Comparison Between Conventional Versus 3D-Designed and Printed Stabilization Splints for Treatment of TMD Patients: A Randomized Clinical Trial.

NCT ID: NCT06781138

Last Updated: 2025-01-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-01
• Study Completion Date: 2024-12-01

Brief Summary

This study is a randomized clinical trial comparing the effectiveness of conventional stabilization splints versus 3D-designed and printed stabilization splints in treating temporomandibular disorders (TMDs). TMD is a common cause of orofacial pain affecting the jaw joint and surrounding muscles. The trial evaluates outcomes such as pain reduction, clinical improvement, patient satisfaction, and time efficiency. By exploring a fully digital workflow for splint fabrication, this study aims to provide evidence on whether the newer 3D-printed approach offers superior results to conventional methods in terms of clinical effectiveness and procedural efficiency.

Detailed Description

This study is a randomized clinical trial designed to evaluate the efficacy of 3D-designed and printed stabilization splints compared to conventional stabilization splints in managing temporomandibular disorders (TMDs) of muscular origin. TMD is a prevalent orofacial condition characterized by pain and dysfunction in the temporomandibular joint (TMJ) and associated structures, significantly impacting patients' quality of life. Stabilization splints are a widely used conservative treatment for TMD, aiming to alleviate symptoms by stabilizing occlusion, reducing parafunctional habits, and promoting muscle relaxation. Despite their popularity, controversies remain about their optimal design and long-term efficacy, especially with recent advancements in digital fabrication technologies.

Study Objectives The primary aim is to assess whether 3D-designed and printed stabilization splints offer superior clinical outcomes compared to conventional splints. Outcomes include pain reduction (measured using the Visual Analog Scale, VAS) and clinical improvement based on Diagnostic Criteria for TMD (DC/TMD) evaluations. Secondary objectives include measuring patient satisfaction, chairside time during splint fabrication, and changes in maximal unassisted incisal opening.

Study Design This is a single-blinded, randomized, parallel-group clinical trial with a 1:1 allocation ratio. The study will be conducted at the outpatient clinic of the Department of Orthodontics, Faculty of Dentistry, Cairo University. Adult patients aged 18-40 with muscular TMD are eligible, provided they meet inclusion criteria and have no prior orthodontic treatments.

Methodology

Participants will be randomly assigned to one of two groups:

Intervention Group: Patients will undergo direct intraoral scanning using a digital scanner. The data will be used to design and fabricate stabilization splints using a fully digital, 3D-printing workflow.

Comparator Group: Patients will have conventional alginate impressions taken. Stabilization splints will be fabricated using cold-cure acrylic resin.

Patients in both groups will be instructed to wear their splints at night only. Follow-up assessments will occur at 2, 4, 8, and 12 weeks to evaluate outcomes.

12) Outcomes:

Primary:

• Measuring clinical improvement and pain level using VAS

Secondary:

• Measuring the patient satisfaction during wearing of the splint using VAS
• Chairside time taken during conventional splint impression and fabrication vs digital splint intraoral scan and design
• Changes in maximal incisal opening (fitting day/8 weeks) Significance This study addresses an important clinical question by comparing traditional and modern techniques for splint fabrication. By leveraging a digital workflow, it aims to provide insights into whether 3D-printed splints can improve clinical outcomes, enhance patient satisfaction, and reduce the time required for fabrication, potentially advancing TMD management practices.

Conditions

Temporomandibular Disorders (TMD)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Conventional stabilization splint

Group Type: ACTIVE_COMPARATOR

Conventional stabilization splint

Intervention Type: DEVICE

conventional versus 3D designed and printed stabilization splints

3D designed and printed stabilization splint

Group Type: EXPERIMENTAL

3D designed and printed stabilization splints

Intervention Type: DEVICE

Conventional versus 3D designed and printed stabilization splints

Interventions

Conventional stabilization splint

conventional versus 3D designed and printed stabilization splints

Intervention Type: DEVICE

3D designed and printed stabilization splints

Conventional versus 3D designed and printed stabilization splints

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Adult patients aged (18-40) presenting with myalgia.

Exclusion Criteria

• Previous orthodontic treatment.

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

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Abdallah Ahmed Hassan

Resident

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Abdallah Ahmed Hassan Hamed Refai, MSc candidate

Role: PRINCIPAL_INVESTIGATOR

Cairo University

Locations

Cairo University

Cairo, , Egypt

Countries

Egypt

Other Identifiers

2461994

Identifier Type: -

Identifier Source: org_study_id