Chronic PeriodontitisNCT01233765
Analysis of Neutrophil Response in Chronic Periodontitis
An observational study of Chronic Periodontitis, run by Birmingham Community Healthcare NHS at 1 site in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chronic Periodontitis
- How many people
- 40 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Sep 2011to Jul 2015
- 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: 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.
Who may be able to join
- 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
Who cannot join
- 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)
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- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University of Birmingham School of Dentistry
Birmingham, West Midlands, B4 6NN
About this study
Official title: 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.
Read more
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.
- Conditions
- Chronic Periodontitis
- Keywords
- Periodontitis, Neutrophil, Inflammation
- Medical subject headings
- Chronic Periodontitis, Periodontitis, Inflammation
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 |
|---|---|---|
| Control volunteers with periodontal health | Control volunteers with periodontal health | |
| Patient volunteers with chronic periodontitis | Patient volunteers with chronic periodontitis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Principal Research Question
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?
Measured: Three months for each matched patient and control
Secondary outcomes (1)
Secondary Research Question
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?
Measured: Three months for each matched patient and control
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2010 (estimated)
- Study startSep 2011
- Primary completionJun 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PeriodontitisStudies of the same condition, open and under way.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Birmingham Community Healthcare NHS
- Sponsor type
- Other government
- Collaborators
- University of Birmingham
- Responsible party
- Principal investigator, Professor I Chapple, Birmingham Community Healthcare NHS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01233765
- Sponsor's protocol ID
- RG_10-077
- Status last verified
- Feb 2017
- First submitted
- 2 Nov 2010
- Last updated
- 14 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Neutrophil Response in Chronic Periodontitis (Including the Project Entitled 'Pro-Inflammatory Cytokine Production by Neutrophils in Periodontitis Patients')
- ClinicalTrials.gov ID
- NCT01233765
- Acronym / sponsor ID
- RG_10-077
- Conditions
- Chronic Periodontitis
- Keywords
- Periodontitis, Neutrophil, Inflammation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Birmingham Community Healthcare NHSOther government
- Collaborators
- University of Birmingham
- Study start
- Sep 2011
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 3 Nov 2010 (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.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control volunteers with periodontal health | – | –Control volunteers with periodontal health |
| Patient volunteers with chronic periodontitis | – | –Patient volunteers with chronic periodontitis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (16 listed)
- Patients with aggressive disease
- Mouthwash use
- Special dietary needs (e.g. coeliac)
- Patients with physical or mental disability
- Pregnant women or those breastfeeding
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
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?
1 secondary outcome
Secondary Research Question
Time frame: Three months for each matched patient and control
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2017.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Chronic Periodontitis, run by Birmingham Community Healthcare NHS at 1 site in United Kingdom.
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 4 inclusion and 16 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: finished, as of the sponsor's last update on 14 Feb 2017. 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 United Kingdom. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Principal Research Question (time frame: Three months for each matched patient and control). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Feb 2017.