Plain English Summary
Background and study aims
Periodontitis is a chronic inflammatory disease of the tissues supporting the teeth and one of the main causes of tooth loss. It is caused by bacteria present in a shallow crevice between the gums and the teeth which triggers the host inflammatory response. This exacerbated host inflammatory response is responsible for tissue damage and the loss of the bone that supports teeth. Despite being a very common oral disease, diagnostic procedure and treatment option for periodontitis have not changed significantly for more than a century. It is usually diagnosed too late, once bone less has already occurred, and treated, not very successfully, by mechanical removal of subgingival deposites. Therefore, there is a great need for new diagnostic approaches and treatment options for this widespread disease. Bacterial species that are responsible for development of periodontal diseases are able to produce a very potent substance, lipopolysaccharide (LPS), that triggers the host inflammatory response. If this type of bacterial antigens are detected in the mouth before the development or in early stages of the disease, a successful preventive regimen could be employed and harmful consequences avoided. The aim of this study is to see if there are any differences in the chemical composition of lipopolysaccharides isolated from subgingival dental plaque, saliva from patients with gum diseases and patients with healthy gums.
Who can participate?
Adults with or without chronic periodontitis
What does the study involve?
Saliva and subgingival deposit samples are collected from both patients with periodontitis and healthy volunteers treated at the Peninsula School of Dentistry clinics in Plymouth and Truro. LPS is extracted from these samples and its chemical composition (with a focus on Lipid-A, its most potent part) examined in the research laboratories of the Plymouth University. The chemical composition of LPS is compared between healthy participants and patients with periodontitis as well as between samples from the same periodontitis patient taken before and after routine periodontal treatment.
What are the possible benefits and risks of participating?
Not provided at time of registration
Where is the study run from?
The Peninsula School of Dentistry clinics in Plymouth and Truro (UK)
When is the study starting and how long is it expected to run for?
August 2014 to June 2015
Who is funding the study?
GSK and Oral and Dental Research Trust (UK)
Who is the main contact?
Dr Svetislav Zaric
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
18081
Study information
Scientific title
Subgingival plaque lipid-A profile as a bacterially-derived biomarker for chronic periodontitis
Acronym
Study hypothesis
Are there differences in the chemical composition of lipopolysaccharides isolated from subgingival dental plaque and saliva from patients with gum diseases and patients with healthy gums?
Ethics approval
NRES Committee South West - Cornwall and Plymouth, 03/03/2014, ref:14/SW/0020
Study design
Non-randomised study
Primary study design
Interventional
Secondary study design
Non randomised study
Trial setting
Other
Trial type
Treatment
Patient information sheet
Not available in web format, please use contact details to request a patient information sheet
Condition
Topic: Oral & Dental; Subtopic: Oral & Dental Public Health; Disease: All Oral & Dental
Intervention
1. Full mouth periodontal therapy
2. Full mouth periodontal debridement
Intervention type
Procedure/Surgery
Phase
Drug names
Primary outcome measures
Change in subginigval lipid-A profile; Timepoint(s): 3 months after completion of periodontal therapy
Secondary outcome measures
N/A
Overall trial start date
20/08/2014
Overall trial end date
30/06/2015
Reason abandoned
Eligibility
Participant inclusion criteria
1. Healthy (PD <4 mm, no evidence of attachment and bone loss, and <10% of sites with BOP)
2. Chronic periodontitis (presence of 1/3 bone loss or more and presence of 6 mm pocket or more, with evidence of attachment loss at 2 or more teeth per quadrant and evidence of generalized bleeding)
Participant type
Mixed
Age group
Adult
Gender
Both
Target number of participants
Planned Sample Size: 60; UK Sample Size: 60; Description: 30 patients with chronic periodontitis and 30 individuals with healthy periodontium
Participant exclusion criteria
1. Systemic chronic diseases
2. Acute medical interventions or diseases 4 weeks before baseline
3. Pregnancy
4. Antibiotics 6 months before intake and or repeated use of NSAID's medications 4 weeks before intake
Recruitment start date
20/08/2014
Recruitment end date
30/06/2015
Locations
Countries of recruitment
United Kingdom
Trial participating centre
University of Plymouth
Peninsula Dental School
Plymouth University
Portland Square C406
Plymouth
PL4 8AA
United Kingdom
Funders
Funder type
Government
Funder name
GSK and Oral and Dental Research Trust (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Results of the study will be reported and disseminated by conference presentations and peer reviewed scientific journal publications by the end of 2017.
IPD sharing statement
The datasets generated during and/or analysed during the current study are not expected to be made available. The participant level data is confidential and is stored in the patients’ record system SoelHealth.
Intention to publish date
31/12/2017
Participant level data
Not expected to be available
Results - basic reporting
Publication summary