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

NCT06957665 | Completed

• 1 other identifier: RHMCK62722815
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Temporomandibular Disorders (TMD)

Keywords

Temporomandibular Disorders; Stabilization Splints; T-scan System

Outcome Measures

Primary Outcomes (1)

• Change in Pain Intensity (VAS score)

  Pain intensity will be assessed using the Visual Analog Scale (VAS, 0-10) at baseline, 1 month, and 3 months after treatment initiation.

  Baseline, 1 month, 3 months

Secondary Outcomes (2)

• Change in Maximum Comfortable Mouth Opening (MCO)

  Baseline, 1 month, 3 months

• Change in Occlusal Time (OT)

  Baseline, 1 month

Study Arms (1)

Stabilization Splint with T-scan Assisted Adjustment

EXPERIMENTAL

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.

Device: T-scan Assisted Occlusal Adjustment with Stabilization Splint

Interventions

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.

Stabilization Splint with T-scan Assisted Adjustment

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hanoi Medical University: lead

Study Sites (1)

Hanoi Medical Univeristy Hospital

Hanoi, Vietnam

Location

MeSH Terms

Conditions

Temporomandibular Joint Disorders

Condition Hierarchy (Ancestors)

Craniomandibular Disorders; Mandibular Diseases; Jaw Diseases; Musculoskeletal Diseases; Joint Diseases; Muscular Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Model Details: 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.

Study Record Dates

• First Submitted: April 26, 2025
• First Posted: May 4, 2025
• Study Start: December 29, 2023
• Primary Completion: October 31, 2024
• Study Completion: December 31, 2024
• Last Updated: May 4, 2025

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

VN (1)