NCT05872789

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: University of Catania · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

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.

Detailed 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

Conditions

• Burning Mouth Syndrome

Interventions

Type	Name	Description
DRUG	Diazepam 1% oral gel	Diazepam 1% used with topic oral gel on tongue and palate twice daily.
DRUG	Placebo	Placebo oral gel used on tongue and palate twice daily.

Timeline

• Start date: 2020-05-02
• Primary completion: 2023-09-12
• Completion: 2023-10-20
• First posted: 2023-05-24
• Last updated: 2023-12-01

Locations

1 site across 1 country: Italy