Burning Mouth SyndromePhase 4BurnLasCLoNCT04313907
Low Level Laser Therapy Plus Topical Clonazepam Treatment to Burning Mouth Symdrome
A Phase 4 study testing low level laser therapy plus topical clonazepam in people with Burning Mouth Syndrome, run by Universidad Nacional Autonoma de Mexico at 1 site in Mexico.
Trial summary
Burning mouth syndrome (BMS) is a condition that affects the oral mucosa; this is seen mainly in postmenopausal women. The intensity of burning and its clinical manifestations may be variable between patients. Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Burning Mouth Syndrome
- What is being tested?
- low level laser therapy plus topical clonazepam
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 27 participants
- Where
- 1 siteMexico
- Study dates
- 16 Aug 2019to 16 Oct 2020
- 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 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Burning mouth sensation without oral lesions that could be involved with painful symptoms
- Symtoms of burning sensation more than 3 months
Who cannot join
- Patients who are under antineoplastic treatment or with a history of malignant neoplasms of the head and neck
- Active treatment with benzodiazepines or systemic antidepressants
- Pregnant women
- Patients unable to follow the indications for administration of oral topical medications
- Unstimulated saliva production ≤ 0,1 mililiters/minute
- Sistemic diseases that can produce burning sensation
Trial locations and contacts
1 site in 1 country.
Mexico1 site, 1 recruiting
- Recruiting
Division de Estudios de Posgrado e Investigacion en Odontologia, Universidad Nacional Autonoma de Mexico
Mexico City, 04360
Javier Portilla-Robertson, PhD, +525554183594, jpr@unam.mx
Carlos Contreras-Castellanos, DDS, +525563163406, carlosecontrerasc@gmail.com
About this study
Official title: Use of Low Intensity Laser Combined With Topical Clonazepam for the Treatment of Burning Mouth Syndrome
Burning mouth syndrome (BMS) is a condition that affects the oral mucosa; this is seen mainly in postmenopausal women. The intensity of burning and its clinical manifestations may be variable between patients. The etiology of the BMS is unknown, just as it is the therapeutic; hence the latter has not been fully accepted. Therefore, the use of low-level laser therapy (LLLT) and topical clonazepam have been proposed as treatment alternatives. The objective is to assess the effectiveness of the combination of LLLT and topical clonazepam for the reduction of burning symptoms. Three groups will be randomly formed: 1) the first group will received topical clonazepam therapy (half of a 2 mg tablet), patients in this group will be asked to applied it in a mouthwash type for 3 minutes and then spit it out; to the same group, six sessions of LLLT (Biolase 10 ©) will be applied in every second day intervals; 2) the second group, will received the same treatment with clonazepam and laser therapies with similar characteristics to the study group, but the laser will be deactivated; 3) the third group, will receive six sessions of LLLT (Biolase 10 ©) in every second day intervals and placebo tablets with similar characteristics to those of clonazepam. For all groups, both treatments will be received for two weeks. For the assessment of oral burning the visual analog scale (VAS) and the Oral Health Impact Profile-14 (OHIP-14) will be used; with these tools we will measure how oral disorders affect daily life. The measurement scales will be applied at the initial assessment and at day 14th, one month, two months and three months post treatment. The means obtained to assess the effectiveness of the treatment will be compared.
Read the detailed description
The study will be carried out at the oral medicine clinic of the Division of Postgraduate Studies and Research of the Faculty of Dentistry of the National Autonomous University of Mexico, during the period of August 2019 to June 2020. This research was approved by the Ethics and Research Committee of the Faculty of Dentistry - Universidad Nacional Autonoma de Mexico. Inclusion criteria will be all patients with BMS, indistinctively of gender. The sample size will be 10 patients in each group, calculated using PaaS computer program with a power of 90.552% to reject the null hypothesis; based on the literature where an average difference of 4 points was obtained in the visual analogue scale from 8.0 to 4.0 with a standard deviation of 1.5 for the group that used laser and 3.0 for the control group, with a significance level of 0.05, in this calculation a number of 9 participants were obtained and the final group size was calculated adding a loss of 10%.
Initially, the patient will be assessed by an oral medicine resident and professor. If abnormalities of the mucosa are observed during the assessment, the patient will undergo blood and microbiological tests or biopsy according to the suspected diagnosis; if a diagnosis of BMS is confirmed, the patient will be invited to be part of the study.
