Role of Macrophage in Inflammation Resolution in Periodontal Patients

Periodontitis Clinical Trial

Official title:

The Role of Macrophages in the Inflammatory Resolution Phase in Periodontal Patients

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01379950
• Other study ID #: perio1-HMO-CTIL
• Status: Not yet recruiting
• Phase: N/A
• First received: May 25, 2011
• Last updated: June 22, 2011
• Start date: August 2011
• Est. completion date: August 2012

Study information

• Verified date: June 2011
• Source: Hadassah Medical Organization
• Contact: jacob ekstein, Dr.
• Phone: 00 972 6777826
• Email: drcobi[@]gmail.com
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: August 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 18 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

Exclusion Criteria:

• pregnancy or nursing

• chronic use of alcohol

• systemic conditions - diseases, neoplastic lesions in the oral cavity

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Periodontitis

Locations

Country	Name	City	State
Israel	Periodontal Clinic, Faculty of Dental Medicine, Hebrew University and Hadassah Medical Center	Jerusalem

Sponsors (1)

Lead Sponsor	Collaborator
Hadassah Medical Organization

Country where clinical trial is conducted

Israel, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No