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

Digital Occlusal Analysis and Enamel Wear Assessment in Temporomandibular Disorder Patients Treated with Fully Digital Versus Conventional Stabilization Splints: a Randomized Controlled Clinical 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

Study Overview

• Status: Not yet recruiting
• Conditions: TMD; Temporomandibular Disorders (TMD)
• Intervention / Treatment: Device: stabilization splint

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.

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mohamed Sawi Mohamed Sawi, Assistant lecturer; Phone Number: 00201113669910; Email: drmohamedelsawi@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Fully Digital Stabilization Splint (FD-SS); Description: Participants in this group will receive a stabilization splint fabricated using a fully digital workflow. The intervention includes: Intraoral scanning of the 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: 3D printing technology to manufacture the splint. Purpose: The FD-SS is designed to provide optimal occlusal stabilization, reduce TMJ stress, and minimize enamel wear over a 6-month period. Device Name: Fully Digital Stabilization Splint (FD-SS)	Device: stabilization 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.
Active Comparator: Conventional Stabilization Splint (C-SS); Description: Participants in this group will receive a stabilization splint fabricated using conventional methods. The intervention includes: Taking alginate impressions of the maxillary and mandibular arches to create plaster casts.; Jaw registration using a Lucia jig and a semi-adjustable articulator for occlusal adjustment.; Manual fabrication of the splint using polymethyl methacrylate (PMMA) resin. Purpose: The C-SS is designed to achieve occlusal stabilization and provide symptom relief for patients with temporomandibular disorders (TMD) over 6 months. Device Name: Conventional Stabilization Splint (C-SS)	Device: stabilization 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
1. Occlusal Force Measurement: • Measured using OccluSense in Newtons (N).	Occlusal Force Measurement: Measured using OccluSense in Newtons (N)	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	6 months

Collaborators and Investigators

• Sponsor: Minia University

Study record dates

Study Major Dates

• Study Start (Estimated): January 26, 2025
• Primary Completion (Estimated): December 25, 2025
• Study Completion (Estimated): July 17, 2026

Study Registration Dates

• First Submitted: December 30, 2024
• First Submitted That Met QC Criteria: January 15, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 15, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: Digital occlusal analysis; temporomandibular disorder, TMD,; enamel wear assessment; stabilization splints
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Stomatognathic Diseases; Muscular Diseases; Joint Diseases; Jaw Diseases; Mandibular Diseases; Craniomandibular Disorders; Myofascial Pain Syndromes; Temporomandibular Joint Disorders; Temporomandibular Joint Dysfunction Syndrome
• Other Study ID Numbers: 112/498

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No