An interventional study of Jaw exercise therapy and Somatosensory Awareness-Based Training in Bruxism, sponsored by Aydin Adnan Menderes University. Recruiting at 2 sites in Turkey (Türkiye). Open to participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2026-01-13.
Sponsored by Aydin Adnan Menderes University · Not applicable, Interventional, and Treatment
Awake bruxism (daytime teeth clenching or jaw tension) is a common condition that can cause jaw pain, facial pain, muscle fatigue, and reduced quality of life. Although current treatments often focus on the jaw muscles and posture, recent research suggests that changes in the brain's sensory processing may also play an important role in bruxism-related pain.
This randomized controlled trial aims to compare two physiotherapy-based treatment approaches with a wait-list control group in adults with awake bruxism. Participants will be randomly assigned to one of three groups: (1) somatosensory awareness-based training, (2) jaw and posture exercise therapy, or (3) a wait-list control group.
The somatosensory training program focuses on improving body awareness and sensory perception of the face and jaw, while the exercise program includes jaw mobility, postural alignment, and cervical exercises. Both active interventions will be delivered over a 4-week period. Participants will be assessed at baseline, immediately after treatment, and during follow-up to evaluate changes over time.
The main outcome of this study is orofacial pain intensity. Secondary outcomes include jaw function, sensory processing, muscle structure, oral parafunctional behaviors, and oral health-related quality of life. The results of this study may help improve physiotherapy-based treatment strategies for people with awake bruxism by addressing both physical and sensory aspects of the condition.
Awake bruxism is a repetitive jaw muscle activity occurring during wakefulness and is frequently associated with orofacial pain, muscle fatigue, functional limitations, and reduced oral health-related quality of life. Increasing evidence suggests that bruxism-related pain cannot be fully explained by peripheral mechanisms alone and that central nervous system processes, including maladaptive neuroplasticity and somatosensory cortical reorganization, may play a key role in symptom persistence. Distortions in somatosensory processing, such as impaired tactile acuity, altered laterality recognition, and disrupted facial emotion recognition, have been reported in individuals with chronic orofacial pain.
This single-blind, parallel-group, randomized controlled pilot trial aims to investigate whether a somatosensory awareness-based training program leads to greater improvements in pain, function, and somatosensory processing compared with a conventional jaw and posture exercise program and a wait-list control group in individuals with awake bruxism.
The study will be conducted at the Physiotherapy and Rehabilitation Unit and the Faculty of Dentistry of Aydın Adnan Menderes University. Participant recruitment is planned between December 2025 and September 2026. Eligible participants will be adults aged 18-45 years with a diagnosis of awake bruxism confirmed by an expert dentist using the Standardised Tool for the Assessment of Bruxism (STAB) and DC/TMD Axis I criteria. Additional inclusion criteria include self-reported daytime clenching behavior, baseline orofacial pain intensity of at least 5/10, and the presence of at least one measurable somatosensory impairment identified during clinical or digital assessment. Individuals with severe disability (GCPS Grade IV), systemic inflammatory or neurological disorders, recent jaw-related treatments, or conditions that may interfere with participation will be excluded.
Following baseline assessment (T0), participants will be randomly allocated in a 1:1:1 ratio to one of three groups using stratified block randomization based on age and sex. Allocation concealment will be ensured using sequentially numbered, sealed opaque envelopes managed by an independent research assistant. Due to the nature of the interventions, participant and therapist blinding will not be possible; however, all outcome assessments and data analyses will be performed by assessors blinded to group allocation.
151 studies on the registry are indexed under Bruxism; 39 are open to participants now.
This study's planned enrollment of 20 is below the median of 39 across 94 interventional studies indexed under Bruxism.
Browse Bruxism studies →Aydin Adnan Menderes University is the lead sponsor of 241 studies on the registry; 51 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants assigned to this group will receive a somatosensory retraining and patient education program based on CRAFTA principles. The intervention focuses on tactile and proprioceptive stimulation, body awareness, and body schema-oriented techniques, including tasks such as two-point discrimination training, light touch awareness, mirror-based posture observation, and self-monitoring of parafunctional behaviors. No conventional strengthening or mobility exercises will be provided. Participants will complete daily awareness-based home tasks, and adherence will be monitored weekly through brief structured follow-ups conducted by a research assistant.
Other: Somatosensory Awareness-Based Training
Participants in this group will receive a structured physiotherapy program based on previously published protocols. The intervention includes jaw mobility and relaxation exercises, postural alignment and scapular stabilization exercises, and cervical stretching and strengthening exercises. Participants will attend supervised face-to-face sessions twice weekly for four weeks and will also receive a home exercise booklet.
Other: Jaw exercise therapy
Participants in the wait-list group will not receive any active intervention during the first four weeks but will continue their usual daily routines. They will be assessed at the same time points as the intervention groups to allow comparison of natural symptom progression. After completion of the primary endpoint assessment, participants in this group will be offered an active intervention according to clinical need.
Other: Wait-List Control
Participants assigned to this group receive a structured jaw and posture exercise therapy program delivered by a physiotherapist. The intervention consists of supervised face-to-face sessions twice per week over a 4-week period, combined with a home exercise program performed on non-supervised days. The program includes jaw mobility and relaxation exercises, postural correction and stabilization exercises, and cervical region exercises. In addition, manual therapy techniques are applied as clinically indicated, including ischemic trigger point therapy, cervical joint mobilization, and intraoral manual techniques. Each treatment session lasts approximately 40-45 minutes. Adherence to the home exercise program is monitored throughout the intervention period.
