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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-35
SponsorUniversity of Lahore

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Cervical Stabilization Exercises

    Other intervention

    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.

  • Orofacial Myofunctional Therapy

    Other intervention

    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

Treatment groups

88 Participants
are divided into 2 treatment groups
Group A: Experimental Group: Cervical Stabilization ExercisesExperimental treatment 1 intervention
Group B: Active Experimental Group: Orofacial Myofunctional TherapyActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Jaw Pain

Measured by numeric pain rating scale.

Time frame
12 weeks
2

Jaw Range of Motion

Measured by therabite

Time frame
12 week
3

Occlusal load distribution

Measure by OccluSense analysis device

Time frame
12 weeks
4

Jaw Functions

Measured by Jaw Functional Limitation Scale

Time frame
12 weeks

Secondary outcomes

1

Cervical Pain

Measure by Numeric Pain rating scale

Time frame
12 weeks
2

Cervical Range of Motion

Measure by cervical inclinometer

Time frame
12 weeks
3

Oral Parafunctional Habits

Measured by Oral behavior checklist

Time frame
12 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Lahore

Lead sponsor

Lahore Medical and Dental College

Collaborator

Lahore University of Biological and Applied Sciences

Collaborator

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