Condition category
Oral Health
Date applied
08/01/2015
Date assigned
08/01/2015
Last edited
20/01/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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 deposites 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) wexamined 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. We hope to establish salivary and subgingival LPS profile as an easy detectable, bacterially produced biomarker, for periodontitis.

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

Type

Scientific

Primary contact

Dr Svetislav Zaric

ORCID ID

Contact details

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

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

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

Patient

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

Sponsor information

Organisation

Peninsula Dental Social Enterprise CIC

Sponsor details

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

Sponsor type

Hospital/treatment centre

Website

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 (starting from 2015 onwards).

Intention to publish date

Participant level data

Not expected to be available

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes