Back to results

Chronic Presence of Epstein Barr Virus in Epithelial Cells From Gingiva is Associated With Periodontitis

Primary Purpose

Chronic Periodontitis, Aggressive Periodontitis, Presence / Absence of EBV

Status

Unknown status

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

dental root planing

About this trial

This is an interventional health services research trial for Chronic Periodontitis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

10 patients affected by chronic periodontitis
10 patients affected by aggressive periodontitis
10 healthy patients (orthodontics extraction)
Subject who have read and understood the information note relative under investigation and who have signed the informed consent
major patient

Exclusion Criteria:

Patient with no contre-indication to periodontal treatment
Patient with serious blood disease
Patient who exhibits systemic condition incompatible with realization of the study
Patient treated with oral retinoids, bisphosphonates, oral anticoagulants and anticonvulsivants
Patient who presents a 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

Sites / Locations

Dr Severine VINCENTRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Arm Label

chronic periodontitis

aggressive periodontitis

healthy patient (orthodontics extraction)

Arm Description

Outcomes

Primary Outcome Measures

Percentage of gingival epithelial cells infected by EBV (by immunofluorescence and In situ Hybridization)

Secondary Outcome Measures

Epithelial tissue infected by EBV (by immunofluorescence and in situ hybridization)

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

Full Information

NCT ID

NCT01246596

First Posted

November 17, 2010

Last Updated

December 17, 2012

Sponsor

Centre Hospitalier Universitaire de Nice

1. Study Identification

Unique Protocol Identification Number

NCT01246596

Brief Title

Chronic Presence of Epstein Barr Virus in Epithelial Cells From Gingiva is Associated With 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

June 2011 (Actual)

Study Completion Date

January 2014 (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

Chronic Periodontitis, Aggressive Periodontitis, Presence / Absence of EBV

7. Study Design

Primary Purpose

Health Services Research

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

chronic periodontitis

Arm Type

Active Comparator

Arm Title

aggressive periodontitis

Arm Type

Active Comparator

Arm Title

healthy patient (orthodontics extraction)

Arm Type

Active Comparator

Intervention Type

Procedure

Intervention Name(s)

dental root planing

Intervention Description

The objective of root planing, otherwise known as conventional periodontal therapy, non-surgical periodontal therapy, or dental prophylaxis is to remove or eliminate the etiologic agents which cause inflammation: dental plaque, its products and calculus,[1] thus helping to establish a periodontium that is free of disease.[2]

Intervention Type

Procedure

Intervention Name(s)

dental root planing

Intervention Description

The objective of root planing, otherwise known as conventional periodontal therapy, non-surgical periodontal therapy, or dental prophylaxis is to remove or eliminate the etiologic agents which cause inflammation: dental plaque, its products and calculus, thus helping to establish a periodontium that is free of disease.

Intervention Type

Procedure

Intervention Name(s)

dental root planing

Intervention Description

The objective of root planing, otherwise known as conventional periodontal therapy, non-surgical periodontal therapy, or dental prophylaxis is to remove or eliminate the etiologic agents which cause inflammation: dental plaque, its products and calculus, thus helping to establish a periodontium that is free of disease.

Primary Outcome Measure Information:

Title

Percentage of gingival epithelial cells infected by EBV (by immunofluorescence and In situ Hybridization)

Time Frame

at time=0

Secondary Outcome Measure Information:

Title

Epithelial tissue infected by EBV (by immunofluorescence and in situ hybridization)

Time Frame

at time = 0

Title

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

Time Frame

at time = 0

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 10 patients affected by chronic periodontitis 10 patients affected by aggressive periodontitis 10 healthy patients (orthodontics extraction) Subject who have read and understood the information note relative under investigation and who have signed the informed consent major patient Exclusion Criteria: Patient with no contre-indication to periodontal treatment Patient with serious blood disease Patient who exhibits systemic condition incompatible with realization of the study Patient treated with oral retinoids, bisphosphonates, oral anticoagulants and anticonvulsivants Patient who presents a 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

Central Contact Person:

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

Severine VINCENT, PH

severine.VINCENT@unice.fr

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

Vanina OLIVERI, ARC promoteur

Phone

0033 4 92 03 42 54

oliveri.v@chu-nice.fr

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Severine VINCENT, PH

Organizational Affiliation

CHU de Nice Hôpital Saint Roch

Official's Role

Principal Investigator

Facility Information:

Facility Name

Dr Severine VINCENT

City

Nice

ZIP/Postal Code

0600

Country

France

Individual Site Status

Recruiting

Facility Contact:

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 Epithelial Cells From Gingiva is Associated With Periodontitis

We'll reach out to this number within 24 hrs