About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Parallel
Treatments tested in this trial
Conventional Stabilization Splints
DeviceConventional chairside stabilization splints for treatment of temporomandibular joint disorders.
3d printed Stabilization splint
Device3d printed stabilization splint for treatment of temporomandibular joint disorders.
Novel hybrid stabilization splint
Device3d printed hybrid stabilization splint for treatment of temporomandibular joint disorders.
Treatment groups
Trial outcomes
Primary outcomes
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.
Maximum Mouth Opening
To evaluate functional improvement by Measuring the change in Maximum Mouth Opening (MMO) in millimetres from baseline to 1 month.
Maximum Bite Force
To quantify masticatory efficiency by measuring changes in Maximum Bite Force (MBF) using a bite force analyser device.
Secondary outcomes
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.
Sponsors and contacts
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