receive non-surgical periodontal treatment in half jaws within 2 weeks. Clinical measurements, serum and saliva sample collection will be repeated 3 months after the treatment. Biomarker levels in serum and saliva samples will be analysed by ELISA.

Primary outcomes

  1. Examination of TIM-3 levels of periodontal disease and inflammatory bowel disease

    Time frame: up to 1 year

    Examination of TIM-3 levels, which are stated to be associated with periodontal disease, in serum and saliva samples obtained from individuals with periodontitis and periodontitis individuals with inflammatory bowel disease.

Secondary outcomes

  1. Evaluation of the effect of non-surgical periodontal treatment on changes in TIM-3 level.

    Time frame: up to 1 year

    Evaluation of the effect of non-surgical periodontal treatment on changes in TIM-3 level.

Other outcomes

  1. Comparison biomarkers of study groups.

    Time frame: up to 1 year

    Comparison of serum and saliva samples taken before treatment in individuals with periodontitis and periodontitis individuals with inflammatory bowel disease in terms of TIM-3 levels.

Sponsors and collaborators

Lead sponsor

Biruni University

Other

Registry information

Official study title

The Effect of Non-Surgical Periodontal Therapy on Serum And Salivary Biomarker Levels in Individuals With Inflammatory Bowel Disease

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Feb 7, 2024
Registry last updated
Jun 25, 2025

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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