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

December 13, 2013 updated by: Polak David

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

75

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Jerusalem, Israel
        • Hadassah Medical Organization, Jerusalem, Israel

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 hours after blood extraction

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
12 hours after blood extraction

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Polak David

Investigators

  • Principal Investigator: David Polak, DMD, PhD, Haddasah medical center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2014

Primary Completion (Anticipated)

January 1, 2015

Study Completion (Anticipated)

October 1, 2015

Study Registration Dates

First Submitted

December 9, 2013

First Submitted That Met QC Criteria

December 9, 2013

First Posted (Estimate)

December 12, 2013

Study Record Updates

Last Update Posted (Estimate)

December 16, 2013

Last Update Submitted That Met QC Criteria

December 13, 2013

Last Verified

December 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • davidp-HMO-CTIL

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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