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Burning mouth syndrome (BMS) is a syndrome characterized by burning and persistent oral pain, ranging from mild to intense, in the absence of organic disorders of the oral cavity and with a major impact on the quality of life of the sufferer. Although several etiological theories have been proposed to explain BMS, none has been universally accepted to date, and its origin remains unclear. Currently, several scientific evidences would suggest that underlying BMS would be alterations in certain neuropathic mechanisms.
The purpose of the study is to evaluate the efficacy of Diazepam 1% oral gel in the treatment of burning mouth syndrome.
A double-blind placebo-controlled trial is conducted in order to evaluate the efficacy of Diazepam 1% oral gel and determine the statistical significance of the outcome variables. 40 patients with BMS, in two groups:
Follow-up of 2 months
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diazepam 1% Oral gel | Experimental | Patients were treated with Diazepam 1% oral gel. |
|
| Placebo | Placebo Comparator | Patients treated with a placebo gel control. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Diazepam 1% oral gel | Drug | Diazepam 1% used with topic oral gel on tongue and palate twice daily. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Evolution of burning mouth | Evolution of burning mouth symptoms change through questionnaries. The Visual Pain Analog Scale (VAS) will be used to assess pain, in which the value 0 indicates no pain and the value 100 maximum pain. The Oral Health Impact Profile Short Form (OHIP-14) will be used to assess the impact of oral problems on quality of life, in which the presence or absence of physical pain, functional limitation, psychological distress, physical, psychological and social disabilities, and handicap will be assessed. | 2 Months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gaetano Isola | University of Catania | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AOU Policlinico G. Rodolico | Catania | 95124 | Italy |
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1 year
Pubmed
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| ID | Term |
|---|---|
| D002054 | Burning Mouth Syndrome |
| ID | Term |
|---|---|
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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| ID | Term |
|---|---|
| D003975 | Diazepam |
| D005782 | Gels |
| ID | Term |
|---|---|
| D001570 | Benzodiazepinones |
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
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The main objective of this study was to evaluate the efficacy of Diazepam 1% oral gel over placebo in the management of BMS
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| Placebo | Drug | Placebo oral gel used on tongue and palate twice daily. |
|
| D000072471 |
| Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D003102 | Colloids |
| D045424 | Complex Mixtures |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |