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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified December 2013 by Hadassah Medical Organization
Sponsor:
Information provided by (Responsible Party):
Polak David, Hadassah Medical Organization
ClinicalTrials.gov Identifier:
NCT02010307
First received: December 9, 2013
Last updated: December 13, 2013
Last verified: December 2013
  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: Open Label
Primary Purpose: Basic Science

Further study details as provided by Hadassah Medical Organization:

Primary Outcome Measures:
  • flow cytometry [ Time Frame: 12 hours after blood extraction ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: December 9, 2013
Last Updated: December 13, 2013
Health Authority: Israel: Ministry of Health

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

ClinicalTrials.gov processed this record on July 31, 2014