Impact of Alpha Lipoic Acid Efficacy in Burning Mouth Syndrome
- Conditions
- Burning Mouth Syndrome
- Interventions
- Drug: PlaceboOther: Lipoid acid gel
- Registration Number
- NCT05729529
- Lead Sponsor
- University of Catania
- Brief 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 60
- 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
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Patients treated with a placebo gel control Lipoic acid gel Lipoid acid gel Patients were treated with a topic gel of lipoic acid
- Primary Outcome Measures
Name Time Method Evolution of burning mouth 6 months Evolution of burning mouth symptoms change through a questionnaire
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
AOU Policlinico G. Rodolico
🇮🇹Catania, Italy