Chronic Pain
Conditions
Keywords
Oral pain, Local anesthetic, Bupivacaine hydrochloride
Brief summary
The aim of the project is to do a fase two trial, where the effect of a local anesthetic lozenge will be tested in regard to oral pain, dryness of the mouth, irregularity of taste as well as investigate a potential antiinflammatory effect in patients with burning mouth syndrome, Sjögrens syndrome and lichen planus.
Interventions
DRUGBupivacaine
Bupivacaine lozenge taken 3 times a day for two weeks
DRUGPlacebo
Placebo lozenge taken three times a day for two weeks
Sponsors
Oracain II Aps
Hvidovre University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosed with burning mouth syndrome, Sjögrens syndrome or lichen planus * All fertile women need to use save contraception * Age between 18 and 75 years * Able to speak, read and understand the danish language * Must be informed orally and release a written consent and a signed authorization statement
Exclusion criteria
* Pregnant or breastfeeding women * Known allergy to bupivacaine or other local anesthetics of the amide type * Active infection which requires antibiotic treatment * Patients in immune suppressive treatment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of oral pain on the Visual Analog Scale | The patients assess their oral pain when they attend the four examinations and they fill in a diary for a total of four weeks. | Assessment of oral pain in patients with burning mouth syndrome, Sjögrens syndrome or lichen planus after treatment with a bupivacaine lozenge or a placebo lozenge. The patient assess their oral pain on the visual analog scale when they attend the four examinations. The patients also fill in a diary for a total of four weeks where they are in treatment where they assess VAS for pain, dryness of the mouth and irregularity of taste |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Measure the inflammation markers in blood, saliva and tissue | Blood- and saliva samples are taken the four times the patient attend the examinations. They are taken over a periode of five weeks. Tissue samples are taken before the first treatment period starts and when the final treatment period is finished. | The inflammation markers in blood, saliva and tissue will be analyzed to investigate if there are changes in the level in patients with chronic oral pain. |
Countries
Denmark
Outcome results
None listed