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临床试验/NCT07828587
NCT07828587尚未招募不适用

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

Lahore University of Biological and Applied Sciences1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2026年9月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
80
试验地点
1
主要终点
Maximum Mouth Opening

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 35 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 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)

排除标准

  • 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.

研究组 & 干预措施

Orofacial myofunctional therapy

Experimental

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

干预措施: orofacial myofunctional therapy (Other)

cervical stabilization exercises

Active Comparator

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

干预措施: cervical stabilization exercises (Other)

结局指标

主要结局

Maximum Mouth Opening

时间窗: 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.

jaw pain intensity

时间窗: 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

occlusal load

时间窗: 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.

Functional limitations

时间窗: 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.

次要结局

未报告次要终点

研究者

发起方
Lahore University of Biological and Applied Sciences
申办方类型
Other
责任方
Principal Investigator
主要研究者

Umber Nawaz

Assistant Professor

Lahore University of Biological and Applied Sciences

研究点 (1)

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