Gut Microbial Changes After Periodontal Treatment

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

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.

Study Overview

• Status: Completed
• Conditions: Periodontitis; Dysbiosis; Intestinal Disease
• Intervention / Treatment: Procedure: Non-surgical periodontal treatment

• Study Type: Observational
• Enrollment (Actual): 94

Contacts and Locations

Study Locations

• Italy
  • Turin, Italy, 10126
    • CIR Dental School

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Study population will be consecutively selected among the patients diagnosed of Stage III-IV periodontitis at the Section of Periodontology of the C.I.R. Dental School of Turin.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Non-surgical periodontal treatment NSPT; Subgingival instrumentation with ultrasonic devices and curettes of all periodontal pockets in 2 or 4 appointments	Procedure: Non-surgical periodontal treatment; Subgingival instrumentation with ultrasonic devices and curettes of all periodontal pockets

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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]
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]
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]
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]

Collaborators and Investigators

• Sponsor: University of Turin, Italy

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2021
• Primary Completion (Actual): October 1, 2022
• Study Completion (Actual): February 1, 2023

Study Registration Dates

• First Submitted: July 19, 2021
• First Submitted That Met QC Criteria: July 19, 2021
• First Posted (Actual): July 29, 2021

Study Record Updates

• Last Update Posted (Actual): May 18, 2023
• Last Update Submitted That Met QC Criteria: May 17, 2023
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Gastrointestinal Diseases; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Periodontitis; Intestinal Diseases; Dysbiosis
• Other Study ID Numbers: Perio-gut connection

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No