Back to resultsPolymorphonuclear Cells' Sensitivity to Aggregatibacter Actinomycetemcomitans Bacteria in Patients With Aggressive Periodontitis
Primary Purpose
Periodontal Disease
Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
blood extraction
Sponsored by
About this trial
This is an interventional basic science trial for Periodontal Disease
Eligibility Criteria
Inclusion Criteria:
- patients in periodontal department
- healthy
- diagnosed with chronic/aggressive periodontal disease
- interested in participating the research
Exclusion Criteria:
- diagnosed with diabetes, heart disease, immunosuppression, thrombocytopenia, clotting enzyme deficiency.
- using alcohol, or drugs
- pregnancy
Sites / Locations
- Hadassah Medical Organization, Jerusalem, Israel
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
aggressive periodontitis
chronic periodontitis
healthy
Arm Description
25 patients with aggressive periodontitis blood extraction
25 patients with chronic periodontitis blood extraction
25 healthy periodontal patients blood extraction
Outcomes
Primary Outcome Measures
flow cytometry
the investigators use flow cytometry technique in order to determine the influence of gingival bacteria on the leukocytes, after culturing the two together.
Secondary Outcome Measures
microscopy observation
the investigators use microscopy in order to determine the influence of gingival bacteria on the leukocytes, after culturing the two together
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02010307
Brief Title
Polymorphonuclear Cells' Sensitivity to Aggregatibacter Actinomycetemcomitans Bacteria in Patients With Aggressive Periodontitis
Study Type
Interventional
2. Study Status
Record Verification Date
December 2013
Overall Recruitment Status
Unknown status
Study Start Date
January 2014 (undefined)
Primary Completion Date
January 2015 (Anticipated)
Study Completion Date
October 2015 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Polak David
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
aggressive periodontitis is an inflammatory disease which damage the teeth supporting structures mostly in young patients. and has genetic basis.
a specific bacteria: Aggregatibacter actinomycetemcomitans (Aa) is associated with this disease, and found to damage leukocytes by using a specific leukotoxin.
in the research the investigators are aiming to find molecular and immunological basis to aggressive periodontitis.
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
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
75 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
aggressive periodontitis
Arm Type
Experimental
Arm Description
25 patients with aggressive periodontitis blood extraction
Arm Title
chronic periodontitis
Arm Type
Experimental
Arm Description
25 patients with chronic periodontitis blood extraction
Arm Title
healthy
Arm Type
Experimental
Arm Description
25 healthy periodontal patients blood extraction
Intervention Type
Other
Intervention Name(s)
blood extraction
Intervention Description
6 ml blood extraction from each patients in all 3 arms of the study
Primary Outcome Measure Information:
Title
flow cytometry
Description
the investigators use flow cytometry technique in order to determine the influence of gingival bacteria on the leukocytes, after culturing the two together.
Time Frame
12 hours after blood extraction
Secondary Outcome Measure Information:
Title
microscopy observation
Description
the investigators use microscopy in order to determine the influence of gingival bacteria on the leukocytes, after culturing the two together
Time Frame
12 hours after blood extraction
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
patients in periodontal department
healthy
diagnosed with chronic/aggressive periodontal disease
interested in participating the research
Exclusion Criteria:
diagnosed with diabetes, heart disease, immunosuppression, thrombocytopenia, clotting enzyme deficiency.
using alcohol, or drugs
pregnancy
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
David Polak, DMD, PhD
Phone
00972- 52-593-3961
Email
polak@mail.huji.ac.il
First Name & Middle Initial & Last Name or Official Title & Degree
Hadas Lemberg, PhD
Phone
00-972-2-6777572
Email
lhadas@hadassah.org.il
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Polak, DMD, PhD
Organizational Affiliation
Haddasah Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hadassah Medical Organization, Jerusalem, Israel
City
Jerusalem
Country
Israel
12. IPD Sharing Statement
Learn more about this trial
Polymorphonuclear Cells' Sensitivity to Aggregatibacter Actinomycetemcomitans Bacteria in Patients With Aggressive Periodontitis
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