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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2013 by Polak David, Hadassah Medical Organization.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT02010307
First Posted: December 12, 2013
Last Update Posted: December 16, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Polak David, Hadassah Medical Organization
  Purpose

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 Intervention
Periodontal Disease Other: blood extraction

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science

Further study details as provided by Polak David, Hadassah Medical Organization:

Primary Outcome Measures:
  • 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:
  • 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


Estimated Enrollment: 75
Study Start Date: January 2014
Estimated Study Completion Date: October 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

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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
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
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
Israel
Hadassah Medical Organization, Jerusalem, Israel
Jerusalem, Israel
Sponsors and Collaborators
Polak David
Investigators
Principal Investigator: David Polak, DMD, PhD Haddasah Medical Center
  More Information

Responsible Party: Polak David, senior dentist, periodontology department, Hadassah Medical Organization
ClinicalTrials.gov Identifier: NCT02010307     History of Changes
Other Study ID Numbers: davidp-HMO-CTIL
First Submitted: December 9, 2013
First Posted: December 12, 2013
Last Update Posted: December 16, 2013
Last Verified: December 2013

Additional relevant MeSH terms:
Periodontal Diseases
Gingival Diseases
Aggressive Periodontitis
Mouth Diseases
Stomatognathic Diseases
Periodontitis