Effectiveness of two physical therapy interventions, relative to dental treatment in individuals with bruxism: study protocol of a randomized clinical trial

BACKGROUND Bruxism is a parafunctional habit characterized by grinding and/or clenching of the teeth. It may happen while awake (awake bruxism) or while sleeping (sleep bruxism). In adults, the prevalence is 20% for the awake bruxism and 8% for the sleep bruxism. Peripheral, central, and psychosocial factors influence the disorder, which may predispose to pain in the masticatory muscles and neck, headache, decreased pain thresholds in the masticatory and cervical muscles, limitation mandibular range of motion, sleep disorders, stress, anxiety, depression, and overall impairment of oral health. The aim of this study is to compare two distinct physical therapy interventions with dental treatment in pain, mandibular range of motion, sleep quality, anxiety, stress, depression, and oral health in individuals with bruxism. METHODS/DESIGN Participants will be randomized into one of three groups: Group 1 (n=24) intervention will consist of massage and stretching exercises; Group 2 (n=24) will consist of relaxation and imagination therapies; and Group 3 (n=24) will receive dental treatment. The evaluations will be performed at baseline, immediately after treatment, and at 2-month follow-up. Pain intensity will be assessed using the visual analogical scale, while pain thresholds will be determined using dolorimetry. Mandibular range of motion will be assessed using digital pachymeter. Sleep quality will be assessed by the Pittsburgh Sleep Quality Index, anxiety by the State-Trait Anxiety Inventory, stress by the Perceived Stress Scale-10, depression by the Beck Depression Inventory, and oral health will be assessed using the Oral Health Impact Profile--14. Significance level will be determined at the 5% level. DISCUSSION This project describes the randomization method that will be used to compare two physical therapy interventions with dental treatment in the management of pain, mandibular range of motion, sleep quality, anxiety, stress, depression, and oral health in individuals with bruxism. The study will support the practice of evidence-based physical therapy for individuals with bruxism. Data will be published after study is completed. TRIAL REGISTRATION ClinicalTrials.gov, NCT01778881.