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

NCT05872789 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2023-12-01

No results posted yet for this study

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.

Conditions

  • Burning Mouth Syndrome

Interventions

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.

Sponsors & Collaborators

  • University of Catania

    lead OTHER

Principal Investigators

  • Gaetano Isola · University of Catania

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-05-02
Primary Completion
2023-09-12
Completion
2023-10-20

Countries

  • Italy

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05872789 on ClinicalTrials.gov