Effectiveness of Transcutaneous Auricular Vagus Nerve Stimulation in Bruxism

Bandırma Onyedi Eylül University

Status

Not yet enrolling

Conditions

Bruxism

Treatments

Device: TAVNS

Other: Exercise program

Study type

Interventional

Funder types

Other

Identifiers

NCT06386809

2024 -25

Details and patient eligibility

About

Our study aimed to investigate the effects of transcutaneous auricular vagus nerve stimulation (TAVNS) application on treatment efficacy in bruxism in terms of masseter muscle activity, pain, stress level, sleep and life quality, and autonomic functions.

Full description

Our study was designed as a randomized, single-blind experimental clinical trial. It was planned to include 40 individuals diagnosed with bruxism in our research. Outcome measurements and assessments will be performed immediately after the participants are recruited and at the end of the 8-week program. Pain intensity, oral health quality of life, stress level and sleep quality will be assessed by self-report through questionnaires. Pressure pain threshold and muscle activation for the masseter muscle and heart rate variables measurements will be performed by physiotherapists. After completing the initial evaluations, the participants will be randomly divided into two groups. An eight-week exercise program will be applied to the control group. In the TAVNS group, in addition to the eight-week exercise program, TAVNS will be used twice weekly for 16 sessions with the VAGUSTIM device.

Enrollment

40 estimated patients

Sex

All

Ages

20 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Diagnosed with bruxism between the ages of 18-65,
A history of bruxism for at least 6 months,
Individuals with masseter muscle pain GAS≥4 at rest and during mastication

Exclusion criteria

Masseter botox application in the last 6 months,
Regular use of analgesics and anti-inflammatories that affect the OSS,
Presence of infection or tumoral structures within intraoral structures,
Wearing multiple ear piercings,
With TMJ disc displacement and joint degeneration,
Musculoskeletal problem with evidence of cervical or TMJ fracture, systemic disease, specific pathologic condition,
Any surgical operation related to a cervical or TMJ problem,
Less than 6 months of cervical or TMJ-related physiotherapy and rehabilitation services,
The one with facial paralysis,
Diagnosed psychiatric illness