Effects of Orofacial Myofunctional Therapy and Cervical Stabilization Exercises in Patients With Axis-i Group Iia Temporomandibular Dysfunction (OMT)
The proposed PhD study, "Effects of Orofacial Myofunctional Therapy and Cervical Stabilization Exercises in Patients with Axis-I, Group II-a Temporomandibular Dysfunction," aims to evaluate an integrated physiotherapy approach for patients with anterior disc displacement with reduction (ADDwR/DDwR) of the temporomandibular joint.
The rationale is based on the interaction between the orofacial and cervical systems. Although OMT may improve orofacial muscle coordination and function, evidence specifically addressing ADDwR remains limited. Similarly, cervical dysfunction and impaired neuromuscular control may contribute to altered mandibular mechanics and pain. The study therefore proposes combining OMT with cervical stabilization exercises to address both regional and local dysfunctions.
The study will use a randomized controlled design at Lahore Medical and Dental College. A total of 88 participants (44 per group) are planned after accounting for 20% attrition. Participants will be adults aged 18-35 years with clinically diagnosed ADDwR, recruited using convenience sampling and subsequently randomly allocated to two groups.
The primary objective is to determine the effects of OMT with and without cervical stabilization exercises on jaw pain, mandibular range of motion, functional limitation, maximum relative occlusal load, oral repetitive behaviours, and burnout syndrome. Cervical pain and cervical range of motion are identified as secondary outcomes.
The intervention is planned for 12 weeks. OMT includes education, tongue/lip/cheek and jaw exercises, functional training, TMJ mobilization, soft-tissue release, and home exercises. Cervical stabilization includes deep neck-flexor activation, cervical bracing, progressive stabilization and strengthening exercises.
Outcome measures include the Numeric Pain Rating Scale, TheraBite for mandibular ROM, OccluSense for occlusal loading, cervical inclinometer, Jaw Functional Limitation Scale, Oral Behavior Checklist, and Stress Data will be analyzed using SPSS, with intention-to-treat analysis. Linear mixed-effects models or repeated-measures ANOVA will assess group, time, and group × time effects, while ANCOVA/LMM contrasts will examine changes from baseline to 12 weeks. Effect sizes and 95% confidence intervals will also be reported.
In essence: the study investigates whether adding cervical stabilization exercises to OMT provides additional improvements in pain, jaw function, occlusal loading, oral behaviours, burnout, and cervical outcomes in patients with Axis-I Group II-a TMD/ADDwR.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Temporomandibular disorders (TMDs) are common musculoskeletal conditions affecting the temporomandibular joint, masticatory muscles, and associated structures, often presenting with pain, restricted mandibular function, joint sounds, and functional limitations. Axis-I Group II-a TMD, characterized by disc displacement with reduction (DDwR), is associated with altered disc-condyle mechanics and may coexist with abnormal orofacial muscle activity and cervical musculoskeletal dysfunction. Although orofacial myofunctional therapy (OMT) has been investigated for TMD management, the potential additional contribution of cervical stabilization exercises remains insufficiently explored, particularly in patients with DDwR.
This randomized controlled trial aims to determine the effects of OMT with and without cervical stabilization exercises in patients with Axis-I Group II-a TMD. The study will recruit 88 participants aged 18-35 years who meet the specified diagnostic and eligibility criteria. Participants will be randomly allocated into two groups: an OMT group and a combined OMT plus cervical stabilization group. Both interventions will be provided over 12 weeks, with cervical stabilization incorporating deep cervical muscle activation, cervical motor-control training, and progressive resistance exercises.
The primary outcomes will include jaw pain, mandibular range of motion, functional limitation, maximum relative occlusal load, oral repetitive behaviours, and burnout syndrome. Secondary outcomes will include cervical pain and cervical range of motion. Pain will be assessed using the Numerical Pain Rating Scale, mandibular function using jaw range-of-motion measures and the Jaw Functional Limitation Scale, occlusal parameters using the OccluSense system, cervical mobility using an inclinometer, and oral behaviours and burnout using standardized questionnaires.
Data will be analysed using SPSS, with descriptive and inferential analyses and longitudinal models used to examine within-group changes, between-group differences, and group-by-time interactions. Intention-to-treat analysis and appropriate methods for handling missing data will be applied. The study is expected to provide evidence regarding whether integrating cervical stabilization with OMT produces additional benefits in pain, mandibular and cervical function, occlusal loading, oral behaviours, and psychosocial outcomes in individuals with Axis-I Group II-a TMD.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Sahreen Anwar Professor
- Número de teléfono: 00923346591705
- Correo electrónico: sahreen.anwar@uipt.uol.edu.pk
Copia de seguridad de contactos de estudio
- Nombre: Ashfaq Ahmad Professor
- Correo electrónico: ashfaq.ahmad@uipt.uol.edu.pk
Ubicaciones de estudio
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Punjab Province
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Lahore, Punjab Province, Pakistán, 534000
- Lahore Medical and Dental College
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Intra-articular, anterior disc displacement with reduction of TMJ, based on RDC/ TMD criteria. Axis-I, group II- Disc displacement with reduction.
- Clinically diagnosed patients with Anterior Disc Displacement with Reduction (ADDR) from Maxillo-facial surgery department.
