Protozoans in Biofilm From Patients With Periodontitis (Paro-Proto)

Multicentric Clinical Trials on the Prevalence of Entamoeba Gingivalis and Its Associated Bacterial Flora in Patients With Periodontitis

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.

Study Overview

• Status: Unknown
• Conditions: Periodontitis, Adult
• Intervention / Treatment: Other: non applicable

• Study Type: Observational
• Enrollment (Anticipated): 231

Contacts and Locations

• Study Contact: Name: El Mehdi SIAGHY; Phone Number: +33 383 15 52 85; Email: m.siaghy@chru-nancy.fr

Study Locations

• France
  • Nancy, France, 54000
    • Recruiting
    • Catherine BISSON
    • Contact: Catherine BISSON, DDS; Phone Number: +33 383852952; Email: catherine.bisson@univ-lorraine.fr
    • Sub-Investigator: Severine VINCENT-BUGNAS, DDS
    • Sub-Investigator: Sara LAURENCINS, DDS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients consulting to periodontal department of CHRU (Nancy-Nice- Toulouse) presenting at least two PPD of 5mm and more, without any medecines which could modify microbiota were included in this study

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
presence of protozoans	identification of protozoans by molecular technique (PCR) -	6 months after the last inclusion: DNA samples were frozen and identified later.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Periodontal pocket depth (PPD in mm)	Measure of PPD thanks to periodontal probe	One day: measure realised during examination of the patient for periodontal treatment.
Clinical attachment Loss (CAL in mm)	Measure of CAL with periodontal probe	One day: measure realied during clincal examination of patient.
Plaque and gingival index	Measure of plaque and gingival index (Loe and Silness, Silness and Loe)	One day: measure of index during the clinical examination of patient.
Mobility of tooth	Measure of tooth mobility: Yes or not	One day: measure of tooth mobility during the clinical examination of patient.
Bleeding On Probing (BOP)	Measure of BOP : Yes or not	One day: measure of BOP during the clinical examination of patient.

Collaborators and Investigators

• Sponsor: Central Hospital, Nancy, France
• Collaborators: Centre Hospitalier Universitaire de Nice; University Hospital, Toulouse

Study record dates

Study Major Dates

• Study Start (Actual): April 10, 2017
• Primary Completion (Anticipated): November 10, 2022
• Study Completion (Anticipated): November 30, 2022

Study Registration Dates

• First Submitted: July 26, 2017
• First Submitted That Met QC Criteria: August 2, 2017
• First Posted (Actual): August 7, 2017

Study Record Updates

• Last Update Posted (Actual): April 21, 2021
• Last Update Submitted That Met QC Criteria: April 20, 2021
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Periodontitis; Chronic Periodontitis
• Other Study ID Numbers: PSS2016/PARO-PROTO-BISSON/ER

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: non applicable

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No