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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04790825
Other study ID # IBD-perio project
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date May 2, 2021
Est. completion date May 15, 2023

Study information

Verified date October 2022
Source University of Turin, Italy
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 40
Est. completion date May 15, 2023
Est. primary completion date May 15, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 60 Years
Eligibility 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


Intervention

Procedure:
Full mouth scaling and root planing (FMSRP)
Subgingival instrumentation with ultrasonic devices and curettes of all periodontal pockets completed within 48 hours

Locations

Country Name City State
Italy CIR Dental School Turin

Sponsors (1)

Lead Sponsor Collaborator
University of Turin, Italy

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
Secondary Change of the inflammatory markers levels in plasma Concentration of cytokines and biomarkers in plasma samples Baseline and 90 days
Secondary 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
Secondary 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
Secondary 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
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