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Immunoregulation of Periodontal Diseases

Primary Purpose

Parodontosis

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
blood samples
Sponsored by
Assistance Publique Hopitaux De Marseille
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Parodontosis

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

First Posted
August 31, 2015
Last Updated
July 6, 2016
Sponsor
Assistance Publique Hopitaux De Marseille
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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

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Immunoregulation of Periodontal Diseases

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