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Completed

NCT Number: NCT06957665

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.

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Key information

Conditions

Temporomandibular Disorders (TMD) Craniomandibular Disorders Jaw Diseases Joint Diseases Mandibular Diseases Muscular Diseases Musculoskeletal Diseases Stomatognathic Diseases Temporomandibular Joint Disorders

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hanoi Medical Univeristy Hospital

Hanoi, Vietnam

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

T-scan Assisted Occlusal Adjustment with Stabilization Splint

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.

Primary outcomes

  1. Change in Pain Intensity (VAS score)

    Time frame: 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 outcomes

  1. Change in Maximum Comfortable Mouth Opening (MCO)

    Time frame: 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.

  2. Change in Occlusal Time (OT)

    Time frame: Baseline, 1 month

    Occlusal Time (in seconds) will be measured by the T-scan system at baseline and after 1 month of splint therapy.

Sponsors and collaborators

Lead sponsor

Hanoi Medical University

Other

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
May 4, 2025
Registry last updated
May 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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