Clinical Trials With a Local Anesthetic Lozenge for the Treatment of Chronic Oral Pain

Study Overview
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Brief Summary
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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.

Official Title
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Clinical Trials With a Local Anesthetic Lozenge for the Treatment of Oral Mucosal Pain in Burning Mouth Syndrome, Sjögrens Syndrome and Lichen Planus.

Conditions
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Chronic Pain

Intervention / Treatment
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* Drug: Bupivacaine
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo lozenge<br>The patients will be randomized to start two weeks treatment with either a bupivacaine lozenge or a placebo lozenge (taken three times a day). The two weeks treatment is followed by a week without treatment. Afterwards they start another two weeks treatment with the opposite type of lozenge from the first treatment period. | Drug: Placebo<br>* Placebo lozenge taken three times a day for two weeks<br>|
| Active Comparator: Bupivacaine lozenge<br>The patient will be randomized to start two weeks treatment with either a bupivacaine lozenge or a placebo lozenge (taken three times a day). The two weeks treatment is followed by a week without treatment. Afterwards the patient starts another two weeks treatment with the opposite type of lozenge from the first treatment period. | Drug: Bupivacaine<br>* Bupivacaine lozenge taken 3 times a day for two weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of oral pain on the Visual Analog Scale | 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 | The patients assess their oral pain when they attend the four examinations and they fill in a diary for a total of four weeks. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure the inflammation markers in blood, saliva and tissue | 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. | 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Oral pain, Local anesthetic, Bupivacaine hydrochloride