Using a computer program, randomized block allocation was performed to guarantee equitable participation in each group. Closed envelopes will be used, each envelope will contain the information of which group each patient belongs to and the measurement tools (questionnaires EVA and OHIP-14) that will be applied at the initial moment, at 14 days, 1 month, 2 months and 3 months post treatment.
On an individual basis, all patients included in the study will be explained how to use and apply topical clonazepam or placebo tablets, which the patient must suck for 3 minutes periods, after their meals, trying to pass it through all the oral areas; the treatment must not be swallowed nor be placed exclusively under the tongue; to later spit out the leftovers. The tablets corresponding to the days between each laser application will be delivered and the application maneuvers of topical clonazepam or placebo will be evaluated on the morning of the application of the laser treatment, the corresponding observations will be made if necessary. A form with the instructions will be delivered.
Patients will be applied Biolase brand InGaAsp diode laser, wavelength 940 nm, tip 400 um, with applications in 10 sites in the oral cavity [lateral of tongue (2 sites), jugal mucosa, lower lip and floor of the mouth) bilaterally at a distance of 15 mm, 10 seconds per point, 15 joules each poit. If the patient reports other specific places where he perceives burning symptoms, it will be applied at the site and the information will be collected for inclusion in the results. Sham laser group will be applying laser inactive therapy with the same specifications. They will carry out 6 sessions, for the same 2 weeks that the topical treatment will last.
This research is in according with the regulations of the general health law regarding health research and is at greater than minimum risk.
- Conditions
- Burning Mouth Syndrome
- Being tested
- low level laser therapy plus topical clonazepam, Sham laser plus topical clonazepam, Active laser plus placebo of topical clonazepam
- Keywords
- low-level laser therapy, topical clonazepam
- 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.
low level laser therapy plus topical clonazepamCombination product
combination of treatment, low level laser therapy (15 joules, 6 sesions, 14 days) plus topical clonazepam (1 mg,3 times per day, 14 days)
Sham laser plus topical clonazepamDrug
Sham laser therapy (0 joules, 6 sesions, 14 days) plus topical clonazepam(1 mg,3 times per day, 14 days)
Active laser plus placebo of topical clonazepamRadiation
low level laser therapy (15 joules, 6 sesions, 14 days) plus placebo topical clonazepam(lactose,3 times per day, 14 days)
| Study group | Role | What they receive |
|---|---|---|
| Acitve laser+topical clonazepam | Experimental | Using active laser (six sesions) 980 nm, 14 j , plus topical clonazepam 1 mg, 3 times at day, same 14 days both Receives: Combination Product: low level laser therapy plus topical clonazepam |
| Sham laser+topical clonazepam | Sham comparator | Using sham laser (six sesions) plus topical clonazepam 1 mg, 3 times at day, same 14 days both Receives: Drug: Sham laser plus topical clonazepam |
| Active laser+placebo of topical clonazepam | Placebo comparator | Using active laser (six sesions) 980 nm, 14 j , plus placebo of topical clonazepam (lactose), 3 times at day, same 14 days both Receives: Radiation: Active laser plus placebo of topical clonazepam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Burning Sensation
Visual Analogue Scale using scale from 0 (No burning sensation) to 10 (maximum burning sensation)
Measured: Change from baseline of Burning sensation using Visual Analogue Scale at 15 days, 1 month, 2 months, 3 months.
Secondary outcomes (1)
Quality of life- Oral Health Impact Profile
Oral Health Impact Profile short form of 14 questions, 7 dimensions. Values from 0 to 56, value of 0 is better quality of life and 56 very poor quality of life
Measured: Change from baseline of Quality of life using OHIP-14 at 15 days, 1 month, 2 months, 3 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2020
- Study start16 Aug 2019
- Primary completion16 Jun 2020 (estimated)
- Study completion16 Oct 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- 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
- Model description
- group 1:active laser+topical clonazepam, group 2:inactive laser+topical clonazepam, group 3:active laser+placebo clonazepam
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 27 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad Nacional Autonoma de Mexico
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elba Rosa Leyva Huerta, Universidad Nacional Autonoma de Mexico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04313907
- Sponsor's protocol ID
- CIE/0505/02/2019
- Acronym
- BurnLasCLo
- Status last verified
- Mar 2020
- First submitted
- 6 Mar 2020
- Last updated
- 18 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
dos Santos Lde F, de Andrade SC, Nogueira GE, Leao JC, de Freitas PM. Phototherapy on the Treatment of Burning Mouth Syndrome: A Prospective Analysis of 20 Cases. Photochem Photobiol. 2015 Sep-Oct;91(5):1231-6. doi: 10.1111/php.12490. Epub 2015 Aug 4.
