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

University of Catania

Status

Completed

Conditions

Burning Mouth Syndrome

Treatments

Drug: Placebo

Drug: Diazepam 1% oral gel

Study type

Interventional

Funder types

Other

Identifiers

NCT05872789

121-24

Details and patient eligibility

About

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.

Full 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

Enrollment

40 patients

Sex

All

Ages

18 to 80 years old

Volunteers

Accepts Healthy Volunteers

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