About the project
Aim with the study
The project aims to develop and establish diagnostic criteria for primary Burning Mouth Syndrome (BMS) and evaluate the treatment effect of two drugs that in studies and in a recently published systematic review showed promising results. The two drugs are topical treatment with clonazepam and capsaicin in patients with BMS.
Burning Mouth Syndrome (BMS) is common and often has major negative consequences for the sufferer in the form of reduced quality of life, depression and chronic pain. The Swedish Agency for Health Technology Assessment and Assessment of Social Services (SBU) has identified knowledge gaps regarding the diagnosis and treatment of oral mucosal pain and specifically pointed out the need for more and better primary studies.
BMS usually causes a severe suffering for most affected patients, often right from the onset but especially in a longer perspective. Both the pain itself and the consequences for the quality of life and daily activities caused by the chronic pain (depression, anxiety, stress, reduced quality of life) naturally affect the sufferer. Unfortunately, clear, clinically useful and validated clinical diagnostic criteria and effective and established treatment options have been lacking. The treatments that have been available have usually have mediocre long-term effects, at best. Together, this has probably contributed to the limited opportunities to diagnose and apply successful treatment.
- Study designs
Evaluation of diagnostic criteria (field study)
- N-of-1 design to investigate treatment effects in two patient groups and with three different treatments. Each group uses the three treatments (clonazepam, capsaicin and placebo) in random order for two weeks for each drug and with a one-week wash-out between these three intervals.
- Longitudinal observational study where patients are followed up after 6 months of treatment with the drug that each patient prefers.
Twenty patients with BMS, 20 with TMD and 20 healthy will be recruited. Recruitment of patients via the Orofacial Pain Unit, Malmö University and the Oral and Maxillofacial Surgery Clinic, Skåne University Hospital.
Our project thus intends to improve and establish diagnostic criteria for BMS and evaluate the treatment effect of two drugs that in studies and systematic reviews have shown very promising results. The project therefore has the potential to form the basis for rapid implementation of an effective care program for BMS in dentistry (and health care).