Periodontal Therapy on the Gut Microbiome of Inflammatory Bowel Disease

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

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.

Study Overview

• Status: Recruiting
• Conditions: Inflammation; Periodontal Diseases; Dysbiosis; IBD
• Intervention / Treatment: Procedure: Full mouth scaling and root planing (FMSRP)

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Turin, Italy, 10126
    • Recruiting
    • CIR Dental School

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Intensive periodontal treatment; Adjunctive full-mouth intensive removal of subgingival dental plaque biofilms with the use of scaling and root planing after the administration of local anesthesia.	Procedure: Full mouth scaling and root planing (FMSRP); Subgingival instrumentation with ultrasonic devices and curettes of all periodontal pockets completed within 48 hours
ACTIVE_COMPARATOR: Community-based periodontal care; Standard cycle of supragingival mechanical scaling and polishing.	Procedure: Full mouth scaling and root planing (FMSRP); Subgingival instrumentation with ultrasonic devices and curettes of all periodontal pockets completed within 48 hours

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Change of the inflammatory markers levels in plasma	Concentration of cytokines and biomarkers in plasma samples	Baseline and 90 days
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
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
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

Collaborators and Investigators

• Sponsor: University of Turin, Italy

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 2, 2021
• Primary Completion (ANTICIPATED): May 15, 2023
• Study Completion (ANTICIPATED): May 15, 2023

Study Registration Dates

• First Submitted: February 4, 2021
• First Submitted That Met QC Criteria: March 5, 2021
• First Posted (ACTUAL): March 10, 2021

Study Record Updates

• Last Update Posted (ACTUAL): November 2, 2022
• Last Update Submitted That Met QC Criteria: October 31, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Gastrointestinal Diseases; Gastroenteritis; Stomatognathic Diseases; Mouth Diseases; Intestinal Diseases; Inflammation; Inflammatory Bowel Diseases; Periodontal Diseases; Dysbiosis
• Other Study ID Numbers: IBD-perio project

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No