Condition category
Oral Health
Date applied
Date assigned
Last edited
Retrospectively registered
Overall trial status
Recruitment status
No longer recruiting
Publication status

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

Contact information



Primary contact

Dr Svetislav Zaric


Contact details

University of Plymouth
Peninsula Dental School
Portland Square C406
United Kingdom

Additional identifiers

EudraCT number number

Protocol/serial number


Study information

Scientific title

Subgingival plaque lipid-A profile as a bacterially-derived biomarker for chronic periodontitis


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


Secondary study design

Non randomised study

Trial setting


Trial type


Patient information sheet

Not available in web format, please use contact details to request a patient information sheet


Topic: Oral & Dental; Subtopic: Oral & Dental Public Health; Disease: All Oral & Dental


1. Full mouth periodontal therapy
2. Full mouth periodontal debridement

Intervention type



Drug names

Primary outcome measure

Change in subginigval lipid-A profile; Timepoint(s): 3 months after completion of periodontal therapy

Secondary outcome measures


Overall trial start date


Overall trial end date


Reason abandoned (if study stopped)


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


Age group




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


Recruitment end date



Countries of recruitment

United Kingdom

Trial participating centre

University of Plymouth
Peninsula Dental School Plymouth University Portland Square C406
United Kingdom

Sponsor information


Peninsula Dental Social Enterprise CIC

Sponsor details

Peninsula Dental School
Plymouth University
Portland Square C406
United Kingdom

Sponsor type

Hospital/treatment centre



Funder type


Funder name

GSK and Oral and Dental Research Trust (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype


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


Participant level data

Not expected to be available

Basic results (scientific)

Publication list

1. 2018 results in (added 22/01/2019)

Publication citations

Additional files

Editorial Notes

23/01/2019: ORCID number added 22/01/2019: Publication reference added 15/08/2017: Publication and dissemination plan updated and IPD sharing statement added.