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

27 september 2026 bijgewerkt door: Umber Nawaz, University of Lahore

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.

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Geschat)

88

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Contact Back-up

Studie Locaties

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

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar tot 35 jaar (Volwassen)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Enkel

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 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.
Ander: 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.

Andere namen:
  • CST
  • CSE
Actieve vergelijker: 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
Ander: 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

Andere namen:
  • OMT
  • OME

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Jaw Pain
Tijdsspanne: 12 weeks

Measured by numeric pain rating scale.
12 weeks
Jaw Range of Motion
Tijdsspanne: 12 week

Measured by therabite
12 week
Occlusal load distribution
Tijdsspanne: 12 weeks

Measure by OccluSense analysis device
12 weeks
Jaw Functions
Tijdsspanne: 12 weeks

Measured by Jaw Functional Limitation Scale
12 weeks

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Cervical Pain
Tijdsspanne: 12 weeks

Measure by Numeric Pain rating scale
12 weeks
Cervical Range of Motion
Tijdsspanne: 12 weeks

Measure by cervical inclinometer
12 weeks
Oral Parafunctional Habits
Tijdsspanne: 12 weeks

Measured by Oral behavior checklist
12 weeks

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

University of Lahore

Medewerkers

Lahore University of Biological and Applied Sciences
Lahore Medical and Dental College

Onderzoekers

  • Hoofdonderzoeker: Umber Nawaz, PhD Scholar, University of Lahore

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

1 oktober 2026

Primaire voltooiing (Geschat)

30 mei 2027

Studie voltooiing (Geschat)

30 juni 2027

Studieregistratiedata

Eerst ingediend

27 september 2026

Eerst ingediend dat voldeed aan de QC-criteria

27 september 2026

Eerst geplaatst (Werkelijk)

1 oktober 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

1 oktober 2026

Laatste update ingediend die voldeed aan QC-criteria

27 september 2026

Laatst geverifieerd

1 september 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • UOL/IREB/26/24/01/0005
  • U1111-1347-5139 (Andere identificatie: WHO UTN)

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

JA

Beschrijving IPD-plan

3 months after the publication of the study

IPD-tijdsbestek voor delen

2 years

IPD-toegangscriteria voor delen

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

IPD delen Ondersteunend informatietype

  • LEERPROTOCOOL
  • SAP

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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