Protozoans in Biofilm From Patients With Periodontitis

• Conditions: Periodontitis, Adult

• Registration Number: NCT03240666
• Lead Sponsor: Central Hospital, Nancy, France

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-04-10
• Study First Submitted: 2017-07-26
• Study First Submitted QC: 2017-08-02
• Study First Posted: 2017-08-07
• Status Verified: 2020-07
• Last Update Submitted: 2021-04-20
• Last Update Posted: 2021-04-21
• Primary Completion: 2022-11-10
• Study Completion: 2022-11-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 231

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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
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)
Mobility of tooth	One day: measure of tooth mobility during the clinical examination of patient.	Measure of tooth mobility: Yes or not
Bleeding On Probing (BOP)	One day: measure of BOP during the clinical examination of patient.	Measure of BOP : Yes or not
Clinical attachment Loss (CAL in mm)	One day: measure realied during clincal examination of patient.	Measure of CAL with periodontal probe

Trial Locations

Locations (1)

Catherine BISSON; 🇫🇷 Nancy, France