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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01246648
Recruitment Status : Unknown
Verified November 2010 by Centre Hospitalier Universitaire de Nice.
Recruitment status was:  Recruiting
First Posted : November 23, 2010
Last Update Posted : August 7, 2012
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nice

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.

Condition or disease Intervention/treatment Phase
Parodontitis Aggressive Parodontitis Chronic Procedure: Biopsy Procedure: biopsy Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 6 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Study Start Date : January 2011
Actual Primary Completion Date : February 2011
Estimated Study Completion Date : January 2013

Arm Intervention/treatment
Active Comparator: chronic periodontitis Procedure: Biopsy
dental extraction and gingival epithelial biopsy
Active Comparator: agressive periodontitis Procedure: biopsy
dental extraction and gingival epithelial biopsy
Active Comparator: healthy patients Procedure: Biopsy
dental extraction and gingival epithelial biopsy

Primary Outcome Measures :
  1. 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 Measures :
  1. Presence/ absence of latency and/or lytic proteins (by immunofluorescence and in situ hybridization [ Time Frame: at time = 0 (baseline) ]
  2. - Epithelial tissue infected (by Immunofluorescence and In situ Hybridization) : detection of oral gingival epithelium, sulcular epithelium, junctional epithelium. [ Time Frame: at time = 0 (baseline) ]

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01246648

Contact: OLIVERI Vanina, ARC promoteur 0033 4 92 03 42 54
Contact: DEL CONT Delphine, ARC promoteur 0033 4 92 03 47 02

CHU de Nice, Hôpital Saint Roch Recruiting
Nice, France, 06000
Contact: Severine VINCENT, PH   
Contact: Vanina OLIVERI, ARC Promoteur    0033 4 92 03 42 54   
Principal Investigator: Severine VINCENT, PH         
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nice
Principal Investigator: VINCENT Severine, PH CHU de Nice

Responsible Party: Centre Hospitalier Universitaire de Nice Identifier: NCT01246648     History of Changes
Other Study ID Numbers: 10-PP-13
First Posted: November 23, 2010    Key Record Dates
Last Update Posted: August 7, 2012
Last Verified: November 2010

Additional relevant MeSH terms:
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases