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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

Study Description
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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.


Condition or disease Intervention/treatment Phase
Periodontal Disease Other: blood extraction Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 75 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Study Start Date : January 2014
Estimated Primary Completion Date : January 2015
Estimated Study Completion Date : October 2015
Arms and Interventions
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Arm Intervention/treatment
Experimental: aggressive periodontitis
25 patients with aggressive periodontitis blood extraction
 Other: blood extraction
6 ml blood extraction from each patients in all 3 arms of the study
Experimental: chronic periodontitis
25 patients with chronic periodontitis blood extraction
 Other: blood extraction
6 ml blood extraction from each patients in all 3 arms of the study
Experimental: healthy
25 healthy periodontal patients blood extraction
 Other: blood extraction
6 ml blood extraction from each patients in all 3 arms of the study


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02010307


Contacts
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Contact: David Polak, DMD, PhD 00972- 52-593-3961 polak@mail.huji.ac.il
Contact: Hadas Lemberg, PhD 00-972-2-6777572 lhadas@hadassah.org.il

Locations
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Israel
Hadassah Medical Organization, Jerusalem, Israel
Jerusalem, Israel
Sponsors and Collaborators
Polak David
Investigators
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Principal Investigator: David Polak, DMD, PhD Haddasah Medical Center
More Information
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Responsible Party: Polak David, senior dentist, periodontology department, Hadassah Medical Organization
ClinicalTrials.gov Identifier: NCT02010307    
Other Study ID Numbers: davidp-HMO-CTIL
First Posted: December 12, 2013    Key Record Dates
Last Update Posted: December 16, 2013
Last Verified: December 2013
Additional relevant MeSH terms:
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Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases