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PAROMIP Pilot Study PAROdontites & MIcrobiota Periodontal

N

Nantes University Hospital (NUH)

Status

Unknown

Conditions

Periodontitis

Treatments

Other: CGF sample
Other: subgingival plaque sample

Study type

Observational

Funder types

Other

Identifiers

NCT04251650
30042019

Details and patient eligibility

About

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.

Full 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)

Enrollment

25 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

25 participants in 2 patient groups

low severity
Description:
patient with periodontitis stage I and II
Treatment:
Other: subgingival plaque sample
Other: CGF sample
high severity
Description:
patient with periodontitis stage III and IV
Treatment:
Other: subgingival plaque sample
Other: CGF sample

Trial contacts and locations

1

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Central trial contact

Assem SOUEIDAN, Pr

Data sourced from clinicaltrials.gov

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