Gut Microbial Changes After Periodontal Treatment

Periodontitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04982302
• Other study ID #: Perio-gut connection
• Status: Completed
• 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
• 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
• 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

Related Conditions & MeSH terms

• Dysbiosis
• Intestinal Disease
• Intestinal Diseases
• Periodontitis

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]