Impact of Alpha Lipoic Acid Efficacy in Burning Mouth Syndrome

NCT05729529 | Unknown

• 1 other identifier: 121-20
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Burning Mouth Syndrome

Outcome Measures

Primary Outcomes (1)

• Evolution of burning mouth

  Evolution of burning mouth symptoms change through a questionnaire

  6 months

Study Arms (2)

Lipoic acid gel

ACTIVE COMPARATOR

Patients were treated with a topic gel of lipoic acid

Other: Lipoid acid gel

Placebo

PLACEBO COMPARATOR

Patients treated with a placebo gel control

Drug: Placebo

Interventions

Lipoid acid gel OTHER

Topic lipoid acid gel used with topic oral gel used on tongue

Lipoic acid gel

Placebo DRUG

Placebo oral gel used on tongue

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Catania: lead

Study Sites (1)

AOU Policlinico G. Rodolico

Catania, 95124, Italy

RECRUITING

MeSH Terms

Conditions

Burning Mouth Syndrome

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases

Study Officials

• Gaetano Isola

  Università degli Studi di Catania

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gaetano Isola

CONTACT

0953785652; gaetano.isola@unict.it

Rosalia Leonardi

CONTACT

rleonardi@unict.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Sealed envelopes
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Researcher

Model Details: The main objective of this study was to evaluate the efficacy of lipoic acid over placebo in the management of BMS

Study Record Dates

• First Submitted: February 6, 2023
• First Posted: February 15, 2023
• Study Start: January 20, 2020
• Primary Completion: May 25, 2023
• Study Completion: May 30, 2023
• Last Updated: February 15, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will share
• Time Frame: 1 year
• Access Criteria: Pubmed

Locations

IT (1)