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Effects of Orofascial Myofunctional Therapy and Cervical Stabilization Exercises on Temporomandibular Dysfunction (OMT)

15 settembre 2026 aggiornato da: Umber Nawaz, Lahore University of Biological and Applied Sciences

Effects of Orofascial Myofunctional Therapy and Cervical Stabilization Exercises on Jaw Pain, Range of Motion, Occlusal Load and Functional Limitation in Patients With Temporomandibular Dysfunction

Temporomandibular disorders (TMDs) are among the most common musculoskeletal conditions affecting the craniofacial region and are characterized by pain, joint sounds, restricted movement, and functional limitations. Anterior disc displacement is one of the most frequently observed temporomandibular joint (TMJ) disorders and is classified as anterior disc displacement with reduction (ADDwR) or without reduction (ADDwoR). In ADDwR, the articular disc becomes displaced during mandibular movement but returns to its normal position during opening, commonly producing a clicking sound. Although disc displacement can occur in asymptomatic individuals, repeated episodes may interfere with normal joint mechanics, alter mandibular movement, and contribute to maladaptive muscular activity. In some patients, ADDwR may progress to disc displacement without reduction, resulting in limited mouth opening, restricted lateral movement, minimal condylar translation, and deviation of the mandible toward the affected side. TMDs have a multifactorial etiology involving trauma, parafunctional activities such as clenching and bruxism, emotional stress, anxiety, depression, sleep disturbances, abnormal muscle recruitment, occlusal characteristics, and disc or bony morphology. Epidemiological evidence indicates that TMDs are particularly common among adults aged 18-60 years, with a consistent female predominance. Individuals exposed to repetitive masticatory activities and high-stress occupations may also be at increased risk.

Normal orofacial function depends on coordinated activation of the jaw, tongue, lips, cheeks, palate, pharyngeal, and laryngeal muscles. Orofacial Myofunctional Therapy (OMT) consists of individualized oral and peri-oral exercises designed to retrain muscle function and improve the coordination of the stomatognathic system. OMT may promote appropriate tongue posture, nasal breathing, lip seal, swallowing, mastication, and jaw-muscle coordination. Although OMT has demonstrated benefits in several orofacial conditions, its specific role in TMD, particularly ADDwR, remains insufficiently explored. The TMJ also has a close anatomical and neurophysiological relationship with the cervical spine. Cervical muscles contribute to head stabilization during chewing, swallowing, speaking, and breathing, while convergence between trigeminal and cervical sensory pathways can facilitate pain referral between the neck and craniofacial region. Consequently, cervical postural abnormalities, instability, and impaired neuromuscular control may contribute to mandibular dysfunction and TMJ-related pain. Cervical stabilization exercises (CSE) may therefore complement OMT by improving deep cervical muscle activation, reducing excessive superficial muscle activity, and enhancing overall neuromuscular control.

Current research suggests that OMT may improve pain, oral function, muscle activity, and other functional outcomes; however, the evidence remains inconclusive because many studies involve heterogeneous TMD populations, small samples, methodological limitations, combined interventions, and potential placebo effects. Most previous research has also failed to focus specifically on joint-level characteristics such as disc position, reduction mechanics, and condylar-disc coordination. Therefore, a diagnostically precise investigation of patients with ADDwR is warranted. Examining OMT combined with cervical stabilization may provide a more comprehensive rehabilitation approach by addressing both local orofacial dysfunction and associated cervical impairments. Such an integrated intervention could improve mandibular function, muscle coordination, pain, and overall TMJ-related disability. Further high-quality research is therefore needed to establish the effectiveness of combined OMT and cervical stabilization specifically in patients with ADDwR and to guide evidence-based, outcome-oriented management of this common condition.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

Temporomandibular disorders (TMDs) are among the most common musculoskeletal conditions of the craniofacial region, characterized by pain, joint noises, and functional limitation. Anterior disc displacement is one of the most frequent TMJ disorders, classified as displacement with or without reduction (ADDwR/ADDwoR). In the RDC/TMD Validation Project, about 30% of asymptomatic participants showed disc displacement with reduction; 11% involved transient limited opening (intermittent closed locking) and 10% were displacement without reduction with limited opening, both clearly affecting masticatory function. The term "internal derangement" an intra-articular mechanical disturbance interfering with smooth joint action is reserved for stages with apparent functional consequences such as significant deviation on opening, locking, or limited opening. Axis-I, Group II-a TMD (DDwR) is a prevalent subtype: the disc displaces during jaw function but repositions on opening, often producing clicking, and repeated episodes can compromise joint mechanics, trigger pain, and produce maladaptive muscle patterns. Signs may progress to ADDwoR limited opening after the click disappears, minimal condylar translation, restricted lateral movement, and mandibular deviation toward the affected side staged as acute (≤2 months) or chronic (>2 months). Pain may eventually ease, but cartilage and subarticular bone abrasion can develop over time, prompting some to recommend disc repositioning (4).

Global TMD incidence is about 34%, concentrated in ages 18-60 with consistent female predominance, and is highest in South America (47%) versus Asia (33%) and Europe (29%). A 2021 meta-analysis showed wide variability arthralgia 5.7-17%, DDwR 2.1-33%, DDwoR without limited opening 0-0.74%, osteoarthritis 1.9-3.2%, osteoarthrosis 4.8-70% with much lower rates in children and adolescents (5), underscoring the need for standardized diagnostic and management strategies. Etiology is multifactorial and poorly understood, linked to malocclusion, trauma, emotional stress, parafunction (clenching, bruxism), sleep disorders, depression, abnormal muscle recruitment, and discal or bony morphology. The psycho-emotional component is substantial, with stress, anxiety, fatigue, and poor sleep affecting the psyche, and such patients often presenting a muscular component. Occlusal traits such as open bite, deep bite, and posterior crossbite have been linked to TMD, and greater overbite and interincisal angle to joint sounds, though some found no conclusive association Abnormal joint loading rarely stems from one factor, being compounded by parafunction, internal derangement, morphology, occlusal trauma, and childhood experiences. High-risk groups include those with repetitive masticatory use and high-stress occupations musicians, teachers, office and healthcare workers, military, and emergency services. Standardized diagnosis began with the RDC/TMD, comprising Axis I (physical) and Axis II (psychological), later refined into the DC/TMD in 2014.

Orofacial functions require coordinated activation of facial, jaw, tongue, palatal, pharyngeal, and laryngeal muscles under central control, so any occlusal, joint, or muscular change alters mastication. Masticatory efficiency reflects food breakdown, while maximum occlusal force and maximum voluntary bite force are key indicators, measurable with digital devices that detect premature contacts and TMJ problems early. Oral motor exercises aim to strengthen the articulators, with jaw-muscle synergy for speech derived from the chewing central pattern generator. OMT uses individualized oral and peri-oral exercises to retrain muscle function and stabilize the stomatognathic system, improving coordination of the jaw, tongue, lips, and cheeks, and promoting functional tongue posture, nasal breathing, lip seal, and proper mastication. Felicio's protocol enables scored evaluation of appearance, posture, mobility, functions, occlusion, and mandibular movement. Although OMT benefits conditions such as atypical swallowing, tongue-tie, and mouth breathing, its role in TMD remains underexplored.

A clear anatomical and biomechanical relationship connects the TMJ and cervical spine: cervical muscles stabilize the head and neck, enabling controlled TMJ movement essential to chewing, swallowing, speaking, and breathing, so cervical alterations affect TMJ position. Neurophysiologically, trigeminal and cervical neurons converge in the brainstem's cervical trigeminal complex, integrating nociception and allowing pain referral between regions, which justifies cervical evaluation in TMD. Postural deviations, cervical instability, and impaired neuromuscular control may worsen mandibular dysfunction and pain, and TMD patients frequently show coexisting cervical impairments. Jaw stretching, strengthening, range-of-motion, and coordination exercises improve muscle balance, pain, and mobility, and cervical exercises also help. Cervical stabilization exercises activate deep muscles and reduce surface-muscle overactivity, making them plausibly effective in TMJ disorders.

Because most OMT studies exclude complex conditions like TMD, existing evidence has limited real-world relevance, and recent reviews recommend extending OMT research to such populations. This study examines combined orofacial neuromuscular training and cervical stabilization in Axis-I, Group II-a TMD, addressing local and regional dysfunction together to guide integrated, outcome-oriented management. Current evidence remains mixed. A systematic review of ten RCTs found photo-biomodulation (PBM) plus OMT produced greater pain reduction and functional gain than either alone in seven trials, one showing raised pressure-pain thresholds at the TMJ, masseter, and temporalis. An RCT in children aged 5-14 showed EF Line myofunctional devices with myo-gymnastics improved bite patterns and orbicularis oris strength on EMG. A scoping review of 58 studies found 86% reported favorable OMT outcomes, yet only 19% were RCTs and none conclusive found OMT with active or sham laser both improved pain and oral-health quality of life, highlighting placebo effects. A study showed OMT reduced facial-aging signs, with gains regressing without maintenance. A retrospective cohort found orthodontics plus myofunctional therapy gave 25% greater PAR reduction and higher satisfaction (85% vs 60%) than orthodontics alone. Overall, OMT's direct role in TMD particularly ADDwR as a discrete entity remains limited, confounded by placebo effects and combined modalities, and weakened by small samples and poor randomization. Most studies use broadly defined TMD populations and overlook joint-level parameters such as disc position, reduction mechanics, and condylar-disc coordination, so a focused, diagnostically precise study of OMT in ADDwR is warranted.

Tipo di studio

Interventistico

Iscrizione (Stimato)

80

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Backup dei contatti dello studio

Luoghi di studio

    • Punjab Province
      • Lahore, Punjab Province, Pakistan, 54770
        • Dr. Umber Nawaz
        • Contatto:
        • Contatto:
        • Investigatore principale:
          • Wajeeha Khan, MSPT

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto

Accetta volontari sani

No

Descrizione

Inclusion Criteria:

  • All genders
  • Aged between 18-35 years
  • 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 4/10 on NPRS
  • Maximum mouth opening ≥ 40mm
  • Maximum relative occlusal load (50% rule)

Exclusion Criteria:

  • Severe systemic conditions affecting muscles or joints (e.g., rheumatoid arthritis, fibromyalgia, generalized joint hypermobility, neuromuscular disorders).
  • Any psychiatric or neurological disorders interfering with adherence (e.g., uncontrolled epilepsy, major psychiatric illness such as anxiety, stress, or depression).
  • Previous TMJ surgery, arthroscopy, arthrocentesis, or injection therapy in the past 6 months.
  • Ongoing dental appliance therapy (splints/braces) unless stabilized for at least 3 months.
  • Suspected neoplasm, infection, or fracture in the craniofacial region.
  • Progressive neurological deficits (e.g., facial numbness, motor weakness).
  • Severe or constant night pain not relieved by rest (which may indicate pathology beyond disc displacement with reduction).
  • Insomnia or disturbed sleep quality.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Separare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Orofacial myofunctional therapy
The intervention was conducted at a frequency of one supervised session per week along with daily home exercises, with the same frequency maintained during the subsequent weeks. The intensity initially consisted of 8 repetitions of each exercises, with TMJ mobilization performed for 3-5 repetitions and soft tissue release applied for approximately 2 minutes per muscle. As the intervention progressed, the number of repetitions was gradually increased to 10-12 repetitions, while manual therapy techniques were continued. Each supervised session lasted approximately 40 minutes. The intervention included orofacial myofunctional therapy (OMT) exercises targeting the tongue, lips, cheeks, jaw, and breathing, along with TMJ mobilization, soft tissue release, and prescribed TMJ home exercises. During the progression phase, the same exercises were continued with gradual improvements in endurance, coordination, and neuromuscular control to enhance functional performance and maintain treatment
Orofacial Myofunctional Therapy (OMT) targets the muscles involved in mastication, mandibular movement, tongue posture, swallowing, lip closure, and overall orofacial coordination. In patients with temporomandibular disorders (TMD), OMT primarily aims to normalize muscle activity, improve neuromuscular coordination, and restore efficient mandibular function rather than directly repositioning the displaced articular disc. The major muscles involved include the masseter, temporalis, medial pterygoid, and lateral pterygoid, which are responsible for mandibular elevation, stabilization, protrusion, and lateral movements. Exercises involving controlled jaw opening, closing, protrusion, and lateral movements may improve coordination and reduce abnormal recruitment of these muscles.Thesuprahyoid muscles, including the digastric, mylohyoid, and geniohyoid, are also targeted through controlled jaw-opening, tongue, and swallowing exercises to improve mandibular dysfunction
Altri nomi:
  • OMT
Comparatore attivo: cervical stabilization exercises
The intervention followed the FITT (Frequency, Intensity, Time, and Type) principle over a 12-week period, divided into Weeks 1-6 and Weeks 7-12. During Weeks 1-6, the intervention was performed three sessions per week, consisting of one supervised session and two home-based sessions. The exercises were performed at low-to-moderate intensity, beginning with 8 repetitions per exercise and progressing according to the participant's tolerance. Each session lasted 40 minutes, including 10 minutes of warm-up, stretching, and cool-down, followed by 30 minutes of Orofacial Myofunctional Therapy (OMT) and Cervical Stabilization Training (CST). CST consisted of deep neck flexor activation using a Pressure Biofeedback Unit in the supine position, cervical stabilization exercises, gentle strengthening, and postural correction. OMT included tongue strengthening and elevation, lip-seal exercises, cheek strengthening, mandibular control, tongue-to-palate positioning, nasal breathing

