Dysbiosis, IBD, Inflammation, Periodontal Diseases
Conditions
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.
Interventions
PROCEDUREFull mouth scaling and root planing (FMSRP)
Subgingival instrumentation with ultrasonic devices and curettes of all periodontal pockets completed within 48 hours
Sponsors
University of Turin, Italy
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 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 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 |
Countries
Italy
Outcome results
None listed