Relationship between mouth and gut microbiomes in patients with periodontal diseases - cross-sectional study

• Conditions: Periodontal Diseases; G06.591

• Registration Number: RBR-10cc7t2f
• Lead Sponsor: niversidade de São Paulo

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-08-01
• Last Update Posted: 19 August 2024
• Study Completion: 2024-12-01

Recruitment & Eligibility

• Status: Recruitment completed
• Sex: Not specified
• Target Recruitment: Not specified

Inclusion Criteria

All individuals must be systemically healthy; of either gender; at least 18 years old; have at least 15 natural teeth, excluding third molars and teeth indicated for extraction; and be willing to adhere to the study protocol. In the Periodontal Health group: absence of attachment loss and bone loss due to periodontitis; probing depth (PD) up to 3 mm at all sites and bleeding on probing (BOP) at no more than 10% of sites throughout the entire oral cavity. For the Gingivitis group: presence of generalized gingivitis, with more than 30% of the sites in the whole mouth showing BOP; all sites with PD up to 3 mm and absence of attachment loss and bone loss due to periodontitis. In the Periodontitis group: presence of generalized stage III periodontitis, grades B or C, with at least 30% of the teeth having at least one site with PD and Clinical Attachment Level (CAL) = 5 mm and BOP

Exclusion Criteria

Use of antibiotics, probiotics, and/or prebiotics in the last six months; undergoing periodontal treatment in the last six months; continuous use of mouthwashes containing antimicrobial agents; long-term use of anti-inflammatory or immunosuppressive medication; any systemic involvement that may interfere with the onset and/or progression of periodontal diseases; chronic gastrointestinal diseases; extensive prosthetic involvement; need for antibiotic prophylaxis for routine dental procedures; smoking; pregnancy; lactation

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The study aims to characterize the periodontal and fecal microbiomes of volunteers who are periodontally healthy, those with gingivitis (G), and those with periodontitis (PE) (stage III, grades B or C generalized). It also seeks to evaluate the interrelationship between these two microbiomes across the three conditions presented by the volunteers.

Secondary Outcome Measures

Name	Time	Method
The study aims to correlate the periodontal and fecal microbiomes with clinical, sociodemographic, and lifestyle parameters.