Periodontal Therapy on the Gut Microbiome of Inflammatory Bowel Disease

NCT ID: NCT04790825

Last Updated: 2022-11-02

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-02
• Study Completion Date: 2023-05-15

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Full mouth scaling and root planing (FMSRP)

Intervention Type: PROCEDURE

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

Community-based periodontal care

Standard cycle of supragingival mechanical scaling and polishing.

Group Type: ACTIVE_COMPARATOR

Full mouth scaling and root planing (FMSRP)

Intervention Type: PROCEDURE

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

Interventions

Full mouth scaling and root planing (FMSRP)

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

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Turin, Italy

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

CIR Dental School

Turin, , Italy

Site Status: RECRUITING

Countries

Italy

Facility Contacts

Mario Aimetti, Prof.

Role: primary

mario.aimetti@unito.it

+39116331541

Other Identifiers

IBD-perio project

Identifier Type: -

Identifier Source: org_study_id