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.

Study Overview

• Status: Not yet recruiting
• Conditions: Axis I Diagnosis; Temporo-mandibular Dysfunction; Disc Displacement; Disc Displacement With Reduction
• Intervention / Treatment: Other: Cervical Stabilization Exercises; Other: Orofacial Myofunctional Therapy

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.

• Study Type: Interventional
• Enrollment (Estimated): 88
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sahreen Anwar Professor; Phone Number: 00923346591705; Email: sahreen.anwar@uipt.uol.edu.pk
• Study Contact Backup: Name: Ashfaq Ahmad Professor; Email: ashfaq.ahmad@uipt.uol.edu.pk

Study Locations

• Pakistan
  • Punjab Province
    • Lahore, Punjab Province, Pakistan, 534000
      • Lahore Medical and Dental College

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Other: Cervical Stabilization Exercises; 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.; Other Names: CST; CSE
Active Comparator: 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: Tongue Slide; Tongue Stretch; Gum Chewing; Tongue Forces; Tongue Clench; Finger Cheek; Inflate a Balloon; Nasal Breathing	Other: Orofacial Myofunctional Therapy; 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; Other Names: OMT; OME

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Jaw Pain	Measured by numeric pain rating scale.	12 weeks
Jaw Range of Motion	Measured by therabite	12 week
Occlusal load distribution	Measure by OccluSense analysis device	12 weeks
Jaw Functions	Measured by Jaw Functional Limitation Scale	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cervical Pain	Measure by Numeric Pain rating scale	12 weeks
Cervical Range of Motion	Measure by cervical inclinometer	12 weeks
Oral Parafunctional Habits	Measured by Oral behavior checklist	12 weeks

Collaborators and Investigators

• Sponsor: University of Lahore
• Collaborators: Lahore University of Biological and Applied Sciences; Lahore Medical and Dental College
• Investigators: Principal Investigator: Umber Nawaz, PhD Scholar, University of Lahore

Study record dates

Study Major Dates

• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): May 30, 2027
• Study Completion (Estimated): June 30, 2027

Study Registration Dates

• First Submitted: September 27, 2026
• First Submitted That Met QC Criteria: September 27, 2026
• First Posted (Actual): October 1, 2026

Study Record Updates

• Last Update Posted (Actual): October 1, 2026
• Last Update Submitted That Met QC Criteria: September 27, 2026
• Last Verified: September 1, 2026

More Information

Terms related to this study

• Keywords: Temporomandibular dysfunction; disc displacement with reduction; cervical stabilization exercises; Orofacial myofunctional therapy; axis-i TMD; group iia TMD
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Stomatognathic Diseases; Muscular Diseases; Joint Diseases; Jaw Diseases; Mandibular Diseases; Craniomandibular Disorders; Temporomandibular Joint Disorders; Therapeutics; Physical Therapy Modalities; Patient Care; Rehabilitation; Aftercare; Continuity of Patient Care; Rehabilitation of Speech and Language Disorders; Dentistry; Myofunctional Therapy
• Other Study ID Numbers: UOL/IREB/26/24/01/0005; U1111-1347-5139 (Other Identifier: WHO UTN)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

3 months after the publication of the study

IPD Sharing Time Frame

2 years

IPD Sharing Access Criteria

The IPD plan will be accessed by the principal investigator Dr. Umber Nawaz throught her email (dr.umber21@gmail.com)

• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No