Sleep Bruxism
Conditions
Interventions
This is a randomized controlled clinical trial with two arms, double-blind. Twenty participants with a reported history of sleep bruxism, defined as the patients perception of clenching or grinding th
E02.319
Sponsors
Universidade de São Paulo
Universidade de São Paulo
Eligibility
Age
18 Years to 50 Years
Inclusion criteria
Inclusion criteria: Volunteers of both sexes; age between 18 and 50 years; self-reported teeth clenching and/or grinding during sleep (at least once a week in the last month) or sleep partner or family-reported clenching and/or grinding in the past 3 months; dental wear compatible with possible sleep bruxism, based on clinical evaluation; secondary manifestations related to sleep bruxism, such as discomfort/tension/facial pain (excluding persistent headache or migraine), temporal headache, or jaw locking upon waking; frequent history of tooth or restoration fracture; clinical signs of tongue mucosa indentation and masseter muscle hypertrophy
Exclusion criteria
Exclusion criteria: History of dizziness and syncope; sensitivity to drowsiness induced by alcohol and medications such as muscle relaxants and anxiolytics; history of any type of heart disease, such as tachycardia, arrhythmia, heart failure, and myocardial infarction; diagnosis of obstructive sleep apnea-hypopnea syndrome, periodic limb movement disorder, and insomnia; liver dysfunction; diagnosis of hyperthyroidism or hypothyroidism; pregnancy or suspected pregnancy, postpartum and breastfeeding, as well as the use of oral contraceptives and/or other related methods; use of anxiolytics, antidepressants, sleep inducers, analgesics, and monoamine oxidase inhibitors in the last 14 days; history of cannabis use; report of persistent intense headaches, migraines, facial pain, and temporomandibular joint pain that interfere with daily activities; limited mouth opening of less than 25 mm; history of allergy to electrode gel adhesive; history of severe and persistent gastroesophageal reflux?
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| It is expected to find a reduction of the rhythmic masticatory muscle activity by at least 30% compared to baseline measured by surface electromyography in the pre- and post-intervention measurements with the administration of 5 mg of cyclobenzaprine when compared to placebo | — |
Secondary
| Measure | Time frame |
|---|---|
| It is expected to find an improvement of subjective sleep quality recorded by self-report in the pre- and post-intervention measurements with the administration of 5 mg of cyclobenzaprine when compared to placebo;It is expected to find a reduction of maximum bite force measured by a bite force measuring device in the pre- and post-intervention measurements with the administration of 5 mg of cyclobenzaprine when compared to placebo | — |
Countries
Brazil
Contacts
Public ContactLeonardo Bonjardim
Faculdade de Odontologia de Bauru da Universidade de São Paulo
Outcome results
None listed