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Clinical Trials/NCT04982302
NCT04982302
Completed
Not Applicable

Evaluation of Salivary and Intestinal Microbiological Response in Patients With Stage III-IV Periodontitis After Non-surgical Periodontal Therapy

University of Turin, Italy1 site in 1 country94 target enrollmentMay 1, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Periodontitis
Sponsor
University of Turin, Italy
Enrollment
94
Locations
1
Primary Endpoint
Changes in microbiome alpha diversity measured from stool samples at 3 months
Status
Completed
Last Updated
2 years ago

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 non-surgical periodontal treatment may reduce bacterial alpha diversity in stool samples. Fifty patients affected by stage III-IV periodontitis will be recruited, and treated by means of full-mouth scaling and root planing. Salivary and stool samples, together with a complete periodontal charting and a food diary will be collected and compared at baseline and 3 months after treatment. Age, gender and BMI-matched healthy individuals will be recruited as controls.

Registry
clinicaltrials.gov
Start Date
May 1, 2021
End Date
February 1, 2023
Last Updated
2 years ago
Study Type
Observational
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 30 days
  • pregnancy or breast feeding

Outcomes

Primary Outcomes

Changes in microbiome alpha diversity measured from stool samples at 3 months

Time Frame: [Time Frame: Baseline and 90 days]

Taxonomic and functional variation of gut bacteria after treatment

Secondary Outcomes

  • Changes in microbiome alpha diversity measured from saliva samples at 3 months([Time Frame: Baseline and 90 days])
  • Changes in mean clinical attachment level (CAL) at 3 months([Time Frame: Baseline and 90 days])
  • Changes in periodontal pocket depth (PPD) at 3 months([Time Frame: Baseline and 90 days])
  • Changes in full mouth bleeding score (FMBS) at 3 months([Time Frame: Baseline and 90 days])

Study Sites (1)

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