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Temporo-mandibular DysfunctionOMTNCT07853144

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

A study testing Cervical Stabilization Exercises and Orofacial Myofunctional Therapy in people with Temporo-mandibular Dysfunction and Disc Displacement, run by University of Lahore at 1 site in Pakistan.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 35 years
What is being tested?
Cervical Stabilization Exercises and Orofacial Myofunctional Therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
88 participants
Where
1 sitePakistan
Study dates
1 Oct 2026to 30 Jun 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 35 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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)

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Sahreen Anwar Professor contact

00923346591705

sahreen.anwar@uipt.uol.edu.pk

Ashfaq Ahmad Professor contact

ashfaq.ahmad@uipt.uol.edu.pk

Pakistan1 site
  • Lahore Medical and Dental College

    Lahore, Punjab Province, 534000

Other trials in Pakistan

About this study

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.

Read more

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.

Read the 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.

Being tested
Cervical Stabilization Exercises, Orofacial Myofunctional Therapy
Keywords
Temporomandibular dysfunction, axis-i TMD, group iia TMD, disc displacement with reduction, Orofacial myofunctional therapy, cervical stabilization exercises
Medical subject headings
Temporomandibular Joint Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cervical Stabilization ExercisesOther

    Also called CST, CSE

    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 TherapyOther

    Also called OMT, OME

    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

Study groups in NCT07853144
Study groupRoleWhat they receive
Experimental Group: Cervical Stabilization ExercisesExperimentalCervical 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.
Receives: Other: Cervical Stabilization Exercises
Active Experimental Group: Orofacial Myofunctional TherapyActive comparatorBriefly, 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
Receives: Other: Orofacial Myofunctional Therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Jaw Pain

    Measured by numeric pain rating scale.

    Measured: 12 weeks

  2. Jaw Range of Motion

    Measured by therabite

    Measured: 12 week

  3. Occlusal load distribution

    Measure by OccluSense analysis device

    Measured: 12 weeks

  4. Jaw Functions

    Measured by Jaw Functional Limitation Scale

    Measured: 12 weeks

Secondary outcomes (3)
  1. Cervical Pain

    Measure by Numeric Pain rating scale

    Measured: 12 weeks

  2. Cervical Range of Motion

    Measure by cervical inclinometer

    Measured: 12 weeks

  3. Oral Parafunctional Habits

    Measured by Oral behavior checklist

    Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Oct 2026
  2. Study start1 Oct 2026 (estimated)
  3. Primary completion30 May 2027 (estimated)
  4. Study completion30 Jun 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
88 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07853144
Sponsor's protocol ID
UOL/IREB/26/24/01/0005
Other IDs
U1111-1347-5139
Acronym
OMT
Status last verified
Sep 2026
First submitted
27 Sep 2026
Last updated
1 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 3 months after the publication of the study

Questions about this trial

What is this clinical trial studying?

A study testing Cervical Stabilization Exercises and Orofacial Myofunctional Therapy in people with Temporo-mandibular Dysfunction and Disc Displacement, run by University of Lahore at 1 site in Pakistan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 1 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Sahreen Anwar Professor (00923346591705, sahreen.anwar@uipt.uol.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Jaw Pain (time frame: 12 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2026.

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