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Photobiomodulation versus light-emitting diode (LED) therapy in the treatment of temporomandibular disorder: study protocol for a randomized, controlled clinical trial.

ABSTRACT: BACKGROUND:Temporomandibular disorder (TMD) is described as a subgroup of orofacial pain with a set of signs and symptoms that involve the temporomandibular joint, masticatory muscles, ears, and neck. TMD can occur unilaterally or bilaterally and approximately 70% of the population is affected with at least one sign. The disorder progresses with orofacial pain, muscle pain involving the masticatory and cervical muscles, joint noises (clicks and pops), joint block, mandibular dysfunction, and headache. The etiology can be abnormal occlusion and/or posture, trauma involving local tissues, repetitive microtrauma, parafunctional habits, and an increase in emotional stress. Studies have demonstrated that phototherapy is an efficient option for the treatment of TMD, leading to improvements in pain and orofacial function. METHODS:The aim of the proposed study is to compare the effects of two sources of photobiomodulation in individuals with TMD. A randomized, controlled, double-blind, clinical trial is proposed, which will involve 80 individuals aged 18-65 years allocated to either a laser group or light-emitting diode (LED) group submitted to 12 sessions of phototherapy. The Research Diagnostic Criteria for TMDs will be used to evaluate all participants. Pain will be measured using the visual analog scale and maximum vertical mandibular movement will be determined with the aid of digital calipers. DISCUSSION:This study compares the effects of two modalities of laser therapy on the pain and orofacial function of patients with TMD dysfunction. Photobiomodulation and LED therapy are treatment options for reducing the inflammatory process and pain as well as inducing the regeneration of the target tissue. TRIAL REGISTRATION:ClinicalTrials.gov, NCT03257748 . Registered on 8 August 2017.

SUBMITTER: Langella LG

PROVIDER: S-EPMC5787298 | biostudies-literature | 2018 Jan

REPOSITORIES: biostudies-literature

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Photobiomodulation versus light-emitting diode (LED) therapy in the treatment of temporomandibular disorder: study protocol for a randomized, controlled clinical trial.

Langella Luciana G LG Silva Paula F C PFC Costa-Santos Larissa L Gonçalves Marcela L L MLL Motta Lara J LJ Deana Alessandro M AM Fernandes Kristianne P S KPS Mesquita-Ferrari Raquel A RA Bussadori Sandra Kalil SK

Trials 20180126 1

<h4>Background</h4>Temporomandibular disorder (TMD) is described as a subgroup of orofacial pain with a set of signs and symptoms that involve the temporomandibular joint, masticatory muscles, ears, and neck. TMD can occur unilaterally or bilaterally and approximately 70% of the population is affected with at least one sign. The disorder progresses with orofacial pain, muscle pain involving the masticatory and cervical muscles, joint noises (clicks and pops), joint block, mandibular dysfunction, ...[more]

PMID: 29373998

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Project description:BackgroundRecent research has emphasized that the human circadian rhythm system is differentially sensitive to short wavelength light. Light treatment devices using efficient light-emitting diodes (LEDs) whose output is relatively concentrated in short wavelengths may enable a more convenient effective therapy for Seasonal Affective Disorder (SAD).MethodsThe efficacy of a LED light therapy device in the treatment of SAD was tested in a randomized, double-blind, placebo-controlled, multi-center trial. Participants aged 18 to 65 with SAD (DSM-IV major depression with seasonal pattern) were seen at Baseline and Randomization visits separated by 1 week, and after 1, 2, 3 and 4 weeks of treatment. Hamilton Depression Rating Scale scores (SIGH-SAD) were obtained at each visit. Participants with SIGH-SAD of 20 or greater at Baseline and Randomization visits were randomized to active or control treatment: exposure to the Litebook LED treatment device (The Litebook Company Ltd., Alberta, Canada) which delivers 1,350 lux white light (with spectral emission peaks at 464 nm and 564 nm) at a distance of 20 inches or to an inactivated negative ion generator at a distance of 20 inches, for 30 minutes a day upon awakening and prior to 8 A.M.ResultsOf the 26 participants randomized, 23 completed the trial. Mean group SIGH-SAD scores did not differ significantly at randomization. At trial end, the proportions of participants in remission (SIGH-SAD less than 9) were significantly greater (Fisher's exact test), and SIGH-SAD scores, as percent individual score at randomization, were significantly lower (t-test), with active treatment than with control, both in an intent-to-treat analysis and an observed cases analysis. A longitudinal repeated measures ANOVA analysis of SIGH-SAD scores also indicated a significant interaction of time and treatment, showing superiority of the Litebook over the placebo condition.ConclusionThe results of this pilot study support the hypothesis that light therapy with the Litebook is an effective treatment for SAD.Trial registrationClinicaltrials.gov: NCT00139997.

