Impact of Alpha Lipoic Acid Efficacy in Burning Mouth Syndrome

University of Catania

Status: Enrolling

Conditions: Burning Mouth Syndrome

Treatments: Drug: Placebo; Other: Lipoid acid gel

Study type: Interventional

Funder types: Other

Identifiers

NCT05729529

121-20

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups, including a placebo group

Lipoic acid gel

Active Comparator group

Description:

Patients were treated with a topic gel of lipoic acid

Treatment:

Other: Lipoid acid gel

Placebo

Placebo Comparator group

Description:

Patients treated with a placebo gel control

Treatment:

Drug: Placebo