Bruxism
Conditions
Interventions
-Buspirone Group: formed by 33 participants with awake bruxism who will use the oral medication buspirone hydrochloride every 8 hours, for 90 days
-Placebo Group: formed by 33 participants with awake bruxism who will use oral placebo medication every 8 hours for 90 days
-Non-pharmacological group (non-treatment): formed by 33 participants with awake bruxism who will use the “BruxApp” application everyday for 90 days.
The minimum daily dose of the buspirone hydrochlor
Sponsors
Universidade Federal do Paraná
Universidade Federal do Paraná
Eligibility
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Both sexes; Older than 18 years; Diagnosis of probable sleep bruxism and definite awake bruxism
Exclusion criteria
Exclusion criteria: Under 18 years old; Epilepsy and seizure; Acute intoxication and/or chronic use of alcohol, hypnotics, analgesics, or antipsychotic drugs; Smokers; Consumption of more than three cups of coffee per day; Severe kidney and liver failure; • Severe neurological or psychiatric disorders; History of chronic musculoskeletal pain; Previous diagnosis or signs and symptoms of chronic TMD and sleep disorders (snoring, sleep apnea, and periodic limb movement); Use of prescription drugs or drugs with possible effects on sleep or changes in motor behavior or drug interactions with buspirone hydrochloride; Gastroesophageal reflux; Enlarged tonsils; BMI > 30; Allergy to electrode gel; Currently undergoing medical or dental treatment; Pregnant women; Users of pacemaker or implanted defibrillator; Loss of more than two posterior teeth, except third molars; Users of complete dentures, removable partial dentures and orthodontic appliances; Skeletal Class II
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the effect of buspirone hydrochloride on the frequency of awake bruxism as a somatic manifestation of anxiety , through a symptom questionnaire and through the Diagnostic Criteria for Temporomandibular Disorders (CD) /TMD), Generalized Anxiety Disorders Questionnaire (GAD-7), Depression Symptom Severity Questionnaire (PHQ-9), and Oral Behavior Verification Questionnaire (OBC), clinical assessment when the presence of signs of brain activity bruxism, electromyography exam (EMG - NeuroUp) and ecological assessment method (EMA) through apps. The frequency of bruxism as a somatic manifestation of anxiety is expected to decrease with the use of buspirone hydrochloride. | — |
Secondary
| Measure | Time frame |
|---|---|
| to evaluate the association between wakefulness bruxism Anxiety, verified by the GAD-7 entity. We will see if there is an association between wakefulness bruxism and anxiety.;To evaluate the association between wakefulness bruxism and Anxiety and Depression, verified by the PHQ-9 questionnaires. We will observe if there is an association between wakefulness bruxism and depression.;To evaluate the impact of buspirone hydrochloride on Anxiety, verified through the GAD-7 questionnaire. We will see if there is a reduction in anxiety with the use of medication.;To evaluate the impact of buspirone hydrochloride on Depression, verified through the PHQ-9 questionnaire. We will see if there is a reduction in depression with the use of medication.;To evaluate the alteration pattern caused by buspirone hydrochloride in the electromyography exam, verified by the electromyography exam itself. We will observe if there is any kind of change in the electromyography exam with the use of medication. | — |
Countries
Brazil
Contacts
Public ContactJordana Senff
Universidade Federal do Paraná
Outcome results
None listed