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

March 17, 2020 updated by: Elba Rosa Leyva Huerta, Universidad Nacional Autonoma de Mexico

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

27

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
      • Mexico City, Mexico, 04360
        • Recruiting
        • Division de Estudios de Posgrado e Investigacion en Odontologia, Universidad Nacional Autonoma de Mexico
        • Contact:
        • Contact:
          • Javier Portilla-Robertson, PhD
          • Phone Number: +525554183594
          • Email: jpr@unam.mx

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Acitve laser+topical clonazepam
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
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 Comparator: Sham laser+topical clonazepam
Using sham laser (six sesions) plus topical clonazepam 1 mg, 3 times at day, same 14 days both
Drug: Sham laser plus topical clonazepam
Sham laser therapy (0 joules, 6 sesions, 14 days) plus topical clonazepam(1 mg,3 times per day, 14 days)
Placebo Comparator: Active laser+placebo of topical clonazepam
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
low level laser therapy (15 joules, 6 sesions, 14 days) plus placebo topical clonazepam(lactose,3 times per day, 14 days)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Change from baseline of Burning sensation using Visual Analogue Scale at 15 days, 1 month, 2 months, 3 months.

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad Nacional Autonoma de Mexico

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 16, 2019

Primary Completion (Anticipated)

June 16, 2020

Study Completion (Anticipated)

October 16, 2020

Study Registration Dates

First Submitted

March 6, 2020

First Submitted That Met QC Criteria

March 17, 2020

First Posted (Actual)

March 18, 2020

Study Record Updates

Last Update Posted (Actual)

March 18, 2020

Last Update Submitted That Met QC Criteria

March 17, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CIE/0505/02/2019

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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