PubMed 26138316Minor JS, Epstein JB. Burning mouth syndrome and secondary oral burning. Otolaryngol Clin North Am. 2011 Feb;44(1):205-19, vii. doi: 10.1016/j.otc.2010.09.008.
PubMed 21093630Kisely S, Forbes M, Sawyer E, Black E, Lalloo R. A systematic review of randomized trials for the treatment of burning mouth syndrome. J Psychosom Res. 2016 Jul;86:39-46. doi: 10.1016/j.jpsychores.2016.05.001. Epub 2016 May 9.
PubMed 27302545Heckmann SM, Kirchner E, Grushka M, Wichmann MG, Hummel T. A double-blind study on clonazepam in patients with burning mouth syndrome. Laryngoscope. 2012 Apr;122(4):813-6. doi: 10.1002/lary.22490. Epub 2012 Feb 16.
PubMed 22344742Romeo U, Del Vecchio A, Capocci M, Maggiore C, Ripari M. The low level laser therapy in the management of neurological burning mouth syndrome. A pilot study. Ann Stomatol (Roma). 2010 Jan;1(1):14-8. Epub 2010 Jun 29.
PubMed 22238700Valenzuela S, Lopez-Jornet P. Effects of low-level laser therapy on burning mouth syndrome. J Oral Rehabil. 2017 Feb;44(2):125-132. doi: 10.1111/joor.12463. Epub 2016 Dec 22.
PubMed 27893167Al-Maweri SA, Javed F, Kalakonda B, AlAizari NA, Al-Soneidar W, Al-Akwa A. Efficacy of low level laser therapy in the treatment of burning mouth syndrome: A systematic review. Photodiagnosis Photodyn Ther. 2017 Mar;17:188-193. doi: 10.1016/j.pdpdt.2016.11.017. Epub 2016 Dec 2.
PubMed 27919663Gremeau-Richard C, Woda A, Navez ML, Attal N, Bouhassira D, Gagnieu MC, Laluque JF, Picard P, Pionchon P, Tubert S. Topical clonazepam in stomatodynia: a randomised placebo-controlled study. Pain. 2004 Mar;108(1-2):51-7. doi: 10.1016/j.pain.2003.12.002.
PubMed 15109507Arbabi-Kalati F, Bakhshani NM, Rasti M. Evaluation of the efficacy of low-level laser in improving the symptoms of burning mouth syndrome. J Clin Exp Dent. 2015 Oct 1;7(4):e524-7. doi: 10.4317/jced.52298. eCollection 2015 Oct.
PubMed 26535101Arduino PG, Cafaro A, Garrone M, Gambino A, Cabras M, Romagnoli E, Broccoletti R. A randomized pilot study to assess the safety and the value of low-level laser therapy versus clonazepam in patients with burning mouth syndrome. Lasers Med Sci. 2016 May;31(4):811-6. doi: 10.1007/s10103-016-1897-8. Epub 2016 Feb 12.
PubMed 26873501Sugaya NN, Silva EF, Kato IT, Prates R, Gallo CB, Pellegrini VD. Low Intensity laser therapy in patients with burning mouth syndrome: a randomized, placebo-controlled study. Braz Oral Res. 2016 Oct 10;30(1):e108. doi: 10.1590/1807-3107BOR-2016.vol30.0108.
PubMed 27737361Spanemberg JC, Lopez Lopez J, de Figueiredo MA, Cherubini K, Salum FG. Efficacy of low-level laser therapy for the treatment of burning mouth syndrome: a randomized, controlled trial. J Biomed Opt. 2015 Sep;20(9):098001. doi: 10.1117/1.JBO.20.9.098001.
