Comparison of Conventional,3D Printed and Novel Hybrid Stabilization Splints in the Management of Temporomandibular Joint Disorders

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.

• Conventional Stabilization Splints (Device): Conventional chairside stabilization splints for treatment of temporomandibular joint disorders.
• 3d printed Stabilization splint (Device), also known as 3d printed single material stabilization splint: 3d printed stabilization splint for treatment of temporomandibular joint disorders.
• Novel hybrid stabilization splint (Device), also known as novel hybrid dual material stabilization splint: 3d printed hybrid stabilization splint for treatment of temporomandibular joint disorders.

Primary outcomes

• 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 outcomes

• 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.

Sex: All, ages: 18 Years to 60 Years

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.

• Dr. Harneet Singh, MDS, Study director, Post Graduate Institute of Dental Sciences, Rohtak