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Patient Satisfaction in Occlusal Splints Fabricated Using Fully Digital Versus Conventional Workflow

NCT06985173 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2025-05-22

No results posted yet for this study

Summary

According to published literatures, the prevalence of TMD is approximately 10% in patients over 18 years of age with a considerable proportion being women of reproductive age. The treatment of TMD presents the following goals: decreasing joint and masticatory muscle pain, increasing the range of motion in the mandible, preventing degenerative changes in the articulating tissues. Management of TMD can be either conservative or surgical treatments, the conservative treatments include analgesia, medications, physical therapy, occlusal adjustment, splint therapy, localized steam application, and external muscle massage. The occlusal splint therapy is considered a common treatment option for TMD management. Flat stabilization splint is the preferred splint for such cases. It is designed to promote occlusal stability and decrease muscles tension by altering occlusion and allowing complete seating of the condyle in centric relation.

The evolution of digital technology created new era of dentistry that successfully digitalized the traditional workflow of occlusal splints including designing and manufacturing. Furthermore, virtual facebow and dynamic jaw relation record using jaw tracking device are another digital reward. The digital workflow can offer more predictable approach for occlusal splint construction, It could eliminate the traditional technical errors and enhance the occlusal accuracy

Conditions

  • Temporomandibular Joint Disorders

Interventions

DEVICE

Occlusal splints manufactured with fully digital workflow.

The intervention involves the fabrication of 3D printed occlusal splint with fully digitalization technique by the aid of Jaw Tracing Device. The acquisition and scanning of the patients are done by using an intra oral scanner and designing them using a designing software. This device will be printed with a 3D printer utilizing printable resin material

DEVICE

Occlusal splints manufactured with Conventional workflow

For the comparator group, maxillary and mandibular impressions will be made with Cavex CA37 alginate impression material (Cavex Holland B.V, Holland), models will be poured with gypsum (Kimberlit, Type IV Dental Stone, Protechno Spain), facebow (Bio-art) record and interocclusal registrations will be recorded at centric by using bite registration material after patient deprogramming with Lucia jig. The models will be mounted in a semi-adjustable articulator (Bio-art, A7Plus, Brazil), wax pattern fabrication on surveyed and mounted casts to be invested finally to form a clear, heated-cured acrylic resin splint

Sponsors & Collaborators

  • Cairo University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2025-07-01
Primary Completion
2025-10-01
Completion
2026-01-01

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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 NCT06985173 on ClinicalTrials.gov