Temporomandibular Disorders (TMD)NCT06957665
Treatment Outcomes of Temporomandibular Disorders Using Stabilization Splint Supported by the T-scan System
A study testing T-scan Assisted Occlusal Adjustment with Stabilization Splint in people with Temporomandibular Disorders (TMD), run by Hanoi Medical University at 1 site in Vietnam.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Temporomandibular Disorders (TMD)
- What is being tested?
- T-scan Assisted Occlusal Adjustment with Stabilization Splint
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteVietnam
- Study dates
- 29 Dec 2023to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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)
- Being tested
- T-scan Assisted Occlusal Adjustment with Stabilization Splint
- Keywords
- Temporomandibular Disorders, Stabilization Splints, T-scan System
- Medical subject headings
- Temporomandibular Joint Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
T-scan Assisted Occlusal Adjustment with Stabilization SplintDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: T-scan Assisted Occlusal Adjustment with Stabilization Splint |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 1 month, 3 months
Secondary outcomes (2)
Change in Maximum Comfortable Mouth Opening (MCO)
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.
Measured: Baseline, 1 month, 3 months
Change in Occlusal Time (OT)
Occlusal Time (in seconds) will be measured by the T-scan system at baseline and after 1 month of splint therapy.
Measured: Baseline, 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2025
- Study start29 Dec 2023
- Primary completion31 Oct 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Temporomandibular Disorders (TMD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- 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.
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hanoi Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, DUC NGUYEN MINH, Hanoi Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06957665
- Sponsor's protocol ID
- RHMCK62722815
- Status last verified
- Jun 2023
- First submitted
- 26 Apr 2025
- Last updated
- 4 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment Outcomes of Temporomandibular Disorders Using Stabilization Splint Supported by the T-scan System
- ClinicalTrials.gov ID
- NCT06957665
- Acronym / sponsor ID
- RHMCK62722815
- Conditions
- Temporomandibular Disorders (TMD)
- Keywords
- Temporomandibular Disorders, Stabilization Splints, T-scan System
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Hanoi Medical UniversityUniversity, hospital or other
- Study start
- 29 Dec 2023 (actual)
- Primary completion
- 31 Oct 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 4 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Stabilization Splint with T-scan Assisted Adjustment | Experimental | Device: T-scan Assisted Occlusal Adjustment with Stabilization SplintParticipants 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| T-scan Assisted Occlusal Adjustment with Stabilization SplintParticipants 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. | Device | Stabilization Splint with T-scan Assisted Adjustment |
Primary outcome
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.
2 secondary outcomes
Change in Maximum Comfortable Mouth Opening (MCO)
Time frame: Baseline, 1 month, 3 months
Change in Occlusal Time (OT)
Time frame: Baseline, 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing T-scan Assisted Occlusal Adjustment with Stabilization Splint in people with Temporomandibular Disorders (TMD), run by Hanoi Medical University at 1 site in Vietnam.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Pain Intensity (VAS score) (time frame: Baseline, 1 month, 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2025.