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 Hadassah Medical Organization.
Recruitment status was:  Not yet recruiting
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 ]
    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

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
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

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 
Study First Received: December 9, 2013
Last Updated: December 13, 2013

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

ClinicalTrials.gov processed this record on January 19, 2017