Effectiveness of the Mindfulness-Based Intervention in the Management of Awake Bruxism: A Randomized Controlled Clinical Trial

• Grant number: 25/15283-5
• Support Opportunities: Scholarships in Brazil - Master
• Start date: September 01, 2025
• End date: June 30, 2027
• Field of knowledge: Health Sciences - Dentistry
• Principal Investigator: Laís Valencise Magri
• Grantee: Victor Hugo Alves Ribeiro Silva
• Host Institution: Faculdade de Odontologia de Ribeirão Preto (FORP). Universidade de São Paulo (USP). Ribeirão Preto , SP, Brazil
• Associated research grant: 24/23302-7 - EFFECTIVENESS OF MINDFULNESS-BASED INTERVENTION IN CONTROLLING AWAKE BRUXISM: A RANDOMIZED CONTROLLED CLINICAL TRIAL, AP.R

Abstract

Introduction: Awake bruxism (AB) is defined as a masticatory muscle activity involving cognitive, behavioral, and emotional components. Mindfulness refers to an innate trait of being attentively and consciously present in the moment in a non-reactive and non-judgmental way. Mindfulness-based interventions aim to enhance mindfulness levels, leading to positive outcomes in cognitive, behavioral, and emotional domains. To date, no studies have explored the relationship between AB and mindfulness (trait or intervention). Objective: To evaluate the effectiveness of a mindfulness-based intervention in reducing AB, with respect to episode frequency, associated cognitive-behavioral-emotional aspects, and complementary variables (electromyographic, salivary, and stress/anxiety biomarkers). Materials and Methods: A randomized controlled clinical trial will be conducted with 96 young adults (aged 18 to 45 years) of both genders diagnosed with AB. Participants will be randomly allocated into four groups: Mindfulness Group (MG, n=24), which will receive an eight-week mindfulness-based intervention; Ecological Momentary Intervention Group (EMIG, n=24), which will receive a four-week EMI; Mindfulness + EMI Group (MEMIG, n=24), which will undergo an eight-week mindfulness-based intervention combined with EMI during the first four weeks; and Control Group (CG, n=24), which will receive no intervention. The following assessments will be conducted: AB evaluation (self-report and clinical inspection), one-week Ecological Momentary Assessment using the BruxApp® application, complementary assessments (surface electromyography during a focused attention task, intraoral acidity and xerostomia, assessment of risk factors, etiological factors, and comorbid conditions related to AB - Axis B of the Standardised Tool for the Assessment of Bruxism), quantification of salivary alpha-amylase and cortisol, and additional questionnaires (Perceived Stress Scale - PSS-10 and Five Facets of Mindfulness Questionnaire - FFMQ). Data will be collected at four time points: T0 (baseline), T1 (week 5, after four weeks of intervention), T2 (week 9, after completion of the mindfulness-based intervention), and T3 (three months after T2). Data analysis will include descriptive statistics and specific statistical tests: repeated measures ANOVA with Bonferroni post-hoc tests to evaluate intervention effectiveness, and linear regression to investigate the relationship between mindfulness and reduction in AB episodes. A significance level of 5% will be adopted. Main Expected Outcomes: Intervention groups will show a mean reduction of more than 60% in AB episode frequency, with the following comparisons: MG - T0 vs. T2, EMIG - T0 vs. T1, and MEMIG - T0 vs. T1 and T1 vs. T2. Mindfulness is expected to exert an additional positive effect on the cognitive-behavioral-emotional aspects associated with AB. Groups receiving mindfulness-based interventions (MG and MEMIG) are expected to maintain the reduction in AB episodes at T3 compared to the group receiving only EMI (indicating more lasting results).