Multi-omics Analysis of Oral-gut Microbial Profiles

Periodontitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06261515
• Other study ID #: Perio-gut PRIN
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 15, 2024
• Est. completion date: February 15, 2026

Study information

• Verified date: February 2024
• Source: University of Turin, Italy
• Contact: Mario Aimetti, PA
• Phone: +390116331541
• Email: mario.aimetti[@]unito.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 70
• Est. completion date: February 15, 2026
• Est. primary completion date: January 15, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Periodontitis

Intervention

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).

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Turin, Italy

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	Changes in oral-gut metabolome measured in stool samples	Untargeted metabolic variation of oral-gut environment after treatment	Baseline and 90 days
Secondary	Changes in oral-gut miRNAome measured in stool samples	miRNA variation of oral-gut environment after treatment	Baseline and 90 days
Secondary	Metabolic plasma changes	Concentration of IL-1ß, IL-6, IL-10, TNF-a, INF-?, glucose, and cortisol released in plasma	Baseline and 90 days