MedTrace Logo

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

NCT07760428 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2026-08-12

No results posted yet for this 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.

Conditions

  • Temporomandibular Disorders (TMDs)
  • Myofascial Pain - Dysfunction Syndrome of TMJ
  • Myofascial Pain Dysfunction Syndrome, Temporomandibular Joint
  • Anterior Disc Displacement

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.

Sponsors & Collaborators

  • Postgraduate Institute of Dental Sciences Rohtak

    lead OTHER

Principal Investigators

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

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-16
Primary Completion
2027-10-31
Completion
2027-12-31

Countries

  • India

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07760428 on ClinicalTrials.gov