Influence of behavioral therapies on awake bruxism, biopsychosocial factors and orofacial pain

Influence of behavioral therapies on awake bruxism, biopsychosocial factors and orofacial pain: Randomized controlled clinical trial

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

REBEC

Registry ID

RBR-10gz4s59

Enrollment

Unknown

Registered

2021-02-08

Start date

2019-06-10

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

Bruxism

Interventions

Experimental group 1: 30 adults between 18 and 40 years old, of both sexes, will receive therapy by visual and audible biofeedback. Therapy will be performed in 10 sessions, lasting 30 minutes each, t

E02.190.525.123

L01.224.900.685

Eligibility

Age

18 Years to 40 Years

Inclusion criteria

Inclusion criteria: Adults with at least 24 teeth; diagnosed with awake bruxism; body mass index (BMI) between 18.5 and 24.9 kg, considered normal; and good general health.

Exclusion criteria

Exclusion criteria: Individuals under medical, psychological or pharmacological treatment; individuals that have received any therapy for awake or sleep bruxism in the past 12 months; patients with any type of prosthesis, orthodontic appliances, and those with neuropathic pain, primary headache or neuralgias.

Design outcomes

Primary

Measure	Time frame
It is expected to find, by using surface electromyography, a reduction of at least 10% of the masseter muscles activity in the pre and post-intervention measurements	—

Secondary

Measure	Time frame
It is expected to find, with the pressure pain threshold test by using a digital algometer, a reduction of at least 30% sensitivity of the masseter and temporal muscles, in the pre and post-intervention measurements;It is expected to find, by means of the Perceived Stress Scale questionnaire, a reduction of at least 20% in stress levels, in the pre and post-intervention measurements;It is expected to find, by means of the Hospital Anxiety and Depression Scale questionnaire, a reduction of at least 20% in anxiety levels, in the pre and post-intervention measurements.;It is expected to find, by means of the Hospital Anxiety and Depression Scale questionnaire, a reduction of at least 20% in depression levels, in the pre and post-intervention measurements.;It is expected to find, by means of the WHOQOL-bref questionnaire, an improvement of at least 10% in quality of life scores, in the pre and post-intervention measurements	—

Measure

Time frame

It is expected to find, with the pressure pain threshold test by using a digital algometer, a reduction of at least 30% sensitivity of the masseter and temporal muscles, in the pre and post-intervention measurements;It is expected to find, by means of the Perceived Stress Scale questionnaire, a reduction of at least 20% in stress levels, in the pre and post-intervention measurements;It is expected to find, by means of the Hospital Anxiety and Depression Scale questionnaire, a reduction of at least 20% in anxiety levels, in the pre and post-intervention measurements.;It is expected to find, by means of the Hospital Anxiety and Depression Scale questionnaire, a reduction of at least 20% in depression levels, in the pre and post-intervention measurements.;It is expected to find, by means of the WHOQOL-bref questionnaire, an improvement of at least 10% in quality of life scores, in the pre and post-intervention measurements

—

Countries

Brazil

Contacts

Public ContactMariana Souza

Faculdade de Odontologia de Piracicaba - UNICAMP

mariana_mbcs@hotmail.com+55 (19) 99171-6006

Outcome results

None listed

Source: REBEC (via WHO ICTRP)