Behavioral Therapy and Self-care vs Thermoformed Occlusal Splints in the Treatment of Masticatory Muscles Pain
Condition: Myalgia of Mastication Muscle
MeSH terms: Myalgia
Study type: Interventional

Summary: 
      The objective of this study was to compare the clinical effectiveness of personalized
      thermoformed occlusal splints together with behavioral and self-care therapy in the
      management of myalgia of the masticatory muscles. A controlled clinical trial was carried out
      with a total of 46 subjects diagnosed with myalgia according to the diagnostic criteria for
      temporomandibular disorders (DC / TMD). All subjects were treated with behavioral and
      self-care therapy (BST) at the beginning of the study, and were then randomized into 4
      groups: behavioral and self-care control group; rigid occlusal splint group; soft occlusal
      splint group and non-occlusive splint group. Follow-ups were carried out at 2, 6 and 10
      weeks, where it was evaluated: pain in the masticatory muscles, mandibular range of motion,
      mandibular functional limitation and occlusal discomfort.
    

Detailed description: 
      Materials and method This randomized controlled clinical trial was conducted between October
      2017 and January 2018 at the Dental Clinic of the Andrés Bello University (Viña del Mar,
      Chile). The study subjects were recruited from the universe of patients seeking treatment for
      jaw pain at the School of Dentistry. All subjects were informed about the study by their
      operator and gave their written consent before starting the study. The protocol, design and
      implementation were approved by the Scientific Ethics Committee of the Faculty of Dentistry
      of the Andrés Bello University, Viña del Mar, Chile (Folio No. 033, October 2017). Which was
      in accordance with the latest version of the Declaration of Helsinki of the World Medical
      Association (World Medical Association Declaration of Helsinki, 2013).

      Sample Size Calculation It was calculated according to a confidence level of 95% and a
      statistical power of 80%. Based on a previous study by Niemelä et al. (Niemelä et al., 2012)
      it was determined that the variance of the main variable (masticatory muscle pain) of the
      reference group is 2.6. In turn, the pain variable was measured on the visual analog scale
      (VAS), where a minimum clinically relevant difference was considered if a 3.5 point decrease
      was achieved on the VAS scale with respect to treatment, a reference that was also considered
      in this study.

      Randomization and interventions. After meeting the inclusion and exclusion criteria, the
      subjects were randomly assigned to four groups through a computationally generated sequence
      "list randomizer" developed by random.org.

      Evaluation methods The initial evaluation, to determine the degree of involvement of axis I,
      was carried out following the symptom questionnaire and clinical examination guidelines
      according to the DC / TMD protocol. Additionally, the questionnaire for the chronic pain
      degree scale (GCPS v2.0) and the functional limitation scale (JFLS-20) of axis II of the DC /
      TMD protocol were applied. In turn, an intraoral clinical examination was performed to
      exclude pain of dental origin. No subject was excluded for odontogenic pain.

      Statistic analysis The demographic characteristics of the sample were reported descriptively.
      The data studied were tested to determine normality by using the Shapiro-Wilk and
      Doornik-Hansen tests, data that were parametric, so they were analyzed with a mixed ANOVA
      test, a factorial part and a repeated means part for the variables degree of chronic pain,
      masticatory muscle pain, mandibular range of motion, functional limitation and occlusal
      discomfort. The level of significance used was established at p 0.05. All statistical
      analysis was performed using Statistical Package for the Social Sciences (SPSS) version 17
      software (IBM, Chicago, USA).
    

Intervention name(s): behavioral and self-care therapy; rigid occlusal splint (ROS); soft occlusal splint (SOS); non-occlusive splint (NOS)
Intervention type(s): Behavioral; Device; Device; Device
Intervention description(s): It is based on the premise that cognition, the process of acquiring knowledge and forming beliefs, is a primary determinant of mood and behavior. The therapy uses behavioral and self-care techniques to identify, correct and prevent behaviors or situations capable of altering the subject's state; Occlusal splint formed in a vacuum from rigid individual sheets of 2 mm thick polyethylene terephthalate (Biolon, Dreve, Unna, Germany).; Occlusal splint formed in a vacuum from 3 mm thick individual soft sheets of ethyl vinyl acetate (Drufosoft, Dreve, Unna, Germany).; non-occlusive splint formed under vacuum from individual sheets of rigid polyethylene terephthalate 2 mm thick (Biolon, Dreve, Unna, Germany), from which the occlusal surfaces were cut and incisal edges, allowing the usual occlusal contact of each subject.
Other intervention name(s): BST; ROS; SOS; NOS
Intervention MeSH terms: Salicylic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: To protect the blinding of the study, it was carried out by two operators: A (examiner) and B (therapist). The treatment of the subjects consisted of 5 sessions: (1) evaluation and diagnosis of recruited subjects, and taking an impression of the upper jaw by operator A; (2) teaching BST and delivery of OS by operator B; (3) first treatment control and BST booster at 2 weeks; (4) second treatment control and BST booster at 6 weeks; (5) third control of treatment and removal of OS if it corresponds to 10 weeks. All controls were performed by operator A in order to use a blind design without the knowledge of the outcome assessor. To protect this, it is explained to the subject that operator A cannot know the treatment that was delivered. Operator B delivered the treatments at random among the subjects selected by operator A after the initial examination, being himself in charge of contacting them and delivering the corresponding treatment.
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: temporomandibular Joint Disorders; myalgia; occlusal splints; cognitive behavioral therapy; pain management