Multi-omics Analysis of Oral-gut Microbial Profiles

Not Applicable

Recruiting

• Conditions: Periodontitis
• Interventions: Procedure: Active periodontal treatment

• Registration Number: NCT06261515
• Lead Sponsor: University of Turin, Italy

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-01-29
• Study First Submitted QC: 2024-02-07
• Study Start: 2024-02-15
• Study First Posted: 2024-02-15
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-30
• Last Update Posted: 2024-05-31
• Primary Completion: 2026-01-15
• Study Completion: 2026-02-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 70

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Conventional periodontal treatment	Active periodontal treatment	Periodontal treatment of stage III-IV periodontitis patients according to the guideline recommendation from the European Federation of Periodontology will be provided.

Primary Outcome Measures

Name	Time	Method
Changes in gut microbial profile measured in stool samples	Baseline and 90 days	Taxonomic variation of gut bacteria concentration after treatment assessed through shotgun metagenomics
Changes in oral microbial profile measured in saliva samples	Baseline and 90 days	Taxonomic variation of salivary bacteria concentration after treatment assessed through shotgun metagenomics
Changes in oral microbial profile measured in subgingival plaque samples	Baseline and 90 days	Taxonomic variation of subgingival bacteria concentration after treatment assessed through shotgun metagenomics

Secondary Outcome Measures

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

Trial Locations

Locations (1)

CIR Dental School; 🇮🇹 Turin, Italy