Role of Macrophage in Inflammation Resolution in Periodontal Patients
| Tracking Information | |||||
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| First Received Date ICMJE | May 25, 2011 | ||||
| Last Updated Date | June 22, 2011 | ||||
| Start Date ICMJE | August 2011 | ||||
| Estimated Primary Completion Date | August 2012 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
The macrophage phenotype (M1, M2, resolution phase macrophage) [ Time Frame: 1 year ] [ Designated as safety issue: No ] 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. |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01379950 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Role of Macrophage in Inflammation Resolution in Periodontal Patients | ||||
| Official Title ICMJE | The Role of Macrophages in the Inflammatory Resolution Phase in Periodontal Patients | ||||
| 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. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | patients coming to the periodontal clinic in the dental school in order to attend a periodontal treatment |
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| Condition ICMJE | Periodontitis | ||||
| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) | periodontitis
patients diagnosed with periodontal disease |
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| Publications * | 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. Epub 2008 Sep 8. | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Not yet recruiting | ||||
| Estimated Enrollment ICMJE | 30 | ||||
| Estimated Completion Date | August 2012 | ||||
| Estimated Primary Completion Date | August 2012 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | Israel | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01379950 | ||||
| Other Study ID Numbers ICMJE | perio1-HMO-CTIL | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Jacob (Cobi) Ekstein - principal investigator, Hadassah Medical Organization | ||||
| Study Sponsor ICMJE | Hadassah Medical Organization | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE | Not Provided | ||||
| Information Provided By | Hadassah Medical Organization | ||||
| Verification Date | June 2011 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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