Immunoregulation of Periodontal Disease

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2010 by Assistance Publique Hopitaux De Marseille.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier:
NCT00702429
First received: June 18, 2008
Last updated: January 29, 2010
Last verified: January 2010
  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

Study Type: Interventional
Study Design: Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
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
Experimental: 1
Patients achieve of parodontopathies
Other: Blood sampling
Analysis of the PNN, analysis of the monocytes
Placebo Comparator: 2
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
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: 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

No publications provided

Responsible Party: Assitance Publique des Hôpitaux de Marseille
ClinicalTrials.gov Identifier: NCT00702429     History of Changes
Other Study ID Numbers: 2007-A00632-51
Study First Received: June 18, 2008
Last Updated: January 29, 2010
Health Authority: France: Ministry of Health

Additional relevant MeSH terms:
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases

ClinicalTrials.gov processed this record on July 20, 2014