Back to resultsImpact of Alpha Lipoic Acid Efficacy in Burning Mouth Syndrome
Primary Purpose
Burning Mouth Syndrome
Status
Recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Lipoid acid gel
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Burning Mouth Syndrome
Eligibility Criteria
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
Sites / Locations
- AOU Policlinico G. RodolicoRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Lipoic acid gel
Placebo
Arm Description
Patients were treated with a topic gel of lipoic acid
Patients treated with a placebo gel control
Outcomes
Primary Outcome Measures
Evolution of burning mouth
Evolution of burning mouth symptoms change through a questionnaire
Secondary Outcome Measures
Full Information
NCT ID
NCT05729529
First Posted
February 6, 2023
Last Updated
February 6, 2023
Sponsor
University of Catania
1. Study Identification
Unique Protocol Identification Number
NCT05729529
Brief Title
Impact of Alpha Lipoic Acid Efficacy in Burning Mouth Syndrome
Official Title
Impact of Alpha Lipoic Acid Efficacy in Burning Mouth Syndrome Using a Topical Gel
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 20, 2020 (Actual)
Primary Completion Date
May 25, 2023 (Anticipated)
Study Completion Date
May 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Catania
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Burning Mouth Syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The main objective of this study was to evaluate the efficacy of lipoic acid over placebo in the management of BMS
Masking
ParticipantInvestigator
Masking Description
Sealed envelopes
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Lipoic acid gel
Arm Type
Active Comparator
Arm Description
Patients were treated with a topic gel of lipoic acid
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Patients treated with a placebo gel control
Intervention Type
Other
Intervention Name(s)
Lipoid acid gel
Intervention Description
Topic lipoid acid gel used with topic oral gel used on tongue
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo oral gel used on tongue
Primary Outcome Measure Information:
Title
Evolution of burning mouth
Description
Evolution of burning mouth symptoms change through a questionnaire
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gaetano Isola
Phone
0953785652
Email
gaetano.isola@unict.it
First Name & Middle Initial & Last Name or Official Title & Degree
Rosalia Leonardi
Email
rleonardi@unict.it
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gaetano Isola
Organizational Affiliation
Università degli Studi di Catania
Official's Role
Principal Investigator
Facility Information:
Facility Name
AOU Policlinico G. Rodolico
City
Catania
ZIP/Postal Code
95124
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gaetano Isola, DDS
Phone
+3909537800
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Study protocol
IPD Sharing Time Frame
1 year
IPD Sharing Access Criteria
Pubmed
Learn more about this trial
Impact of Alpha Lipoic Acid Efficacy in Burning Mouth Syndrome
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