Impact of Diazepam 1% Oral Gel Efficacy in Burning Mouth Syndrome

Study Overview
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Brief Summary
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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.

Detailed Description
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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: case group with Diazepam 1% oral gel (Galenic formulation) control group with placebo in oral gel formulation Follow-up of 2 months

Official Title
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Impact of the Efficacy of Diazepam 1% Oral Gel in Burning Mouth Syndrome

Conditions
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Burning Mouth Syndrome

Intervention / Treatment
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* Drug: Diazepam 1% oral gel
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: clinically diagnosed with BMS who reported a history of continuous oral burning pain for more than 4 months with no clinical signs that could justify the syndrome Exclusion Criteria: • clinically diagnosed with BMS who reported a history of continuous oral burning pain for more than 4 months with clinical signs that could justify the syndrome

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The main objective of this study was to evaluate the efficacy of Diazepam 1% oral gel over placebo in the management of BMS
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Diazepam 1% Oral gel<br>Patients were treated with Diazepam 1% oral gel. | Drug: Diazepam 1% oral gel<br>* Diazepam 1% used with topic oral gel on tongue and palate twice daily.<br>|
| Placebo Comparator: Placebo<br>Patients treated with a placebo gel control. | Drug: Placebo<br>* Placebo oral gel used on tongue and palate twice daily.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 |