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

NCT ID: NCT06957665

Last Updated: 2025-05-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-12-29
• Study Completion Date: 2024-12-31

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.

Conditions

Temporomandibular Disorders (TMD)

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

T-scan Assisted Occlusal Adjustment with Stabilization Splint

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hanoi Medical University

OTHER

Sponsor Role: lead

Responsible Party

DUC NGUYEN MINH

Lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Hanoi Medical Univeristy Hospital

Hanoi, , Vietnam

Countries

Vietnam

Other Identifiers

RHMCK62722815

Identifier Type: -

Identifier Source: org_study_id