Clinical trial NCT06781320: Digital Occlusal Analysis and Enamel Wear Assessment in Temporomandibular Disorder Patients Treated with Fully Digital Versus Conventional Stabilization Splints
Official title: Digital Occlusal Analysis and Enamel Wear Assessment in Temporomandibular Disorder Patients Treated with Fully Digital Versus Conventional Stabilization Splints: a Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: TMD
Temporomandibular Disorders (TMD)
Keywords: temporomandibular disorder, TMD,
Digital occlusal analysis
enamel wear assessment
stabilization splints
Lead sponsor: Minia University
Sponsor class: OTHER
First posted: 2025-01-17
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: 1. Occlusal Force Measurement: • Measured using OccluSense in Newtons (N).
timeFrame: 6 months
Secondary outcomes:
measure: Tooth Wear Measurement using an intraoral scanner
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
References: