Ignite Creation Date:
2025-12-24 @ 5:24 PM
Ignite Modification Date:
2025-12-28 @ 5:20 AM
Study NCT ID:
NCT04251650
Status:
UNKNOWN
Last Update Posted:
2020-02-05
First Post:
2020-01-30
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
PAROMIP Pilot Study PAROdontites & MIcrobiota Periodontal
Sponsor:
Nantes University Hospital
Organization:
Study Overview
Official Title:
Search for a Microbiotic Signature Associated With Periodontitis According to the Chicago Classification 2018
Status:
UNKNOWN
Status Verified Date:
2020-01
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PAROMIP
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)
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: