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

January 14, 2025 updated by: Abdallah Ahmed Hassan, Cairo University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

32

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt
        • Cairo University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Previous orthodontic treatment.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Conventional stabilization splint
Device: Conventional stabilization splint
conventional versus 3D designed and printed stabilization splints
Experimental: 3D designed and printed stabilization splint
Device: 3D designed and printed stabilization splints
Conventional versus 3D designed and printed stabilization splints

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
clinical improvement
Time Frame: after 8 weeks
Visual analogue scale
after 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Investigators

  • Principal Investigator: Abdallah Ahmed Hassan Hamed Refai, MSc candidate, Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2024

Primary Completion (Actual)

December 1, 2024

Study Completion (Actual)

December 1, 2024

Study Registration Dates

First Submitted

January 14, 2025

First Submitted That Met QC Criteria

January 14, 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 14, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2461994

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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