BruxismNCT07336082
Somatosensory Training Versus Exercise Therapy in Awake Bruxism
A study testing Jaw exercise therapy and Somatosensory Awareness-Based Training in people with Bruxism, run by Aydin Adnan Menderes University at 2 sites in Turkey (Türkiye).
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Bruxism
- What is being tested?
- Jaw exercise therapy and Somatosensory Awareness-Based Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 16 Dec 2025to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Adults aged 18 to 45 years
- Clinical diagnosis of awake bruxism confirmed using standardized diagnostic criteria (STAB and DC/TMD Axis I)
- Presence of at least one measurable somatosensory alteration confirmed at baseline using digital and clinical assessments
- Self-reported daytime jaw clenching or parafunctional activity
- Baseline orofacial pain intensity of ≥5/10 on a Visual Analog Scale (VAS)
- Chronic pain graded as GCPS Grades I-III according to DC/TMD Axis II (Turkish validated version)
- Willingness to comply with the study protocol and attend scheduled treatment sessions
- Ability to understand the study procedures and provide written informed consent
Who cannot join
- GCPS Grade IV (high disability level)
- Presence of systemic inflammatory, neurological, or rheumatological disorders
- Diagnosis of severe chronic pain conditions unrelated to bruxism
- Use of occlusal splints or participation in jaw, neck, or facial therapy within the past 3 months
- Psychiatric disorders or cognitive impairment that could interfere with study participation
- Pregnancy, due to potential effects on joint laxity and postural parameters
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)2 sites, 2 recruiting
- Recruiting
Aydin Adnan Menderes University, Faculty of Health Sciences, Physiotherapy and Rehabilitation Unit
Aydin, 09100
Gul Oznur KARABICAK, PhD, +905053569409, guloznur@gmail.com
Gurkan GUNAYDIN, PhD, +90 554 724 27 42, gunaydingrkn@gmail.com
- Recruiting
Aydin Adnan Menderes University, Faculty of Health Sciences, Physiotherapy and Rehabilitation Unit
Aydin, 09100
Gul Oznur KARABICAK, PhD, +90 505 3569409, gul.karabicak@adu.edu.tr
Gurkan Gunaydin, PhD, +90 554 724 27 42, gunaydingrkn@gmail.com
About this study
Official title: Somatosensory Training Versus Exercise Therapy in Awake Bruxism: A Randomized Controlled Trial
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.
Read more
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.
Read the detailed description
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.
- Conditions
- Bruxism
- Being tested
- Jaw exercise therapy, Somatosensory Awareness-Based Training, Wait-List Control
- Keywords
- orofacial pain, somatosensory awareness, exercise therapy, awake bruxism, sensorimotor training, neuroplasticity, physical therapy
- Medical subject headings
- Bruxism, Facial Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Jaw exercise therapyOther
Also called exercise therapy
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.
Somatosensory Awareness-Based TrainingOther
Also called Somatosensory training, Sensorimotor awareness training
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.
Wait-List ControlOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Somatosensory Awareness Training Group | Experimental | 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. Receives: Other: Somatosensory Awareness-Based Training |
| Jaw and Posture Exercise Group | Active comparator | 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. Receives: Other: Jaw exercise therapy |
| Wait-List Control Group | Other | 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. Receives: Other: Wait-List Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline, Week 4 (post-intervention), Week 6, Week 12
Secondary outcomes (13)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline; Week 4; Week 6; Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2026
- Study start16 Dec 2025
- Primary completionOct 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for BruxismStudies of the same condition, open and under way.
- More trials run by Aydin Adnan Menderes UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are randomly assigned to one of three parallel groups: somatosensory awareness-based training, jaw and posture exercise therapy, or a wait-list control group. Each group is followed concurrently, and outcomes are compared between groups over time.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aydin Adnan Menderes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, GulOznur KARABICAK, Aydin Adnan Menderes University
- Investigators
- Gul Oznur KARABICAK, PhD, Principal investigator, Aydin Adnan Menderes University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07336082
- Sponsor's protocol ID
- E-15189967-050.04-2500084155
- Status last verified
- Dec 2025
- First submitted
- 19 Dec 2025
- Last updated
- 13 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
Soares-Silva L, de Amorim CS, Magno MB, Tavares-Silva C, Maia LC. Effects of different interventions on bruxism: an overview of systematic reviews. Sleep Breath. 2024 Jun;28(3):1465-1476. doi: 10.1007/s11325-023-02961-7. Epub 2024 Jan 4.
