PAROMIP Pilot Study PAROdontites & MIcrobiota Periodontal

Periodontitis Clinical Trial

— PAROMIP  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04251650
• Other study ID #: 30042019
• Status: Recruiting
• Start date: May 1, 2019
• Est. completion date: March 31, 2020

Study information

• Verified date: January 2020
• Source: Nantes University Hospital
• Contact: Assem SOUEIDAN, Pr
• Phone: 02.40.41.29.23
• Email: assem.soueidan[@]chu-nantes.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 25
• Est. completion date: March 31, 2020
• Est. primary completion date: October 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Periodontitis

Intervention

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.
• 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

Locations

Country	Name	City	State
France	Nantes Universitary Hospital	Nantes	Loire Atlantique

Sponsors (1)

Lead Sponsor	Collaborator
Nantes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Microbiota analysis of subgingival plaque	sample analysis by microbiome sequencing with 16S technics of subgingival plaque of affected sites and healthy sites	through study completion, an average of 1 year
Secondary	Cytokinic concentrations in CGF	cytokinic concentration analysis (IL1ß, IL , TNFa, IL2, IL4, IL10, IL17a) in CGF of affected sites and healthy sites	through study completion, an average of 1 year