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

Burning Mouth Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05872789
• Other study ID #: 121-24
• Status: Completed
• Phase: N/A
• Start date: May 2, 2020
• Est. completion date: October 20, 2023

Study information

• Verified date: November 2023
• Source: University of Catania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: October 20, 2023
• Est. primary completion date: September 12, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Burning Mouth Syndrome
• Burns
• Syndrome

Intervention

Drug:
• Diazepam 1% oral gel
Diazepam 1% used with topic oral gel on tongue and palate twice daily.
• Placebo
Placebo oral gel used on tongue and palate twice daily.

Locations

Country	Name	City	State
Italy	AOU Policlinico G. Rodolico	Catania

Sponsors (1)

Lead Sponsor	Collaborator
University of Catania

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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