Protozoans in Biofilm From Patients With Periodontitis

Periodontitis, Adult Clinical Trial

— Paro-Proto  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03240666
• Other study ID #: PSS2016/PARO-PROTO-BISSON/ER
• Status: Recruiting
• Start date: April 10, 2017
• Est. completion date: November 30, 2022

Study information

• Verified date: July 2020
• Source: Central Hospital, Nancy, France
• Contact: El Mehdi SIAGHY
• Phone: +33 383 15 52 85
• Email: m.siaghy[@]chru-nancy.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 231
• Est. completion date: November 30, 2022
• Est. primary completion date: November 10, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Periodontitis
• Periodontitis
• Periodontitis, Adult

Intervention

Other:
• non applicable
non applicable

Locations

Country	Name	City	State
France	Catherine BISSON	Nancy

Sponsors (3)

Lead Sponsor	Collaborator
Central Hospital, Nancy, France	Centre Hospitalier Universitaire de Nice, University Hospital, Toulouse

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	presence of protozoans	identification of protozoans by molecular technique (PCR) -	6 months after the last inclusion: DNA samples were frozen and identified later.
Secondary	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.
Secondary	Clinical attachment Loss (CAL in mm)	Measure of CAL with periodontal probe	One day: measure realied during clincal examination of patient.
Secondary	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.
Secondary	Mobility of tooth	Measure of tooth mobility: Yes or not	One day: measure of tooth mobility during the clinical examination of patient.
Secondary	Bleeding On Probing (BOP)	Measure of BOP : Yes or not	One day: measure of BOP during the clinical examination of patient.