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Status unknownNCT04251650PAROMIPUpdated Feb 5, 2020

PAROMIP Pilot Study PAROdontites & MIcrobiota Periodontal

An observational study in Periodontitis, sponsored by Nantes University Hospital. Status unknown at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-02-05.

Sponsored by Nantes University Hospital · Observational

The sponsor has not verified this record recently (last verified Jan 2020), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
25
Ages
18 Years and older
Sex
All
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Study 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.

Read the 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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Conditions studied

  • Periodontitis

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Keywords

  • subgingival microbiota
  • chronic periodontitis
  • dysbiosis
  • deep sequencing
  • gingival crevicular fluid
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In context

Periodontitis

1,635 studies on the registry are indexed under Periodontitis; 327 are open to participants now.

This study's planned enrollment of 25 is below the median of 90 across 428 observational studies indexed under Periodontitis.

Browse Periodontitis studies →

Lead sponsor

Nantes University Hospital is the lead sponsor of 825 studies on the registry; 195 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

All patient coming in consultation for generalized periodontitis .

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

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
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Study design

Observational model
Other
Time perspective
Prospective
Enrollment
25 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • low severity

    patient with periodontitis stage I and II

    Other: subgingival plaque sample · Other: CGF sample

  • high severity

    patient with periodontitis stage III and IV

    Other: subgingival plaque sample · Other: CGF sample

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

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What researchers measure

Primary outcomes

  1. Microbiota analysis of subgingival plaque

    sample analysis by microbiome sequencing with 16S technics of subgingival plaque of affected sites and healthy sites

    Time frame: through study completion, an average of 1 year

Secondary outcomes

  1. Cytokinic concentrations in CGF

    cytokinic concentration analysis (IL1β, IL , TNFα, IL2, IL4, IL10, IL17α) in CGF of affected sites and healthy sites

    Time frame: through study completion, an average of 1 year

07

Study locations

1 of 1 sites recruiting
  • Nantes Universitary Hospital
    Nantes, Loire Atlantique 44093, France
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 5, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04251650
Lead sponsor
Nantes University Hospital
Responsible party
Sponsor
First posted
Feb 5, 2020
Start date
May 1, 2019
Primary completion
Oct 30, 2019
Completion
Mar 31, 2020 (estimated)
Last update
Feb 5, 2020

Study contacts

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

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jan 2020. You cannot join it, but the record below documents what was studied.

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