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

NCT ID: NCT06781320

Last Updated: 2025-01-17

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-26
• Study Completion Date: 2026-07-17

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.

Conditions

TMD; Temporomandibular Disorders (TMD)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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)

Group Type: EXPERIMENTAL

stabilization splint

Intervention Type: 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.

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)

Group Type: ACTIVE_COMPARATOR

stabilization splint

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Minia University

OTHER

Sponsor Role: lead

Responsible Party

Mohamed Sawi Mohamed

Dr

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Mohamed Sawi Mohamed Sawi, Assistant lecturer

Role: CONTACT

drmohamedelsawi@hotmail.com

00201113669910

Other Identifiers

112/498

Identifier Type: -

Identifier Source: org_study_id