Effect of the medication buspirone hydrochloride on teeth grinding as a side effect of anxiety: a previous study

Phase 3

• Conditions: General Anxiety; Bruxism; K07.6

• Registration Number: RBR-89z5hb7
• Lead Sponsor: niversidade Federal do Paraná

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-10-05
• Last Update Posted: 29 May 2023
• Study Completion: 2023-07-30

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

female volunteers, over 18 years old, diagnosed with definitive awake bruxism

Exclusion Criteria

participants who do not agree to participate in this study or who have some cognitive difficulty that prevents them from answering the questionnaires; under 18 years old; individuals with epilepsy; with acute intoxication and/or chronic use of alcohol, hypnotics, analgesics, or antipsychotic drugs; with severe kidney and liver failure; history of seizure; current illness or history of serious neurological or psychiatric disorders; history of chronic musculoskeletal pain; previous diagnosis or signs and symptoms of other chronic temporomandibular disorders; use of prescription drugs or drugs with possible effects on sleep or changes in motor behavior or drug interactions with buspirone hydrochloride; smoking; currently undergoing medical or dental treatment; with some dental characteristics, such as loss of more than two posterior teeth, except third molars and users of complete dentures, removable partial dentures and orthodontic appliances.

Study & Design

• Study Type: Intervention
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
o 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 Outcome Measures

Name	Time	Method
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 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.