Clinical trial NCT04251650: PAROMIP Pilot Study PAROdontites & MIcrobiota Periodontal
Official title: Search for a Microbiotic Signature Associated With Periodontitis According to the Chicago Classification 2018
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Periodontitis
Keywords: subgingival microbiota
chronic periodontitis
dysbiosis
deep sequencing
gingival crevicular fluid
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2020-02-05
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patient coming in consultation for generalized periodontitis .

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)

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

Primary outcomes:
measure: Microbiota analysis of subgingival plaque
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: Cytokinic concentrations in CGF
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Nantes
country: France
facility: Nantes Universitary Hospital
state: Loire Atlantique
Study officials:
References: