Somatosensory Training Versus Exercise Therapy in Awake Bruxism

January 2, 2026 updated by: GulOznur KARABICAK, Aydin Adnan Menderes University

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.

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

20

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 Contact

Study Locations

  • Turkey (Türkiye)
      • Aydin, Turkey (Türkiye), 09100
        • Recruiting
        • Aydin Adnan Menderes University, Faculty of Health Sciences, Physiotherapy and Rehabilitation Unit
        • Contact:
        • Contact:

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

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Somatosensory Awareness Training Group
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 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 Names:
  • Somatosensory training
  • Sensorimotor awareness training
Active Comparator: Jaw and Posture Exercise Group
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 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 Names:
  • exercise therapy
Other: Wait-List Control Group
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 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline, Week 4 (post-intervention), Week 6, Week 12
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.
Baseline, Week 4 (post-intervention), Week 6, Week 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mandibular Range of Motion
Time Frame: Baseline, Week 4 (post-intervention), Week 6, Week 12
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.
Baseline, Week 4 (post-intervention), Week 6, Week 12
Masseter Muscle Thickness
Time Frame: Baseline, Week 12
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.
Baseline, Week 12
Oral Parafunctional Behaviors
Time Frame: Baseline, Week 4 (post-intervention), Week 12
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.
Baseline, Week 4 (post-intervention), Week 12
Facial Emotion Recognition Accuracy
Time Frame: Baseline, Week 4 (post-intervention), Week 6, Week 12
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.
Baseline, Week 4 (post-intervention), Week 6, Week 12
Oral Health-Related Quality of Life
Time Frame: Baseline, Week 4 (post-intervention), Week 12
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.
Baseline, Week 4 (post-intervention), Week 12
Bruxism severity
Time Frame: Baseline, Week 4 (post-intervention), Week 12
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.
Baseline, Week 4 (post-intervention), Week 12
Mandibular Function
Time Frame: Baseline, Week 4 (post-intervention), Week 6, Week 12
Mandibular functional mobility will be assessed by measuring maximum mouth opening, lateral excursions, and protrusion using standardized clinical procedures.
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 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.
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
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.
Baseline, Week 4 (post-intervention), Week 6, Week 12
Laterality Recognition Accuracy
Time Frame: Baseline, Week 4, Week 6, Week 12

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.
Baseline, Week 4, Week 6, Week 12
Laterality Recognition Reaction Time
Time Frame: Baseline, Week 4 (post-intervention), Week 6, Week 12

Reaction time (seconds) required to make correct left-right judgments will be recorded.

Lower values indicate faster laterality processing.
Baseline, Week 4 (post-intervention), Week 6, Week 12
Two-Point Discrimination Threshold
Time Frame: Baseline; Week 4; Week 6; Week 12
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.
Baseline; Week 4; Week 6; Week 12
Light Touch Detection
Time Frame: Baseline; Week 4; Week 6; Week 12
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.
Baseline; Week 4; Week 6; Week 12

Collaborators and Investigators

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

Sponsor

Aydin Adnan Menderes University

Investigators

  • Principal Investigator: Gul Oznur KARABICAK, PhD, Aydin Adnan Menderes University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Actual)

December 16, 2025

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

December 19, 2025

First Submitted That Met QC Criteria

January 2, 2026

First Posted (Actual)

January 13, 2026

Study Record Updates

Last Update Posted (Actual)

January 13, 2026

Last Update Submitted That Met QC Criteria

January 2, 2026

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • E-15189967-050.04-2500084155

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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.

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.

Subscribe