Multi-omics Analysis of Oral-gut Microbial Profiles

NCT ID: NCT06261515

Last Updated: 2024-05-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-15

Study Completion Date

2026-02-15

Brief Summary

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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

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Conditions

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Periodontitis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Active periodontal treatment

Intervention Type PROCEDURE

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

Interventions

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Active periodontal treatment

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Turin, Italy

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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CIR Dental School

Turin, , Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Mario Aimetti, PA

Role: CONTACT

+390116331541

Facility Contacts

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Mario Aimetti, PA

Role: primary

+390116331541

Other Identifiers

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Perio-gut PRIN

Identifier Type: -

Identifier Source: org_study_id

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