NCT04251650

PAROMIP Pilot Study PAROdontites & MIcrobiota Periodontal

Search for a Microbiotic Signature Associated With Periodontitis According to the Chicago Classification 2018

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 25 (estimated)
• Sponsor: Nantes University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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)

Conditions

• Periodontitis

Interventions

Type	Name	Description
OTHER	subgingival plaque sample	for subgingival plaque sample, on three affected sites (PD\>3mm) and three healthy sites (PD≤3mm), after supra-gingival plaque removal, sterile endodontic paper points were inserted in selects pockets for 30s to collect the subgingival plaque. The material was transferred into eppendorf tube, one for affected samples and one for healthy samples.
OTHER	CGF sample	each site was sampled with a PerioPaper Strip® (Oraflow), and the volumes collected were measured with a Periotron® (Oraflow). Then samples of affected sites were stowed in an eppendorf tube with 120µL of PBS Tween. The same procedure was performed for the healthy sites

Timeline

• Start date: 2019-05-01
• Primary completion: 2019-10-30
• Completion: 2020-03-31
• First posted: 2020-02-05
• Last updated: 2020-02-05

Locations

1 site across 1 country: France