NIHR TRF: saliva self-sampling in diabetes to monitor periodontitis
Research type
Research Study
Full title
Do diabetic patients with periodontitis benefit from self-monitoring their periodontal inflammation profile? A feasibility study.
IRAS ID
165948
Contact name
Katrin Jaedicke
Contact email
Sponsor organisation
Newcastle upon Tyne Hospitals NHS Foundation Trust
Duration of Study in the UK
1 years, 11 months, 31 days
Research summary
Diabetes carries a high risk of morbidity and mortality. Compared to non-diabetic individuals, people with diabetes are at an approximately 3-fold increased risk for gum disease. Importantly, treatment of gum disease in diabetes is associated with improvements in diabetes control. Full compliance rates with the treatment of diabetes and gum disease are frequently poor. Any improvements in compliance of diabetic patients undergoing treatment for gum disease could have a beneficial impact on both conditions. We have identified three salivary mediators (HGF, MMP-8, IL-1β) to be strongly associated with inflammation in gum disease. In the proposed study, I will evaluate if it is feasible to motivate patients with diabetes and gum disease in their personal disease management programme using monthly updates of their salivary inflammation profile based on the levels of these mediators.
I will recruit male or female patients with diabetes (both type I and type II) and gum disease and will randomise them to either a saliva sample or no saliva sample group. The first saliva sample will be given on site before gum disease treatment commences, then saliva will be self-sampled at home each month for 3 months. Venous blood samples will be taken to assess diabetes control.
I will assess the concentrations of the three mediators in saliva. The mediator levels will be presented to the patients over the course of their treatment. To determine if these salivary inflammation profiles resulted in any behavioural changes regarding attitude and compliance with the gum disease treatment, interviews will be conducted with all of the patients at the 3-months review appointment.
The proposed research will give an indication if patients feel a saliva screening would influence their health behaviours.REC name
North West - Liverpool Central Research Ethics Committee
REC reference
15/NW/0294
Date of REC Opinion
26 Mar 2015
REC opinion
Favourable Opinion