PeriodontitisNCT01379950
Role of Macrophage in Inflammation Resolution in Periodontal Patients
An observational study of Periodontitis, run by Hadassah Medical Organization at 1 site in Israel.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Periodontitis
- How many people
- 30 participants
- Where
- 1 siteIsrael
- Study dates
- Aug 2011to Aug 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: patients coming to the periodontal clinic in the dental school in order to attend a periodontal treatment
Who may be able to join
- 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
Who cannot join
- pregnancy or nursing
- chronic use of alcohol
- systemic conditions - diseases, neoplastic lesions in the oral cavity
Trial locations and contacts
1 site in 1 country.
Israel1 site
Periodontal Clinic, Faculty of Dental Medicine, Hebrew University and Hadassah Medical Center
Jerusalem
jacob ekstein, Dr., 00-972-6777826, drcobi@gmail.com
jacob ekstein, Dr.
About this study
Official title: The Role of Macrophages in the Inflammatory Resolution Phase in Periodontal Patients
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".
Read more
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.
- Conditions
- Periodontitis
- Medical subject headings
- Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| periodontitis | patients diagnosed with periodontal disease |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2011 (estimated)
- Study startAug 2011
- Primary completionAug 2012 (estimated)
- Study completionAug 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PeriodontitisStudies of the same condition, open and under way.
- More trials run by Hadassah Medical OrganizationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01379950
- Sponsor's protocol ID
- perio1-HMO-CTIL
- Status last verified
- Jun 2011
- First submitted
- 25 May 2011
- Last updated
- 23 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
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. doi: 10.1182/blood-2007-12-129767. Epub 2008 Sep 8.
PubMed 18779392
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Macrophages in the Inflammatory Resolution Phase in Periodontal Patients
- ClinicalTrials.gov ID
- NCT01379950
- Acronym / sponsor ID
- perio1-HMO-CTIL
- Conditions
- Periodontitis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Study start
- Aug 2011
- Primary completion
- Aug 2012 (estimated)
- Study completion
- Aug 2012 (estimated)
- First posted
- 23 Jun 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| periodontitis | – | –patients diagnosed with periodontal disease |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- patients coming to the periodontal clinic in the dental school in order to attend a periodontal treatment
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (3 listed)
- pregnancy or nursing
- chronic use of alcohol
- systemic conditions - diseases, neoplastic lesions in the oral cavity
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The macrophage phenotype (M1, M2, resolution phase macrophage)
Time frame: 1 year
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2011.
- Background: PubMed 18779392Bystrom 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Periodontitis, run by Hadassah Medical Organization at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact jacob ekstein, Dr. (00 972 6777826, drcobi@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The macrophage phenotype (M1, M2, resolution phase macrophage) (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01379950, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2011.