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

Status Completed

Clinical Trial Summary

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.

Clinical Trial Description

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 ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05872789
Study type	Interventional
Source	University of Catania
Contact
Status	Completed
Phase	N/A
Start date	May 2, 2020
Completion date	October 20, 2023

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