Effects of Photobiomodulation in Burning Mouth Syndrome
Condition: Burning Mouth Syndrome
MeSH terms: Burning Mouth Syndrome; Syndrome; Burns
Study type: Interventional

Summary: 
      The main objective of this study is to assess the effects of Photobiomodulation with
      Low-level Laser Therapy to the pain management in Burning Mouth Syndrome patients, besides
      assessing their impact on the different aspects of their quality of life, using the necessary
      questionnaires to evaluate all the outcomes of chronic pain.
    

Detailed description: 
      Study design A randomized, single blind, clinical trial was performed among patients with
      Burning Mouth Syndrome who attended the Oral Medicine Specialist Degree Program at the School
      of Dentistry at Complutense University in Madrid. This study was approved by the Hospital San
      Carlos Ethics Committee in Madrid (IEC no. 17/311-R_P) according with the principles of the
      Helsinki Declaration. This clinical study followed the guidelines established by the Consort
      Statement (http://www.consort-statement.org/).

      Participants Adult patients older than 18 years of age who fulfilled the International
      Classification of Headache Disorders (ICHD-3) diagnostic criteria for BMS were consecutively
      included in this study. Patients not interested in participate in the study, unable to
      understand or answer the questionnaires and follow the appointments, patients suffering
      hiposialia or Sjögren's syndrome, patients who had received head and neck radiotherapy,
      pregnant women, patients with uncontrolled systemic diseases (diabetes, thyroid diseases,
      fibromyalgia or anemia) and patients suffering burning mouth symptoms secondary to local
      factors were excluded. Patients also had to read and sign and informed consent prior to
      inclusion in the study.

      Before beginning the treatment, all patients provided a full medical history and a complete
      blood test including blood levels of iron, vitamin B12, folic acid, TSH and basal glucose
      levels. Patients who did not provide the blood tests, did not attend any of the appointments
      or follow-ups or did not fulfill correctly the questionnaires were removed from the study.

      Interventions LLLT was applied in the study group with a Diode Laser Fox (A.R.C. Laser,
      Italy) using these parameters: a wavelength of 810 nm, a power of 0.6 W, a power density of
      1.2 W/cm2, a beam area of 0.08 cm2 and an energy of 6 J with an application time per point of
      10 seconds in 56 points (3 in the vestibular mucosa of the 4 quadrants, 6 in each of the two
      buccal mucosa, 6 in the hard palate, 4 in each lateral of the tongue, 6 in the dorse of the
      tongue and 4 sublingual points) with a distance between points of 2mm. It was applied,
      therefore, a dose of 12 J/cm2 in a continuous mode in a total of 10 sessions, 2 sessions per
      week for 5 weeks. The laser was applied perpendicularly in contact with the mucosa. All
      patients and the clinician wore the protective eyeglasses provided with the laser device.

      For the placebo group the Low-Level Laser Therapy was applied in the same 56 points, 10
      seconds per point and the same number of sessions but with the device turned off.

      Outcomes Medical reports, medical questionnaires and blood tests (iron, vit B12, folic acid,
      TSH and basal glucose) were collected before starting the laser application. Pain was
      assessed using a Visual Analogue Scale (0-10 cm) by the patients before starting each session
      and at two follow-up sessions, 1 and 4 months after finishing the treatment.

      Different questionnaires validated to Spanish were also fulfilled by patients. The
      questionnaires were the Short Form 36 Health Survey (SF-36) for the general health status,
      the Oral Health Impact Profile (OHIP-14) for the oral patient's quality of life, the Epworth
      sleepiness scale, the psychometric test Symptom Check List 90 (SCL 90), the Beck's depression
      inventory and the McGill Pain Questionnaire. These questionnaires were fulfilled baseline and
      at the end of the 10 laser sessions and in the 1st and 4th-months follow-ups.

      Sample size The sample size was calculated considering the previous study performed by Sikora
      et al, 2018 applying Low-Level Laser Therapy in similar parameters with a placebo group. We
      considered that the acceptable improvement in Laser group would be 4 points in VAS for pain.
      With a p = 0.05, a statistical power of 90% to detect this difference would require 10
      subjects in each study group.

      Randomization Burning Mouth Syndrome patients were randomly assigned to one of the treatments
      (Low-Level Laser Therapy or placebo) in a 1:1 ratio using a computer-generated algorithm
      stratified by using a block sized of 4. The patient's arrival number was his assigned number
      for the study following a correlative sequence. Group assignation for each number was kept in
      a sealed envelope that was no opened until the moment of treatment. An investigator not
      involved in the Low-Level Laser Therapy performed the randomization. The clinician who
      applied the Low-Level Laser Therapy was not involved in this process.

      Blinding All patients were blinded during all the trial. They wore protective glasses and
      were also advised to close their eyes during treatment. In addition, the laser was programmed
      not to emit any type of sound alarm. One clinician collected the VAS and the questionnaires
      fulfilled by the patients and another clinician applied the laser treatment. All patients
      were warned of not speaking with the laser clinician. Blinding was revealed after all
      participants finished the trial, and all the data were analyzed

      Statistical methods All the analysis was done using SPSS version 25.0 (SPSS Inc. New York,
      NY, USA). Statistical analysis included basic descriptive statistics. Comparison of
      categorical variables was done using chi-square or Fisher's exact test and comparison of
      continuous variables between test and placebo groups was done using Mann-Whitney U test.
      Wilcoxon signed-rank test was used to determine whether the intragroup decreases in the
      different questionnaires were statistically significant. Differences were considered
      significant if p was less than 0.05.
    

Intervention name(s): Photobiomodulation; Placebo
Intervention type(s): Radiation; Radiation
Intervention description(s): Photobiomodulation whit Low-Level Laser Therapy; Device turned off
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized single blind placebo controlled study
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Low-level Laser Therapy; Burning Mouth Syndrome; Photobiomodulation; Visual Analogue Scale; Oral Health Impact Profile; Clinical Trial