Multi-omics Analysis of Oral-gut Microbial Profiles

Multi-omics Multi-specimens Evaluation of Oral-gut-systemic Profiles in Patients With Stage III-IV Periodontitis Pre- and After-therapy

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.

Study Overview

• Status: Recruiting
• Conditions: Periodontitis
• Intervention / Treatment: Procedure: Active periodontal treatment

• Study Type: Interventional
• Enrollment (Estimated): 70
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mario Aimetti, PA; Phone Number: +390116331541; Email: mario.aimetti@unito.it

Study Locations

• Italy
  • Turin, Italy, 10126
    • Recruiting
    • CIR Dental School
    • Contact: Mario Aimetti, PA; Phone Number: +390116331541; Email: mario.aimetti@unito.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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 90 days
• pregnancy or breast feeding

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Conventional periodontal treatment; 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; Subgingival instrumentation with ultrasonic devices and curettes of all periodontal pockets; periodontal surgery if needed (residual probing pocket depths ≥ 6 mm).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in oral-gut metabolome measured in stool samples	Untargeted metabolic variation of oral-gut environment after treatment	Baseline and 90 days
Changes in oral-gut miRNAome measured in stool samples	miRNA variation of oral-gut environment after treatment	Baseline and 90 days
Metabolic plasma changes	Concentration of IL-1β, IL-6, IL-10, TNF-α, INF-γ, glucose, and cortisol released in plasma	Baseline and 90 days

Collaborators and Investigators

• Sponsor: University of Turin, Italy

Study record dates

Study Major Dates

• Study Start (Actual): February 15, 2024
• Primary Completion (Estimated): January 15, 2026
• Study Completion (Estimated): February 15, 2026

Study Registration Dates

• First Submitted: January 29, 2024
• First Submitted That Met QC Criteria: February 7, 2024
• First Posted (Actual): February 15, 2024

Study Record Updates

• Last Update Posted (Actual): May 31, 2024
• Last Update Submitted That Met QC Criteria: May 30, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Periodontitis
• Other Study ID Numbers: Perio-gut PRIN

Drug and device information, study documents

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