Project description:INTRODUCTION:Temporomandibular disorder (TMD) is considered the main cause of orofacial pain of non-dental origin, and a public health problem. The symptomatology is muscular and/or articular pain, restriction of the mandibular range of motion, and changes in the mandibular movement pattern. Due to its complexity there are already treatments using various forms of therapy. Photobiomodulation using light sources, such as low-level laser or light emitting diodes (LED), with different wavelengths, in a single or combined form, allows one more therapeutic resource to be explored. The objective of this study is to evaluate the effects of photobiomodulation with the simultaneous use of red and infrared LEDs, on pain, range of mandibular movements, and on the electrical activity of masticatory muscles in individuals with TMD. METHODS:A randomized, controlled, double-blind clinical trial is proposed, which will involve 33 individuals (n?=?11 per group) of both sexes, ages 18 to 45 years in 3 groups: LED group; placebo group; and control group, submitted to 6 non-consecutive sessions of photobiomodulation totaling 2 weeks of treatment. The Research Diagnostic Criteria for Temporomandibular Disorders-RDC/TMD will be used to assess and determine the participants' TMD. The pain will be assessed using the Visual Analog Scale - VAS, the mandibular range of motion will be determined with the aid of a digital caliper, and the electrical activity of the masticatory muscles will be verified by electromyography. A mixed plate of 18 red LEDs-660?nm and 18 infrared LEDs-850?nm with power of 3.5?mW per LED, 4.45?mW/cm, radiant exposure of 5.35?J/cm, will be used for photobiomodulation. The irradiated area will be 14.13?cm, and energy of 75.6?J, in the TMJ region and in the bilateral masseter and temporal muscles. Participants from all groups will be reassessed after the first therapeutic intervention, and at the end of treatment. DISCUSSION:We expect the use of photobiomodulation with LEDs, infra and red, to reduce pain, improve temporomandibular joint function in patients with TMD, and thus improve the general conditions of the patient.

Project description:Skin fibrosis is involved in a variety of pathologic conditions ranging from scar formation secondary to surgery or trauma to immune-mediated processes. Skin fibrosis is a significant international health problem with an estimated incidence of greater than 100 million people affected per year worldwide with few effective treatment options available. Preliminary in vitro data generated by our research group suggests that red light can function as a stand-alone treatment for skin fibrosis. To our knowledge, no prior clinical trials have been performed to determine the safety of high-fluence (dose) light-emitting diode-red light (LED-RL) phototherapy. The goal of this study is to evaluate the safety of LED-RL fluences from 160 J/cm(2) up to 640 J/cm(2) in healthy subjects.This is a single-blind, dose escalation, randomized controlled, phase I study to evaluate the safety of high-fluence LED-RL on human skin. The protocol for dose escalation requires subjects be enrolled sequentially in groups of five. Within each group, three subjects will be randomized to LED-RL phototherapy and two subjects randomized to mock therapy. Subjects in group 1 randomized to LED-RL phototherapy will receive the maximum recommended starting dose (160 J/cm(2)). LED-RL dose will be escalated in subsequent groups (320 J/cm(2), 480 J/cm(2) and 640 J/cm(2)). The maximally tolerated dose (MTD) is defined as the dose level below the dose producing unacceptable but reversible toxicity and is considered to be the upper limit of subject tolerance. After either a MTD has been established, or the study endpoint of 640 J/cm(2) has been achieved, an additional 27 LED-RL phototherapy subjects (for a total of 30) and 18 mock therapy subjects (for a total of 20) (determined randomly) will be enrolled. Each subject will receive a total of nine procedures, three times per week for three consecutive weeks.This study may provide important safety information on the effects of high-fluence LED-RL phototherapy on human skin and help facilitate future phase II studies to evaluate the efficacy of high-fluence LED-RL as a potential noninvasive, safe, portable, at-home therapy for treatment of skin fibrosis.ClinicalTrials.gov NCT02630303 . Registered on 9 December 2015.

Dataset Information

Photobiomodulation versus light-emitting diode (LED) therapy in the treatment of temporomandibular disorder: study protocol for a randomized, controlled clinical trial.

Publications

Photobiomodulation versus light-emitting diode (LED) therapy in the treatment of temporomandibular disorder: study protocol for a randomized, controlled clinical trial.

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