Temporomandibular Disorders (TMD), TMD
Conditions
Keywords
temporomandibular disorder, TMD,, Digital occlusal analysis, enamel wear assessment, stabilization splints
Brief summary
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
Detailed description
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.
Interventions
DEVICEstabilization splint
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.
Sponsors
Minia University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
No
Inclusion criteria
1. 18-40 years old 2. complete dentition 3. intact tooth 4. no occlusal disorder 5. stable jaw relation 6. No ongoing dental therapy, such as orthodontic or prosthodontics treatment.
Exclusion criteria
1. pregnant/lactating women 2. temporomandibular joint lesions found on clinical palpation or medical imaging examination 3. dentoalveolar pathology or ongoing treatment related to TMD 4. jaw opening less than 3 fingers 5. patients with occlusal dysfunctions 6. Patients with severe or moderate periodontitis. 7. Unable to undergo examination or treatment due to the presence of a psychological or mental disorder. 8. Severe jaw functional limitations. 9. Removable dentures or partially dentate patients 10. Trauma of recent date towards face, head or neck
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 1. Occlusal Force Measurement: • Measured using OccluSense in Newtons (N). | 6 months | Occlusal Force Measurement: * Measured using OccluSense in Newtons (N) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Tooth Wear Measurement using an intraoral scanner | 6 months | Comparison of STL datasets using Geomagic Control X software. * Measured as % of surface overlap or deviation in microns. |
Contacts
Primary ContactMohamed Sawi Mohamed Sawi, Assistant lecturer
Outcome results
None listed