Clinical Trials Logo
  1. Home
  2. Burning Mouth Syndrome
  3. NCT05729529
  4. Details
NCT05729529 Clinical Trial

Impact of Alpha Lipoic Acid Efficacy in Burning Mouth Syndrome

Burning Mouth Syndrome Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05729529
Other study ID # 121-20
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date January 20, 2020
Est. completion date May 30, 2023

Study information
Verified date February 2023
Source University of Catania
Contact Gaetano Isola
Phone 0953785652
Email gaetano.isola@unict.it
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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 information / eligibility
Status Recruiting
Enrollment 60
Est. completion date May 30, 2023
Est. primary completion date May 25, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 75 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Lipoid acid gel
Topic lipoid acid gel used with topic oral gel used on tongue
Drug:
• Placebo
Placebo oral gel used on tongue

Locations
Country Name City State
Italy AOU Policlinico G. Rodolico Catania

Sponsors (1)
Lead Sponsor Collaborator
University of Catania

Country where clinical trial is conducted

Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary Evolution of burning mouth Evolution of burning mouth symptoms change through a questionnaire 6 months
See also
  Status Clinical Trial Phase
Completed NCT04475614 - Therapeutic Options for Treatment of Burning Mouth Syndrome N/A
Completed NCT00374673 - Efficacy of Transcranial Magnetic Stimulation (TMS) in Chronic Idiopathic Pain Disorders Phase 3
Completed NCT02964728 - Botulinum Toxin in Burning Mouth Syndrome Phase 2
Completed NCT04535973 - Hormonal Status and Quality of Life in Female Postmenopausal Patients With Burning Mouth Syndrome
Recruiting NCT06040190 - Effect of Treatments on Pain and Quality of Life in Individual With Burning Mouth Syndrome Phase 4
Not yet recruiting NCT05059418 - Burning Mouth Syndrome - New Diagnostic Criteria and Treatment N/A
Recruiting NCT01867151 - Effect of Gluten Free Diet in Patients With Burning Mouth Syndrome N/A
Completed NCT05872789 - Impact of Diazepam 1% Oral Gel Efficacy in Burning Mouth Syndrome N/A
Completed NCT05871580 - Effect to the Photobiomodulation in the Burning Mouth Syndrome N/A
Recruiting NCT05309070 - The Efficacy of N-acetyl-cysteine in the Treatment of Burning Mouth Syndrome N/A
Completed NCT05399238 - Thermography and Burning Mouth Syndrome
Completed NCT02580734 - Efficacy of Melatonin in Burning Mouth Syndrome (BMS) N/A
Completed NCT02382029 - Acupuncture Versus Clonazepam in Burning Mouth Syndrome Phase 0
Recruiting NCT05819697 - Reducing Patient Memory Recall in the Burning Mouth Patient Population
Completed NCT02757612 - Study Evaluating the Laser Diode Effect Burning Mouth Syndrome N/A
Completed NCT00862576 - A Study of the Association of Sleep Dysfunction and Burning Mouth Syndrome N/A
Not yet recruiting NCT04189367 - Treatment of Burning Mouth Syndrome With Integration of Traditional Chinese Medicine and Western Medicine Phase 3
Completed NCT00001524 - Thalidomide to Treat Oral Lesions in HIV-Infected Patients Phase 2
Recruiting NCT04481841 - Head Yuanshi Dian Therapy in Burning Mouth Syndrome Early Phase 1
Completed NCT02686359 - Opiorphin Levels in Fluids of Burning Mouth Syndrome Patients (OPIODYN) N/A