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

NCT07853144 | Not Yet Recruiting DMC

• 2 other identifiers: UOL/IREB/26/24/01/0005U1111-1347-5139
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

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.

Conditions

Disc Displacement; Temporo-mandibular Dysfunction; Axis I Diagnosis; Disc Displacement With Reduction

Keywords

Temporomandibular dysfunction; axis-i TMD; group iia TMD; disc displacement with reduction; Orofacial myofunctional therapy; cervical stabilization exercises

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (3)

• Cervical Pain

  12 weeks

• Cervical Range of Motion

  12 weeks

• Oral Parafunctional Habits

  12 weeks

Study Arms (2)

Experimental Group: Cervical Stabilization Exercises

EXPERIMENTAL

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

Active Experimental Group: Orofacial Myofunctional Therapy

ACTIVE COMPARATOR

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

Interventions

Cervical Stabilization Exercises OTHER

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.

Also known as: CST, CSE

Experimental Group: Cervical Stabilization Exercises

Orofacial Myofunctional Therapy OTHER

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

Also known as: OMT, OME

Active Experimental Group: Orofacial Myofunctional Therapy

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Lahore: lead
• Lahore University of Biological and Applied Sciences: collaborator
• Lahore Medical and Dental College: collaborator

Study Sites (1)

Lahore Medical and Dental College

Lahore, Punjab Province, 534000, Pakistan

Location

MeSH Terms

Conditions

Temporomandibular Joint Disorders

Interventions

Myofunctional Therapy

Condition Hierarchy (Ancestors)

Craniomandibular Disorders; Mandibular Diseases; Jaw Diseases; Musculoskeletal Diseases; Joint Diseases; Muscular Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Rehabilitation of Speech and Language Disorders; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Dentistry

Study Officials

• Umber Nawaz, PhD Scholar

  University of Lahore

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sahreen Anwar Professor

CONTACT

00923346591705; sahreen.anwar@uipt.uol.edu.pk

Ashfaq Ahmad Professor

CONTACT

ashfaq.ahmad@uipt.uol.edu.pk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Umber Nawaz

Study Record Dates

• First Submitted: September 27, 2026
• First Posted: October 1, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): May 30, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: October 1, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: 2 years
• Access Criteria: The IPD plan will be accessed by the principal investigator Dr. Umber Nawaz throught her email (dr.umber21@gmail.com)

Locations

PA (1)