Periodontal Therapy on the Gut Microbiome of Inflammatory Bowel Disease

NCT04790825 | Unknown

• 1 other identifier: IBD-perio project
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Periodontal Diseases; IBD; Dysbiosis; Inflammation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• 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 periodontal pocket depth (PPD) at 3 months

  Baseline and 90 days

• Changes in full mouth bleeding score (FMBS) at 3 months

  Baseline and 90 days

Study Arms (2)

Intensive periodontal treatment

EXPERIMENTAL

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)

Community-based periodontal care

ACTIVE COMPARATOR

Standard cycle of supragingival mechanical scaling and polishing.

Procedure: Full mouth scaling and root planing (FMSRP)

Interventions

Full mouth scaling and root planing (FMSRP) PROCEDURE

Subgingival instrumentation with ultrasonic devices and curettes of all periodontal pockets completed within 48 hours

Community-based periodontal care; Intensive periodontal treatment

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Turin, Italy: lead

Study Sites (1)

CIR Dental School

Turin, 10126, Italy

RECRUITING

MeSH Terms

Conditions

Periodontal Diseases; Dysbiosis; Inflammation

Interventions

Root Planing

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dental Scaling; Dental Prophylaxis; Periodontics; Dentistry; Subgingival Curettage; Preventive Dentistry

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 4, 2021
• First Posted: March 10, 2021
• Study Start: May 2, 2021
• Primary Completion: May 15, 2023
• Study Completion: May 15, 2023
• Last Updated: November 2, 2022

Record last verified: 2022-10

Locations

IT (1)