Cervical stabilization exercises (CSE) are designed to improve cervical muscle strength, endurance, posture, and neuromuscular control. They are relevant in temporomandibular dysfunction (TMD) because the cervical spine and temporomandibular joint (TMJ) have a close anatomical and neurophysiological relationship. Poor cervical posture, particularly forward head posture, may alter mandibular positioning and increase abnormal activity of the masticatory and cervical muscles.

The main muscles targeted by CSE are the deep cervical flexors, especially the longus colli and longus capitis, along with the cervical multifidus. The suboccipital muscles also contribute to head positioning and proprioception. CSE aims to activate these deep stabilizing muscles while reducing excessive compensatory activity of superficial muscles such as the sternocleidomastoid, anterior scalenes, and upper trapezius. Craniocervical flexion and controlled stabilization exercises can improve cervical alignment.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Maximum Mouth Opening
Lasso di tempo: 12 weeks
Measuring tape for jaw range of motion (MMO; Opening, Closing, lateral deviation) A measuring tape (or millimeter ruler) is a simple, inexpensive, and commonly used clinical tool to measure jaw range of motion (ROM) in patients with temporomandibular disorders. Itis primarily used to measure maximum mouth opening by recording the distance (inmillimeters) between the upper and lower central incisors during maximal mouth opening. It can also be used to assess lateral excursion and protrusion.
12 weeks
jaw pain intensity
Lasso di tempo: 12 Weeks
Numeric Pain rating scale is a numeric pain rating scale. This 11-point scale allows participants to rate their pain level on a scale of 0 to 10, where 0 indicates no pain and ten indicates pain as bad as it can .In this study patients have pain not less than 4-8
12 Weeks
occlusal load
Lasso di tempo: 12 weeks
Maximum relative occlusal load / Right-Left Load Distribution (Occlusense Analysis).Right-left load distribution describes the percentage distribution of occlusal force between the right and left sides of the dental arch during occlusion. It reflects the symmetry or imbalance of bite force across both sides. Right-left load distribution describes the percentage distribution of occlusal force between the right and left sides of the dental arch during occlusion. It reflects the symmetry or imbalance of bite force across both sides.
12 weeks
Functional limitations
Lasso di tempo: 12 weeks
Jaw functional limitation scale (JFLS- 20 items) The Jaw Functional Limitation Scale (JFLS) is a validated patient-reported questionnaire used to assess functional limitations in individuals with temporomandibular disorders. It measures difficulties in jaw-related activities such as chewing, opening the mouth, and verbal or emotional communication. The JFLS is available in 20-item (JFLS-20) and 8-item (JFLS8) versions, with each item scored on an 11-point scale (0-10), where higher scores indicate greater functional limitation.
12 weeks

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

15 settembre 2026

Completamento primario (Stimato)

15 dicembre 2026

Completamento dello studio (Stimato)

15 febbraio 2027

Date di iscrizione allo studio

Primo inviato

9 settembre 2026

Primo inviato che soddisfa i criteri di controllo qualità

15 settembre 2026

Primo Inserito (Effettivo)

18 settembre 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

18 settembre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

15 settembre 2026

Ultimo verificato

1 settembre 2026

Maggiori informazioni

Termini relativi a questo studio

Altri numeri di identificazione dello studio

  • UBAS/ERB/26/07/075
  • U1111-1346-5878 (Identificatore di registro: WHO Primary Registry)

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

INDECISO

Descrizione del piano IPD

will be shared after completion of study

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

prodotto fabbricato ed esportato dagli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .