Immunoregulation of Periodontal Disease - Full Text View

Sponsored by:	Assistance Publique Hopitaux De Marseille
Information provided by:	Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier:	NCT00702429

Purpose

Our design is to test in hospital practice a selection of immune parameters that could assess the pathophysiology and progression of periodontal lesions.

Condition	Intervention
Periodontal Disease	Other: Blood sampling

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Open Label, Uncontrolled, Parallel Assignment
Official Title:	Immunoregulation of Periodontal Disease

Further study details as provided by Assistance Publique Hopitaux De Marseille:

Primary Outcome Measures:

Percentage of positive cells and intensity of expression for the molecules of surface studied there cytometric in stream [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Rate of secretion of cytokines and the other substances [ Time Frame: 24 months ] [ Designated as safety issue: No ]
Detection and quantification of ARN messengers [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	40
Study Start Date:	August 2008
Estimated Study Completion Date:	December 2010
Estimated Primary Completion Date:	April 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Patients achieve of parodontopathies	Other: Blood sampling Analysis of the PNN, analysis of the monocytes
2: Placebo Comparator Patients without parodontales diseases	Other: Blood sampling Analysis of the PNN, analysis of the monocytes

Detailed Description:

These parameters will be measured in 25 healthy volunteers and 25 moderate-to severe periodontal disese patients. Phagocytes will be tested phenotypically and functionally, both ex vivo and in vitro.

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Persons appearing spontaneously at the consultation of parodontologie for parodontale disease,
persons agreeing to undergo a sampling of blood intended for the search

Exclusion Criteria:

Presence of a chronic or pointed pathology,
an age 18-year-old subordinate or 65-year-old superior,
pregnant women,

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00702429

Contacts

Contact: Joana VITTE, MD

49-174-4047

joana.vitte@mail.ap-hm.fr

Locations

France
Hopital de la Conception- Laboratoire d'Immunologie	Recruiting
MARSEILLE, France, 13274
Contact: Joana VITTE, MD 49-174-4047 joana.vitte@mail.ap-hm.fr

Sponsors and Collaborators

Assistance Publique Hopitaux De Marseille

Investigators

Principal Investigator:

Joana VITTE, MD

Assistance Publique des Hôpitaux de Marseille

More Information

Responsible Party:	Assitance Publique des Hôpitaux de Marseille ( Assitance Publique des Hôpitaux de Marseille )
Study ID Numbers:	2007-A00632-51
Study First Received:	June 18, 2008
Last Updated:	December 22, 2008
ClinicalTrials.gov Identifier:	NCT00702429
Health Authority:	France: Ministry of Health

Study placed in the following topic categories:

Mouth Diseases
Periodontal Diseases
Stomatognathic Diseases

ClinicalTrials.gov processed this record on January 15, 2009