Clinical trial NCT06937502: Functionality and Clinical Correlates in TMD
Official title: The Relationship Between Functionality and Pain, Range of Motion, Neck Disability, and Quality of Life in Temporomandibular Disorders: A Cross-Sectional Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Temporomandibular Disorders (TMD)
Functional Limitation
Pain Severity
Neck Disability
Quality of Life
Lead sponsor: Istinye University
Sponsor class: OTHER
First posted: 2025-04-22
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: The study will include individuals aged 18-55 diagnosed with temporomandibular disorders (TMD) who present at least one main symptom (jaw pain, limited mouth opening, or TMJ sounds), have a VAS pain score ≥3, and an MMSE score ≥24. Participation will be voluntary with informed consent.

Exclusion criteria include history of head/neck surgery, trauma, cancer treatment, significant tooth loss, dental prosthesis use, ongoing tooth pain, current medication affecting pain perception, previous orthodontic or TMD-specific treatment, and diagnosis of disc displacement without reduction.

Brief summary: Temporomandibular disorders (TMD) are among the most common causes of orofacial pain and refer to structural and functional impairments related to the masticatory muscles, surrounding soft tissues, and/or the temporomandibular joint (TMJ). They negatively affect individuals physically, psychologically, and socially. The structural and functional impairments observed in TMD typically manifest as pain, restricted jaw movement, joint sounds, and muscle tension. In addition to these core symptoms, secondary issues such as chewing difficulties may also occur. Pain in TMD can negatively impact many orofacial functions, especially chewing. Functional impairment in individuals with TMD may result from pain, restricted jaw mobility, muscle tension, alterations in muscle activation, mandibular asymmetry, and morphological changes in the joint. These findings highlight the importance of addressing factors associated with functional impairment in individuals with TMD.

Pain severity is strongly associated with functional limitations of the TMJ and neck disability. Particularly in cases of muscular-origin TMD, significant impairments in neck muscle function and joint mobility have been observed. This condition directly affects jaw function and leads to a decrease in quality of life. The impact of TMD on quality of life is directly related to pain severity and functional limitations. As pain severity increases, limitations in daily activities and reductions in overall quality of life also increase. Therefore, a multidisciplinary approach to TMD is essential for pain management, functional rehabilitation, and improving quality of life.

The aim of this study is to investigate the relationships between functionality and pain, range of motion, neck disability, and quality of life in individuals with TMD. Understanding these relationships will form a basis for the effective management of TMD and improving individuals' quality of life.


Eligibility criteria: Inclusion Criteria:

* Voluntary participation in the study
* Aged between 18 and 55 years
* Diagnosed with temporomandibular disorders (TMD) and exhibiting at least one of the three main symptoms (jaw pain, limited mouth opening, and/or temporomandibular joint sound)
* A Mini-Mental State Examination (MMSE) score of 24 or higher
* Pain score of 3 or above on the Visual Analog Scale (VAS)

Exclusion Criteria:

* History of complex surgery, trauma, chemoradiotherapy, and/or tumors involving the head and neck region
* Ongoing use of analgesics, anti-inflammatory or psychiatric medications, and/or substance abuse
* Significant tooth loss that interferes with chewing function
* Use of dental prosthesis
* Ongoing tooth pain
* Receiving any TMD-specific treatment prior to or during the evaluation period
* History of orthodontic treatment
* Diagnosis of disc displacement without reduction

Primary outcomes:
measure: Temporomandibular Joint Functionality Assessment
timeFrame: At baseline
measure: Temporomandibular Joint Range of Motion Assessment
timeFrame: At baseline
measure: Pain Assessment
timeFrame: At baseline
measure: Neck Disability Assessment
timeFrame: At baseline
measure: Quality of Life Assessment
timeFrame: At baseline
Secondary outcomes:
Other outcomes:
Locations:
city: İstanbul
country: Turkey
facility: Istınye University, Istanbul,
Study officials:
References: