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Paro-Proto: Protozoans in Biofilm From Patients With Periodontitis

Sponsor
Central Hospital, Nancy, France (Other)
Overall Status
Recruiting
CT.gov ID
NCT03240666
Collaborator
Centre Hospitalier Universitaire de Nice (Other), University Hospital, Toulouse (Other)
231
Enrollment
1
Location
67.7
Anticipated Duration (Months)
3.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The buccal cavity is colonized by numerous microorganisms whose the number and composition could be modified with medical background (diseases and drugs) and the level of oral hygiene of the patients. Among all microorganisms identified in the periodontium, few of them are implicated in the etiopathogenesis of periodontal pathologies. To date, four major bacteria are identified for their ability to degrade periodontal tissues.

Although the periodontitis is established to be the consequence of bacterial virulence and immune dysfunction, these factors fail to explain the refractory periodontitis of some patients to etiologic treatment .

Others microorganisms such as protozoans could have an impact on this disease.

Condition or Disease Intervention/Treatment Phase
  • Other: non applicable

Study Design

Study Type:
Observational
Anticipated Enrollment :
231 participants
Observational Model:
Cohort
Time Perspective:
Other
Official Title:
Multicentric Clinical Trials on the Prevalence of Entamoeba Gingivalis and Its Associated Bacterial Flora in Patients With Periodontitis
Actual Study Start Date :
Apr 10, 2017
Anticipated Primary Completion Date :
Nov 10, 2022
Anticipated Study Completion Date :
Nov 30, 2022

Outcome Measures

Primary Outcome Measures

  1. presence of protozoans [6 months after the last inclusion: DNA samples were frozen and identified later.]

    identification of protozoans by molecular technique (PCR) -

Secondary Outcome Measures

  1. Periodontal pocket depth (PPD in mm) [One day: measure realised during examination of the patient for periodontal treatment.]

    Measure of PPD thanks to periodontal probe

  2. Clinical attachment Loss (CAL in mm) [One day: measure realied during clincal examination of patient.]

    Measure of CAL with periodontal probe

  3. Plaque and gingival index [One day: measure of index during the clinical examination of patient.]

    Measure of plaque and gingival index (Loe and Silness, Silness and Loe)

  4. Mobility of tooth [One day: measure of tooth mobility during the clinical examination of patient.]

    Measure of tooth mobility: Yes or not

  5. Bleeding On Probing (BOP) [One day: measure of BOP during the clinical examination of patient.]

    Measure of BOP : Yes or not

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:

  • Adults > 18 years-old

  • consulting in periodontal department of CHRU

  • Patients with moderate to severe periodontitis

  • At least 2 periodontal sites with PPD ≥ 5mm and one healthy site

  • No scaling root planing in the last 6 months

  • Patients insured under the Franch social security system

Exclusion Criteria:

  • Pregnants patients

  • Patients with antibiotic therapy and/ or all medecines which could modify the buccal microbiota in the last 6 months

  • Tooth with endodontics periapical lesion

  • Patients having a scaling root planing in the last 6 months

  • Patients with guardianship

Contacts and Locations

Locations

Site City State Country Postal Code
1 Catherine BISSON Nancy France 54000

Sponsors and Collaborators

  • Central Hospital, Nancy, France
  • Centre Hospitalier Universitaire de Nice
  • University Hospital, Toulouse

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Central Hospital, Nancy, France
ClinicalTrials.gov Identifier:
NCT03240666
Other Study ID Numbers:
  • PSS2016/PARO-PROTO-BISSON/ER
First Posted:
Aug 7, 2017
Last Update Posted:
Apr 21, 2021
Last Verified:
Jul 1, 2020
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Periodontitis
Chronic Periodontitis

Study Results

No Results Posted as of Apr 21, 2021