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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified November 2010 by Centre Hospitalier Universitaire de Nice.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01246596
First Posted: November 23, 2010
Last Update Posted: December 18, 2012
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.
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nice
November 17, 2010
November 23, 2010
December 18, 2012
January 2011
June 2011   (Final data collection date for primary outcome measure)
Percentage of gingival epithelial cells infected by EBV (by immunofluorescence and In situ Hybridization) [ Time Frame: at time=0 ]
Same as current
Complete list of historical versions of study NCT01246596 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Chronic Presence of Epstein Barr Virus in Epithelial Cells From Gingiva is Associated With 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: None (Open Label)
Primary Purpose: Health Services Research
  • Chronic Periodontitis
  • Aggressive Periodontitis
  • Presence / Absence of EBV
  • 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.
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
30
January 2014
June 2011   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
France
 
 
NCT01246596
10-AOI-01
No
Not Provided
Not Provided
Centre Hospitalier Universitaire de Nice
Centre Hospitalier Universitaire de Nice
Not Provided
Principal Investigator: Severine VINCENT, PH CHU de Nice Hôpital Saint Roch
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