RESUMEN
OBJECTIVES: To test the safety and efficacy of onabotulinum toxin-A (BoNT-A) injections into the masseter and temporalis muscles in patients with symptomatic sleep bruxism. METHODS: Participants 18 to 85 years old with clinically diagnosed sleep bruxism confirmed by polysomnography were enrolled in this randomized, placebo-controlled, 1:1, parallel-design trial with open-label extension. Participants were injected with BoNT-A 200 units (60 into each masseter and 40 into each temporalis) or placebo and were evaluated at 4 to 8 weeks after the initial treatment visit. The primary efficacy endpoint was clinical global impression (CGI), and the secondary efficacy endpoint was a visual analog scale (VAS) of change in bruxism and in pain at 4 to 8 weeks after injection. Exploratory endpoints included modified Montreal Bruxism Questionnaire, Headache Impact Test-6, total Pittsburgh Sleep Quality Index, Epworth Sleepiness Scale, Self-Rated Anxiety Scale, and polysomnography data, including EMG recordings of the masseter and temporalis muscle bruxing events. Adverse events were recorded. RESULTS: Thirty-one participants were recruited and 23 were randomized (19 female, age 47.4 ± 16.9 years). All 13 randomized to BoNT-A and 9 of 10 randomized to placebo completed the study. CGI (p < 0.05) and VAS of change (p < 0.05) favored the BoNT-A group. None of the exploratory endpoints changed significantly, but total sleep time and number/duration of bruxing episodes favored the BoNT-A group. Two participants randomized to BoNT-A reported a cosmetic change in their smile. No dysphagia or masticatory adverse events were reported. CONCLUSIONS: BoNT-A effectively and safely improved sleep bruxism in this placebo-controlled pilot trial. A large multicenter trial is needed to confirm these encouraging data. CLINICALTRIALSGOV IDENTIFIER: NTC00908050. CLASS OF EVIDENCE: This study provides Class II evidence that botulinum injections into the masseter and temporalis muscles improve subjective bruxism and painful symptoms associated with sleep bruxism.
Asunto(s)
Toxinas Botulínicas Tipo A/uso terapéutico , Fármacos Neuromusculares/uso terapéutico , Bruxismo del Sueño/tratamiento farmacológico , Toxinas Botulínicas Tipo A/efectos adversos , Método Doble Ciego , Músculos Faciales , Femenino , Humanos , Inyecciones Intramusculares , Masculino , Persona de Mediana Edad , Fármacos Neuromusculares/efectos adversos , Dolor/tratamiento farmacológico , Satisfacción del Paciente , Proyectos Piloto , Polisomnografía , Resultado del TratamientoRESUMEN
Conditions that affect sleep can impact overall health. More than 70 million Americans suffer from problems with sleep. The purpose of this article is to provide the basic science of sleep physiology and how it relates to disorders that are pertinent to dentistry. Concepts are presented that explain airway dynamics and how the jaw and tongue influence airway obstruction. Additionally, explanation is given on an association between temporomandibularj aw dysfunction and bruxism during sleep.
Asunto(s)
Encéfalo/fisiología , Síndromes de la Apnea del Sueño/complicaciones , Bruxismo del Sueño/etiología , Sueño/fisiología , Obstrucción de las Vías Aéreas/complicaciones , Encéfalo/fisiopatología , Humanos , Mandíbula/patología , Paladar Blando/patología , Síndromes de la Apnea del Sueño/fisiopatología , Bruxismo del Sueño/fisiopatología , Fases del Sueño/fisiología , Trastornos de la Articulación Temporomandibular/etiología , Lengua/patologíaRESUMEN
Sleep disorders affect more than 20 percent of the U.S. population, but less than 7 percent have been medically diagnosed. Dentists are ideally positioned to identify many patients who fall under the grouping of sleep-disordered breathing. This paper presents perspectives on sleep-related issues from various medical specialties with a goal to broaden the dentist's appreciation of this topic and open avenues of communication. Algorithms are proposed to guide dentists following positive screenings for sleep-disordered breathing.