- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04251650
PAROMIP Pilot Study PAROdontites & MIcrobiota Periodontal (PAROMIP)
Search for a Microbiotic Signature Associated With Periodontitis According to the Chicago Classification 2018
Study Overview
Status
Conditions
Intervention / Treatment
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)
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Assem SOUEIDAN, Pr
- Phone Number: +(33) 02.40.41.29.23
- Email: assem.soueidan@chu-nantes.fr
Study Locations
-
-
Loire Atlantique
-
Nantes, Loire Atlantique, France, 44093
- Recruiting
- Nantes Universitary Hospital
-
Contact:
- Assem Soueidan, PU-PH
- Phone Number: +33 2 40 41 29 23
- Email: assem.soueidan@chu-nantes.fr
-
Principal Investigator:
- Assem SOUEIDAN, PU-PH
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
low severity
patient with periodontitis stage I and II
|
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.
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
|
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.
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Microbiota analysis of subgingival plaque
Time Frame: through study completion, an average of 1 year
|
sample analysis by microbiome sequencing with 16S technics of subgingival plaque of affected sites and healthy sites
|
through study completion, an average of 1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cytokinic concentrations in CGF
Time Frame: through study completion, an average of 1 year
|
cytokinic concentration analysis (IL1β, IL , TNFα, IL2, IL4, IL10, IL17α) in CGF of affected sites and healthy sites
|
through study completion, an average of 1 year
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 30042019
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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