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
  Purpose

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 Intervention
Parodontitis Aggressive
Parodontitis Chronic
Procedure: Biopsy
Procedure: biopsy

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science

Further study details as provided by Centre Hospitalier Universitaire de Nice:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 6
Study Start Date: January 2011
Estimated Study Completion Date: January 2013
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01246648

Contacts
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

Locations
France
CHU de Nice, Hôpital Saint Roch Recruiting
Nice, France, 06000
Contact: Severine VINCENT, PH       Severine.VINCENT@unice.fr   
Contact: Vanina OLIVERI, ARC Promoteur    0033 4 92 03 42 54    oliveri.v@chu-nice.fr   
Principal Investigator: Severine VINCENT, PH         
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nice
Investigators
Principal Investigator: VINCENT Severine, PH CHU de Nice
  More Information

No publications provided

Responsible Party: Centre Hospitalier Universitaire de Nice
ClinicalTrials.gov Identifier: NCT01246648     History of Changes
Other Study ID Numbers: 10-PP-13
Study First Received: November 17, 2010
Last Updated: August 6, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
Periodontitis
Mouth Diseases
Periodontal Diseases
Stomatognathic Diseases

ClinicalTrials.gov processed this record on October 23, 2014