Patients and methods
myofascial pain, TCTR, pain, tenderness, trismus
TEMPOROMANDIBULAR DISORDERS, MYOFASCIAL PAIN, TRISMUS, GROUP B
This study was a non-invasive, case–control, randomized and double-blind clinical trial. It has been conducted at the Oral and Maxillofacial Surgery Unit of the Dental Teaching Hospital, from October 2019 to August 2020, according to the ethical principles and in compliance with the Declaration of Helsinki and its later amendments.The included patients were undergraduate students in the College of Dentistry who presented with myofascial pain with or without limitation (Axis Ιa and Ιb) according to the Diagnostic Criteria for Temporomandibular Disorders (DC/TMD) [A flow diagram showing patients enrollment along the 3 groupsSample size was determined by means of G Power 3.1 software. Informed consent was taken from all participants. Randomization to divide those patients into 3 groups was done by Microsoft Excel 2016, which used to create permuted blocks to ensure that all treatment groups will have the same number of patients. Group A (placebo control group) were managed by applying the red LED light device near the tender points without switching the machine on. Group B (study group) received red LED light to the tender sites that applied for 5 min to each point (masseter, temporalis and pre-auricular muscle areas) extra orally according to the manufacturer instructions. In group C (study group), the patients were treated using low-level LASER therapy applied for 30 s on the affected points (masseter, temporalis and pre-auricular muscle areas) extra orally. The LED light device used in the current study had a wavelength of 660 nm (red light) with a power of 1.6 Watt, which is equivalent to 1.6 J of work per second. The Diode LASER had the following parameters: wavelength = 810 nm, 2.5 Hz, and power = 1 Watt. Additional sessions of LASER were given to group A patients who still complaining from pain related to TMD; all patients were followed up until complete relief of pain.The initial diagnosis and subsequent evaluations of the treatment progress were made by an independent Maxillofacial Surgeon along 4 visits (1 week interval between each visit); the last one (4th visit) was just a follow-up appointment without any intervention. Any change in the pain score, presence of tenderness in the muscles of mastication (number of trigger points), trismus and/or side effects were assessed and reported.The treatments for both study groups in the first 3 visits were achieved by other operators. Both participants and the independent maxillofacial surgeon did not know the type of treatment offered to the patients. This clinical trial was prospectively registered (TCTR ID: TCTR20190507002) on 07/05/2019. The study protocol was approved by the Research Ethics Committee (Institutional Review Board).The statistical analysis was performed using GraphPad Prism version 6.0 for Windows (GraphPad Software, La Jolla, CA, USA). Descriptive statistical analysis included demographic data, calculation of percentage, mean ± standard deviation (SD), and median. Shapiro–Wilk test was utilized to check the normality of data distribution. Mann–Whitney 