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NOT YET RECRUITING
NCT07760428
NA

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

Sponsor: Postgraduate Institute of Dental Sciences Rohtak

View on ClinicalTrials.gov

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.

Official title: Comparative Efficacy of Conventional, 3D-Printed, and Novel Hybrid Stabilization Splints in the Management of Temporomandibular Joint Disorders: A Randomized Clinical Trial

Key Details

Gender

All

Age Range

18 Years - 60 Years

Study Type

INTERVENTIONAL

Enrollment

36

Start Date

2026-08-16

Completion Date

2027-12-31

Last Updated

2026-08-12

Healthy Volunteers

No

Interventions

DEVICE

Conventional Stabilization Splints

Conventional chairside stabilization splints for treatment of temporomandibular joint disorders.

DEVICE

3d printed Stabilization splint

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

DEVICE

Novel hybrid stabilization splint

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

Locations (1)

Post Graduate Institute of Dental Sciences, Rohtak

Rohtak, Haryana, India