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NCT Number: NCT06781320

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

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

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 18-40 years old
  • complete dentition
  • intact tooth
  • no occlusal disorder
  • stable jaw relation
  • No ongoing dental therapy, such as orthodontic or prosthodontics treatment.

Exclusion criteria

  • 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
  • patients with occlusal dysfunctions
  • Patients with severe or moderate periodontitis.
  • Unable to undergo examination or treatment due to the presence of a psychological or mental disorder.
  • Severe jaw functional limitations.
  • Removable dentures or partially dentate patients
  • Trauma of recent date towards face, head or neck

Treatment and study plan

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.

Primary outcomes

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

    Time frame: 6 months

    Occlusal Force Measurement:

    • Measured using OccluSense in Newtons (N)

Secondary outcomes

  1. Tooth Wear Measurement using an intraoral scanner

    Time frame: 6 months

    Comparison of STL datasets using Geomagic Control X software.

    • Measured as % of surface overlap or deviation in microns.

Study contacts

Contact information is provided by the study sponsor or research team.

Mohamed Sawi Mohamed Sawi, Assistant lecturer

CONTACT

[email protected]

00201113669910

Sponsors and collaborators

Lead sponsor

Minia University

Other

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Jan 17, 2025
Registry last updated
Jan 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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