NCT02010307

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
75

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2014

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 9, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 12, 2013

Completed
20 days until next milestone

Study Start

First participant enrolled

January 1, 2014

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
Last Updated

December 16, 2013

Status Verified

December 1, 2013

Enrollment Period

1 year

First QC Date

December 9, 2013

Last Update Submit

December 13, 2013

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • microscopy observation

    12 hours after blood extraction

Study Arms (3)

aggressive periodontitis

EXPERIMENTAL

25 patients with aggressive periodontitis blood extraction

Other: blood extraction

chronic periodontitis

EXPERIMENTAL

25 patients with chronic periodontitis blood extraction

Other: blood extraction

healthy

EXPERIMENTAL

25 healthy periodontal patients blood extraction

Other: blood extraction

Interventions

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

aggressive periodontitischronic periodontitishealthy

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • patients in periodontal department
  • healthy
  • diagnosed with chronic/aggressive periodontal disease
  • interested in participating the research

You may not qualify if:

  • diagnosed with diabetes, heart disease, immunosuppression, thrombocytopenia, clotting enzyme deficiency.
  • using alcohol, or drugs
  • pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hadassah Medical Organization, Jerusalem, Israel

Jerusalem, Israel

Location

MeSH Terms

Conditions

Periodontal Diseases

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic Diseases

Study Officials

  • David Polak, DMD, PhD

    Haddasah Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

David Polak, DMD, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
senior dentist, periodontology department

Study Record Dates

First Submitted

December 9, 2013

First Posted

December 12, 2013

Study Start

January 1, 2014

Primary Completion

January 1, 2015

Study Completion

October 1, 2015

Last Updated

December 16, 2013

Record last verified: 2013-12

Locations