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

Hanoi Medical University

Status: Completed

Conditions: Temporomandibular Disorders (TMD)

Treatments: Device: T-scan Assisted Occlusal Adjustment with Stabilization Splint

Study type: Interventional

Funder types: Other

Identifiers

NCT06957665

RHMCK62722815

Details and patient eligibility

About

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.

Full 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.

Enrollment: 36 patients

Sex: All

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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36 participants in 1 patient group

Stabilization Splint with T-scan Assisted Adjustment

Experimental group

Description:

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.

Treatment:

Device: T-scan Assisted Occlusal Adjustment with Stabilization Splint