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NCT05729529 Clinical Trial

Impact of Alpha Lipoic Acid Efficacy in Burning Mouth Syndrome

Burning Mouth Syndrome Clinical Trial

Official title:
Impact of Alpha Lipoic Acid Efficacy in Burning Mouth Syndrome Using a Topical Gel

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05729529
Other study ID # 121-20
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date January 20, 2020
Est. completion date May 30, 2023

Study information
Verified date February 2023
Source University of Catania
Contact Gaetano Isola
Phone 0953785652
Email gaetano.isola@unict.it
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

A double-blind placebo-controlled trial is conducted in order to evaluate the efficacy of alpha lipoic acid (ALA) and determine the statistical significance of the outcome variables. Burning mouth syndrome (BMS) is defined as an oral burning sensation in the absence of clinical signs which could justify the syndrome. Recent studies suggest the existence of neurological factors as a possible cause of the disease.

Description:

A double-blind placebo-controlled trial is conducted in order to evaluate the efficacy of alpha lipoic acid (ALA) and determine the statistical significance of the outcome variables. 60 patients with BMS, in two groups: case group with 600 mg/day and placebo as control group; with a follow-up of 2 months.

Recruitment information / eligibility
Status Recruiting
Enrollment 60
Est. completion date May 30, 2023
Est. primary completion date May 25, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 75 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 no clinical signs that could justify the syndrome

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Lipoid acid gel
Topic lipoid acid gel used with topic oral gel used on tongue
Drug:
• Placebo
Placebo oral gel used on tongue

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 a questionnaire 6 months
See also
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