Low Level Laser Therapy Plus Topical Clonazepam Treatment to Burning Mouth Symdrome

NCT04313907 | Unknown Phase 4 DMC

• 1 other identifier: CIE/0505/02/2019
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Burning Mouth Syndrome

Keywords

low-level laser therapy; topical clonazepam

Outcome Measures

Primary Outcomes (1)

• Burning Sensation

  Visual Analogue Scale using scale from 0 (No burning sensation) to 10 (maximum burning sensation)

  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

  Change from baseline of Quality of life using OHIP-14 at 15 days, 1 month, 2 months, 3 months.

Study Arms (3)

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

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

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

Radiation: Active laser plus placebo of topical clonazepam

Interventions

low level laser therapy plus topical clonazepam COMBINATION_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)

Acitve laser+topical clonazepam

Sham laser plus topical clonazepam DRUG

Sham laser therapy (0 joules, 6 sesions, 14 days) plus topical clonazepam(1 mg,3 times per day, 14 days)

Sham laser+topical clonazepam

Active laser plus placebo of topical clonazepam RADIATION

low level laser therapy (15 joules, 6 sesions, 14 days) plus placebo topical clonazepam(lactose,3 times per day, 14 days)

Active laser+placebo of topical clonazepam

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Burning mouth sensation without oral lesions that could be involved with painful symptoms
• Symtoms of burning sensation more than 3 months

You may not qualify if:

• 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

Sponsors & Collaborators

• Universidad Nacional Autonoma de Mexico: lead

Study Sites (1)

Division de Estudios de Posgrado e Investigacion en Odontologia, Universidad Nacional Autonoma de Mexico

Mexico City, 04360, Mexico

RECRUITING

Related Publications (12)

• 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.

  PMID: 26138316 BACKGROUND

• Minor 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.

  PMID: 21093630 RESULT

• Kisely 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.

  PMID: 27302545 RESULT

• Heckmann 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.

  PMID: 22344742 RESULT

• Romeo 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.

  PMID: 22238700 RESULT

• Valenzuela 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.

  PMID: 27893167 RESULT

• Al-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.

  PMID: 27919663 RESULT

• Gremeau-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.

  PMID: 15109507 RESULT

• Arbabi-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.

  PMID: 26535101 RESULT

• Arduino 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.

  PMID: 26873501 RESULT

• Sugaya 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.

  PMID: 27737361 RESULT

• Spanemberg 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.

  PMID: 26359814 RESULT

MeSH Terms

Conditions

Burning Mouth Syndrome

Interventions

Low-Level Light Therapy; Clonazepam

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics; Phototherapy; Benzodiazepinones; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Central Study Contacts

Elba Rosa Leyva-Huerta, PhD

CONTACT

+525516514783; docelbaleyva@unam.mx

Carlos Contreras-Castellanos, DDS

CONTACT

+525563163406; carlosecontrerasc@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor full time, PhD

Model Details: group 1:active laser+topical clonazepam, group 2:inactive laser+topical clonazepam, group 3:active laser+placebo clonazepam

Study Record Dates

• First Submitted: March 6, 2020
• First Posted: March 18, 2020
• Study Start: August 16, 2019
• Primary Completion: June 16, 2020
• Study Completion: October 16, 2020
• Last Updated: March 18, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)