NCT05872789

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

Completed NA Last updated 1 December 2023

What this trial tests

NA trial testing Diazepam 1% oral gel in Burning Mouth Syndrome in 40 participants. Completed in 20 October 2023.

Timeline

2 May 2020

Primary endpoint
12 September 2023

20 October 2023

Quick facts

Lead sponsor	University of Catania
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	40
Start date	2 May 2020
Primary completion	12 September 2023
Estimated completion	20 October 2023
Sites	1 location across Italy

Drugs / interventions tested

• Diazepam 1% oral gel — full drug profile →
• Placebo

Conditions studied

• Burning Mouth Syndrome — all drugs for Burning Mouth Syndrome →

Sponsor

University of Catania

Who can join

Adults 18 to 80, any sex, with Burning Mouth Syndrome. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.