Protozoans in Biofilm From Patients With Periodontitis

NCT03240666 | Unknown

• 1 other identifier: PSS2016/PARO-PROTO-BISSON/ER
• Study Type: observational
• Target: 231
• Locations: 1 country
• Sites: 1

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.

Conditions

Periodontitis, Adult

Outcome Measures

Primary Outcomes (1)

• presence of protozoans

  identification of protozoans by molecular technique (PCR) -

  6 months after the last inclusion: DNA samples were frozen and identified later.

Secondary Outcomes (5)

• Periodontal pocket depth (PPD in mm)

  One day: measure realised during examination of the patient for periodontal treatment.

• Clinical attachment Loss (CAL in mm)

  One day: measure realied during clincal examination of patient.

• Plaque and gingival index

  One day: measure of index during the clinical examination of patient.

• Mobility of tooth

  One day: measure of tooth mobility during the clinical examination of patient.

• Bleeding On Probing (BOP)

  One day: measure of BOP during the clinical examination of patient.

Interventions

non applicable OTHER

non applicable

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Catherine BISSON

Nancy, 54000, France

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Bacterial DNA, protozoan DNA

MeSH Terms

Conditions

Chronic Periodontitis

Condition Hierarchy (Ancestors)

Periodontitis; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

El Mehdi SIAGHY

CONTACT

+33 383 15 52 85; m.siaghy@chru-nancy.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 26, 2017
• First Posted: August 7, 2017
• Study Start: April 10, 2017
• Primary Completion: November 10, 2022
• Study Completion: November 30, 2022
• Last Updated: April 21, 2021

Record last verified: 2020-07

Locations

FR (1)