Chronic Presence of Epstein Barr Virus in Epithelial Cells From Gingiva is Associated With 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:
NCT01246596
First received: November 17, 2010
Last updated: December 17, 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
Chronic Periodontitis
Aggressive Periodontitis
Presence / Absence of EBV
Procedure: dental root planing

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research

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

Primary Outcome Measures:
  • Percentage of gingival epithelial cells infected by EBV (by immunofluorescence and In situ Hybridization) [ Time Frame: at time=0 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Epithelial tissue infected by EBV (by immunofluorescence and in situ hybridization) [ Time Frame: at time = 0 ] [ 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 ]

Estimated Enrollment: 30
Study Start Date: January 2011
Estimated Study Completion Date: January 2014
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: chronic periodontitis 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]
Active Comparator: aggressive periodontitis 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: healthy patient (orthodontics extraction) 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  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: NCT01246596

Contacts
Contact: Severine VINCENT, PH severine.VINCENT@unice.fr
Contact: Vanina OLIVERI, ARC promoteur 0033 4 92 03 42 54 oliveri.v@chu-nice.fr

Locations
France
Dr Severine VINCENT Recruiting
Nice, France, 0600
Contact: Severine VINCENT, PH         
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nice
Investigators
Principal Investigator: Severine VINCENT, PH CHU de Nice Hôpital Saint Roch
  More Information

No publications provided

Responsible Party: Centre Hospitalier Universitaire de Nice
ClinicalTrials.gov Identifier: NCT01246596     History of Changes
Other Study ID Numbers: 10-AOI-01
Study First Received: November 17, 2010
Last Updated: December 17, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
France: National Consultative Ethics Committee for Health and Life Sciences

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

ClinicalTrials.gov processed this record on September 18, 2014