An interventional study of TAVNS and Exercise program in Bruxism, sponsored by Bandırma Onyedi Eylül University. Not yet recruiting at 1 site in Turkey. Open to participants aged 20 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-04-26.
Sponsored by Bandırma Onyedi Eylül University · Not applicable, Interventional, and Treatment
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.
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.
151 studies on the registry are indexed under Bruxism; 39 are open to participants now.
This study's planned enrollment of 40 is close to the median of 39 across 94 interventional studies indexed under Bruxism.
Browse Bruxism studies →Bandırma Onyedi Eylül University is the lead sponsor of 70 studies on the registry; 19 are open to participants now.
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Device: TAVNS · Other: Exercise program
Other: Exercise program
TAVNS is a recently introduced treatment involving transcutaneous electrical stimulation of the auricular branch of the vagus nerve with VAGUSTIM device.
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.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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".
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 8 weeks
Start is estimated for May 2024; primary completion for Aug 2024, 3 months later.
Of 59 non-industry interventional studies with no phase under Bruxism, half reached primary completion within 8 months of starting (the median), counting those still running; a quarter within 3 and three quarters within 13. This study's planned 3 months is below that.
Counting every sponsor, half of 60 studies reached it within 7 months; a quarter within 3 and three quarters within 13.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.
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Bandırma Onyedi Eylül University