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Because of a very slow patient recruitment.
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| Name | Class |
|---|---|
| Oracain II Aps | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo lozenge | Placebo Comparator | 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. |
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| Bupivacaine lozenge | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bupivacaine | Drug | Bupivacaine lozenge taken 3 times a day for two weeks |
| |
| 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. |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anne Marie L Pedersen, Ph.d. | Department of Odontology, University of Copenhagen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Odontology, University of Copenhagen | Copenhagen | DK-2200 | Denmark |
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| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D002045 | Bupivacaine |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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| Placebo |
| Drug |
Placebo lozenge taken three times a day for two weeks |
|
| D000588 |
| Amines |