PubMed 26359814
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Low Intensity Laser Combined With Topical Clonazepam for the Treatment of Burning Mouth Syndrome
- ClinicalTrials.gov ID
- NCT04313907
- Acronym / sponsor ID
- BurnLasCLo / CIE/0505/02/2019
- Conditions
- Burning Mouth Syndrome
- Keywords
- low-level laser therapy, topical clonazepam
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 27 participants (estimated)
- Lead sponsor
- Universidad Nacional Autonoma de MexicoUniversity, hospital or other
- Study start
- 16 Aug 2019 (actual)
- Primary completion
- 16 Jun 2020 (estimated)
- Study completion
- 16 Oct 2020 (estimated)
- First posted
- 18 Mar 2020 (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 a condition that affects the oral mucosa; this is seen mainly in postmenopausal women. The intensity of burning and its clinical manifestations may be variable between patients. The etiology of the BMS is unknown, just as it is the therapeutic; hence the latter has not been fully accepted. Therefore, the use of low-level laser therapy (LLLT) and topical clonazepam have been proposed as treatment alternatives. The objective is to assess the effectiveness of the combination of LLLT and topical clonazepam for the reduction of burning symptoms. Three groups will be randomly formed: 1) the first group will received topical clonazepam therapy (half of a 2 mg tablet), patients in this group will be asked to applied it in a mouthwash type for 3 minutes and then spit it out; to the same group, six sessions of LLLT (Biolase 10 ©) will be applied in every second day intervals; 2) the second group, will received the same treatment with clonazepam and laser therapies with similar characteristics to the study group, but the laser will be deactivated; 3) the third group, will receive six sessions of LLLT (Biolase 10 ©) in every second day intervals and placebo tablets with similar characteristics to those of clonazepam. For all groups, both treatments will be received for two weeks. For the assessment of oral burning the visual analog scale (VAS) and the Oral Health Impact Profile-14 (OHIP-14) will be used; with these tools we will measure how oral disorders affect daily life. The measurement scales will be applied at the initial assessment and at day 14th, one month, two months and three months post treatment. The means obtained to assess the effectiveness of the treatment will be compared.
Detailed description
The study will be carried out at the oral medicine clinic of the Division of Postgraduate Studies and Research of the Faculty of Dentistry of the National Autonomous University of Mexico, during the period of August 2019 to June 2020. This research was approved by the Ethics and Research Committee of the Faculty of Dentistry - Universidad Nacional Autonoma de Mexico. Inclusion criteria will be all patients with BMS, indistinctively of gender. The sample size will be 10 patients in each group, calculated using PaaS computer program with a power of 90.552% to reject the null hypothesis; based on the literature where an average difference of 4 points was obtained in the visual analogue scale from 8.0 to 4.0 with a standard deviation of 1.5 for the group that used laser and 3.0 for the control group, with a significance level of 0.05, in this calculation a number of 9 participants were obtained and the final group size was calculated adding a loss of 10%.
Initially, the patient will be assessed by an oral medicine resident and professor. If abnormalities of the mucosa are observed during the assessment, the patient will undergo blood and microbiological tests or biopsy according to the suspected diagnosis; if a diagnosis of BMS is confirmed, the patient will be invited to be part of the study.
Using a computer program, randomized block allocation was performed to guarantee equitable participation in each group. Closed envelopes will be used, each envelope will contain the information of which group each patient belongs to and the measurement tools (questionnaires EVA and OHIP-14) that will be applied at the initial moment, at 14 days, 1 month, 2 months and 3 months post treatment.
On an individual basis, all patients included in the study will be explained how to use and apply topical clonazepam or placebo tablets, which the patient must suck for 3 minutes periods, after their meals, trying to pass it through all the oral areas; the treatment must not be swallowed nor be placed exclusively under the tongue; to later spit out the leftovers. The tablets corresponding to the days between each laser application will be delivered and the application maneuvers of topical clonazepam or placebo will be evaluated on the morning of the application of the laser treatment, the corresponding observations will be made if necessary. A form with the instructions will be delivered.
Patients will be applied Biolase brand InGaAsp diode laser, wavelength 940 nm, tip 400 um, with applications in 10 sites in the oral cavity [lateral of tongue (2 sites), jugal mucosa, lower lip and floor of the mouth) bilaterally at a distance of 15 mm, 10 seconds per point, 15 joules each poit. If the patient reports other specific places where he perceives burning symptoms, it will be applied at the site and the information will be collected for inclusion in the results. Sham laser group will be applying laser inactive therapy with the same specifications. They will carry out 6 sessions, for the same 2 weeks that the topical treatment will last.
