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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2010 by Centre Hospitalier Universitaire de Nice.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nice
ClinicalTrials.gov Identifier:
NCT01246648
First received: November 17, 2010
Last updated: August 6, 2012
Last verified: November 2010

November 17, 2010
August 6, 2012
January 2011
February 2011   (final data collection date for primary outcome measure)
Presence/absence of EBV in the epithelial cells of periodontal pockets (by Immunofluorescence and in situ Hybridization [ Time Frame: at time = 0 (baseline) ] [ Designated as safety issue: No ]
Presence/absence of EBV in the epithelial cells of periodontal pockets (by Immunofluorescence and in situ Hybridization [ Time Frame: at time = 0 ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01246648 on ClinicalTrials.gov Archive Site
  • Presence/ absence of latency and/or lytic proteins (by immunofluorescence and in situ hybridization [ Time Frame: at time = 0 (baseline) ] [ Designated as safety issue: No ]
  • - Epithelial tissue infected (by Immunofluorescence and In situ Hybridization) : detection of oral gingival epithelium, sulcular epithelium, junctional epithelium. [ Time Frame: at time = 0 (baseline) ] [ Designated as safety issue: No ]
  • Presence/ absence of latency and/or lytic proteins (by immunofluorescence and in situ hybridization [ Time Frame: at time = 0 ] [ Designated as safety issue: No ]
  • - Epithelial tissue infected (by Immunofluorescence and In situ Hybridization) : detection of oral gingival epithelium, sulcular epithelium, junctional epithelium. [ Time Frame: at time = 0 ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Chronic Presence of Epstein Barr Virus in Sulcular and Junctional Epithelial Tissue From Gingiva is Associated With Severe Periodontitis
Not Provided

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.

Not Provided
Interventional
Not Provided
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
  • Parodontitis Aggressive
  • Parodontitis Chronic
  • Procedure: Biopsy
    dental extraction and gingival epithelial biopsy
  • Procedure: biopsy
    dental extraction and gingival epithelial biopsy
  • Active Comparator: chronic periodontitis
    Intervention: Procedure: Biopsy
  • Active Comparator: agressive periodontitis
    Intervention: Procedure: biopsy
  • Active Comparator: healthy patients
    Intervention: Procedure: Biopsy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
6
January 2013
February 2011   (final data collection date for primary outcome measure)

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
Male
12 Years and older
Yes
Contact: OLIVERI Vanina, ARC promoteur 0033 4 92 03 42 54 oliveri.v@chu-nice.fr
Contact: DEL CONT Delphine, ARC promoteur 0033 4 92 03 47 02 delcont.d@chu-nice.fr
France
 
NCT01246648
10-PP-13
No
Centre Hospitalier Universitaire de Nice
Centre Hospitalier Universitaire de Nice
Not Provided
Principal Investigator: VINCENT Severine, PH CHU de Nice
Centre Hospitalier Universitaire de Nice
November 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP