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The effect of transdermal devices on bruxism

Evaluation of a Transdermal Device for the complementary treatment of Bruxism

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-3n8w4pc
Enrollment
Unknown
Registered
2025-07-07
Start date
2024-01-20
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

Temporomandibular Joint Disorders

Interventions

This is a pilot, open-label, single-arm clinical trial. Study group: 10 patients, men and women aged between 18 and 70 years, diagnosed with bruxism for more than five years, who are indicated for bru

Sponsors

Faculdade de Ciências Médicas e da Saúde da Pontifícia Universidade Católica de São Paulo
Lead Sponsor
Faculdade de Ciências Médicas e da Saúde da Pontifícia Universidade Católica de São Paulo
Collaborator

Eligibility

Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: Male and female patients. Age range between 18 and 70 years old. Report of severe bruxism. Who do or do not use myorelaxing interocclusion plates

Exclusion criteria

Exclusion criteria: Patients with mild bruxism. Patients with bruxism in sporadic situations. Patients reporting allergies to lidocaine. Patients with skin lesions on the face

Design outcomes

Primary

MeasureTime frame
It is expected to find a reduction in pain, assessed by Visual Analogue Scale – VAS, to at least moderate pain. Data collected before treatment and at the end of treatment, 30 days;The transposition of a 5% lidocaine patch as an adjuvant treatment for patients with severe or moderate sleep bruxism provided muscle relaxation, with a reduction in orofacial pain, good acceptance and improved sleep quality without causing adverse reactions.

Secondary

MeasureTime frame
No secondary outcomes are expected

Countries

Brazil

Contacts

Public ContactMarli Gerenutti

Faculdade de Ciências Médicas e da Saúde da Pontifícia Universidade Católica de São Paulo

marli.gerenutti@gmail.com+55 (15)991550151

Outcome results

None listed

Source: REBEC (via WHO ICTRP)