Periodontal Therapy on the Gut Microbiome of Inflammatory Bowel Disease

Not Applicable

Recruiting

• Conditions: Dysbiosis; Periodontal Diseases; IBD; Inflammation

• Registration Number: NCT04790825
• Lead Sponsor: University of Turin, Italy

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-02-04
• Study First Submitted QC: 2021-03-05
• Study First Posted: 2021-03-10
• Study Start: 2021-05-02
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-31
• Last Update Posted: 2022-11-02
• Primary Completion: 2023-05-15
• Study Completion: 2023-05-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Changes in microbiome alpha diversity measured from stool samples at 3 months	Baseline and 90 days	Taxonomic and functional variation of gut bacteria after treatment

Secondary Outcome Measures

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

Trial Locations

Locations (1)

CIR Dental School; 🇮🇹 Turin, Italy