| ISRCTN | ISRCTN17598447 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN17598447 |
| Secondary identifying numbers | 18081 |
- 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
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
Scientific
University of Plymouth
Peninsula Dental School
Portland Square C406
Plymouth
PL4 8AA
United Kingdom
 ORCID ID |
0000-0003-4127-0253 |
|---|
Study information
| Study design | Non-randomised study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a patient 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 | Change in subginigval lipid-A profile; Timepoint(s): 3 months after completion of periodontal therapy |
| Secondary outcome measures | N/A |
| Overall study start date | 20/08/2014 |
| Completion date | 30/06/2015 |
Eligibility
| Participant type(s) | Mixed |
|---|---|
| Age group | Adult |
| Sex | 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 |
| 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
- England
- United Kingdom
Study participating centre
Plymouth University
Portland Square C406
Plymouth
PL4 8AA
United Kingdom
Sponsor information
Hospital/treatment centre
Peninsula Dental School
Plymouth University
Portland Square C406
Plymouth
PL4 8AA
England
United Kingdom
"ROR" |
https://ror.org/04dtfyh05 |
|---|
Funders
Funder type
Government
No information available
Results and Publications
| Intention to publish date | 31/12/2017 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| 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 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 |
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.
