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

Periodontal Disease Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02010307
• Other study ID #: davidp-HMO-CTIL
• Status: Not yet recruiting
• Phase: N/A
• First received: December 9, 2013
• Last updated: December 13, 2013
• Start date: January 2014
• Est. completion date: October 2015

Study information

• Verified date: December 2013
• Source: Hadassah Medical Organization
• Contact: David Polak, DMD, PhD
• Phone: 00972- 52-593-3961
• Email: polak[@]mail.huji.ac.il
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 75
• Est. completion date: October 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

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 Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Aggressive Periodontitis
• Gingival Diseases
• Periodontal Disease
• Periodontal Diseases

Intervention

Other:
• blood extraction
6 ml blood extraction from each patients in all 3 arms of the study

Locations

Country	Name	City	State
Israel	Hadassah Medical Organization, Jerusalem, Israel	Jerusalem

Sponsors (1)

Lead Sponsor	Collaborator
Polak David

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	flow cytometry	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	No
Secondary	microscopy observation	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	No