Temporo-mandibular Dysfunction, Disc Displacement, Axis I Diagnosis, Disc Displacement With Reduction
Conditions
Keywords
Temporomandibular dysfunction, axis-i TMD, group iia TMD, disc displacement with reduction, Orofacial myofunctional therapy, cervical stabilization exercises
Brief summary
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.
Detailed description
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.
Interventions
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.
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
Sponsors
University of Lahore
Lahore Medical and Dental College
Lahore University of Biological and Applied Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
It will be a single-blinded study, where the assessor will remain blinded by not being informed of group allocation. After completing the assessment, the assessor will place the findings in a sealed, opaque envelope and hand it to the patient, who will then deliver the envelope to the therapist.
Eligibility
Sex/Gender
ALL
Age
18 Years to 35 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Jaw Pain | 12 weeks | Measured by numeric pain rating scale. |
| Jaw Range of Motion | 12 week | Measured by therabite |
| Occlusal load distribution | 12 weeks | Measure by OccluSense analysis device |
| Jaw Functions | 12 weeks | Measured by Jaw Functional Limitation Scale |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cervical Pain | 12 weeks | Measure by Numeric Pain rating scale |
| Cervical Range of Motion | 12 weeks | Measure by cervical inclinometer |
| Oral Parafunctional Habits | 12 weeks | Measured by Oral behavior checklist |
Countries
Pakistan
Contacts
CONTACTSahreen Anwar Professor
CONTACTAshfaq Ahmad Professor
PRINCIPAL_INVESTIGATORUmber Nawaz, PhD Scholar
University of Lahore
Outcome results
None listed