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

Luciana G Langella, Paula F C Silva, Larissa Costa-Santos, Marcela L L Gonçalves, Lara J Motta, Alessandro M Deana, Kristianne P S Fernandes, Raquel A Mesquita-Ferrari, Sandra Kalil Bussadori, Luciana G Langella, Paula F C Silva, Larissa Costa-Santos, Marcela L L Gonçalves, Lara J Motta, Alessandro M Deana, Kristianne P S Fernandes, Raquel A Mesquita-Ferrari, Sandra Kalil Bussadori

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.

Keywords: Light-emitting diode (LED); Photobiomodulation; Temporomandibular disorder.

Conflict of interest statement

Ethics approval and consent to participate

This protocol study received approval from the Human Research Ethics Committee of University Nove de Julho (São Paulo, Brazil) under process number 1.706.160. All potential participants will receive clarifications regarding the objectives and procedures and those who agree to participate voluntarily will sign a statement of informed consent, as stipulated in Resolution 196/96 of the Brazilian National Board of Health.

Consent for publication

Written informed consent for publication of their clinical details and/or clinical images will be obtained from the patient/parent/guardian/relative of the patient. A copy of the consent form will be available for review by the Editor of this journal.

Competing interests

The authors declare that they have no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
The SPIRIT Statement is important to detail the methodology, ensuring a high quality of clinical trial protocols
Fig. 2
Fig. 2
Flow chart illustrating phases of study (CONSORT, 2010)

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