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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04982302
Other study ID # Perio-gut connection
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 1, 2021
Est. completion date February 1, 2023

Study information

Verified date October 2022
Source University of Turin, Italy
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

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 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.


Recruitment information / eligibility

Status Completed
Enrollment 94
Est. completion date February 1, 2023
Est. primary completion date October 1, 2022
Accepts healthy volunteers
Gender All
Age group 18 Years to 75 Years
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 30 days - pregnancy or breast feeding

Study Design


Intervention

Procedure:
Non-surgical periodontal treatment
Subgingival instrumentation with ultrasonic devices and curettes of all periodontal pockets

Locations

Country Name City State
Italy CIR Dental School Turin

Sponsors (1)

Lead Sponsor Collaborator
University of Turin, Italy

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary Changes in microbiome alpha diversity measured from stool samples at 3 months Taxonomic and functional variation of gut bacteria after treatment [Time Frame: Baseline and 90 days]
Secondary Changes in microbiome alpha diversity measured from saliva samples at 3 months Taxonomic and functional variation of salivary bacteria after treatment [Time Frame: Baseline and 90 days]
Secondary Changes in mean clinical attachment level (CAL) at 3 months Variation in CAL after therapy assessed using a millimetre marked manual periodontal probe at 6 sites per tooth element [Time Frame: Baseline and 90 days]
Secondary Changes in periodontal pocket depth (PPD) at 3 months Variation in PPD after therapy assessed using a millimetre marked manual periodontal probe at 6 sites per tooth element [Time Frame: Baseline and 90 days]
Secondary Changes in full mouth bleeding score (FMBS) at 3 months Variation in the percentage of bleeding sites after therapy assessed by gentle probing at 6 sites per tooth element [Time Frame: Baseline and 90 days]
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