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

Not Applicable

Completed

• Conditions: Temporomandibular Disorders (TMD)

• Registration Number: NCT06957665
• Lead Sponsor: Hanoi Medical University

Brief Summary

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.

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 Timeline

• Status Verified: 2023-06
• Study Start: 2023-12-29
• Primary Completion: 2024-10-31
• Study Completion: 2024-12-31
• Study First Submitted: 2025-04-26
• Study First Submitted QC: 2025-04-26
• Last Update Submitted: 2025-04-26
• Study First Posted: 2025-05-04
• Last Update Posted: 2025-05-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Change in Occlusal Time (OT)	Baseline, 1 month	Occlusal Time (in seconds) will be measured by the T-scan system at baseline and after 1 month of splint therapy.
Change in Maximum Comfortable Mouth Opening (MCO)	Baseline, 1 month, 3 months	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.

Trial Locations

Locations (1)

Hanoi Medical Univeristy Hospital; 🇻🇳 Hanoi, Vietnam