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RecruitingNCT07336082

Somatosensory Training Versus Exercise Therapy in Awake Bruxism

Somatosensory Training Versus Exercise Therapy in Awake Bruxism: A Randomized Controlled Trial

Status
Recruiting
Phase
N/A
Study type
Interventional
Enrollment
20 (estimated)
Sponsor
Aydin Adnan Menderes University · Academic / Other
Sex
All
Age
18 Years – 45 Years
Healthy volunteers
Not accepted

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.

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

Interventions

TypeNameDescription
OTHERJaw 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.
OTHERSomatosensory Awareness-Based 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.
OTHERWait-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.

Timeline

Start date
2025-12-16
Primary completion
2026-10-01
Completion
2026-12-01
First posted
2026-01-13
Last updated
2026-01-13

Locations

2 sites across 1 country: Turkey (Türkiye)

Source: ClinicalTrials.gov record NCT07336082. Inclusion in this directory is not an endorsement.