PubMed 38177829Ainoosah S, Farghal AE, Alzemei MS, Saini RS, Gurumurthy V, Quadri SA, Okshah A, Mosaddad SA, Heboyan A. Comparative analysis of different types of occlusal splints for the management of sleep bruxism: a systematic review. BMC Oral Health. 2024 Jan 5;24(1):29. doi: 10.1186/s12903-023-03782-6.
PubMed 38182999Fernandez-de-Las-Penas C, Von Piekartz H. Clinical Reasoning for the Examination and Physical Therapy Treatment of Temporomandibular Disorders (TMD): A Narrative Literature Review. J Clin Med. 2020 Nov 17;9(11):3686. doi: 10.3390/jcm9113686.
PubMed 33212937Uchima Koecklin KH, Aliaga-Del Castillo A, Li P. The neural substrates of bruxism: current knowledge and clinical implications. Front Neurol. 2024 Oct 1;15:1451183. doi: 10.3389/fneur.2024.1451183. eCollection 2024.
PubMed 39410996Kluskens TJ, Kessler PA, Jansma BM, Kaas A, van de Ven V. Neural Correlates of Tooth Clenching in Patients with Bruxism and Temporomandibular Disorder-Related Pain. J Oral Facial Pain Headache. 2023 Spring;37(2):139-148. doi: 10.11607/ofph.3091.
PubMed 373898408. von Piekartz, H., Paris-Aliaga, A., & La Touche, R. (2019). Bruxism and temporomandibular disorders: The role of somatosensory representation distortions in the trigeminal system. Musculoskeletal Science and Practice, 42, 102073. https://doi.org/10.1016/j.msksp.2019.102073
7. Moseley, G. L. (2007). Reconceptualising pain according to modern pain science. Physical Therapy Reviews, 12(3), 169-178. https://doi.org/10.1179/108331907X223010
von Piekartz H, Bleiss S, Herzer S, Hall T, Ballenberger N. Does combining oro-facial manual therapy with bruxism neuroscience education affect pain and function in cases of awake bruxism? A pilot study. J Oral Rehabil. 2024 Sep;51(9):1692-1700. doi: 10.1111/joor.13740. Epub 2024 Jun 18.
PubMed 38894567La Touche R, Cuenca-Martinez F, Suso-Marti L, Garcia-Vicente A, Navarro-Morales B, Paris-Alemany A. Tactile trigeminal region acuity in temporomandibular disorders: A reliability and cross-sectional study. J Oral Rehabil. 2020 Jan;47(1):9-18. doi: 10.1111/joor.12870. Epub 2019 Aug 26.
PubMed 313940084. Osiewicz, M., Lobbezoo, F., Bracci, A., & Manfredini, D. (2024). From bruxism to somatosensory changes and back: A narrative review on the bidirectional link between orofacial pain and cortical reorganization. Frontiers in Oral Health, 5, 1374090. https://doi.org/10.3389/froh.2024.1374090
3. Paris, A. J., Piekartz, H. v., Rinne, P., & Tardif, C. (2021). Altered brain activation in patients with temporomandibular disorders: Evidence from functional imaging studies. Journal of Oral Rehabilitation, 48(6), 685-696. https://doi.org/10.1111/joor.13144
Lobbezoo F, Ahlberg J, Glaros AG, Kato T, Koyano K, Lavigne GJ, de Leeuw R, Manfredini D, Svensson P, Winocur E. Bruxism defined and graded: an international consensus. J Oral Rehabil. 2013 Jan;40(1):2-4. doi: 10.1111/joor.12011. Epub 2012 Nov 4.
PubMed 23121262Manfredini D, Ahlberg J, Aarab G, Bender S, Bracci A, Cistulli PA, Conti PC, De Leeuw R, Durham J, Emodi-Perlman A, Ettlin D, Gallo LM, Haggman-Henrikson B, Hublin C, Kato T, Klasser G, Koutris M, Lavigne GJ, Paesani D, Peroz I, Svensson P, Wetselaar P, Lobbezoo F. Standardised Tool for the Assessment of Bruxism. J Oral Rehabil. 2024 Jan;51(1):29-58. doi: 10.1111/joor.13411. Epub 2023 Feb 10.
