PAROMIP Pilot Study PAROdontites & MIcrobiota Periodontal

NCT ID: NCT04251650

Last Updated: 2020-02-05

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 25 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-05-01
• Study Completion Date: 2020-03-31

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)

Conditions

Periodontitis

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

low severity

patient with periodontitis stage I and II

subgingival plaque sample

Intervention Type: OTHER

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

Intervention Type: OTHER

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

subgingival plaque sample

Intervention Type: OTHER

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

Intervention Type: OTHER

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

Interventions

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.

Intervention Type: 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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nantes University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Nantes Universitary Hospital

Nantes, Loire Atlantique, France

Site Status: RECRUITING

Countries

France

Central Contacts

Assem SOUEIDAN, Pr

Role: CONTACT

assem.soueidan@chu-nantes.fr

02.40.41.29.23 ext. +(33)

Facility Contacts

Assem Soueidan, PU-PH

Role: primary

assem.soueidan@chu-nantes.fr

+33 2 40 41 29 23

Other Identifiers

30042019

Identifier Type: -

Identifier Source: org_study_id