Analysis of Neutrophil Response in Chronic Periodontitis

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2010 by NHS South Birmingham.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
University of Birmingham
Information provided by:
NHS South Birmingham
ClinicalTrials.gov Identifier:
NCT01233765
First received: November 2, 2010
Last updated: July 21, 2011
Last verified: July 2010
  Purpose

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.


Condition
Chronic Periodontitis

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Analysis of Neutrophil Response in Chronic Periodontitis (Including the Project Entitled 'Pro-Inflammatory Cytokine Production by Neutrophils in Periodontitis Patients')

Further study details as provided by NHS South Birmingham:

Primary Outcome Measures:
  • 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?


Secondary Outcome Measures:
  • 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?


Estimated Enrollment: 40
Study Start Date: September 2011
Groups/Cohorts
Control volunteers with periodontal health
Control volunteers with periodontal health
Patient volunteers with chronic periodontitis
Patient volunteers with chronic periodontitis

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

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.

Criteria

Inclusion Criteria:

  • Be aged 18 or over
  • Have a minimum of 20 teeth
  • Have chronic periodontitis or otherwise healthy volunteers (controls)
  • Be capable of giving informed consent themselves and are able and willing to participate in the study

Exclusion Criteria:

  • Patients with aggressive disease
  • Mouthwash use
  • Special dietary needs (e.g. coeliac)
  • Patients with physical or mental disability
  • Pregnant women or those breastfeeding
  • Patients whose medical history may place them at risk of complications from periodontal therapy (e.g. warfarinised volunteers)
  • Patients taking long term anti-microbial or anti-inflammatory drugs
  • Patients unable or unwilling to provide informed consent
  • Taking dietary supplements (e.g. multivitamins, antioxidants, fish oils)
  • Shows unwillingness, inability or lack of motivation to carry out the study procedures, or cannot conform to the protocol
  • A course of antibiotic or anti-inflammatory therapy currently or in the previous 3 months
  • Current orthodontic treatment (e.g. wearing braces or orthodontic devices)
  • Currently participating in another dental trial
  • Diabetics
  • Smokers or have smoked up to within 5 years
  • Those patients who disclose previous or current recreational drug use
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01233765

Contacts
Contact: Martin R Ling, BDS 01212372806 m.r.ling@bham.ac.uk

Locations
United Kingdom
University of Birmingham School of Dentistry Not yet recruiting
Birmingham, West Midlands, United Kingdom, B4 6NN
Contact: Iain LC Chapple, BDS    01212372808    i.l.c.chapple@bham.ac.uk   
Principal Investigator: Martin R Ling, BDS         
Sponsors and Collaborators
NHS South Birmingham
University of Birmingham
  More Information

No publications provided

Responsible Party: Mr Martin Robert Ling, University of Birmingham School of Dentistry
ClinicalTrials.gov Identifier: NCT01233765     History of Changes
Other Study ID Numbers: RG_10-077
Study First Received: November 2, 2010
Last Updated: July 21, 2011
Health Authority: UK: University of Birmingham

Keywords provided by NHS South Birmingham:
Periodontitis
Neutrophil
Inflammation

Additional relevant MeSH terms:
Periodontitis
Chronic Periodontitis
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases

ClinicalTrials.gov processed this record on July 31, 2014