Digital Occlusal Analysis and Enamel Wear Assessment in Temporomandibular Disorder Patients Treated with Fully Digital Versus Conventional Stabilization Splints

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-40
SponsorMinia University

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

20 Participants
are divided into 2 treatment groups
Group A: Fully Digital Stabilization Splint (FD-SS)Experimental treatment 1 intervention
Group B: Conventional Stabilization Splint (C-SS)Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

1. Occlusal Force Measurement: • Measured using OccluSense in Newtons (N).

Occlusal Force Measurement: * Measured using OccluSense in Newtons (N)

Time frame
6 months

Secondary outcomes

1

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.

Time frame
6 months

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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