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Chronic Presence of Epstein Barr Virus in Sulcular and Junctional Epithelial Tissue From Gingiva is Associated With Severe Periodontitis

Primary Purpose

Parodontitis Aggressive, Parodontitis Chronic

Status

Unknown status

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

Biopsy

biopsy

Biopsy

About this trial

This is an interventional basic science trial for Parodontitis Aggressive

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

Men exclusively
12 years minimum
2 patients affected by chronic periodontitis
2 patients affected by aggressive periodontitis
2 healthy patients (orthodontics extraction)
Subject who have read and understood the information note relative under investigation and who have signed the informed consent
Subject whose legal representative signed the parental consent (if minor patient)

Exclusion Criteria:

Patient with contre-indication to dental extraction
Patient witn serious blood disease
Patient who exhibits systemic condition incompatible with the realization of the study
Patient treated with oral retinoids, bisphosphonates, oral anticoagulants and anticonvulsivants
Patient who presents za buccal carcinoma treated with radiotherapy
Patient who have received during the past 6 months: anti-inflammatory drugs, anti-cancerous or immunosuppressive chemiotherapy
Patient who presents a linguistic or psychic incapacity to understand information
Female patient

Sites / Locations

CHU de Nice, Hôpital Saint RochRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Arm Label

chronic periodontitis

agressive periodontitis

healthy patients

Arm Description

Outcomes

Primary Outcome Measures

Presence/absence of EBV in the epithelial cells of periodontal pockets (by Immunofluorescence and in situ Hybridization

Secondary Outcome Measures

Presence/ absence of latency and/or lytic proteins (by immunofluorescence and in situ hybridization

- Epithelial tissue infected (by Immunofluorescence and In situ Hybridization) : detection of oral gingival epithelium, sulcular epithelium, junctional epithelium.

Full Information

NCT ID

NCT01246648

First Posted

November 17, 2010

Last Updated

August 6, 2012

Sponsor

Centre Hospitalier Universitaire de Nice

1. Study Identification

Unique Protocol Identification Number

NCT01246648

Brief Title

Chronic Presence of Epstein Barr Virus in Sulcular and Junctional Epithelial Tissue From Gingiva is Associated With Severe Periodontitis

Study Type

Interventional

2. Study Status

Record Verification Date

November 2010

Overall Recruitment Status

Unknown status

Study Start Date

January 2011 (undefined)

Primary Completion Date

February 2011 (Actual)

Study Completion Date

January 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Centre Hospitalier Universitaire de Nice

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The etiopathogenesis of periodontal disease results from complex interaction between infectious agents, mainly including bacteria, and host cellular and humoral immune responses. However it is thought that bacteria-induced pathogenesis is not sufficient alone to explain all biological and clinical features of the destructive periodontal disease. The main hypothesis is that herpesviruses, such as Epstein-Barr Virus, may participate as well by altering epithelial gingival cell biology and consequently may promote the initiation and progression of periodontitis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Parodontitis Aggressive, Parodontitis Chronic

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

6 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

chronic periodontitis

Arm Type

Active Comparator

Arm Title

agressive periodontitis

Arm Type

Active Comparator

Arm Title

healthy patients

Arm Type

Active Comparator

Intervention Type

Procedure

Intervention Name(s)

Biopsy

Intervention Description

dental extraction and gingival epithelial biopsy

Intervention Type

Procedure

Intervention Name(s)

biopsy

Intervention Description

dental extraction and gingival epithelial biopsy

Intervention Type

Procedure

Intervention Name(s)

Biopsy

Intervention Description

dental extraction and gingival epithelial biopsy

Primary Outcome Measure Information:

Title

Presence/absence of EBV in the epithelial cells of periodontal pockets (by Immunofluorescence and in situ Hybridization

Time Frame

at time = 0 (baseline)

Secondary Outcome Measure Information:

Title

Presence/ absence of latency and/or lytic proteins (by immunofluorescence and in situ hybridization

Time Frame

at time = 0 (baseline)

Title

- Epithelial tissue infected (by Immunofluorescence and In situ Hybridization) : detection of oral gingival epithelium, sulcular epithelium, junctional epithelium.

Time Frame

at time = 0 (baseline)

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

12 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Men exclusively 12 years minimum 2 patients affected by chronic periodontitis 2 patients affected by aggressive periodontitis 2 healthy patients (orthodontics extraction) Subject who have read and understood the information note relative under investigation and who have signed the informed consent Subject whose legal representative signed the parental consent (if minor patient) Exclusion Criteria: Patient with contre-indication to dental extraction Patient witn serious blood disease Patient who exhibits systemic condition incompatible with the realization of the study Patient treated with oral retinoids, bisphosphonates, oral anticoagulants and anticonvulsivants Patient who presents za buccal carcinoma treated with radiotherapy Patient who have received during the past 6 months: anti-inflammatory drugs, anti-cancerous or immunosuppressive chemiotherapy Patient who presents a linguistic or psychic incapacity to understand information Female patient

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

OLIVERI Vanina, ARC promoteur

Phone

0033 4 92 03 42 54

oliveri.v@chu-nice.fr

First Name & Middle Initial & Last Name or Official Title & Degree

DEL CONT Delphine, ARC promoteur

Phone

0033 4 92 03 47 02

delcont.d@chu-nice.fr

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

VINCENT Severine, PH

Organizational Affiliation

Centre Hospitalier Universitaire de Nice

Official's Role

Principal Investigator

Facility Information:

Facility Name

CHU de Nice, Hôpital Saint Roch

City

Nice

ZIP/Postal Code

06000

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Severine VINCENT, PH

Severine.VINCENT@unice.fr

First Name & Middle Initial & Last Name & Degree

Vanina OLIVERI, ARC Promoteur

Phone

0033 4 92 03 42 54

oliveri.v@chu-nice.fr

First Name & Middle Initial & Last Name & Degree

Severine VINCENT, PH

12. IPD Sharing Statement

Learn more about this trial

Chronic Presence of Epstein Barr Virus in Sulcular and Junctional Epithelial Tissue From Gingiva is Associated With Severe Periodontitis

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