Somatosensory Training Versus Exercise Therapy in Awake Bruxism

NCT07336082 | Recruiting

• 1 other identifier: E-15189967-050.04-2500084155
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

Brief 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 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.

Conditions

Bruxism

Keywords

orofacial pain; somatosensory awareness; exercise therapy; awake bruxism; sensorimotor training; neuroplasticity; physical therapy

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Baseline, Week 4 (post-intervention), Week 6, Week 12

Secondary Outcomes (13)

• Mandibular Range of Motion

  Baseline, Week 4 (post-intervention), Week 6, Week 12

• Masseter Muscle Thickness

  Baseline, Week 12

• Oral Parafunctional Behaviors

  Baseline, Week 4 (post-intervention), Week 12

• Facial Emotion Recognition Accuracy

  Baseline, Week 4 (post-intervention), Week 6, Week 12

• Oral Health-Related Quality of Life

  Baseline, Week 4 (post-intervention), Week 12

Study Arms (3)

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.

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.

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.

Other: Wait-List Control

Interventions

Jaw exercise therapy OTHER

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

Jaw and Posture Exercise Group

Somatosensory Awareness-Based Training OTHER

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

Somatosensory Awareness Training Group

Wait-List Control OTHER

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.

Wait-List Control Group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Aydin Adnan Menderes University: lead

Study Sites (2)

Aydin Adnan Menderes University, Faculty of Health Sciences, Physiotherapy and Rehabilitation Unit

Aydin, 09100, Turkey (Türkiye)

RECRUITING

Aydin Adnan Menderes University, Faculty of Health Sciences, Physiotherapy and Rehabilitation Unit

Aydin, 09100, Turkey (Türkiye)

RECRUITING

Related Publications (13)

• 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.

  PMID: 38177829 BACKGROUND

• Ainoosah 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.

  PMID: 38182999 BACKGROUND

• Fernandez-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.

  PMID: 33212937 BACKGROUND

• Uchima 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.

  PMID: 39410996 BACKGROUND

• Kluskens 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.

  PMID: 37389840 BACKGROUND

• 8. 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

  BACKGROUND

• 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

  BACKGROUND

• 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.

  PMID: 38894567 BACKGROUND

• La 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.

  PMID: 31394008 BACKGROUND

• 4. 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

  BACKGROUND

• 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

  BACKGROUND

• 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.

  PMID: 23121262 BACKGROUND

• Manfredini 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.

  PMID: 36597658 BACKGROUND

MeSH Terms

Conditions

Bruxism; Facial Pain

Interventions

Exercise Therapy

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases; Habits; Behavior; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities

Study Officials

• Gul Oznur KARABICAK, PhD

  Aydin Adnan Menderes University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gul Oznur Karabicak, Phd

CONTACT

+905053569409; guloznur@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Due to the nature of the interventions, participants and treating physiotherapists cannot be blinded to group allocation. However, all outcome assessments are performed by an independent assessor who is blinded to treatment allocation. Data analysis is also conducted by a researcher who is not involved in treatment delivery and is blinded to group assignment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc Prof

Model Details: 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.

Study Record Dates

• First Submitted: December 19, 2025
• First Posted: January 13, 2026
• Study Start: December 16, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: January 13, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (2)