Impact of Alpha Lipoic Acid Efficacy in Burning Mouth Syndrome

NCT ID: NCT05729529

Last Updated: 2023-02-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-20

Study Completion Date

2023-05-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Burning Mouth Syndrome

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The main objective of this study was to evaluate the efficacy of lipoic acid over placebo in the management of BMS
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators
Sealed envelopes

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Lipoic acid gel

Patients were treated with a topic gel of lipoic acid

Group Type ACTIVE_COMPARATOR

Lipoid acid gel

Intervention Type OTHER

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

Placebo

Patients treated with a placebo gel control

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo oral gel used on tongue

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Lipoid acid gel

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

Intervention Type OTHER

Placebo

Placebo oral gel used on tongue

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Catania

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Gaetano Isola

Researcher

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Gaetano Isola

Role: PRINCIPAL_INVESTIGATOR

Università degli Studi di Catania

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

AOU Policlinico G. Rodolico

Catania, , Italy

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Italy

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Gaetano Isola

Role: CONTACT

0953785652

Rosalia Leonardi

Role: CONTACT

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Gaetano Isola, DDS

Role: primary

+3909537800

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

121-20

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Burning Mouth Syndrome: Symptoms and Management
NCT07016555 RECRUITING EARLY_PHASE1