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

NCT06781320 | Not Yet Recruiting

• 1 other identifier: 112/498
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

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

Conditions

TMD; Temporomandibular Disorders (TMD)

Keywords

temporomandibular disorder, TMD,; Digital occlusal analysis; enamel wear assessment; stabilization splints

Outcome Measures

Primary Outcomes (1)

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

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

  6 months

Secondary Outcomes (1)

• Tooth Wear Measurement using an intraoral scanner

  6 months

Study Arms (2)

Fully Digital Stabilization Splint (FD-SS)

EXPERIMENTAL

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

Conventional Stabilization Splint (C-SS)

ACTIVE COMPARATOR

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

Interventions

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.

Conventional Stabilization Splint (C-SS); Fully Digital Stabilization Splint (FD-SS)

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Minia University: lead

MeSH Terms

Conditions

Temporomandibular Joint Disorders

Condition Hierarchy (Ancestors)

Craniomandibular Disorders; Mandibular Diseases; Jaw Diseases; Musculoskeletal Diseases; Joint Diseases; Muscular Diseases; Stomatognathic Diseases

Central Study Contacts

Mohamed Sawi Mohamed Sawi, Assistant lecturer

CONTACT

00201113669910; drmohamedelsawi@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: December 30, 2024
• First Posted: January 17, 2025
• Study Start: January 26, 2025
• Primary Completion: December 25, 2025
• Study Completion (Estimated): July 17, 2026
• Last Updated: January 17, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share