PubMed 36597658
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Somatosensory Training Versus Exercise Therapy in Awake Bruxism: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07336082
- Acronym / sponsor ID
- E-15189967-050.04-2500084155
- Conditions
- Bruxism
- Keywords
- orofacial pain, somatosensory awareness, exercise therapy, awake bruxism, sensorimotor training, neuroplasticity, physical therapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Aydin Adnan Menderes UniversityUniversity, hospital or other
- Study start
- 16 Dec 2025 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 13 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Participants are randomly assigned to one of three parallel groups: somatosensory awareness-based training, jaw and posture exercise therapy, or a wait-list control group. Each group is followed concurrently, and outcomes are compared between groups over time.
| Arm | Type | Receives |
|---|---|---|
| Somatosensory Awareness Training Group | Experimental | Other: Somatosensory Awareness-Based TrainingParticipants 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. |
| Jaw and Posture Exercise Group | Active comparator | Other: Jaw exercise therapyParticipants 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. |
| Wait-List Control Group | Other | Other: Wait-List ControlParticipants 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Adults aged 18 to 45 years
- Clinical diagnosis of awake bruxism confirmed using standardized diagnostic criteria (STAB and DC/TMD Axis I)
- Presence of at least one measurable somatosensory alteration confirmed at baseline using digital and clinical assessments
- Self-reported daytime jaw clenching or parafunctional activity
- Baseline orofacial pain intensity of ≥5/10 on a Visual Analog Scale (VAS)
Key exclusion criteria (6 listed)
- GCPS Grade IV (high disability level)
- Presence of systemic inflammatory, neurological, or rheumatological disorders
- Diagnosis of severe chronic pain conditions unrelated to bruxism
- Use of occlusal splints or participation in jaw, neck, or facial therapy within the past 3 months
- Psychiatric disorders or cognitive impairment that could interfere with study participation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Jaw exercise therapyAlso: exercise therapyParticipants 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. | Other | Jaw and Posture Exercise Group |
| Somatosensory Awareness-Based TrainingAlso: Somatosensory training, Sensorimotor awareness trainingParticipants 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. | Other | Somatosensory Awareness Training Group |
| Wait-List ControlParticipants 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. | Other | Wait-List Control Group |
Primary outcome
Orofacial Pain-Related Disability
Time frame: Baseline, Week 4 (post-intervention), Week 6, Week 12
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.
Orofacial Pain Intensity
Time frame: Baseline, Week 4 (post-intervention), Week 6, Week 12
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.
13 secondary outcomes
Mandibular Range of Motion
Time frame: Baseline, Week 4 (post-intervention), Week 6, Week 12
Masseter Muscle Thickness
Time frame: Baseline, Week 12
Oral Parafunctional Behaviors
Time frame: Baseline, Week 4 (post-intervention), Week 12
Facial Emotion Recognition Accuracy
Time frame: Baseline, Week 4 (post-intervention), Week 6, Week 12
Oral Health-Related Quality of Life
Time frame: Baseline, Week 4 (post-intervention), Week 12
Bruxism severity
Time frame: Baseline, Week 4 (post-intervention), Week 12
Mandibular Function
Time frame: Baseline, Week 4 (post-intervention), Week 6, Week 12
Facial Emotion Recognition - Accuracy
Time frame: Baseline, Week 4 (post-intervention), Week 6, Week 12
Facial Emotion Recognition Response Time
Time frame: Baseline, Week 4 (post-intervention), Week 6, Week 12
Laterality Recognition Accuracy
Time frame: Baseline, Week 4, Week 6, Week 12
Laterality Recognition Reaction Time
Time frame: Baseline, Week 4 (post-intervention), Week 6, Week 12
Two-Point Discrimination Threshold
Time frame: Baseline; Week 4; Week 6; Week 12
Light Touch Detection
Time frame: Baseline; Week 4; Week 6; Week 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2026.
- Background: PubMed 38177829Soares-Silva L, de Amorim CS, Magno MB, Tavares-Silva C, Maia LC. Effects of different interventions on bruxism: an overview of systematic reviews. Sleep Breath. 2024 Jun;28(3):1465-1476. doi: 10.1007/s11325-023-02961-7. Epub 2024 Jan 4.
