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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06957665
Enrollment
36
Registered
2025-05-04
Start date
2023-12-29
Completion date
2024-12-31
Last updated
2025-05-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Temporomandibular Disorders (TMD)

Keywords

Temporomandibular Disorders, Stabilization Splints, T-scan System

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.

Interventions

DEVICET-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.

Sponsors

Hanoi Medical University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

A single-group, non-randomized clinical study where all enrolled participants received stabilization splint therapy supported by T-scan system-assisted occlusal adjustment. No control or comparison group was used.

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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.

Design outcomes

Primary

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

Secondary

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

Countries

Vietnam

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026