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PAROMIP Pilot Study PAROdontites & MIcrobiota Periodontal

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04251650
Acronym
PAROMIP
Enrollment
25
Registered
2020-02-05
Start date
2019-05-01
Completion date
2020-03-31
Last updated
2020-02-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Periodontitis

Keywords

subgingival microbiota, chronic periodontitis, dysbiosis, deep sequencing, gingival crevicular fluid

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)

Interventions

OTHERsubgingival 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.

OTHERCGF 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

Sponsors

Nantes University Hospital
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Microbiota analysis of subgingival plaquethrough study completion, an average of 1 yearsample analysis by microbiome sequencing with 16S technics of subgingival plaque of affected sites and healthy sites

Secondary

MeasureTime frameDescription
Cytokinic concentrations in CGFthrough study completion, an average of 1 yearcytokinic concentration analysis (IL1β, IL , TNFα, IL2, IL4, IL10, IL17α) in CGF of affected sites and healthy sites

Countries

France

Contacts

Primary ContactAssem SOUEIDAN, Pr
assem.soueidan@chu-nantes.fr02.40.41.29.23

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026