Impact of Alpha Lipoic Acid Efficacy in Burning Mouth Syndrome

Last updated: February 6, 2023
Sponsor: University of Catania
Overall Status: Active - Recruiting

Phase

N/A

Condition

Skin Wounds

Oral Facial Pain

Hyponatremia

Treatment

N/A

Clinical Study ID

NCT05729529
121-20
  • Ages 18-75
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • clinically diagnosed with BMS who reported a history of continuous oral burning painfor more than 4 months with no clinical signs that could justify the syndrome

Exclusion

Exclusion Criteria:

  • clinically diagnosed with BMS who reported a history of continuous oral burning painfor more than 4 months with no clinical signs that could justify the syndrome

Study Design

Total Participants: 60
Study Start date:
January 20, 2020
Estimated Completion Date:
May 30, 2023

Study 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.

Connect with a study center

  • AOU Policlinico G. Rodolico

    Catania, 95124
    Italy

    Active - Recruiting

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