Burning Mouth SyndromeNCT05729529
Impact of Alpha Lipoic Acid Efficacy in Burning Mouth Syndrome
A study testing Lipoid acid gel in people with Burning Mouth Syndrome, run by University of Catania at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Burning Mouth Syndrome
- What is being tested?
- Lipoid acid gel
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteItaly
- Study dates
- 20 Jan 2020to 30 May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Rosalia Leonardi contact
Italy1 site, 1 recruiting
- Recruiting
AOU Policlinico G. Rodolico
Catania, 95124
Gaetano Isola, DDS, +3909537800
About this study
Official title: Impact of Alpha Lipoic Acid Efficacy in Burning Mouth Syndrome Using a Topical Gel
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.
Read the 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.
- Conditions
- Burning Mouth Syndrome
- Being tested
- Lipoid acid gel, Placebo
- Medical subject headings
- Burning Mouth Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lipoid acid gelOther
Topic lipoid acid gel used with topic oral gel used on tongue
PlaceboDrug
Placebo oral gel used on tongue
| Study group | Role | What they receive |
|---|---|---|
| Lipoic acid gel | Active comparator | Patients were treated with a topic gel of lipoic acid Receives: Other: Lipoid acid gel |
| Placebo | Placebo comparator | Patients treated with a placebo gel control Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evolution of burning mouth
Evolution of burning mouth symptoms change through a questionnaire
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2023
- Study start20 Jan 2020
- Primary completion25 May 2023 (estimated)
- Study completion30 May 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Burning Mouth SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The main objective of this study was to evaluate the efficacy of lipoic acid over placebo in the management of BMS
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Catania
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gaetano Isola, University of Catania
- Investigators
- Gaetano Isola, Principal investigator, Università degli Studi di Catania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05729529
- Sponsor's protocol ID
- 121-20
- Status last verified
- Feb 2023
- First submitted
- 6 Feb 2023
- Last updated
- 15 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study protocol
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Alpha Lipoic Acid Efficacy in Burning Mouth Syndrome Using a Topical Gel
- ClinicalTrials.gov ID
- NCT05729529
- Acronym / sponsor ID
- 121-20
- Conditions
- Burning Mouth Syndrome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of CataniaUniversity, hospital or other
- Study start
- 20 Jan 2020 (actual)
- Primary completion
- 25 May 2023 (estimated)
- Study completion
- 30 May 2023 (estimated)
- First posted
- 15 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- The main objective of this study was to evaluate the efficacy of lipoic acid over placebo in the management of BMS
| Arm | Type | Receives |
|---|---|---|
| Lipoic acid gel | Active comparator | Other: Lipoid acid gelPatients were treated with a topic gel of lipoic acid |
| Placebo | Placebo comparator | Drug: PlaceboPatients treated with a placebo gel control |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lipoid acid gelTopic lipoid acid gel used with topic oral gel used on tongue | Other | Lipoic acid gel |
| PlaceboPlacebo oral gel used on tongue | Drug | Placebo |
Primary outcome
Evolution of burning mouth
Time frame: 6 months
Evolution of burning mouth symptoms change through a questionnaire
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2023.
- Individual participant dataSharing planned: Yes. Study protocol
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rosalia Leonardi contact
Gaetano Isola principal investigator
Università degli Studi di Catania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lipoid acid gel in people with Burning Mouth Syndrome, run by University of Catania at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gaetano Isola (0953785652, gaetano.isola@unict.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evolution of burning mouth (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2023.