This research is in according with the regulations of the general health law regarding health research and is at greater than minimum risk.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- group 1:active laser+topical clonazepam, group 2:inactive laser+topical clonazepam, group 3:active laser+placebo clonazepam
| Arm | Type | Receives |
|---|---|---|
| Acitve laser+topical clonazepam | Experimental | Combination Product: low level laser therapy plus topical clonazepamUsing active laser (six sesions) 980 nm, 14 j , plus topical clonazepam 1 mg, 3 times at day, same 14 days both |
| Sham laser+topical clonazepam | Sham comparator | Drug: Sham laser plus topical clonazepamUsing sham laser (six sesions) plus topical clonazepam 1 mg, 3 times at day, same 14 days both |
| Active laser+placebo of topical clonazepam | Placebo comparator | Radiation: Active laser plus placebo of topical clonazepamUsing active laser (six sesions) 980 nm, 14 j , plus placebo of topical clonazepam (lactose), 3 times at day, same 14 days both |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Burning mouth sensation without oral lesions that could be involved with painful symptoms
- Symtoms of burning sensation more than 3 months
Key exclusion criteria (6 listed)
- Patients who are under antineoplastic treatment or with a history of malignant neoplasms of the head and neck
- Active treatment with benzodiazepines or systemic antidepressants
- Pregnant women
- Patients unable to follow the indications for administration of oral topical medications
- Unstimulated saliva production ≤ 0,1 mililiters/minute
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 |
|---|---|---|
| low level laser therapy plus topical clonazepamcombination of treatment, low level laser therapy (15 joules, 6 sesions, 14 days) plus topical clonazepam (1 mg,3 times per day, 14 days) | Combination product | Acitve laser+topical clonazepam |
| Sham laser plus topical clonazepamSham laser therapy (0 joules, 6 sesions, 14 days) plus topical clonazepam(1 mg,3 times per day, 14 days) | Drug | Sham laser+topical clonazepam |
| Active laser plus placebo of topical clonazepamlow level laser therapy (15 joules, 6 sesions, 14 days) plus placebo topical clonazepam(lactose,3 times per day, 14 days) | Radiation | Active laser+placebo of topical clonazepam |
Primary outcome
Burning Sensation
Time frame: Change from baseline of Burning sensation using Visual Analogue Scale at 15 days, 1 month, 2 months, 3 months.
Visual Analogue Scale using scale from 0 (No burning sensation) to 10 (maximum burning sensation)
1 secondary outcome
Quality of life- Oral Health Impact Profile
Time frame: Change from baseline of Quality of life using OHIP-14 at 15 days, 1 month, 2 months, 3 months.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2020.
- Background: PubMed 26138316dos Santos Lde F, de Andrade SC, Nogueira GE, Leao JC, de Freitas PM. Phototherapy on the Treatment of Burning Mouth Syndrome: A Prospective Analysis of 20 Cases. Photochem Photobiol. 2015 Sep-Oct;91(5):1231-6. doi: 10.1111/php.12490. Epub 2015 Aug 4.
- Results publication: PubMed 21093630Minor JS, Epstein JB. Burning mouth syndrome and secondary oral burning. Otolaryngol Clin North Am. 2011 Feb;44(1):205-19, vii. doi: 10.1016/j.otc.2010.09.008.
- Results publication: PubMed 27302545Kisely S, Forbes M, Sawyer E, Black E, Lalloo R. A systematic review of randomized trials for the treatment of burning mouth syndrome. J Psychosom Res. 2016 Jul;86:39-46. doi: 10.1016/j.jpsychores.2016.05.001. Epub 2016 May 9.
- Results publication: PubMed 22344742Heckmann SM, Kirchner E, Grushka M, Wichmann MG, Hummel T. A double-blind study on clonazepam in patients with burning mouth syndrome. Laryngoscope. 2012 Apr;122(4):813-6. doi: 10.1002/lary.22490. Epub 2012 Feb 16.
