PAROMIP Pilot Study PAROdontites & MIcrobiota Periodontal

• Conditions: Periodontitis
• Interventions: Other: subgingival plaque sample; Other: CGF sample

• Registration Number: NCT04251650
• Lead Sponsor: Nantes University Hospital

Brief Summary

A new classification of periodontal diseases was created in 2018. the investigators want to know if this clinical classification is based, or not, on a biological reality. To do this, the investigators will collect data from the clinical examination (clinical assessment and radiological assessment) as well as non-invasive samples of subgingival plaque and crevicular gingival fluid (CGF). The subgingival plaque samples will be analyzed to define the microbiotic profiles of the patients and the CGF determined to define their inflammatory expression profiles. These results will then be linked to the diagnosis of severity of periodontitis.

Detailed Description

In the new classification of periodontal disease, the investigators will seek to know whether there is a specific bacterial signature associated with the severity of damage on the one hand, and the other hand, the investigators will search for cytokinic biomarkers which can be correlated with the severity of the damage.

In this study, the investigators propose to include 25 patients with periodontitis stage I and II versus stage III and IV according to Chicago classification (2018)

Study Timeline

• Study Start: 2019-05-01
• Primary Completion: 2019-10-30
• Status Verified: 2020-01
• Study First Submitted: 2020-01-30
• Study First Submitted QC: 2020-01-30
• Last Update Submitted: 2020-01-31
• Study First Posted: 2020-02-05
• Last Update Posted: 2020-02-05
• Study Completion: 2020-03-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

• Men and women speaking and understanding French
• Aged over 18
• with generalized periodontitis (more than 30% of affected sites)
• Requiring non-surgical periodontal therapy
• with a minimum of 12 teeth (3 per quadrant), fitted or not
• Having given his oral consent to participate in the study
• Having given his written consent to participate in a biocollection

Exclusion Criteria

• Less than 12 teeth present (3 teeth per quadrant)
• Presence of acute oral lesions (periodontal abscesses, endodontic abscesses, infectious or mycotic lesions...)
• Presence of ulcerative-necrotic gingivitis or periodontitis
• Presence of endo-periodontal lesions
• Chronic or systemic pathology or treatment that can influence the periodontal microbiota : immunotherapy, corticosteroid therapy, biotherapy, unbalanced diabetes, acute inflammatory rheumatism, neurological impairment...
• Antibiotic during the 3 month preceding inclusion
• Psychological or linguistic disability preventing good understanding of the study
• Minors
• Major patients under legal protection
• Patients deprived of their liberty
• Pregnant or lactating woman
• Patient not affiliated to a health insurance scheme

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
low severity	subgingival plaque sample	patient with periodontitis stage I and II
high severity	subgingival plaque sample	patient with periodontitis stage III and IV
high severity	CGF sample	patient with periodontitis stage III and IV
low severity	CGF sample	patient with periodontitis stage I and II

Primary Outcome Measures

Name	Time	Method
Microbiota analysis of subgingival plaque	through study completion, an average of 1 year	sample analysis by microbiome sequencing with 16S technics of subgingival plaque of affected sites and healthy sites

Secondary Outcome Measures

Name	Time	Method
Cytokinic concentrations in CGF	through study completion, an average of 1 year	cytokinic concentration analysis (IL1β, IL , TNFα, IL2, IL4, IL10, IL17α) in CGF of affected sites and healthy sites

Trial Locations

Locations (1)

Nantes Universitary Hospital; 🇫🇷 Nantes, Loire Atlantique, France