Effectiveness of Transcutaneous Auricular Vagus Nerve Stimulation in Bruxism

Bruxism Clinical Trial

Official title:

Investigation of the Effectiveness of Transcutaneous Auricular Vagus Nerve Stimulation in Bruxism- Randomised Controlled Single Blinded Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06386809
• Other study ID #: 2024 -25
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 1, 2024
• Est. completion date: November 1, 2024

Study information

• Verified date: April 2024
• Source: Bandirma Onyedi Eylül University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: November 1, 2024
• Est. primary completion date: August 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Bruxism

Intervention

Device:
• TAVNS
TAVNS is a recently introduced treatment involving transcutaneous electrical stimulation of the auricular branch of the vagus nerve with VAGUSTIM device.

Other:
• Exercise program
Rocabado 6x6 exercises will be applied in our study. Rocabado exercise, which is the most commonly used exercise method in the literature, is a set of exercises for the craniocervical and craniomandibular system.

Locations

Country	Name	City	State
Turkey	Bandirma Onyedi Eylül University	Balikesir

Sponsors (1)

Lead Sponsor	Collaborator
Bandirma Onyedi Eylül University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain Severity	Participants' pain intensity will be assessed using the Visual Analog Scale, is a simple, reliable and short-term method commonly used in the clinic to measure pain intensity.The participant is told that the most severe pain he/she experiences is 10, and if he/she has no pain, the pain intensity is 0. The participant will be asked to mark a number between 0 and 10 corresponding to the intensity of pain in the masticatory muscles at rest and during chewing.	8 weeks
Primary	Oral Health Quality of Life	The Oral Health Impact Profile is revised to comprehensively measure the discomfort, disability and handicap related to oral and dental health. The scale consists of 14 questions in 7 dimensions: functional limitation, physical pain, psychological discomfort, physical disability, psychological disability, social disability and handicap. The lowest score that can be obtained from the scale is 0, while the highest score that can be obtained is 56. A high score indicates poor quality of life.	8 weeks
Primary	Stress Level	The Perceived Stress Scale-14 is a self-report scale designed to assess one's perception of the degree to which a particular situation in daily life is considered stressful. It consists of 14 items and is rated on a 4-point Likert scale ('0: never' to '4: very often'). A high total score indicates a high level of perceived stress.	8 weeks
Primary	Sleep Quality	Pittsburgh Sleep Quality Index will be used to assess the sleep quality of the participants. It assesses sleep duration, sleep disturbance, sleep efficiency, subjective sleep quality, sleep medication use, daytime work disturbance and sleep latency and consists of a total of 24 questions. The total score ranges from 0-21, with 5 and above indicating "poor sleep quality".	8 weeks
Primary	Pressure Pain Threshold	In our study, pressure pain threshold measurement of the dominant and non-dominant side masseter muscle before and after activity will be evaluated with Baseline manual algometer (2.5 kg-11 lb).	8 weeks
Primary	Muscle Activation Measurement	In our study, four-channel 'Neurotrac Myoplus Pro 4 EMG Biofeedback' device will be used for superficial EMG measurements. The EMG work-rest mode of the device will be used in the measurement and the masseter muscle activation during contraction and relaxation will be measured by asking the participant to clench his/her teeth 5 times consecutively, 5 seconds contraction time, 5 seconds relaxation time. Neurotrac PC Software program will be used for electromyographic analysis during the measurement.	8 weeks
Primary	Measurement of heart rate variability/ Autonomic nervous system evaluation	All participants included in the study will undergo a 5-minute heart rate variability measurement test with the Polar H10 chest strap device. The data obtained after the measurement will be analyzed with Kubios program. Stress index (cardiovascular system stress), PNS index (parasympathetic nervous system dominance), SNS index (sympathetic nervous system dominance), LF power (sympathetic activity) and HF power (parasympathetic activity) parameters will be recorded in Kubios program.	8 weeks