NCT04251650

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
25

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2019

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2019

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 30, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 5, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2020

Completed
Last Updated

February 5, 2020

Status Verified

January 1, 2020

Enrollment Period

6 months

First QC Date

January 30, 2020

Last Update Submit

January 31, 2020

Conditions

Periodontitis

Keywords

subgingival microbiotachronic periodontitisdysbiosisdeep sequencinggingival crevicular fluid

Outcome Measures

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

    through study completion, an average of 1 year

Secondary Outcomes (1)

  • Cytokinic concentrations in CGF

    through study completion, an average of 1 year

Study Arms (2)

low severity

patient with periodontitis stage I and II

Other: subgingival plaque sampleOther: CGF sample

high severity

patient with periodontitis stage III and IV

Other: subgingival plaque sampleOther: CGF sample

Interventions

subgingival plaque sampleOTHER

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.

high severitylow severity
CGF sampleOTHER

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 severitylow severity

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patient coming in consultation for generalized periodontitis .

You may qualify if:

  • 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

You may not qualify if:

  • 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…
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nantes Universitary Hospital

Nantes, Loire Atlantique, 44093, France

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

subgingival plaque sample and gingival fluid sample

MeSH Terms

Conditions

PeriodontitisChronic PeriodontitisDysbiosis

Condition Hierarchy (Ancestors)

Periodontal DiseasesMouth DiseasesStomatognathic DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Assem SOUEIDAN, Pr

CONTACT

02.40.41.29.23assem.soueidan@chu-nantes.fr

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 30, 2020

First Posted

February 5, 2020

Study Start

May 1, 2019

Primary Completion

October 30, 2019

Study Completion

March 31, 2020

Last Updated

February 5, 2020

Record last verified: 2020-01

Locations

FR(1)