Clinical trial NCT06245278: The Effect of Non-Surgical Periodontal Therapy on Inflammatory Bowel Disease
Official title: The Effect of Non-Surgical Periodontal Therapy on Serum And Salivary Biomarker Levels in Individuals With Inflammatory Bowel Disease
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Periodontitis
Inflammatory Bowel Diseases
Keywords: Periodontitis
Inflammatory bowel disease
Cytokine
Lead sponsor: Biruni University
Sponsor class: OTHER
First posted: 2024-02-07
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Examination of TIM-3 levels of periodontal disease and inflammatory bowel disease
timeFrame: up to 1 year
Secondary outcomes:
measure: Evaluation of the effect of non-surgical periodontal treatment on changes in TIM-3 level.
timeFrame: up to 1 year
Other outcomes:
measure: Comparison biomarkers of study groups.
timeFrame: up to 1 year
Locations:
Study officials:
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