- Diagnostic screening will be conducted using a cluster of clinical tests, including jaw compression, traction, and translation maneuvers, static and dynamic resistance testing, and clenching provocation. A positive diagnosis will be established when five of the six tests demonstrate positive findings.
- All patients and subjects had permanent dentition; none had dental pain or periodontal problems, neurological or cognitive deficit.
- Symptoms persist for ≥ 3 months
- Pain should not be less than 4-6 on NPRS
- Maximum mouth opening ≥ 40mm
- Maximum relative occlusal load (50% rule)
Exclusion Criteria:
- Severe systemic conditions affecting muscles/joints (e.g., rheumatoid arthritis, fibromyalgia, generalized joint hypermobility, neuromuscular disorders).
- Any psychiatric/neurological disorders interfering with adherence (e.g., uncontrolled epilepsy, major psychiatric illness.
- Previous TMJ surgery, arthroscopy, arthrocentesis, or injection therapy in past 6 months.
- Ongoing dental appliance therapy (splints/braces) unless stabilized ≥3 months.
- Suspected neoplasm, infection, or fracture in craniofacial region.
- Progressive neurological deficits (facial numbness, motor weakness).
- Severe/constant night pain not relieved by rest (may indicate pathology beyond DDWR).
- Insomnia or disturbed sleep quality.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: Experimental Group: Cervical Stabilization Exercises
Cervical stabilization training: Participants performed the exercises for 12 weeks, once a week under the supervision of a physiotherapist and twice a week at home. The exercise program consisted of 10 min of warm-up/cool-down and stretching exercises, followed by 30 min of stabilization exercises. Additionally, correct activation of the deep neck flexor muscles was taught using a stabilizer device. Pressure Biofeedback Unit. CST will be performed using cervical bracing techniques combined with the activation of deep neck flexor muscles. These exercises will be implemented through neurodevelopmental sequences (supine, prone, sitting, crawling, and standing positions). Strengthening and functional exercises using elastic resistance bands will be incorporated. The exercises will begin with 8 repetitions and gradually increase to 12 repetitions. |
Cervical stabilization exercises aiming to train deep stabilizer muscles of the cervical spine and improve coordination between superficial and deep cervical muscles. These exercises require patients to control neutral spinal alignment with stabilizer muscle activations in various conditions, beginning with gentle cranio-cervical nods and proceeding through increased levels of extremity loading.
Otros nombres:
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Comparador activo: Active Experimental Group: Orofacial Myofunctional Therapy
Briefly, the OMT protocol for TMD consisted of the following: (1) instructions to the patients about TMD and care needed to avoid system overloading; (2) OM exercises, i.e., exercises for tongue, lips, and cheeks and jaw muscles (mobility, endurance, muscle strength) and orofacial function training. According to the Garliner. D method of treatment protocol, the patients participated of the OMT sessions, for 12 weeks, lasting 40 minutes each, with a home exercise program will be prescribed during each session. Exercise will be as follows:
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Myofunctional therapy (also called orofacial myofunctional therapy or OMT) trains muscles in your mouth and face to move as they should and rest in the proper positions. It involves doing certain exercises with your cheeks, tongue or lips. These exercises strengthen your muscles and finetune your awareness of facial movements (proprioception). OMT treats orofacial myofunctional disorders (OMDs). OMDs are abnormal muscle movement patterns in your mouth and face that affect how you breathe, chew, swallow and/or speak
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Jaw Pain
Periodo de tiempo: 12 weeks
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Measured by numeric pain rating scale. |
12 weeks
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Jaw Range of Motion
Periodo de tiempo: 12 week
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Measured by therabite |
12 week
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Occlusal load distribution
Periodo de tiempo: 12 weeks
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Measure by OccluSense analysis device |
12 weeks
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Jaw Functions
Periodo de tiempo: 12 weeks
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Measured by Jaw Functional Limitation Scale |
12 weeks
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Cervical Pain
Periodo de tiempo: 12 weeks
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Measure by Numeric Pain rating scale |
12 weeks
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Cervical Range of Motion
Periodo de tiempo: 12 weeks
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Measure by cervical inclinometer |
12 weeks
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Oral Parafunctional Habits
Periodo de tiempo: 12 weeks
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Measured by Oral behavior checklist |
12 weeks
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Umber Nawaz, PhD Scholar, University of Lahore
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Enfermedades musculoesqueléticas
- Enfermedades Estomatognáticas
- Enfermedades Musculares
- Enfermedades Articulares
- Enfermedades de la mandíbula
- Enfermedades mandibulares
- Trastornos Craneomandibulares
- Trastornos de la articulación temporomandibular
- Terapéutica
- Modalidades de fisioterapia
- Atención al paciente
- Rehabilitación
- Cuidado por los convalecientes
- Continuidad de la atención al paciente
- Rehabilitación de trastornos del habla y del lenguaje
- Odontología
- Terapia Miofuncional
Otros números de identificación del estudio
- UOL/IREB/26/24/01/0005
- U1111-1347-5139 (Otro identificador: WHO UTN)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
3 months after the publication of the study
Marco de tiempo para compartir IPD
2 years
Criterios de acceso compartido de IPD
The IPD plan will be accessed by the principal investigator Dr. Umber Nawaz throught her email (dr.umber21@gmail.com)
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
- SAVIA
Información sobre medicamentos y dispositivos, documentos del estudio
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