- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02567019
Immunoregulation of Periodontal Diseases
Study Overview
Detailed Description
Periodontal diseases are a group of diseases that affect 15% of the population and in the absence of treatment causes tooth loss. Periodontal lesions are characterized mainly by strong inflammation and hyper-vascularization. Search in blood cells and inflammatory markers attempts to explain the etiological-pathogenetic mechanisms. Innate immunity can be assessed by qualitative and quantitative analysis of blood phagocytes, natural killer cells, complement, proteins of inflammation and cytokines. Current data from the literature on this subject give contradictory results and the comparison of studies are difficult because the diversity of the populations studied, evaluated cells and the methods used. The aim of the study was to evaluate the innate immunity of patients with periodontal disease and compare it with a group of patients without periodontal disease. The previous conclusions of study focused on the difference in the general immunological parameters in healthy patients and patients suffering from periodontal disease, current advances in immunology have helped to develop new markers on functional status of blood phagocytes all through their anti-microbial action. The adhesion, migration, phagocytosis and bactericidal capacity are assessed and quantified using recognized tests and practiced regularly in analytical laboratory. The identification of altered immunological parameters in patients with periodontal disease would better understand the natural history of these diseases and may lead to new diagnostic criteria, prognostic and therapeutic.
In practice, the project brings together immunological skills (functional analysis of cells and membrane markers) and dental (patient selection and diagnosis of periodontal disease) for further testing applicable to many patients likely to develop periodontal disease.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Virginie MONNET CORTI
- Email: vmonnet-corti@ap-hm.fr
Study Contact Backup
- Name: Alexandra GIULIANI
- Phone Number: 0491382870
- Email: agiuliani@ap-hm.fr
Study Locations
-
-
-
Marseille, France, 13005
- Recruiting
- Assistance Publique Hopitaux de Marseille
-
Contact:
- Virginie MONNET CORTI
- Email: vmonnet-corti@ap-hm.fr
-
Contact:
- Alexandra GIULIANI
- Phone Number: 0491382870
- Email: agiuliani@ap-hm.fr
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
For periodontal subjects
- At least present 20 teeth on the dental arches
- Presence of periodontal deep pockets = 4 mm measured by means of a periodontal probe increased in millimeters and raised on at least 30 % of the dental surfaces (proximal, vestibular and Palatine or lingual) present teeth on the dental arches.
For healthy volunteers : absence of periodontal deep pockets
Exclusion Criteria:
- pathologies or treatments whom could affect the immunological parameters for the both arms
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: periodontal diseases
blood samples will be done for patients suffering of periodontal diseases
|
blood samples will be done for patients patients suffering of periodontal diseases and healthy volunteers
|
Active Comparator: healthy volunteers
blood samples will be done for healthy volunteers
|
blood samples will be done for patients patients suffering of periodontal diseases and healthy volunteers
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
% phagocytes cells of blood
Time Frame: 1 year
|
Identification of altered immunological parameters in patients with periodontal disease
|
1 year
|
Collaborators and Investigators
Investigators
- Principal Investigator: Virgine MONNET CORTI, Assistance Publique Hopitaux de Marseille
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2015-A00882-47
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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