Periodontal Therapy on the Gut Microbiome of Inflammatory Bowel Disease

Study Overview
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Brief Summary
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Periodontitis and inflammatory bowel disease have been associated by meta-epidemiologic evidence, although their mechanistic connection needs to be further explored. Oral-gut axis is implicated in the pathogenesis of several chronic inflammatory conditions, but to date no studies have evaluated the impact of periodontal treatment on gut ecology. Thus, the present randomised clinical trial is aimed at investigating the effect of intensive or conventional periodontal therapy on the gut microbiome and parameters of systemic inflammation of patients diagnosed with inflammatory bowel disease.

Official Title
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Effect of Intensive or Conventional Periodontal Therapy on the Gut Microbiome and Systemic Inflammation of Patients With Inflammatory Bowel Disease: a Single-blinded Randomized Clinical Trial

Conditions
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Periodontal Diseases, IBD, Dysbiosis, Inflammation

Intervention / Treatment
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* Procedure: Full mouth scaling and root planing (FMSRP)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: clinical and instrumental diagnosis of ulcerative colitis or Crohn's disease periodontitis Stage III or IV BMI between 20 and 29 kg/m2 free diet presence of at least 20 teeth Exclusion Criteria: Systemic diseases (including diabetes, thyroid, liver, or kidney diseases) dietary allergies use of antibiotics or probiotics during the previous 30 days pregnancy or breast feeding

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intensive periodontal treatment<br>Adjunctive full-mouth intensive removal of subgingival dental plaque biofilms with the use of scaling and root planing after the administration of local anesthesia. | Procedure: Full mouth scaling and root planing (FMSRP)<br>* Subgingival instrumentation with ultrasonic devices and curettes of all periodontal pockets completed within 48 hours<br>|
| Active Comparator: Community-based periodontal care<br>Standard cycle of supragingival mechanical scaling and polishing. | Procedure: Full mouth scaling and root planing (FMSRP)<br>* Subgingival instrumentation with ultrasonic devices and curettes of all periodontal pockets completed within 48 hours<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in microbiome alpha diversity measured from stool samples at 3 months | Taxonomic and functional variation of gut bacteria after treatment | Baseline and 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in microbiome alpha diversity measured from saliva samples at 3 months | Taxonomic and functional variation of salivary bacteria after treatment | Baseline and 90 days | 
| Change of the inflammatory markers levels in plasma | Concentration of cytokines and biomarkers in plasma samples | Baseline and 90 days | 
| Changes in mean clinical attachment level (CAL) at 3 months | Variation in CAL after therapy assessed using a millimetre marked manual periodontal probe at 6 sites per tooth element | Baseline and 90 days | 
| Changes in periodontal pocket depth (PPD) at 3 months | Variation in PPD after therapy assessed using a millimetre marked manual periodontal probe at 6 sites per tooth element | Baseline and 90 days | 
| Changes in full mouth bleeding score (FMBS) at 3 months | Variation in the percentage of bleeding sites after therapy assessed by gentle probing at 6 sites per tooth element | Baseline and 90 days |