EFFECTIVENESS OF MINDFULNESS-BASED INTERVENTION IN CONTROLLING AWAKE BRUXISM: A RANDOMIZED CONTROLLED CLINICAL TRIAL

• Grant number: 24/23302-7
• Support Opportunities: Regular Research Grants
• Start date: August 01, 2025
• End date: July 31, 2027
• Field of knowledge: Health Sciences - Dentistry
• Principal Investigator: Laís Valencise Magri
• Grantee: Laís Valencise Magri
• Host Institution: Faculdade de Odontologia de Ribeirão Preto (FORP). Universidade de São Paulo (USP). Ribeirão Preto , SP, Brazil
• City of the host institution: Ribeirão Preto
• Associated researchers: Christie Ramos Andrade Leite Panissi ; Edilaine Cristina da Silva Gherardi Donato ; Jardel Francisco Mazzi Chaves ; Kranya Victoria Diaz Serrano ; Melissa de Oliveira Melchior
• Associated scholarship(s): 25/16735-7 - Profile of Awake Bruxism Patients Responsive to Ecological Momentary Intervention: A Subanalysis of a Randomized Clinical Trial, BP.IC; 25/15283-5 - Effectiveness of the Mindfulness-Based Intervention in the Management of Awake Bruxism: A Randomized Controlled Clinical Trial, BP.MS

Abstract

Awake bruxism (AB) is defined as a masticatory muscle activity involving cognitive-behavioral-emotional components. Mindfulness refers to an innate ability to remain attentive and aware of the present moment in a non-reactive and non-judgmental manner, with mindfulness-based interventions aiming to enhance this ability and yield positive outcomes in cognitive-behavioral-emotional aspects. To date, no studies have explored the relationship between AB and mindfulness, whether as a trait or through interventions. This study aims to analyze the effectiveness of a mindfulness-based intervention in reducing AB episodes, addressing associated cognitive-behavioral-emotional aspects and complementary variables (electromyographic, salivary, and stress/anxiety biomarkers). A randomized controlled clinical trial will be conducted with 96 young adults (18-45 years) of both genders diagnosed with AB, divided into four groups: Mindfulness Group (MG, n=24), receiving an eight-week mindfulness-based intervention; Ecological Momentary Intervention Group (EMIG, n=24), receiving a four-week ecological momentary intervention (EMI); Mindfulness + EMI Group (MEMIG, n=24), receiving an eight-week mindfulness-based intervention combined with EMI during the first four weeks; and Control Group (CG, n=24), receiving no intervention. Assessments will include AB evaluation (self-report and clinical inspection), one-week ecological momentary assessment using the BruxApp®, complementary evaluations (surface electromyography during focused attention tasks, intraoral acidity and xerostomia analysis, evaluation of risk/etiological factors and comorbidities related to AB-Axis B of the Standardised Tool for the Assessment of Bruxism), salivary cortisol and alpha-amylase quantification, and 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, T2-week 9, and T3-three months post-T2) and analyzed using repeated measures ANOVA with Bonferroni post-hoc tests to evaluate intervention efficacy and linear regression to investigate the relationship between mindfulness and AB episode reduction. Expected outcomes include a mean reduction of over 60% in AB episode frequency in the intervention groups (MG-T0 vs. T2, EMIG-T0 vs. T1, and MEMIG-T0 vs. T1 and T1 vs. T2), a positive additional effect of mindfulness on the cognitive-behavioral-emotional aspects of AB, and sustained reductions in AB episodes at T3 in groups receiving mindfulness-based interventions (MG and MEMIG) compared to the group receiving only EMI, demonstrating longer-lasting results. (AU)