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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01246648
Other study ID # 10-PP-13
Secondary ID
Status Recruiting
Phase N/A
First received November 17, 2010
Last updated August 6, 2012
Start date January 2011
Est. completion date January 2013

Study information

Verified date November 2010
Source Centre Hospitalier Universitaire de Nice
Contact OLIVERI Vanina, ARC promoteur
Phone 0033 4 92 03 42 54
Email oliveri.v@chu-nice.fr
Is FDA regulated No
Health authority France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 6
Est. completion date January 2013
Est. primary completion date February 2011
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 12 Years and older
Eligibility 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

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science


Intervention

Procedure:
Biopsy
dental extraction and gingival epithelial biopsy
biopsy
dental extraction and gingival epithelial biopsy
Biopsy
dental extraction and gingival epithelial biopsy

Locations

Country Name City State
France CHU de Nice, Hôpital Saint Roch Nice

Sponsors (1)

Lead Sponsor Collaborator
Centre Hospitalier Universitaire de Nice

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Presence/absence of EBV in the epithelial cells of periodontal pockets (by Immunofluorescence and in situ Hybridization at time = 0 (baseline) No
Secondary Presence/ absence of latency and/or lytic proteins (by immunofluorescence and in situ hybridization at time = 0 (baseline) No
Secondary - Epithelial tissue infected (by Immunofluorescence and In situ Hybridization) : detection of oral gingival epithelium, sulcular epithelium, junctional epithelium. at time = 0 (baseline) No