Effectiveness of Transcutaneous Auricular Vagus Nerve Stimulation in Bruxism

NCT06386809 | Not Yet Recruiting

• 1 other identifier: 2024 -25
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Bruxism

Keywords

bruxism; vagus; stimulation; parasympathetic

Outcome Measures

Primary Outcomes (7)

• 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

• 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

• 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

• 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

• 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

• 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

• 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

Study Arms (2)

TAVNS group

EXPERIMENTAL

Device: TAVNS; Other: Exercise program

Exercise group

OTHER

Other: Exercise program

Interventions

TAVNS DEVICE

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

TAVNS group

Exercise program OTHER

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.

Exercise group; TAVNS group

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bandırma Onyedi Eylül University: lead

Study Sites (1)

Bandırma Onyedi Eylül University

Balıkesir, Turkey (Türkiye)

Location

Related Publications (1)

• Guzel HC, Turkmen OB, Mutlu EK, Turkmen G, Sakar O, Ormeci GO. Effectiveness of Transcutaneous Auricular Vagus Nerve Stimulation in Bruxism: A Randomised, Controlled, Single-Blind Experimental Trial. J Oral Rehabil. 2026 Feb;53(2):493-504. doi: 10.1111/joor.70096. Epub 2025 Nov 10.

  PMID: 41211817 DERIVED

MeSH Terms

Conditions

Bruxism

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases; Habits; Behavior

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assist. Prof. Dr

Study Record Dates

• First Submitted: April 22, 2024
• First Posted: April 26, 2024
• Study Start: May 1, 2024
• Primary Completion: August 1, 2024
• Study Completion: November 1, 2024
• Last Updated: April 26, 2024

Record last verified: 2024-04

Locations

TU (1)