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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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06261515
Enrollment
70
Registered
2024-02-15
Start date
2024-02-15
Completion date
2026-02-15
Last updated
2024-05-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Periodontitis

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.

Interventions

PROCEDUREActive periodontal treatment

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

Sponsors

University of Turin, Italy
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Changes in gut microbial profile measured in stool samplesBaseline and 90 daysTaxonomic variation of gut bacteria concentration after treatment assessed through shotgun metagenomics
Changes in oral microbial profile measured in saliva samplesBaseline and 90 daysTaxonomic variation of salivary bacteria concentration after treatment assessed through shotgun metagenomics
Changes in oral microbial profile measured in subgingival plaque samplesBaseline and 90 daysTaxonomic variation of subgingival bacteria concentration after treatment assessed through shotgun metagenomics

Secondary

MeasureTime frameDescription
Changes in oral-gut metabolome measured in stool samplesBaseline and 90 daysUntargeted metabolic variation of oral-gut environment after treatment
Changes in oral-gut miRNAome measured in stool samplesBaseline and 90 daysmiRNA variation of oral-gut environment after treatment
Metabolic plasma changesBaseline and 90 daysConcentration of IL-1β, IL-6, IL-10, TNF-α, INF-γ, glucose, and cortisol released in plasma

Countries

Italy

Contacts

Primary ContactMario Aimetti, PA
mario.aimetti@unito.it+390116331541

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026