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Идёт набор NCT07336082

Somatosensory Training Versus Exercise Therapy in Awake Bruxism

Без фазы С лечением Bruxism

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Jaw exercise therapy, Somatosensory Awareness-Based Training, Wait-List Control.
Кому может быть актуально
Состояния в реестре: Bruxism. Базовые параметры: 18 лет — 45 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Turkey (Türkiye)
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

  • Другое 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 clin
  • Другое 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 a
  • Другое 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.

Первичные конечные точки

  • Orofacial Pain-Related Disability [Срок оценки: Baseline, Week 4 (post-intervention), Week 6, Week 12]
  • Orofacial Pain Intensity [Срок оценки: Baseline, Week 4 (post-intervention), Week 6, Week 12]
Вторичные конечные точки (12)
  • Mandibular Range of Motion [Срок оценки: Baseline, Week 4 (post-intervention), Week 6, Week 12]
  • Masseter Muscle Thickness [Срок оценки: Baseline, Week 12]
  • Oral Parafunctional Behaviors [Срок оценки: Baseline, Week 4 (post-intervention), Week 12]
  • Facial Emotion Recognition Accuracy [Срок оценки: Baseline, Week 4 (post-intervention), Week 6, Week 12]
  • Oral Health-Related Quality of Life [Срок оценки: Baseline, Week 4 (post-intervention), Week 12]
  • Bruxism severity [Срок оценки: Baseline, Week 4 (post-intervention), Week 12]
  • Mandibular Function [Срок оценки: Baseline, Week 4 (post-intervention), Week 6, Week 12]
  • Facial Emotion Recognition - Accuracy [Срок оценки: Baseline, Week 4 (post-intervention), Week 6, Week 12]
  • Facial Emotion Recognition Response Time [Срок оценки: Baseline, Week 4 (post-intervention), Week 6, Week 12]
  • Laterality Recognition Accuracy [Срок оценки: Baseline, Week 4, Week 6, Week 12]
  • Laterality Recognition Reaction Time [Срок оценки: Baseline, Week 4 (post-intervention), Week 6, Week 12]
  • Two-Point Discrimination Threshold [Срок оценки: Baseline; Week 4; Week 6; Week 12]

Критерии участия

Критерии включения

  • 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

Критерии исключения

  • 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Двойное слепое
Основная цель
Лечение

Центры проведения

Turkey (Türkiye) · 2 центра
  • Aydin Adnan Menderes University, Faculty of Health Sciences, Physiotherapy and Rehabilitat — Aydin
  • Aydin Adnan Menderes University, Faculty of Health Sciences, Physiotherapy and Rehabilitat — Aydin

Публикации

  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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. PMID 38894567

Идентификаторы

NCT: NCT07336082 · E-15189967-050.04-2500084155

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