- Results publication: PubMed 22238700Romeo U, Del Vecchio A, Capocci M, Maggiore C, Ripari M. The low level laser therapy in the management of neurological burning mouth syndrome. A pilot study. Ann Stomatol (Roma). 2010 Jan;1(1):14-8. Epub 2010 Jun 29.
- Results publication: PubMed 27893167Valenzuela S, Lopez-Jornet P. Effects of low-level laser therapy on burning mouth syndrome. J Oral Rehabil. 2017 Feb;44(2):125-132. doi: 10.1111/joor.12463. Epub 2016 Dec 22.
- Results publication: PubMed 27919663Al-Maweri SA, Javed F, Kalakonda B, AlAizari NA, Al-Soneidar W, Al-Akwa A. Efficacy of low level laser therapy in the treatment of burning mouth syndrome: A systematic review. Photodiagnosis Photodyn Ther. 2017 Mar;17:188-193. doi: 10.1016/j.pdpdt.2016.11.017. Epub 2016 Dec 2.
- Results publication: PubMed 15109507Gremeau-Richard C, Woda A, Navez ML, Attal N, Bouhassira D, Gagnieu MC, Laluque JF, Picard P, Pionchon P, Tubert S. Topical clonazepam in stomatodynia: a randomised placebo-controlled study. Pain. 2004 Mar;108(1-2):51-7. doi: 10.1016/j.pain.2003.12.002.
- Results publication: PubMed 26535101Arbabi-Kalati F, Bakhshani NM, Rasti M. Evaluation of the efficacy of low-level laser in improving the symptoms of burning mouth syndrome. J Clin Exp Dent. 2015 Oct 1;7(4):e524-7. doi: 10.4317/jced.52298. eCollection 2015 Oct.
- Results publication: PubMed 26873501Arduino PG, Cafaro A, Garrone M, Gambino A, Cabras M, Romagnoli E, Broccoletti R. A randomized pilot study to assess the safety and the value of low-level laser therapy versus clonazepam in patients with burning mouth syndrome. Lasers Med Sci. 2016 May;31(4):811-6. doi: 10.1007/s10103-016-1897-8. Epub 2016 Feb 12.
- Results publication: PubMed 27737361Sugaya NN, Silva EF, Kato IT, Prates R, Gallo CB, Pellegrini VD. Low Intensity laser therapy in patients with burning mouth syndrome: a randomized, placebo-controlled study. Braz Oral Res. 2016 Oct 10;30(1):e108. doi: 10.1590/1807-3107BOR-2016.vol30.0108.
- Results publication: PubMed 26359814Spanemberg JC, Lopez Lopez J, de Figueiredo MA, Cherubini K, Salum FG. Efficacy of low-level laser therapy for the treatment of burning mouth syndrome: a randomized, controlled trial. J Biomed Opt. 2015 Sep;20(9):098001. doi: 10.1117/1.JBO.20.9.098001.
- Individual participant dataSharing planned: No
Related trials for Burning Mouth Syndrome
Not yet recruiting
Improving Prescribing Quality for Oral Mucosal Disorders Using a Pharmacist-Led Model
Oral Lichen Planus, Recurrent Aphthous Stomatitis
Recruiting
MucoLock™ for Treatment of Stomatitis
Stomatitis, Pain
RecruitingObservational study
Reducing Patient Memory Recall in the Burning Mouth Patient Population
Burning Mouth Syndrome
Active, not recruiting
Photobiomodulation Therapy vs. Alpha-Lipoic Acid in Burning Mouth Syndrome Treatment
Burning Mouth Syndrome, Low Level Laser Therapy
Not yet recruiting
Burning Mouth Syndrome: Effects of Occlusal Splint Therapy
Burning Mouth Syndrome, Orofacial Pain
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.
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 low level laser therapy plus topical clonazepam in people with Burning Mouth Syndrome, run by Universidad Nacional Autonoma de Mexico at 1 site in Mexico.
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 2 inclusion and 6 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 18 Mar 2020. 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 Mexico. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Elba Rosa Leyva-Huerta, PhD (+525516514783, docelbaleyva@unam.mx), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Burning Sensation (time frame: Change from baseline of Burning sensation using Visual Analogue Scale at 15 days, 1 month, 2 months, 3 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04313907, which also lists 12 linked publications.
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 18 Mar 2020.