Anterior Disc Displacement, Myofascial Pain - Dysfunction Syndrome of TMJ, Myofascial Pain Dysfunction Syndrome, Temporomandibular Joint, Temporomandibular Disorders (TMDs)
Conditions
Keywords
occlusal splints, temporomandibular disorders, temporomandibular joint disorders, muscle pain, myofascial pain, 3d printed occlusal splints, FDM
Brief summary
Occlusal splint therapy is a well-established conservative approach for the management of temporomandibular disorders (TMDs); however, variability in clinical outcomes suggests that no single splint design is universally optimal. Conventional chairside stabilization splints are widely used and allow immediate intraoral adjustments; however, they are technique-sensitive and may compromise long-term fit and patient comfort. Conversely, 3D-printed occlusal splints provide superior precision, reproducibility, and material stability; however, their uniformly rigid structure may limit initial comfort and patient compliance, particularly in patients with acute pain or muscle tenderness. To address these limitations, the researchers intend to develop an innovative hybrid occlusal splint i.e. Dual material 3D printed stabilization splint, that integrates both hard and soft components. This design aims to combine the biomechanical stability and occlusal precision characteristic of rigid splints with the cushioning effect and enhanced comfort provided by soft splints. The objective is to improve adaptation, compliance, and the sustained therapeutic efficacy of the splint.
Detailed description
Temporomandibular disorders (TMDs) are a diverse group of musculoskeletal and neuromuscular conditions affecting the temporomandibular joint (TMJ), masticatory muscles, and associated structures, leading to pain, functional limitations, and impaired quality of life.5 They encompass more than 30 different conditions that may involve the TMJ, the surrounding masticatory muscles (such as the masseter, temporalis, and pterygoid muscles), or a combination of both.Occlusal splints have long been a cornerstone of TMD management due to their reversibility, simplicity, and efficacy in redistributing occlusal forces, reducing bruxism, and promoting neuromuscular adaptation.16 Understanding their diverse presentation, underlying risk factors, and biopsychosocial context is essential for effective assessment, diagnosis, and management.
Interventions
DEVICEConventional Stabilization Splints
Conventional chairside stabilization splints for treatment of temporomandibular joint disorders.
DEVICE3d printed Stabilization splint
3d printed stabilization splint for treatment of temporomandibular joint disorders.
DEVICENovel hybrid stabilization splint
3d printed hybrid stabilization splint for treatment of temporomandibular joint disorders.
Sponsors
Postgraduate Institute of Dental Sciences Rohtak
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* Patients presenting with clinical symptoms of TMJ pain disorders were diagnosed using the DC/TMD criteria. * Age between 18 and 60. * The same number of original molars was used to avoid affecting periodontal proprioception and bite force. * The Patient's consent to participate in the study.
Exclusion criteria
* Pregnancy * Not willing to participate in the study * Healing disorders or systemic diseases where healing is compromised. * Allergic to PMMA, TPU, PETG or any other 3D printing or conventional prosthetic material. * Patients with epilepsy or any other neurological disorders. * Systemic Arthritis or any other osteo-degenerative disorder. * Acute TMJ trauma or fracture in \< 30 days. * Any obvious dental decay or periodontal disease to which fascial pain could be attributed. * Patient with psychiatric disorder or on anti-anxiety or anti-depressant drugs. * Patients with dental implants. * Any systemic condition associated with widespread pain such as in fibromyalgia.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual Analog Scale (VAS) | Baseline, 1 week, 2 weeks, 4 weeks | To evaluate and contrast pain relief by using the Visual Analog Scale (VAS).The scale ranges from 0 to 10 where 0 is the minimum VAS score and 10 is the maximum score. Score of 0 indicates no pain and score of 10 indicates maximum pain intensity. |
| Maximum Mouth Opening | Baseline, 1 week, 2 weeks, 4 weeks | To evaluate functional improvement by Measuring the change in Maximum Mouth Opening (MMO) in millimetres from baseline to 1 month. |
| Maximum Bite Force | baseline, 1 week, 2 weeks, 4 weeks | To quantify masticatory efficiency by measuring changes in Maximum Bite Force (MBF) using a bite force analyser device. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Compliance | Baseline, 1 week, 2 weeks, 4 weeks | To evaluate patient compliance and comfort using Likert Scale. The Likert Scale is a 5-point scale where 1 is the minimum score and 5 is the maximum score. Score 1 indicates very dissatisfied and Score 5 indicates very satisfied. |
Countries
India
Contacts
CONTACTDr. Subhadeepa Paul
CONTACTDr. Harneet Singh, MDS
STUDY_DIRECTORDr. Harneet Singh, MDS
Post Graduate Institute of Dental Sciences, Rohtak
Outcome results
None listed