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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorPostgraduate Institute of Dental Sciences Rohtak

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Conventional Stabilization Splints

    Device

    Conventional chairside stabilization splints for treatment of temporomandibular joint disorders.

  • 3d printed Stabilization splint

    Device

    3d printed stabilization splint for treatment of temporomandibular joint disorders.

  • Novel hybrid stabilization splint

    Device

    3d printed hybrid stabilization splint for treatment of temporomandibular joint disorders.

Treatment groups

36 Participants
are divided into 3 treatment groups
Group A: Conventional Stabilization SplintsActive comparator 1 intervention
Group B: 3D Printed stabilization splintsActive comparator 1 intervention
Group C: Hybrid Stabilization SplintExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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
2

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
3

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

Secondary outcomes

1

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

Other outcomes

Sponsors and contacts

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