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

Effect of buspirone hydrochloride on awake bruxism as a somatic manifestation of anxiety: a pilot study

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
REBEC
Registry ID
RBR-89z5hb7
Enrollment
Unknown
Registered
2022-10-05
Start date
2022-11-30
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

General Anxiety

Interventions

Buspirone Group: formed by 7 women who will use the medication buspirone hydrochloride every 8 hours, for 90 days
Placebo Group: formed by 7 women who will use placebo medication every 8 hours, for 90 days
Non-pharmacological group: formed by 7 women who will receive Google Forms links via Whatsapp, for 90 days. The minimum daily dose of the buspirone hydrochloride is 5mg every 8 ours and the optimal th

Sponsors

Universidade Federal do Paraná
Lead Sponsor
Universidade Federal do Paraná
Collaborator

Eligibility

Sex/Gender
Female
Age
18 Years to No maximum

Inclusion criteria

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

Exclusion criteria

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.

Design outcomes

Primary

MeasureTime frame
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

MeasureTime 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 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

jordanasenff@hotmail.com+55(48)999122134

Outcome results

None listed

Source: REBEC (via WHO ICTRP)