Conventional Stabilization Splints: Conventional chairside stabilization splints for treatment of temporomandibular joint disorders.
3d printed Stabilization splint: 3d printed stabilization splint for treatment of temporomandibular joint disorders.
Novel hybrid stabilization splint: 3d printed hybrid stabilization splint for treatment of temporomandibular joint disorders.
Study 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
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.
Primary outcome measure(s)
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.
Trial sites (1)
Facility
City
Region
Status
Post Graduate Institute of Dental Sciences, Rohtak
Rohtak
Haryana
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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