Multi-omics Analysis of Oral-gut Microbial Profiles

NCT06261515 | Recruiting

• 1 other identifier: Perio-gut PRIN
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

Periodontitis is a chronic inflammatory disease of the tooth supporting structures induced by a dysbiosis in the oral and subgingival microenvironment of susceptible patients. The long-term swallowing of high doses of periodontal pathogenic microorganisms could induce a dysbiosis of the intestinal microbiota, favouring the establishment of an 'inflamed' microbiome in terms of composition and/or function. The present project is aimed at a better understanding of the etiopathogenetic correlation between periodontitis and intestinal dysbiosis, and aims to explore the hypothesis that periodontal treatment may influence the multi-omics profile on the oral-gut-systemic axis. 70 patients affected by stage III-IV periodontitis will be recruited, and treated by means of full-mouth scaling and root planing. Salivary, subgingival plaque, plasma and stool samples, together with a complete periodontal charting and a food diary will be collected and compared at baseline and after treatment. Age, gender and BMI-matched healthy individuals will be recruited as controls.

Conditions

Periodontitis

Outcome Measures

Primary Outcomes (3)

• Changes in gut microbial profile measured in stool samples

  Taxonomic variation of gut bacteria concentration after treatment assessed through shotgun metagenomics

  Baseline and 90 days

• Changes in oral microbial profile measured in saliva samples

  Taxonomic variation of salivary bacteria concentration after treatment assessed through shotgun metagenomics

  Baseline and 90 days

• Changes in oral microbial profile measured in subgingival plaque samples

  Taxonomic variation of subgingival bacteria concentration after treatment assessed through shotgun metagenomics

  Baseline and 90 days

Secondary Outcomes (3)

• Changes in oral-gut metabolome measured in stool samples

  Baseline and 90 days

• Changes in oral-gut miRNAome measured in stool samples

  Baseline and 90 days

• Metabolic plasma changes

  Baseline and 90 days

Study Arms (1)

Conventional periodontal treatment

EXPERIMENTAL

Periodontal treatment of stage III-IV periodontitis patients according to the guideline recommendation from the European Federation of Periodontology will be provided.

Procedure: Active periodontal treatment

Interventions

Active periodontal treatment PROCEDURE

Subgingival instrumentation with ultrasonic devices and curettes of all periodontal pockets; periodontal surgery if needed (residual probing pocket depths ≥ 6 mm).

Conventional periodontal treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 90 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

Periodontitis

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Central Study Contacts

Mario Aimetti, PA

CONTACT

+390116331541; mario.aimetti@unito.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 29, 2024
• First Posted: February 15, 2024
• Study Start: February 15, 2024
• Primary Completion: January 15, 2026
• Study Completion: February 15, 2026
• Last Updated: May 31, 2024

Record last verified: 2024-05

Locations

IT (1)