Health Condition 1: M279- Disease of jaws, unspecified
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Participants eligible for this study must have a confirmed diagnosis of temporomandibular disorder (TMD) according to the Research Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD), verified by a qualified clinician. Eligible individuals must report subjective pain in the temporomandibular joint and/or masticatory muscles of at least 4 on the Visual Analog Scale (VAS) on a 0 to 10 scale at baseline. Additionally, participants must exhibit functional impairment, such as reduced maximum mouth opening or difficulty chewing, demonstrating the clinical impact of the disorder. Only those with a chronic condition, defined as symptoms persisting for at least three months, will be included. Finally, participants must have the ability and willingness to provide written informed consent and comply with all study procedures.
Exclusion criteria
Exclusion criteria: Previous TMJ Surgery History of surgical intervention on the temporomandibular joint. Systemic Rheumatologic or Autoimmune Disorders Conditions such as rheumatoid arthritis, systemic lupus erythematosus, or ankylosing spondylitis affecting the craniofacial or musculoskeletal system. Neurological Disorders Neuropathies, trigeminal neuralgia, multiple sclerosis, or other central/peripheral nervous system disorders affecting craniofacial function. Active Malignancy Active cancer in the craniofacial region or systemic malignancies. Pregnancy or Breastfeeding Due to unknown effects of LLLT on pregnancy and developing fetus. Photosensitivity Disorders History of conditions like lupus or porphyria making the patient sensitive to light-based therapies. Current Use of Muscle Relaxants or Analgesics (Unstable Regimen) Patients who have changed or plan to change medication within 1 month of study entry. Severe Psychiatric Illness Active major depression, psychosis, or inability to cooperate with the study protocol. Infection or Skin Lesion in Treatment Area Active infection, open wounds, or dermatitis in the TMJ or surrounding areas. Participation in Another Clinical Trial Participation in another interventional study within the past 3 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcomes of this study will focus on three key domains: pain intensity, jaw functionality, and quality of life. Pain intensity will be assessed using both the Visual Analog Scale (VAS) and the Numeric Rating Scale (NRS), each ranging from 0 (no pain) to 10 (worst possible pain), providing a quantitative measure of the patient s subjective pain experience. Jaw functionality will be evaluated through Maximum Mouth Opening (MMO) measured in millimeters, as well as the Jaw Functional Limitation Scale (JFLS), a patient-reported questionnaire assessing limitations in activities such as chewing, speaking, and yawning. Quality of life will be measured using the Oral Health Impact Profile-14 (OHIP-14), which captures the impact of temporomandibular disorder symptoms on daily activities, psychosocial well-being, and overall oral health-related quality of life.Timepoint: Baseline, 4 weeks, and 3 months | — |
Secondary
| Measure | Time frame |
|---|---|
| secondary outcomes will be assessed to evaluate the broader impact of the intervention. Psychological well-being will be measured using the Beck Depression Inventory (BDI) to assess depressive symptoms and the State-Trait Anxiety Inventory (STAI) to capture both temporary and long-standing anxiety levels. Patient-perceived overall improvement will be recorded using the Global Perceived Effect (GPE) scale. Optionally, electromyographic (EMG) activity of the jaw muscles may be measured to provide objective data on neuromuscular function and muscle activity patterns before and after the intervention. Collectively, these primary and secondary outcomes will allow a comprehensive evaluation of the therapeutic effects of the combined Integrative PhysiOsteopathic Therapy and Low-Level Laser Therapy on patients with temporomandibular disorders.Timepoint: Baseline, 4 weeks, and 3 months | — |
Countries
India
Contacts
Lovely Professional University Faculty of Applied Medical Sciences