Lipid-A project

ISRCTN	ISRCTN17598447
DOI	https://doi.org/10.1186/ISRCTN17598447
Protocol serial number	18081
Sponsor	Peninsula Dental Social Enterprise CIC
Funder	GSK and Oral and Dental Research Trust (UK)

Submission date: 08/01/2015
Registration date: 08/01/2015
Last edited: 23/01/2019

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Oral Health

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

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

Contact information

Dr Svetislav Zaric
Scientific

University of Plymouth
Peninsula Dental School
Portland Square C406
Plymouth
PL4 8AA
United Kingdom

ORCID ID	0000-0003-4127-0253

Study information

Primary study design	Interventional
Study design	Non-randomised study
Secondary study design	Non randomised study
Study type	Participant information sheet
Scientific title	Subgingival plaque lipid-A profile as a bacterially-derived biomarker for chronic periodontitis
Study objectives	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(s)	NRES Committee South West - Cornwall and Plymouth, 03/03/2014, ref:14/SW/0020
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	Change in subginigval lipid-A profile; Timepoint(s): 3 months after completion of periodontal therapy
Key secondary outcome measure(s)	N/A
Completion date	30/06/2015

Eligibility

Participant type(s)	Mixed
Age group	Adult
Sex	All
Target sample size at registration	60
Key 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)
Key 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
Date of first enrolment	20/08/2014
Date of final enrolment	30/06/2015

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

University of Plymouth

Peninsula Dental School
Plymouth University
Portland Square C406
Plymouth
PL4 8AA
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not expected to be made available
IPD sharing plan	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.

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/09/2019	22/01/2019	Yes	No
HRA research summary			28/06/2023	No	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

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.