- Background: PubMed 38182999Ainoosah S, Farghal AE, Alzemei MS, Saini RS, Gurumurthy V, Quadri SA, Okshah A, Mosaddad SA, Heboyan A. Comparative analysis of different types of occlusal splints for the management of sleep bruxism: a systematic review. BMC Oral Health. 2024 Jan 5;24(1):29. doi: 10.1186/s12903-023-03782-6.
- Background: PubMed 33212937Fernandez-de-Las-Penas C, Von Piekartz H. Clinical Reasoning for the Examination and Physical Therapy Treatment of Temporomandibular Disorders (TMD): A Narrative Literature Review. J Clin Med. 2020 Nov 17;9(11):3686. doi: 10.3390/jcm9113686.
- Background: PubMed 39410996Uchima Koecklin KH, Aliaga-Del Castillo A, Li P. The neural substrates of bruxism: current knowledge and clinical implications. Front Neurol. 2024 Oct 1;15:1451183. doi: 10.3389/fneur.2024.1451183. eCollection 2024.
- Background: PubMed 37389840Kluskens TJ, Kessler PA, Jansma BM, Kaas A, van de Ven V. Neural Correlates of Tooth Clenching in Patients with Bruxism and Temporomandibular Disorder-Related Pain. J Oral Facial Pain Headache. 2023 Spring;37(2):139-148. doi: 10.11607/ofph.3091.
- Background8. von Piekartz, H., Paris-Aliaga, A., & La Touche, R. (2019). Bruxism and temporomandibular disorders: The role of somatosensory representation distortions in the trigeminal system. Musculoskeletal Science and Practice, 42, 102073. https://doi.org/10.1016/j.msksp.2019.102073
- Background7. Moseley, G. L. (2007). Reconceptualising pain according to modern pain science. Physical Therapy Reviews, 12(3), 169-178. https://doi.org/10.1179/108331907X223010
- Background: PubMed 38894567von Piekartz H, Bleiss S, Herzer S, Hall T, Ballenberger N. Does combining oro-facial manual therapy with bruxism neuroscience education affect pain and function in cases of awake bruxism? A pilot study. J Oral Rehabil. 2024 Sep;51(9):1692-1700. doi: 10.1111/joor.13740. Epub 2024 Jun 18.
- Background: PubMed 31394008La Touche R, Cuenca-Martinez F, Suso-Marti L, Garcia-Vicente A, Navarro-Morales B, Paris-Alemany A. Tactile trigeminal region acuity in temporomandibular disorders: A reliability and cross-sectional study. J Oral Rehabil. 2020 Jan;47(1):9-18. doi: 10.1111/joor.12870. Epub 2019 Aug 26.
- Background4. Osiewicz, M., Lobbezoo, F., Bracci, A., & Manfredini, D. (2024). From bruxism to somatosensory changes and back: A narrative review on the bidirectional link between orofacial pain and cortical reorganization. Frontiers in Oral Health, 5, 1374090. https://doi.org/10.3389/froh.2024.1374090
- Background3. Paris, A. J., Piekartz, H. v., Rinne, P., & Tardif, C. (2021). Altered brain activation in patients with temporomandibular disorders: Evidence from functional imaging studies. Journal of Oral Rehabilitation, 48(6), 685-696. https://doi.org/10.1111/joor.13144
- Background: PubMed 23121262Lobbezoo F, Ahlberg J, Glaros AG, Kato T, Koyano K, Lavigne GJ, de Leeuw R, Manfredini D, Svensson P, Winocur E. Bruxism defined and graded: an international consensus. J Oral Rehabil. 2013 Jan;40(1):2-4. doi: 10.1111/joor.12011. Epub 2012 Nov 4.
- Individual participant dataSharing planned: 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Gul Oznur KARABICAK, PhD principal investigator
Aydin Adnan Menderes University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Jaw exercise therapy and Somatosensory Awareness-Based Training in people with Bruxism, run by Aydin Adnan Menderes University at 2 sites in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gul Oznur Karabicak, Phd (+905053569409, guloznur@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Orofacial Pain-Related Disability (time frame: Baseline, Week 4 (post-intervention), Week 6, Week 12). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07336082, which also lists 13 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2026.