- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00702429
Immunoregulation of Periodontal Disease
August 27, 2014 updated by: Assistance Publique Hopitaux De Marseille
Our design is to test in hospital practice a selection of immune parameters that could assess the pathophysiology and progression of periodontal lesions.
Study Overview
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.
Study Type
Interventional
Enrollment (Actual)
23
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Marseille, France, 13274
- Hopital de la Conception- Laboratoire d'Immunologie
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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,
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
Patients achieve of parodontopathies
|
Analysis of the PNN, analysis of the monocytes
|
Placebo Comparator: 2
Patients without parodontales diseases
|
Analysis of the PNN, analysis of the monocytes
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Percentage of positive cells and intensity of expression for the molecules of surface studied there cytometric in stream
Time Frame: 24 months
|
24 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Rate of secretion of cytokines and the other substances
Time Frame: 24 months
|
24 months
|
Detection and quantification of ARN messengers
Time Frame: 24 months
|
24 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Joana VITTE, MD, Assistance Publique des Hôpitaux de Marseille
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2008
Primary Completion (Actual)
July 1, 2010
Study Completion (Actual)
July 1, 2010
Study Registration Dates
First Submitted
June 18, 2008
First Submitted That Met QC Criteria
June 19, 2008
First Posted (Estimate)
June 20, 2008
Study Record Updates
Last Update Posted (Estimate)
August 28, 2014
Last Update Submitted That Met QC Criteria
August 27, 2014
Last Verified
August 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2007-A00632-51
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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