Analysis of Neutrophil Response in Chronic Periodontitis
Recruitment status was Not yet recruiting
|First Received Date ICMJE||November 2, 2010|
|Last Updated Date||July 21, 2011|
|Start Date ICMJE||September 2011|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE
||Principal Research Question [ Time Frame: Three months for each matched patient and control ] [ Designated as safety issue: No ]
Do leukocyte (neutrophil) responses differ between patients diagnosed with periodontitis compared to matched healthy controls, and what is the effect of standard periodontal treatment and stabilisation on this response?
|Original Primary Outcome Measures ICMJE||Same as current|
|Change History||Complete list of historical versions of study NCT01233765 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE
||Secondary Research Question [ Time Frame: Three months for each matched patient and control ] [ Designated as safety issue: No ]
Can markers of the white blood defence cells (neutrophils) be observed and measured in-vivo within the local tissues and if so do they differ between inflamed and non-inflamed sites?
|Original Secondary Outcome Measures ICMJE||Same as current|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Analysis of Neutrophil Response in Chronic Periodontitis|
|Official Title ICMJE||Analysis of Neutrophil Response in Chronic Periodontitis (Including the Project Entitled 'Pro-Inflammatory Cytokine Production by Neutrophils in Periodontitis Patients')|
Recent scientific evidence suggests that the main defence cell of the body (neutrophil) behaves in a different manner in patients with gum disease; namely how they interact with bacteria and their role in defence systems of the body. This study proposes to examine these responses in periodontitis patients and healthy controls.
The proposed study will include patients undergoing periodontal (gum) treatment who will be matched to periodontally healthy controls. Blood, gingival crevicular (gum) fluid and clinical measures will be collected both pre- and post-therapy to measure differences in cell behaviour both before, and following routine therapy.
Blood samples will be used to isolate peripheral blood neutrophils prior to analysis of their responses to different bacterial stimuli including oxygen radical, cytokine and extracellular trap release. Gingival Crevicular Fluid samples will be used to measure different biochemical markers that result from the production of Neutrophil Extracellular Traps (NETs). Routine clinical measures will be taken both pre- and post-therapy as a measure of treatment response.
Patient volunteers undergoing treatment will be asked to donate a total of four small samples of tissue from the gums whilst they are already anaesthetised for routine treatment. These will be approximately the size of a needle head (2mm2mm) and used to examine NET formation within the tissues and related processes. This will provide novel in-vivo data regarding this recently discovered method of neutrophil defence in innate immunity.
This proposal represents a novel study aimed at improving our current understanding of why inflammatory periodontitis develops in some patients but not others, as well as providing pointers to causal/noncausal relationships between periodontitis and important systemic conditions such as diabetes and rheumatoid arthritis.
Ultimately, novel treatment approaches and primary prevention (for periodontitis) or secondary prevention (for systemic disease) strategies may emerge.
|Detailed Description||Not Provided|
|Study Type ICMJE||Observational|
|Study Design ICMJE||Observational Model: Case Control
Time Perspective: Prospective
|Target Follow-Up Duration||Not Provided|
|Sampling Method||Non-Probability Sample|
The study population will comprise 20 competent adult volunteers (>18 years old) recruited from patients attending for clinical examination following referral for a specialist opinion for periodontal disease, and will be recruited on the basis of clinical need. In addition, 20 periodontally-healthy controls will be recruited from staff or students of the School of Dentistry and Biomaterials and Birmingham Dental Hospital.
|Condition ICMJE||Chronic Periodontitis|
|Intervention ICMJE||Not Provided|
|Study Group/Cohort (s)||
|Publications *||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Not yet recruiting|
|Estimated Enrollment ICMJE||40|
|Completion Date||Not Provided|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
|Ages||18 Years and older|
|Accepts Healthy Volunteers||Yes|
|Location Countries ICMJE||United Kingdom|
|NCT Number ICMJE||NCT01233765|
|Other Study ID Numbers ICMJE||RG_10-077|
|Has Data Monitoring Committee||No|
|Responsible Party||Mr Martin Robert Ling, University of Birmingham School of Dentistry|
|Study Sponsor ICMJE||NHS South Birmingham|
|Collaborators ICMJE||University of Birmingham|
|Investigators ICMJE||Not Provided|
|Information Provided By||NHS South Birmingham|
|Verification Date||July 2010|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP