Burning Mouth SyndromePhase 4NCT06040190
Effect of Treatments on Pain and Quality of Life in Individual With Burning Mouth Syndrome
A Phase 4 study testing topical clonazepam rinse, oral alpha-lipoic acid capsule and topical phytotherapic capsaicin gel in people with Burning Mouth Syndrome, run by Federal University of Minas Gerais at 1 site in Brazil.
Trial summary
Burning Mouth Syndrome (BMS) is characterized by a burning sensation on the tongue or other areas of the mouth, often bilateral but occasionally unilateral. It is more prevalent in postmenopausal women. No specific ethnic or socioeconomic predisposition has been identified. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Burning Mouth Syndrome
- What is being tested?
- topical clonazepam rinse, oral alpha-lipoic acid capsule and topical phytotherapic capsaicin gel
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Nov 2023to 1 Jul 2026
- Phase
- Phase 4
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- burning mouth syndrome;
- oral pain that recurs daily for > 2 hours per day for > 3 months;
- pain with burning quality and felt superficially in the oral mucosa;
- oral mucosa appears normal
- oral clinical examination, including sensory tests, is normal;
Who cannot join
- pregnancy;
- oral mucosal lesions;
- systemic diseases such as diabetes, anemia, deficiency of vitamin B1, B2, B6, B12, Fe, Zinc, and folic acid;
- gastroesophageal reflux;
- previous head and neck radiotherapy;
- Sjogren's disease;
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- allergies;
- candidiasis;
- unstimulated saliva flow < 0.25 ml/min and stimulated flow < 1.0 ml/min will be excluded;
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Effect of Different Treatments on Pain Scores and Self-reported Oral Health-related Quality of Life in Individuals With Burning Mouth Syndrome: a Randomized Controlled Clinical Trial
Burning Mouth Syndrome (BMS) is characterized by a burning sensation on the tongue or other areas of the mouth, often bilateral but occasionally unilateral. It is more prevalent in postmenopausal women. No specific ethnic or socioeconomic predisposition has been identified. The etiology and pathophysiology of BMS remain unknown. Various treatment approaches have been proposed, yielding conflicting outcomes and underscoring the need for further investigation.
Patients with BMS appear to respond well to long-term therapy involving systemic antidepressants and anxiolytics. The most promising therapeutic effects have been observed with clonazepam, which leads to a significant reduction in pain when applied topically or systemically. Capsaicin, an herbal remedy, also presents as an alternative treatment option, showing positive results in alleviating BMS symptoms when compared to a placebo. Photobiomodulation represents another non-pharmacological treatment possibility. It's analgesic action is possibly attributed to the inhibition of pain mediators. Alpha-lipoic acid (ALA) is dietary supplement employed in BMS treatment. It serves as a potent antioxidant naturally produced within the body, contributing to the mitigation of skin aging and reinforcing the effects of other biological antioxidants. Based on these findings, attempts have been made to demonstrate ALA's effectiveness in BMS management, concluding that ALA may offer benefits in this context.
Therefore, the objective of this study is to investigate, in adults with BMS, the impact of different therapeutic approaches on frequency, intensity, and location of pain, as well as on on quality of life.
- Conditions
- Burning Mouth Syndrome
- Being tested
- topical placebo rinse, topical clonazepam rinse, oral alpha-lipoic acid capsule, topical phytotherapic capsaicin gel, local photobiomodulation
- 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.
topical placebo rinseDrug
Participants rinsed with a placebo solution (0.1% saccharin, 0.05% flavoring, 1% paraben solution, propylene glycol q.s. 20 mL; no active ingredient) compounded by Manipulatta Pharmacy (Belo Horizonte, MG) to be organoleptically identical to clonazepam (Rivotril®) in color, flavor, and odor. Ten drops were diluted in 10 mL of water and swished near the painful sites for 3 minutes without swallowing, then expectorated. The protocol was repeated three times daily for 21 days. Solution was provided in two 20 mL amber vials.
topical clonazepam rinseDrug
Participants were instructed to rinse with a solution containing 10 drops of clonazepam (Rivotril®️) at 2.5 mg/mL (0.1 mg/drop, according to the manufacturer's specifications), diluted in 10 mL of water, keeping the solution in the oral cavity, close to the painful sites, for 3 minutes without swallowing, followed by expectoration. This protocol was repeated three times daily for 21 days. Each participant received two 20-mL amber bottles of clonazepam solution at 2.5 mg/mL.
oral alpha-lipoic acid capsuleDietary supplement
Participants in this group will be instructed to take oral capsules containing alpha-lipoic acid.
topical phytotherapic capsaicin gelOther
Participants in this group will to apply the gel containing tocapsaicin on painful oral sites.
local photobiomodulationRadiation
Also called photodynamic therapy
Photobiomodulation will be applied during 10 seconds per point at 56 points (three on the vestibular mucosa of the 4 quadrants, four on each labial mucosa, six on each of the two buccal mucosae, six on the hard palate, four on each lateral edge of the tongue, six on the dorsum of the tongue, and four sublingual points) with an intermediate distance of 2 mm. A dose of 12 J/cm² per session will be applied in continuous mode for 10 sessions. The 10 sessions will be applied twice a week for 5 consecutive weeks. The LASER will be applied perpendicularly in contact with the mucosa. All patients and the clinician will wear protective glasses.
| Study group | Role | What they receive |
|---|---|---|
| topical placebo rinse | Placebo comparator | 10 drops of placebo solution diluted in 10 mL of water, used as an oral rinse three times daily for 21 days. Receives: Drug: topical placebo rinse |
| control | No intervention | artificial saliva |
| topical clonazepam rinse | Experimental | 10 drops of clonazepam solution (2.5 mg/mL) diluted in 10 mL of water, used as an oral rinse three times daily for 21 days. Receives: Drug: topical clonazepam rinse |
| oral alpha-lipoic acid capsule | Experimental | 300 mg alpha-lipoic acid capsule twice a day for 60 days Receives: Dietary Supplement: oral alpha-lipoic acid capsule |
| topical phytotherapic capsaicin gel | Experimental | 0.025 mg capsaicin gel 4 times a day for 14 days Receives: Other: topical phytotherapic capsaicin gel |
| local photobiomodulation | Experimental | Photobiomodulation with wavelength of 810 nm, power of 0.6 W, power density of 1.2 W/cm², beam area of 0.5 cm², and energy of 6 J. Receives: Radiation: local photobiomodulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in pain scores
Change in pain scores measured by a visual analog scale and the short version of the McGill Pain Questionnaire. Visual Analogue Scale: values ranging from 0 (no pain) to 10 (most severe pain). The McGill instrument contains 15 descriptors of pain sensation (11 sensory and 4 affective), with each descriptor ranked on a 4-point rating scale (0 = none, 1 = mild, 2 = moderate and 3 = severe). Three measures of pain experience based on sensory and affective descriptors can be obtained: (1) The total index consists of the sum of all 15 descriptors with the total score ranging from 0 to 45; (2) The sensory index consists of the sum of descriptors 1 - 11 with the total score ranging from 0 to 33; and (3) the affective index consists of the sum of descriptors 12 - 15 with the total score ranging from 0 to 12.
Measured: baseline and 3 weeks
Change in pain scores
Change in pain scores measured by a visual analog scale and the short version of the McGill Pain Questionnaire. Visual Analogue Scale: values ranging from 0 (no pain) to 10 (most severe pain). The McGill instrument contains 15 descriptors of pain sensation (11 sensory and 4 affective), with each descriptor ranked on a 4-point rating scale (0 = none, 1 = mild, 2 = moderate and 3 = severe). Three measures of pain experience based on sensory and affective descriptors can be obtained: (1) The total index consists of the sum of all 15 descriptors with the total score ranging from 0 to 45; (2) The sensory index consists of the sum of descriptors 1 - 11 with the total score ranging from 0 to 33; and (3) the affective index consists of the sum of descriptors 12 - 15 with the total score ranging from 0 to 12.
Measured: baseline and 2 months
Secondary outcomes (2)
Change in quality of life scores
Change in quality of life measured by Oral Impacts on Daily Performance scores. Total score ranging from 0 to 275 being classified as: 0 = no impact, values 1 to 10 = low impact, values 11 to 40 = medium impact and values 41 to 275 = high impact (i.e, worse quality of life).
Measured: baseline and 3 weeks
Change in quality of life scores
Change in quality of life measured by Oral Impacts on Daily Performance scores. Total score ranging from 0 to 275 being classified as: 0 = no impact, values 1 to 10 = low impact, values 11 to 40 = medium impact and values 41 to 275 = high impact (i.e, worse quality of life).
Measured: baseline and 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2023
- Study start1 Nov 2023
- Primary completion1 Jul 2026
- Study completion1 Jul 2026
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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of Minas Gerais
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fernando O Costa, Federal University of Minas Gerais
- Investigators
- Fernando O Costa, PhD, Principal investigator, Federal University of Minas Gerais
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06040190
- Sponsor's protocol ID
- 6.161.933
- Status last verified
- Aug 2026
- First submitted
- 10 Sep 2023
- Last updated
- 17 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual patient data will not be shared.
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of Different Treatments on Pain Scores and Self-reported Oral Health-related Quality of Life in Individuals With Burning Mouth Syndrome: a Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT06040190
- Acronym / sponsor ID
- 6.161.933
- Conditions
- Burning Mouth Syndrome
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Federal University of Minas GeraisUniversity, hospital or other
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 1 Jul 2026 (actual)
- Study completion
- 1 Jul 2026 (actual)
- First posted
- 15 Sep 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.
Burning Mouth Syndrome (BMS) is characterized by a burning sensation on the tongue or other areas of the mouth, often bilateral but occasionally unilateral. It is more prevalent in postmenopausal women. No specific ethnic or socioeconomic predisposition has been identified. The etiology and pathophysiology of BMS remain unknown. Various treatment approaches have been proposed, yielding conflicting outcomes and underscoring the need for further investigation.
Patients with BMS appear to respond well to long-term therapy involving systemic antidepressants and anxiolytics. The most promising therapeutic effects have been observed with clonazepam, which leads to a significant reduction in pain when applied topically or systemically. Capsaicin, an herbal remedy, also presents as an alternative treatment option, showing positive results in alleviating BMS symptoms when compared to a placebo. Photobiomodulation represents another non-pharmacological treatment possibility. It's analgesic action is possibly attributed to the inhibition of pain mediators. Alpha-lipoic acid (ALA) is dietary supplement employed in BMS treatment. It serves as a potent antioxidant naturally produced within the body, contributing to the mitigation of skin aging and reinforcing the effects of other biological antioxidants. Based on these findings, attempts have been made to demonstrate ALA's effectiveness in BMS management, concluding that ALA may offer benefits in this context.
Therefore, the objective of this study is to investigate, in adults with BMS, the impact of different therapeutic approaches on frequency, intensity, and location of pain, as well as on on quality of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| topical placebo rinse | Placebo comparator | Drug: topical placebo rinse10 drops of placebo solution diluted in 10 mL of water, used as an oral rinse three times daily for 21 days. |
| control | No intervention | –artificial saliva |
| topical clonazepam rinse | Experimental | Drug: topical clonazepam rinse10 drops of clonazepam solution (2.5 mg/mL) diluted in 10 mL of water, used as an oral rinse three times daily for 21 days. |
| oral alpha-lipoic acid capsule | Experimental | Dietary Supplement: oral alpha-lipoic acid capsule300 mg alpha-lipoic acid capsule twice a day for 60 days |
| topical phytotherapic capsaicin gel | Experimental | Other: topical phytotherapic capsaicin gel0.025 mg capsaicin gel 4 times a day for 14 days |
| local photobiomodulation | Experimental | Radiation: local photobiomodulationPhotobiomodulation with wavelength of 810 nm, power of 0.6 W, power density of 1.2 W/cm², beam area of 0.5 cm², and energy of 6 J. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- burning mouth syndrome;
- oral pain that recurs daily for > 2 hours per day for > 3 months;
- pain with burning quality and felt superficially in the oral mucosa;
- oral mucosa appears normal
- oral clinical examination, including sensory tests, is normal;
Key exclusion criteria (9 listed)
- pregnancy;
- oral mucosal lesions;
- systemic diseases such as diabetes, anemia, deficiency of vitamin B1, B2, B6, B12, Fe, Zinc, and folic acid;
- gastroesophageal reflux;
- previous head and neck radiotherapy;
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 |
|---|---|---|