Also known as: exercise therapy
Participants in this group receive an individualized somatosensory awareness-based training program designed to target altered sensory perception and body schema related to the face and jaw. The intervention focuses on laterality recognition, body schema representation, and tactile discrimination, including two-point discrimination-based tasks. No conventional exercise therapy or manual therapy techniques are provided in this group. The training is delivered using a flexible, patient-specific approach, supported by structured guidance materials aimed at increasing daily awareness and self-monitoring of somatosensory experiences. Participant adherence and engagement are monitored through regular follow-up and self-report tracking.
Also known as: Somatosensory training, Sensorimotor awareness training
Participants allocated to the wait-list control group do not receive any active treatment during the initial study period and continue their usual daily activities. All outcome assessments are conducted at the same time points as the intervention groups. After completion of the assessment phase, participants in this group are offered exercise therapy according to clinical need.
Orofacial Pain-Related Disability
Orofacial pain-related disability will be assessed using the Craniofacial Pain and Disability Inventory (CF-PDI). The CF-PDI is a self-reported questionnaire evaluating pain-related functional limitations, psychosocial impact, and disability. The Craniofacial Pain and Disability Inventory (CF-PDI) total score ranges from 0 to 100, with higher scores indicating greater pain-related disability.
Time frame: Baseline, Week 4 (post-intervention), Week 6, Week 12
Orofacial Pain Intensity
Orofacial pain intensity will be assessed using a 0-10 Visual Analog Scale (VAS), where 0 indicates "no pain" and 10 indicates "worst imaginable pain." Participants will rate their current orofacial pain intensity at the time of assessment.
Time frame: Baseline, Week 4 (post-intervention), Week 6, Week 12
Mandibular Range of Motion
Mandibular range of motion will be assessed using standardized clinical measurements, including maximum mouth opening, lateral excursion (right and left, averaged), and protrusion, recorded in millimeters. Higher values indicate greater mandibular mobility.
Time frame: Baseline, Week 4 (post-intervention), Week 6, Week 12
Masseter Muscle Thickness
Masseter muscle thickness will be assessed using ultrasound imaging and recorded in millimeters (mm). Changes in muscle thickness over time will be evaluated as an indicator of structural and neuromuscular adaptation. No a priori assumption will be made regarding the direction of change.
Time frame: Baseline, Week 12
Oral Parafunctional Behaviors
The Oral Behaviors Checklist (OBC) assesses the frequency of oral parafunctional behaviors. The total score ranges from 0 to 84, with higher scores indicating more frequent oral behaviors.
Time frame: Baseline, Week 4 (post-intervention), Week 12
Facial Emotion Recognition Accuracy
Facial emotion recognition will be assessed using a standardized computerized task. The primary metric will be accuracy (%), with higher values indicating better emotion recognition performance.
Time frame: Baseline, Week 4 (post-intervention), Week 6, Week 12
Oral Health-Related Quality of Life
Oral health-related quality of life will be evaluated using the Oral Health Impact Profile-14 (OHIP-14). The Oral Health Impact Profile-14 (OHIP-14) total score ranges from 0 to 56, with higher scores indicating worse oral health-related quality of life.
Time frame: Baseline, Week 4 (post-intervention), Week 12
Bruxism severity
Bruxism severity will be assessed using the Bruxism Severity Questionnaire (BSQ), which evaluates the frequency and impact of awake bruxism-related behaviors and symptoms. The Bruxism Status Questionnaire (BSQ) is a 20-item yes/no questionnaire developed to support the clinical evaluation of bruxism. The BSQ is used to provide descriptive background information to assist expert clinicians in confirming the presence of bruxism. Individual item responses will be recorded; no validated total severity score is assumed. The questionnaire will be used for exploratory purposes only.
Time frame: Baseline, Week 4 (post-intervention), Week 12
Mandibular Function
Mandibular functional mobility will be assessed by measuring maximum mouth opening, lateral excursions, and protrusion using standardized clinical procedures.
Time frame: Baseline, Week 4 (post-intervention), Week 6, Week 12
Facial Emotion Recognition - Accuracy
Facial emotion recognition will be assessed using a standardized computerized task. The primary outcome will be accuracy (% of correctly identified emotions). Higher values indicate better emotion recognition performance.
Time frame: Baseline, Week 4 (post-intervention), Week 6, Week 12
Facial Emotion Recognition Response Time
Facial emotion recognition will be assessed using a standardized computerized task. The primary metric will be response time (seconds) required to correctly identify facial emotions, with lower values indicating faster responses.
Time frame: Baseline, Week 4 (post-intervention), Week 6, Week 12
Laterality Recognition Accuracy
Laterality recognition will be assessed using a computerized left-right judgment task involving facial and upper extremity images. Accuracy (% correct responses) will be recorded. Higher values indicate better laterality recognition.
Time frame: Baseline, Week 4, Week 6, Week 12
Laterality Recognition Reaction Time
Reaction time (seconds) required to make correct left-right judgments will be recorded. Lower values indicate faster laterality processing.
Time frame: Baseline, Week 4 (post-intervention), Week 6, Week 12
Two-Point Discrimination Threshold
Tactile spatial discrimination will be assessed using a standardized two-point discrimination test. The minimum distance (in millimeters) at which two distinct points are perceived as separate will be recorded. Lower values indicate better tactile discrimination.
Time frame: Baseline; Week 4; Week 6; Week 12
Light Touch Detection
Light touch sensation will be assessed using standardized clinical testing. The outcome will reflect the participant's ability to detect light tactile stimuli, according to the study protocol. Higher scores indicate better light touch sensitivity.
Time frame: Baseline; Week 4; Week 6; Week 12
Plan to share: No — Individual participant data (IPD) will not be shared publicly at this stage. The dataset contains detailed clinical and somatosensory assessments, and data sharing is restricted due to ethical approvals and participant consent limitations. De-identified data may be made available upon reasonable request after publication, subject to additional ethical approval.
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