About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
18-40 years old
complete dentition
intact tooth
no occlusal disorder
Disqualifiers
pregnant/lactating women
temporomandibular joint lesions found on clinical palpation or medical imaging examination
dentoalveolar pathology or ongoing treatment related to TMD
jaw opening less than 3 fingers
Trial design
Parallel
Treatments tested in this trial
stabilization splint
Devicethe 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.
Treatment groups
Trial outcomes
Primary outcomes
1. Occlusal Force Measurement: • Measured using OccluSense in Newtons (N).
Occlusal Force Measurement: * Measured using OccluSense in Newtons (N)
Secondary outcomes
Tooth Wear Measurement using an intraoral scanner
Comparison of STL datasets using Geomagic Control X software. * Measured as % of surface overlap or deviation in microns.
Locations
Sponsors and contacts
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