| topical placebo rinseParticipants rinsed with a placebo solution (0.1% saccharin, 0.05% flavoring, 1% paraben solution, propylene glycol q.s. 20 mL; no active ingredient) compounded by Manipulatta Pharmacy (Belo Horizonte, MG) to be organoleptically identical to clonazepam (Rivotril®) in color, flavor, and odor. Ten drops were diluted in 10 mL of water and swished near the painful sites for 3 minutes without swallowing, then expectorated. The protocol was repeated three times daily for 21 days. Solution was provided in two 20 mL amber vials. | Drug | topical placebo rinse |
| topical clonazepam rinseParticipants were instructed to rinse with a solution containing 10 drops of clonazepam (Rivotril®️) at 2.5 mg/mL (0.1 mg/drop, according to the manufacturer's specifications), diluted in 10 mL of water, keeping the solution in the oral cavity, close to the painful sites, for 3 minutes without swallowing, followed by expectoration. This protocol was repeated three times daily for 21 days. Each participant received two 20-mL amber bottles of clonazepam solution at 2.5 mg/mL. | Drug | topical clonazepam rinse |
| oral alpha-lipoic acid capsuleParticipants in this group will be instructed to take oral capsules containing alpha-lipoic acid. | Dietary supplement | oral alpha-lipoic acid capsule |
| topical phytotherapic capsaicin gelParticipants in this group will to apply the gel containing tocapsaicin on painful oral sites. | Other | topical phytotherapic capsaicin gel |
| local photobiomodulationAlso: photodynamic therapyPhotobiomodulation will be applied during 10 seconds per point at 56 points (three on the vestibular mucosa of the 4 quadrants, four on each labial mucosa, six on each of the two buccal mucosae, six on the hard palate, four on each lateral edge of the tongue, six on the dorsum of the tongue, and four sublingual points) with an intermediate distance of 2 mm. A dose of 12 J/cm² per session will be applied in continuous mode for 10 sessions. The 10 sessions will be applied twice a week for 5 consecutive weeks. The LASER will be applied perpendicularly in contact with the mucosa. All patients and the clinician will wear protective glasses. | Radiation | local photobiomodulation |
Primary outcome
Change in pain scores
Time frame: baseline and 3 weeks
Change in pain scores measured by a visual analog scale and the short version of the McGill Pain Questionnaire. Visual Analogue Scale: values ranging from 0 (no pain) to 10 (most severe pain). The McGill instrument contains 15 descriptors of pain sensation (11 sensory and 4 affective), with each descriptor ranked on a 4-point rating scale (0 = none, 1 = mild, 2 = moderate and 3 = severe). Three measures of pain experience based on sensory and affective descriptors can be obtained: (1) The total index consists of the sum of all 15 descriptors with the total score ranging from 0 to 45; (2) The sensory index consists of the sum of descriptors 1 - 11 with the total score ranging from 0 to 33; and (3) the affective index consists of the sum of descriptors 12 - 15 with the total score ranging from 0 to 12.
Change in pain scores
Time frame: baseline and 2 months
Change in pain scores measured by a visual analog scale and the short version of the McGill Pain Questionnaire. Visual Analogue Scale: values ranging from 0 (no pain) to 10 (most severe pain). The McGill instrument contains 15 descriptors of pain sensation (11 sensory and 4 affective), with each descriptor ranked on a 4-point rating scale (0 = none, 1 = mild, 2 = moderate and 3 = severe). Three measures of pain experience based on sensory and affective descriptors can be obtained: (1) The total index consists of the sum of all 15 descriptors with the total score ranging from 0 to 45; (2) The sensory index consists of the sum of descriptors 1 - 11 with the total score ranging from 0 to 33; and (3) the affective index consists of the sum of descriptors 12 - 15 with the total score ranging from 0 to 12.
2 secondary outcomes
Change in quality of life scores
Time frame: baseline and 3 weeks
Change in quality of life scores
Time frame: baseline and 2 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2026.
- Individual participant dataSharing planned: No. Individual patient data will not be shared.
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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.
Fernando O Costa, PhD principal investigator
Federal University of Minas Gerais
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing topical clonazepam rinse, oral alpha-lipoic acid capsule and topical phytotherapic capsaicin gel in people with Burning Mouth Syndrome, run by Federal University of Minas Gerais at 1 site in Brazil.
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 5 inclusion and 9 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: finished, as of the sponsor's last update on 17 Aug 2026. 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 Brazil. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in pain scores (time frame: baseline and 3 weeks). The study lists 2 primary outcomes in all. 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 17 Aug 2026.