Periodontal Therapy on the Gut Microbiome of Inflammatory Bowel Disease

Inflammation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04790825
• Other study ID #: IBD-perio project
• Status: Recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Dysbiosis
• IBD
• Inflammation
• Inflammatory Bowel Diseases
• Periodontal Diseases

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