Effectiveness of Transcutaneous Auricular Vagus Nerve Stimulation in Bruxism

April 24, 2024 updated by: Hazel Çelik Güzel, Bandırma Onyedi Eylül University

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Balıkesir, Turkey
        • Bandırma Onyedi Eylül University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: TAVNS group
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.
Other: Exercise group
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain Severity
Time Frame: 8 weeks
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
Time Frame: 8 weeks
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
Time Frame: 8 weeks
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
Time Frame: 8 weeks
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
Time Frame: 8 weeks
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
Time Frame: 8 weeks
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
Time Frame: 8 weeks
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bandırma Onyedi Eylül University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2024

Primary Completion (Estimated)

August 1, 2024

Study Completion (Estimated)

November 1, 2024

Study Registration Dates

First Submitted

April 22, 2024

First Submitted That Met QC Criteria

April 24, 2024

First Posted (Actual)

April 26, 2024

Study Record Updates

Last Update Posted (Actual)

April 26, 2024

Last Update Submitted That Met QC Criteria

April 24, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024 -25

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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