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PAROMIP Pilot Study PAROdontites & MIcrobiota Periodontal (PAROMIP)

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ClinicalTrials.gov Identifier: NCT04251650
Recruitment Status : Recruiting
First Posted : February 5, 2020
Last Update Posted : February 5, 2020
Sponsor:
Information provided by (Responsible Party):
Nantes University Hospital

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.

Condition or disease Intervention/treatment
Periodontitis Other: subgingival plaque sample Other: CGF sample

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)

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Study Type : Observational
Estimated Enrollment : 25 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Search for a Microbiotic Signature Associated With Periodontitis According to the Chicago Classification 2018
Actual Study Start Date : May 1, 2019
Actual Primary Completion Date : October 30, 2019
Estimated Study Completion Date : March 31, 2020

Group/Cohort Intervention/treatment
low severity
patient with periodontitis stage I and II
Other: subgingival 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.

Other: CGF 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

high severity
patient with periodontitis stage III and IV
Other: subgingival 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.

Other: CGF 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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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


Biospecimen Retention:   Samples With DNA
subgingival plaque sample and gingival fluid sample


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All patient coming in consultation for generalized periodontitis .
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04251650


Contacts
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Contact: Assem SOUEIDAN, Pr 02.40.41.29.23 ext +(33) assem.soueidan@chu-nantes.fr

Locations
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France
Nantes Universitary Hospital Recruiting
Nantes, Loire Atlantique, France, 44093
Contact: Assem Soueidan, PU-PH    +33 2 40 41 29 23    assem.soueidan@chu-nantes.fr   
Principal Investigator: Assem SOUEIDAN, PU-PH         
Sponsors and Collaborators
Nantes University Hospital
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Responsible Party: Nantes University Hospital
ClinicalTrials.gov Identifier: NCT04251650    
Other Study ID Numbers: 30042019
First Posted: February 5, 2020    Key Record Dates
Last Update Posted: February 5, 2020
Last Verified: January 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Nantes University Hospital:
subgingival microbiota
chronic periodontitis
dysbiosis
deep sequencing
gingival crevicular fluid
Additional relevant MeSH terms:
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Periodontitis
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases