Gut Microbial Changes After Periodontal Treatment

Completed

• Conditions: Dysbiosis; Intestinal Disease; Periodontitis
• Interventions: Procedure: Non-surgical periodontal treatment

• Registration Number: NCT04982302
• Lead Sponsor: University of Turin, Italy

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-05-01
• Study First Submitted: 2021-07-19
• Study First Submitted QC: 2021-07-19
• Study First Posted: 2021-07-29
• Status Verified: 2022-10
• Primary Completion: 2022-10-01
• Study Completion: 2023-02-01
• Last Update Submitted: 2023-05-17
• Last Update Posted: 2023-05-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 94

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Non-surgical periodontal treatment NSPT	Non-surgical periodontal treatment	Subgingival instrumentation with ultrasonic devices and curettes of all periodontal pockets in 2 or 4 appointments

Primary Outcome Measures

Name	Time	Method
Changes in microbiome alpha diversity measured from stool samples at 3 months	[Time Frame: Baseline and 90 days]	Taxonomic and functional variation of gut bacteria after treatment

Secondary Outcome Measures

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

Trial Locations

Locations (1)

CIR Dental School; 🇮🇹 Turin, Italy