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Multi-omics Analysis of Oral-gut Microbial Profiles

U

University of Turin

Status

Enrolling

Conditions

Periodontitis

Treatments

Procedure: Active periodontal treatment

Study type

Interventional

Funder types

Other

Identifiers

NCT06261515
Perio-gut PRIN

Details and patient eligibility

About

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.

Enrollment

70 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

70 participants in 1 patient group

Conventional periodontal treatment
Experimental group
Description:
Periodontal treatment of stage III-IV periodontitis patients according to the guideline recommendation from the European Federation of Periodontology will be provided.
Treatment:
Procedure: Active periodontal treatment

Trial contacts and locations

1

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Central trial contact

Mario Aimetti, PA

Data sourced from clinicaltrials.gov

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