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Polymorphonuclear Cells' Sensitivity to Aggregatibacter Actinomycetemcomitans Bacteria in Patients With Aggressive Periodontitis

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ClinicalTrials.gov Identifier: NCT02010307
Recruitment Status : Unknown
Verified December 2013 by Polak David, Hadassah Medical Organization.
Recruitment status was:  Not yet recruiting
First Posted : December 12, 2013
Last Update Posted : December 16, 2013
Sponsor:
Information provided by (Responsible Party):
Polak David, Hadassah Medical Organization

Tracking Information
First Submitted Date  ICMJE December 9, 2013
First Posted Date  ICMJE December 12, 2013
Last Update Posted Date December 16, 2013
Study Start Date  ICMJE January 2014
Estimated Primary Completion Date January 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 13, 2013)
flow cytometry [ Time Frame: 12 hours after blood extraction ]
the investigators use flow cytometry technique in order to determine the influence of gingival bacteria on the leukocytes, after culturing the two together.
Original Primary Outcome Measures  ICMJE
 (submitted: December 9, 2013)
flow cytometry [ Time Frame: 12 hours after blood extraction ]
we use flow cytometry technique in order to determine the influence of gingival bacteria on the leukocytes, after culturing the two together.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 13, 2013)
microscopy observation [ Time Frame: 12 hours after blood extraction ]
the investigators use microscopy in order to determine the influence of gingival bacteria on the leukocytes, after culturing the two together
Original Secondary Outcome Measures  ICMJE
 (submitted: December 9, 2013)
microscopy observation [ Time Frame: 12 hours after blood extraction ]
we use microscopy in order to determine the influence of gingival bacteria on the leukocytes, after culturing the two together
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Polymorphonuclear Cells' Sensitivity to Aggregatibacter Actinomycetemcomitans Bacteria in Patients With Aggressive Periodontitis
Official Title  ICMJE Not Provided
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Periodontal Disease
Intervention  ICMJE Other: blood extraction
6 ml blood extraction from each patients in all 3 arms of the study
Study Arms  ICMJE
  • Experimental: aggressive periodontitis
    25 patients with aggressive periodontitis blood extraction
    Intervention: Other: blood extraction
  • Experimental: chronic periodontitis
    25 patients with chronic periodontitis blood extraction
    Intervention: Other: blood extraction
  • Experimental: healthy
    25 healthy periodontal patients blood extraction
    Intervention: Other: blood extraction
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: December 9, 2013)
75
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 2015
Estimated Primary Completion Date January 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Israel
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02010307
Other Study ID Numbers  ICMJE davidp-HMO-CTIL
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Polak David, Hadassah Medical Organization
Study Sponsor  ICMJE Polak David
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: David Polak, DMD, PhD Haddasah Medical Center
PRS Account Hadassah Medical Organization
Verification Date December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP