PAROMIP Pilot Study PAROdontites & MIcrobiota Periodontal (PAROMIP)

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

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.

Study Overview

• Status: Unknown
• Conditions: Periodontitis
• Intervention / Treatment: Other: subgingival plaque sample; Other: CGF sample

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 Type: Observational
• Enrollment (Anticipated): 25

Contacts and Locations

Study Locations

• France
  • Loire Atlantique
    • Nantes, Loire Atlantique, France, 44093
      • Recruiting
      • Nantes Universitary Hospital
      • Contact: Assem Soueidan, PU-PH; Phone Number: +33 2 40 41 29 23; Email: assem.soueidan@chu-nantes.fr
      • Principal Investigator: Assem SOUEIDAN, PU-PH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All patient coming in consultation for generalized periodontitis .

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
low severity; patient with periodontitis stage I and II	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
high severity; patient with periodontitis stage III and IV	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Nantes University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2019
• Primary Completion (Actual): October 30, 2019
• Study Completion (Anticipated): March 31, 2020

Study Registration Dates

• First Submitted: January 30, 2020
• First Submitted That Met QC Criteria: January 30, 2020
• First Posted (Actual): February 5, 2020

Study Record Updates

• Last Update Posted (Actual): February 5, 2020
• Last Update Submitted That Met QC Criteria: January 31, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: chronic periodontitis; subgingival microbiota; gingival crevicular fluid; dysbiosis; deep sequencing
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Periodontitis
• Other Study ID Numbers: 30042019

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No