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

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ClinicalTrials.gov Identifier: NCT01246596
Recruitment Status : Unknown
Verified November 2010 by Centre Hospitalier Universitaire de Nice.
Recruitment status was:  Recruiting
First Posted : November 23, 2010
Last Update Posted : December 18, 2012
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nice

Tracking Information
First Submitted Date  ICMJE November 17, 2010
First Posted Date  ICMJE November 23, 2010
Last Update Posted Date December 18, 2012
Study Start Date  ICMJE January 2011
Actual Primary Completion Date June 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 22, 2010)
Percentage of gingival epithelial cells infected by EBV (by immunofluorescence and In situ Hybridization) [ Time Frame: at time=0 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 22, 2010)
  • Epithelial tissue infected by EBV (by immunofluorescence and in situ hybridization) [ Time Frame: at time = 0 ]
  • Presence / absence of latency and / or lytic proteins (by immunofluorescence and in situ hybridization) [ Time Frame: at time = 0 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Chronic Presence of Epstein Barr Virus in Epithelial Cells From Gingiva is Associated With Periodontitis
Official Title  ICMJE Not Provided
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Condition  ICMJE
  • Chronic Periodontitis
  • Aggressive Periodontitis
  • Presence / Absence of EBV
Intervention  ICMJE
  • Procedure: dental root planing
    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]
  • Procedure: dental root planing
    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.
Study Arms  ICMJE
  • Active Comparator: chronic periodontitis
    Intervention: Procedure: dental root planing
  • Active Comparator: aggressive periodontitis
    Intervention: Procedure: dental root planing
  • Active Comparator: healthy patient (orthodontics extraction)
    Intervention: Procedure: dental root planing
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: November 22, 2010)
30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 2014
Actual Primary Completion Date June 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01246596
Other Study ID Numbers  ICMJE 10-AOI-01
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Centre Hospitalier Universitaire de Nice
Study Sponsor  ICMJE Centre Hospitalier Universitaire de Nice
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Severine VINCENT, PH CHU de Nice Hôpital Saint Roch
PRS Account Centre Hospitalier Universitaire de Nice
Verification Date November 2010

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