Burning Mouth Syndrome
Conditions
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.
Interventions
OTHERLipoid acid gel
Topic lipoid acid gel used with topic oral gel used on tongue
DRUGPlacebo
Placebo oral gel used on tongue
Sponsors
University of Catania
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
Sealed envelopes
Intervention model description
The main objective of this study was to evaluate the efficacy of lipoic acid over placebo in the management of BMS
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evolution of burning mouth | 6 months | Evolution of burning mouth symptoms change through a questionnaire |
Countries
Italy
Contacts
Primary ContactGaetano Isola
Backup ContactRosalia Leonardi
Outcome results
None listed