Immunoregulation of Periodontal Diseases
Primary Purpose
Parodontosis
Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
blood samples
Sponsored by
About this trial
This is an interventional diagnostic trial for Parodontosis
Eligibility Criteria
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
Sites / Locations
- Assistance Publique Hopitaux de MarseilleRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
periodontal diseases
healthy volunteers
Arm Description
blood samples will be done for patients suffering of periodontal diseases
blood samples will be done for healthy volunteers
Outcomes
Primary Outcome Measures
% phagocytes cells of blood
Identification of altered immunological parameters in patients with periodontal disease
Secondary Outcome Measures
Full Information
NCT ID
NCT02567019
First Posted
August 31, 2015
Last Updated
July 6, 2016
Sponsor
Assistance Publique Hopitaux De Marseille
1. Study Identification
Unique Protocol Identification Number
NCT02567019
Brief Title
Immunoregulation of Periodontal Diseases
Official Title
Immunoregulation of Periodontal Diseases
Study Type
Interventional
2. Study Status
Record Verification Date
July 2016
Overall Recruitment Status
Unknown status
Study Start Date
December 2015 (undefined)
Primary Completion Date
September 2016 (Anticipated)
Study Completion Date
December 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique Hopitaux De Marseille
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parodontosis
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
periodontal diseases
Arm Type
Experimental
Arm Description
blood samples will be done for patients suffering of periodontal diseases
Arm Title
healthy volunteers
Arm Type
Active Comparator
Arm Description
blood samples will be done for healthy volunteers
Intervention Type
Other
Intervention Name(s)
blood samples
Intervention Description
blood samples will be done for patients patients suffering of periodontal diseases and healthy volunteers
Primary Outcome Measure Information:
Title
% phagocytes cells of blood
Description
Identification of altered immunological parameters in patients with periodontal disease
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
virginie MONNET CORTI
Email
vmonnet-corti@ap-hm.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Alexandra GIULIANI
Phone
0491382870
Email
agiuliani@ap-hm.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Virgine MONNET CORTI
Organizational Affiliation
Assistance Publique Hopitaux De Marseille
Official's Role
Principal Investigator
Facility Information:
Facility Name
Assistance Publique Hopitaux de Marseille
City
Marseille
ZIP/Postal Code
13005
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Virginie MONNET CORTI
Email
vmonnet-corti@ap-hm.fr
First Name & Middle Initial & Last Name & Degree
Alexandra GIULIANI
Phone
0491382870
Email
agiuliani@ap-hm.fr
12. IPD Sharing Statement
Learn more about this trial
Immunoregulation of Periodontal Diseases
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