Impact of Alpha Lipoic Acid Efficacy in Burning Mouth Syndrome

• Sponsor: University of Catania (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05729529
• Collaborator: (none)
• Enrollment: 60
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 40.3
• Patients Per Site Per Month: 1.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Burning Mouth Syndrome	Other: Lipoid acid gel; Drug: Placebo	N/A

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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: The main objective of this study was to evaluate the efficacy of lipoic acid over placebo in the management of BMSThe main objective of this study was to evaluate the efficacy of lipoic acid over placebo in the management of BMS
• Masking: Double (Participant, Investigator)
• Masking Description: Sealed envelopes
• Primary Purpose: Treatment
• Official Title: Impact of Alpha Lipoic Acid Efficacy in Burning Mouth Syndrome Using a Topical Gel
• Actual Study Start Date: Jan 20, 2020
• Anticipated Primary Completion Date: May 25, 2023
• Anticipated Study Completion Date: May 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Lipoic acid gel Patients were treated with a topic gel of lipoic acid	Other: Lipoid acid gel; Topic lipoid acid gel used with topic oral gel used on tongue
Placebo Comparator: Placebo Patients treated with a placebo gel control	Drug: Placebo; Placebo oral gel used on tongue

Outcome Measures

Primary Outcome Measures

1. Evolution of burning mouth [6 months]

   Evolution of burning mouth symptoms change through a questionnaire

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	AOU Policlinico G. Rodolico	Catania		Italy	95124

Sponsors and Collaborators

• University of Catania

Investigators

• Principal Investigator: Gaetano Isola, Università degli Studi di Catania

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Gaetano Isola, Researcher, University of Catania
• ClinicalTrials.gov Identifier: NCT05729529
• Other Study ID Numbers: 121-20
• First Posted: Feb 15, 2023
• Last Update Posted: Feb 15, 2023
• Last Verified: Feb 1, 2023

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Burning Mouth Syndrome; Syndrome; Burns

Study Results

No Results Posted as of Feb 15, 2023