NCT01379950

Brief Summary

There is a growing body of evidence to suggest that the resolution of an inflammatory reaction is an active process. This process requiring signals that turn off early inflammatory stages, as neutrophil infiltration and promote resolution phase, as clearance of apoptotic cells. In this array,the relationship between neutrophils, monocytes, and macrophages is crucial for the concert process. Macrophages possess a plasticity of phenotype that explains their protective as well as potentially detrimental role in chronic inflammation and tissue injury. Such heterogeneity arises as macrophages differentiate from monocytes and are exposed to specific tissue- and hematopoietic cell-derived stimuli. It is important to be able to identify the different types of macrophages in this setting. Today's literature can distinguish between 3 main phenotypic groups of macrophages. The classically activated M1 macrophages, the alternatively activated-M2 macrophages and the "resolution phase" - rMs macrophages. The third phenotypic macrophage might play a crucial rule in the resolution phase, and is called the "resolving macrophage". All of those pro-resolving lipid mediators promote the return to tissue homeostasis . The investigators hypothesis is that in periodontal patients the inflammatory process continues because the process does not reach the resolution phase, and in that milieu, the macrophage might be a key component. Within the overall concept of periodontal disease as a model for an inflammatory disease with an stoppable inflammatory reaction, the primary aim of the study is to check the macrophage characteristics in periodontal patients and to compare it to healthy people.

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
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2011

Shorter than P25 for all trials

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

May 25, 2011

Completed
29 days until next milestone

First Posted

Study publicly available on registry

June 23, 2011

Completed
1 month until next milestone

Study Start

First participant enrolled

August 1, 2011

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
Last Updated

June 23, 2011

Status Verified

June 1, 2011

Enrollment Period

1 year

First QC Date

May 25, 2011

Last Update Submit

June 22, 2011

Conditions

Outcome Measures

Primary Outcomes (1)

  • The macrophage phenotype (M1, M2, resolution phase macrophage)

    we will try to specify the characteristics of the macrophage phenotype and to see whether there is a difference between periodontal patients and healthy ones.

    1 year

Study Arms (1)

periodontitis

patients diagnosed with periodontal disease

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients coming to the periodontal clinic in the dental school in order to attend a periodontal treatment

You may qualify if:

  • years old and more, male \& female
  • generally healthy
  • does not take medicine on a regular basis
  • has a periodontal disease. control - without a periodontal disease
  • no periodontal treatment for at list 6 months prior to his acceptance to the trail
  • willing to donate 50 ml of blood twice during the trail
  • understands the trail and gave a consent to participate

You may not qualify if:

  • pregnancy or nursing
  • chronic use of alcohol
  • systemic conditions - diseases, neoplastic lesions in the oral cavity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Periodontal Clinic, Faculty of Dental Medicine, Hebrew University and Hadassah Medical Center

Jerusalem, Israel

Location

Related Publications (1)

  • Bystrom J, Evans I, Newson J, Stables M, Toor I, van Rooijen N, Crawford M, Colville-Nash P, Farrow S, Gilroy DW. Resolution-phase macrophages possess a unique inflammatory phenotype that is controlled by cAMP. Blood. 2008 Nov 15;112(10):4117-27. doi: 10.1182/blood-2007-12-129767. Epub 2008 Sep 8.

    PMID: 18779392BACKGROUND

MeSH Terms

Conditions

Periodontitis

Condition Hierarchy (Ancestors)

Periodontal DiseasesMouth DiseasesStomatognathic Diseases

Central Study Contacts

jacob ekstein, Dr.

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 25, 2011

First Posted

June 23, 2011

Study Start

August 1, 2011

Primary Completion

August 1, 2012

Study Completion

August 1, 2012

Last Updated

June 23, 2011

Record last verified: 2011-06

Locations