Treatment Outcomes of Temporomandibular Disorders Using Stabilization Splint Supported by the T-scan System

This study aims to evaluate the treatment outcomes of temporomandibular disorders (TMD) using stabilization splints (SS) supported by the T-scan system at Hanoi Medical University Hospital. Thirty-six patients diagnosed with TMD based on the Diagnostic Criteria for Temporomandibular Disorders (DC/TMD) received customized stabilization splints. The T-scan system was used to optimize occlusal adjustments by providing real-time digital recordings of occlusal force distribution. Clinical outcomes, including pain intensity (measured by Visual Analog Scale - VAS), maximum comfortable mouth opening (MCO), occlusal time (OT), and disocclusion time (DT), were assessed at baseline, 1 month, and 3 months after treatment. The study investigates the effectiveness of T-scan-assisted occlusal adjustments in improving clinical symptoms and enhancing jaw function in patients with TMD.

Study Overview

• Status: Completed
• Conditions: Temporomandibular Disorders (TMD)
• Intervention / Treatment: Device: T-scan Assisted Occlusal Adjustment with Stabilization Splint

Detailed Description

This clinical study evaluates the therapeutic effectiveness of stabilization splints (SS) supported by digital occlusal analysis using the T-scan system in patients with temporomandibular disorders (TMD). Thirty-six participants diagnosed with TMD according to the DC/TMD criteria were enrolled and treated at Hanoi Medical University Hospital. Custom-fabricated Michigan-type stabilization splints were provided to all participants. Occlusal adjustments were initially performed using articulating paper and then refined with the T-scan system, which measures occlusal timing and force distribution in real-time.

The primary focus was on improving clinical symptoms such as pain reduction and jaw mobility enhancement. Pain intensity was assessed with the Visual Analog Scale (VAS), and maximum comfortable mouth opening (MCO) was recorded. Occlusal Time (OT) and Disocclusion Time (DT) were evaluated using the T-scan system. Patients were followed up at 1 and 3 months post-treatment to monitor changes.

The study explores the supportive role of digital occlusal adjustment in the conservative management of TMD and highlights the potential of the T-scan system to enhance the precision of splint therapy without direct modification of the natural dentition.

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Vietnam
  • Hanoi, Vietnam
    • Hanoi Medical Univeristy Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Diagnosed with temporomandibular disorders (TMD) based on the Diagnostic Criteria for Temporomandibular Disorders (DC/TMD).
• Willing and able to wear a stabilization splint as instructed.
• Provided written informed consent.

Exclusion Criteria:

• Presence of systemic diseases (e.g., rheumatoid arthritis, fibromyalgia).
• Unstable general health condition.
• Psychological disorders that could interfere with compliance.
• Ongoing use of other treatments for TMD.
• History of maxillofacial surgery within the past 6 months.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Stabilization Splint with T-scan Assisted Adjustment; Participants received a custom-fabricated stabilization splint (Michigan splint) with occlusal adjustments guided by the T-scan system. The splints were adjusted based on both articulating paper and real-time occlusal force analysis provided by the T-scan system to optimize occlusal balance. No control or comparator arm was used.

Device: T-scan Assisted Occlusal Adjustment with Stabilization Splint; Participants were treated with a custom-fabricated stabilization splint (Michigan-type) whose occlusion was adjusted using the T-scan system (Tekscan, Norwood, MA, USA) to measure and optimize occlusal force distribution. The T-scan system was used in conjunction with articulating paper to guide occlusal refinement until bilateral force balance was achieved.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Pain Intensity (VAS score)	Pain intensity will be assessed using the Visual Analog Scale (VAS, 0-10) at baseline, 1 month, and 3 months after treatment initiation.	Baseline, 1 month, 3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Maximum Comfortable Mouth Opening (MCO)	Maximum comfortable mouth opening (in millimeters) will be measured between the incisal edges of the upper and lower central incisors at baseline, 1 month, and 3 months.	Baseline, 1 month, 3 months
Change in Occlusal Time (OT)	Occlusal Time (in seconds) will be measured by the T-scan system at baseline and after 1 month of splint therapy.	Baseline, 1 month

Collaborators and Investigators

• Sponsor: Hanoi Medical University

Study record dates

Study Major Dates

• Study Start (Actual): December 29, 2023
• Primary Completion (Actual): October 31, 2024
• Study Completion (Actual): December 31, 2024

Study Registration Dates

• First Submitted: April 26, 2025
• First Submitted That Met QC Criteria: April 26, 2025
• First Posted (Actual): May 4, 2025

Study Record Updates

• Last Update Posted (Actual): May 4, 2025
• Last Update Submitted That Met QC Criteria: April 26, 2025
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: Temporomandibular Disorders; Stabilization Splints; T-scan System
• 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; Anti-Infective Agents; Antifungal Agents; Dermatologic Agents; Keratolytic Agents; Salicylic Acid
• Other Study ID Numbers: RHMCK62722815

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No