Clinical trial NCT06386809: Effectiveness of Transcutaneous Auricular Vagus Nerve Stimulation in Bruxism
Official title: Investigation of the Effectiveness of Transcutaneous Auricular Vagus Nerve Stimulation in Bruxism- Randomised Controlled Single Blinded Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Bruxism
Keywords: bruxism
vagus
stimulation
parasympathetic
Lead sponsor: Bandırma Onyedi Eylül University
Sponsor class: OTHER
First posted: 2024-04-26
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Pain Severity
timeFrame: 8 weeks
measure: Oral Health Quality of Life
timeFrame: 8 weeks
measure: Stress Level
timeFrame: 8 weeks
measure: Sleep Quality
timeFrame: 8 weeks
measure: Pressure Pain Threshold
timeFrame: 8 weeks
measure: Muscle Activation Measurement
timeFrame: 8 weeks
measure: Measurement of heart rate variability/ Autonomic nervous system evaluation
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Balıkesir
country: Turkey
facility: Bandırma Onyedi Eylül University
Study officials:
References: