Gut Microbial Changes After Periodontal Treatment

NCT04982302 | Completed

• 1 other identifier: Perio-gut connection
• Study Type: observational
• Target: 94
• Locations: 1 country
• Sites: 1

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.

Conditions

Periodontitis; Dysbiosis; Intestinal Disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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 Arms (1)

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

Interventions

Non-surgical periodontal treatment PROCEDURE

Subgingival instrumentation with ultrasonic devices and curettes of all periodontal pockets

Non-surgical periodontal treatment NSPT

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• periodontitis Stage III or IV
• BMI between 20 and 29 kg/m2
• free diet
• presence of at least 20 teeth

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Turin, Italy: lead

Study Sites (1)

CIR Dental School

Turin, 10126, Italy

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Saliva and stool samples

MeSH Terms

Conditions

Periodontitis; Dysbiosis; Intestinal Diseases

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Gastrointestinal Diseases; Digestive System Diseases

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 19, 2021
• First Posted: July 29, 2021
• Study Start: May 1, 2021
• Primary Completion: October 1, 2022
• Study Completion: February 1, 2023
• Last Updated: May 18, 2023

Record last verified: 2022-10

Locations

IT (1)