Analysis of Neutrophil Response in Chronic Periodontitis

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.

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Key information

Conditions

Chronic Periodontitis Chronic Disease Disease Attributes Inflammation Mouth Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Periodontal Diseases Periodontitis Stomatognathic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Birmingham School of Dentistry

Birmingham, West Midlands, B4 6NN, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

Principal Research Question

Time frame: Three months for each matched patient and control

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 outcomes

Secondary Research Question

Time frame: Three months for each matched patient and control

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?

Sponsors and collaborators

Lead sponsor

Birmingham Community Healthcare NHS

Other Gov

Collaborators

University of Birmingham

Registry information

Official study title

Analysis of Neutrophil Response in Chronic Periodontitis (Including the Project Entitled 'Pro-Inflammatory Cytokine Production by Neutrophils in Periodontitis Patients')

Important dates

Study start: 2011
Primary completion: 2015
Study completion: 2015
First posted: Nov 3, 2010
Registry last updated: Feb 14, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed