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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Periodontal Diseases
- Sponsor
- University of Turin, Italy
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Changes in microbiome alpha diversity measured from stool samples at 3 months
- Status
- Recruiting
- Last Updated
- 3 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Changes in microbiome alpha diversity measured from stool samples at 3 months
Time Frame: Baseline and 90 days
Taxonomic and functional variation of gut bacteria after treatment
Secondary Outcomes
- Changes in periodontal pocket depth (PPD) at 3 months(Baseline and 90 days)
- Changes in microbiome alpha diversity measured from saliva samples at 3 months(Baseline and 90 days)
- Change of the inflammatory markers levels in plasma(Baseline and 90 days)
- Changes in mean clinical attachment level (CAL) at 3 months(Baseline and 90 days)
- Changes in full mouth bleeding score (FMBS) at 3 months(Baseline and 90 days)