Chronic Presence of Epstein Barr Virus in Epithelial Cells From Gingiva is Associated With Periodontitis
1 other identifier
interventional
23
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jan 2011
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 17, 2010
CompletedFirst Posted
Study publicly available on registry
November 23, 2010
CompletedStudy Start
First participant enrolled
January 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 5, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
May 5, 2014
CompletedNovember 13, 2023
November 1, 2023
3.3 years
November 17, 2010
November 9, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage of gingival epithelial cells infected by EBV (by immunofluorescence and In situ Hybridization)
at time=0
Secondary Outcomes (2)
Epithelial tissue infected by EBV (by immunofluorescence and in situ hybridization)
at time = 0
Presence / absence of latency and / or lytic proteins (by immunofluorescence and in situ hybridization)
at time = 0
Study Arms (3)
chronic periodontitis
ACTIVE COMPARATORaggressive periodontitis
ACTIVE COMPARATORhealthy patient (orthodontics extraction)
ACTIVE COMPARATORInterventions
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.\[2\]
Eligibility Criteria
You may qualify if:
- patients affected by chronic periodontitis
- patients affected by aggressive periodontitis
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Dr Severine VINCENT
Nice, 0600, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Severine VINCENT, PH
CHU de Nice Hôpital Saint Roch
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 17, 2010
First Posted
November 23, 2010
Study Start
January 1, 2011
Primary Completion
May 5, 2014
Study Completion
May 5, 2014
Last Updated
November 13, 2023
Record last verified: 2023-11