NCT05729529

Impact of Alpha Lipoic Acid Efficacy in Burning Mouth Syndrome

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: University of Catania · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Burning Mouth Syndrome

Interventions

Type	Name	Description
OTHER	Lipoid acid gel	Topic lipoid acid gel used with topic oral gel used on tongue
DRUG	Placebo	Placebo oral gel used on tongue

Timeline

• Start date: 2020-01-20
• Primary completion: 2023-05-25
• Completion: 2023-05-30
• First posted: 2023-02-15
• Last updated: 2023-02-15

Locations

1 site across 1 country: Italy