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Immunoregulation of Periodontal Disease

Primary Purpose

Periodontal Disease

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Blood sampling
Blood sampling
Sponsored by
Assistance Publique Hopitaux De Marseille
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Periodontal Disease

Eligibility Criteria

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

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,

Sites / Locations

  • Hopital de la Conception- Laboratoire d'Immunologie

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

1

2

Arm Description

Patients achieve of parodontopathies

Patients without parodontales diseases

Outcomes

Primary Outcome Measures

Percentage of positive cells and intensity of expression for the molecules of surface studied there cytometric in stream

Secondary Outcome Measures

Rate of secretion of cytokines and the other substances
Detection and quantification of ARN messengers

Full Information

First Posted
June 18, 2008
Last Updated
August 27, 2014
Sponsor
Assistance Publique Hopitaux De Marseille
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1. Study Identification

Unique Protocol Identification Number
NCT00702429
Brief Title
Immunoregulation of Periodontal Disease
Official Title
Immunoregulation of Periodontal Disease
Study Type
Interventional

2. Study Status

Record Verification Date
August 2014
Overall Recruitment Status
Completed
Study Start Date
August 2008 (undefined)
Primary Completion Date
July 2010 (Actual)
Study Completion Date
July 2010 (Actual)

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
Our design is to test in hospital practice a selection of immune parameters that could assess the pathophysiology and progression of periodontal lesions.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periodontal Disease

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
23 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Patients achieve of parodontopathies
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Patients without parodontales diseases
Intervention Type
Other
Intervention Name(s)
Blood sampling
Intervention Description
Analysis of the PNN, analysis of the monocytes
Intervention Type
Other
Intervention Name(s)
Blood sampling
Intervention Description
Analysis of the PNN, analysis of the monocytes
Primary Outcome Measure Information:
Title
Percentage of positive cells and intensity of expression for the molecules of surface studied there cytometric in stream
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Rate of secretion of cytokines and the other substances
Time Frame
24 months
Title
Detection and quantification of ARN messengers
Time Frame
24 months

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: 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,
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joana VITTE, MD
Organizational Affiliation
Assistance Publique des Hôpitaux de Marseille
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hopital de la Conception- Laboratoire d'Immunologie
City
Marseille
ZIP/Postal Code
13274
Country
France

12. IPD Sharing Statement

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Immunoregulation of Periodontal Disease

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