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Not Yet Recruiting NCT07853144

Effects of Orofacial Myofunctional Therapy and Cervical Stabilization Exercises in Patients With Axis-i Group Iia Temporomandibular Dysfunction

Conditions: Temporo-mandibular Dysfunction, Disc Displacement, Axis I Diagnosis, Disc Displacement With Reduction

Sex: All
Ages: 18 Years – 35 Years
Healthy volunteers: No
Phase: NA
Enrollment: 88
Sponsor: University of Lahore

Location: Lahore Medical and Dental College Lahore Punjab Province

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.

Eligibility Criteria

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.

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Source: ClinicalTrials.gov (NCT07853144). StuddyBuddy aggregates publicly available trial information.