Skip to main content
Clinical Trials/NCT06261515
NCT06261515
Recruiting
Not Applicable

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

University of Turin, Italy1 site in 1 country70 target enrollmentFebruary 15, 2024
ConditionsPeriodontitis

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Periodontitis
Sponsor
University of Turin, Italy
Enrollment
70
Locations
1
Primary Endpoint
Changes in gut microbial profile measured in stool samples
Status
Recruiting
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 15, 2024
End Date
February 15, 2026
Last Updated
last year
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
University of Turin, Italy
Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Changes in gut microbial profile measured in stool samples

Time Frame: 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

Time Frame: 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

Time Frame: Baseline and 90 days

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

Secondary Outcomes

  • 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 Sites (1)

Loading locations...

Similar Trials