An interventional study of Conventional Stabilization Splints and 3d printed Stabilization splint in Temporomandibular Disorders (TMDs), Myofascial Pain - Dysfunction Syndrome of TMJ and Myofascial Pain Dysfunction Syndrome, Temporomandibular Joint, sponsored by Postgraduate Institute of Dental Sciences Rohtak. Not yet recruiting at 1 site in India. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-08-12.
Sponsored by Postgraduate Institute of Dental Sciences Rohtak · Not applicable, Interventional, and Treatment
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.
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.
Exclusion Criteria:
Patients will be given conventional hard stabilization splints.
Device: Conventional Stabilization Splints
Patients will be given single material 3D printed stabilization splints made of PETG.
Device: 3d printed Stabilization splint
Patients will be given Novel Hybrid stabilization splints made of PETG and TPU.
Device: Novel hybrid stabilization splint
Conventional chairside stabilization splints for treatment of temporomandibular joint disorders.
3d printed stabilization splint for treatment of temporomandibular joint disorders.
Also known as: 3d printed single material stabilization splint
3d printed hybrid stabilization splint for treatment of temporomandibular joint disorders.
Also known as: novel hybrid dual material stabilization splint
Visual Analog Scale (VAS)
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.
Time frame: Baseline, 1 week, 2 weeks, 4 weeks
Maximum Mouth Opening
To evaluate functional improvement by Measuring the change in Maximum Mouth Opening (MMO) in millimetres from baseline to 1 month.
Time frame: Baseline, 1 week, 2 weeks, 4 weeks
Maximum Bite Force
To quantify masticatory efficiency by measuring changes in Maximum Bite Force (MBF) using a bite force analyser device.
Time frame: baseline, 1 week, 2 weeks, 4 weeks
Patient Compliance
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.
Time frame: Baseline, 1 week, 2 weeks, 4 weeks
This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Temporomandibular Joint Disorders→
Postgraduate Institute of Dental Sciences Rohtak