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This randomized controlled research aimed to analyse the occlusion and assist the enamel wear before and after using of the stabilization splints produced by the conventional methods with the fully digitally fabricated stabilization splints.
Research question: Will the fully digital stabilization splint offer significantly better occlusal equilibration and enamel wear compared to the conventional stabilization splint? the primary outcome will be Digital occlusal analysis, and secondary outcome will be enamel wear assessment
This randomized controlled clinical trial investigates the effectiveness of fully digitally fabricated stabilization splints (FD-SS) versus conventionally manufactured stabilization splints (C-SS) in patients with temporomandibular disorders (TMD). The study focuses on two primary outcomes: digital occlusal analysis and enamel wear assessment over a 6-month period.
Participants are TMD patients aged 18-40 with stable jaw relations and intact dentition, randomly assigned (1:1) to the FD-SS or C-SS group. Digital occlusal analysis is performed using OccluSense technology, which captures bite force distribution and contact points dynamically and statically. Enamel wear is assessed quantitatively using an intraoral scanner paired with Geomagic Control X 3D software for surface matching analysis. Baseline and follow-up STL datasets are compared to quantify volumetric enamel loss with micrometer precision.
In the FD-SS group, fully digital stabilization splints are fabricated using a digital workflow that includes intraoral scanning, jaw tracking with Zebris JMA devices, and CAD/CAM design in Exocad software. Splints are manufactured using 3D printing technology. In the C-SS group, conventional splints are fabricated using alginate impressions, plaster casts, and manual adjustments on a semi-adjustable articulator.
This study aims to advance the understanding of digital technologies in managing TMD, providing evidence for their efficacy in improving occlusal balance and minimizing enamel wear.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fully Digital Stabilization Splint (FD-SS) | Experimental | Description: Participants in this group will receive a stabilization splint fabricated using a fully digital workflow. The intervention includes:
Purpose: The FD-SS is designed to provide optimal occlusal stabilization, reduce TMJ stress, and minimize enamel wear over a 6-month period. Device Name: Fully Digital Stabilization Splint (FD-SS) |
|
| Conventional Stabilization Splint (C-SS) | Active Comparator | Description: Participants in this group will receive a stabilization splint fabricated using conventional methods. The intervention includes:
Purpose: The C-SS is designed to achieve occlusal stabilization and provide symptom relief for patients with temporomandibular disorders (TMD) over 6 months. Device Name: Conventional Stabilization Splint (C-SS) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| stabilization splint | Device | the patients will receive a stabilization splint fabricated using a fully digital workflow includes: Intraoral scanning of maxillary and mandibular arches to create a digital model. Jaw tracking using the Zebris JMA system to record mandibular movements. CAD design of the splint using Exocad software. Fabrication of the splint via 3D printing technology. The FD-SS is designed to provide optimal occlusal stabilization, reduce TMJ stress, and minimize enamel wear over 6 months. Or the patient will receive stabilization splint fabricated using conventional methods. The intervention includes: Taking alginate impressions of maxillary and mandibular arches to create plaster casts. Jaw registration using a Lucia jig and semi-adjustable articulator for proper occlusal adjustment. Manual fabrication of the splint using polymethyl methacrylate (PMMA) resin. The C-SS is designed to achieve occlusal stabilization and symptom relief for TMD patients over 6 months. |
| Measure | Description | Time Frame |
|---|---|---|
| 1. Occlusal Force Measurement: • Measured using OccluSense in Newtons (N). | Occlusal Force Measurement:
| 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Tooth Wear Measurement using an intraoral scanner | Comparison of STL datasets using Geomagic Control X software.
| 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mohamed Sawi Mohamed Sawi, Assistant lecturer | Contact | 00201113669910 | drmohamedelsawi@hotmail.com |
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|
| ID | Term |
|---|---|
| D013705 | Temporomandibular Joint Disorders |
| ID | Term |
|---|---|
| D017271 | Craniomandibular Disorders |
| D008336 | Mandibular Diseases |
| D007571 | Jaw Diseases |
| D009140 | Musculoskeletal Diseases |
| D007592 | Joint Diseases |
| D009135 | Muscular Diseases |
| D009057 | Stomatognathic Diseases |
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