Temporomandibular Disorder (TMD)NCT07090772
The Effectiveness of Different Therapeutic Jaw Position Determining Methods in Repositioning Splint Therapy for Temporomandibular Joint Disk Displacement Without Reduction：A Randomized Controlled Clinical Trial
A study testing Repositioning splint therapy with jaw position determined by mechanical articulator, Repositioning splint therapy with jaw position determined by ai-assisted virtual articulator and Repositioning splint therapy with jaw position determined by ai-assisted virtual patient in people with Temporomandibular Disorder (TMD), run by Fujian Medical University at 1 site in China.
Trial summary
The goal of this clinical trial is to learn if different therapeutic jaw position determining methods influence the efficacy of repositioning splint therapy for temporomandibular joint disk displacement without reduction. Read more about this study
- Who is it for?
- Ages 13 to 50 years
- Conditions the study is for
- Temporomandibular Disorder (TMD)
- What is being tested?
- Repositioning splint therapy with jaw position determined by mechanical articulator, Repositioning splint therapy with jaw position determined by ai-assisted virtual articulator and Repositioning splint therapy with jaw position determined by ai-assisted virtual patient
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteChina
- Study dates
- 20 Jul 2025to 20 Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 13 to 50 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Aged 13-50 years, with permanent dentition, possessing full autonomy in behavior and expression;
- Meeting the 2014 Diagnostic Criteria for Temporomandibular Disorders (DC/TMD) diagnostic standards for irreducible temporomandibular joint disc displacement;
- MRI-confirmed unilateral irreducible disc displacement: At maximum intercuspation: Posterior band of disc located anterior to the 11:30 position, intermediate zone anterior to condyle; At maximum mouth opening: Intermediate zone remains anterior to condyle.
Who cannot join
- Systemic diseases, psychiatric disorders, or impaired consciousness;
- Pain-only disorders without articular pathology signs;
- Mandibular hypoplasia, TMJ tumors, or prior TMJ trauma;
- History of definitive TMJ disorder treatment.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
The goal of this clinical trial is to learn if different therapeutic jaw position determining methods influence the efficacy of repositioning splint therapy for temporomandibular joint disk displacement without reduction. The main questions it aims to answer are:
Does different therapeutic jaw position determining methods influence the efficacy of repositioning splint therapy for temporomandibular joint disk displacement without reduction? Researchers will compare the efficacy of repositioning splint therapy made with different therapeutic jaw position determining methods for temporomandibular joint disk displacement without reduction.
Read more
Participants will:
Take repositioning splint made with different therapeutic jaw position determining methods every day for 3-6 months.
Visit the clinic once every 3 weeks for checkups and tests.
- Conditions
- Temporomandibular Disorder (TMD)
- Being tested
- Repositioning splint therapy with jaw position determined by mechanical articulator, Repositioning splint therapy with jaw position determined by ai-assisted virtual articulator, Repositioning splint therapy with jaw position determined by ai-assisted virtual patient
- 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.
Repositioning splint therapy with jaw position determined by mechanical articulatorProcedure or surgery
The therapeutic jaw position will be determined by the following steps:
- Pre-treatment Jaw Position Recording Participants were seated upright with relaxed posture, eyes facing forward, and the Frankfort plane parallel to the floor. Intercuspal position (ICP) was recorded using silicone registration material. Edge-to-edge position of central incisors was recorded for protrusive position. Left/right lateral positions were recorded with opposing canines aligned.
- Transfer of Jaw Positions Following the manufacturer's protocol for the Artex CR mechanical facebow (Amann Girrbach, Austria) to transfer Participants' jaw positions.
- Determination of Therapeutic Position The Glenoid fossa was divided into 7 grids in the oblique-sagittal plane using Gelb's method, identifying grid 4 (Gelb 4/7) as the target condylar position.Condylar displacement knobs were set per VTO analysis.
Incisal pin height was increased to establish vertical dimension.
Repositioning splint therapy with jaw position determined by ai-assisted virtual articulatorProcedure or surgery
The jaw position was determined by the following steps:
- AI-Based Segmentation and Reconstruction of Jaw Models CBCT DICOM data was imported into an ai-based craniomaxillofacial bone segmentation system to reconstruct 3D models of the jaws and dentition. The mandibular/maxillary bone models and dental arches were exported as .ply files. These .ply files were then imported into Exocad software.
- Virtual Transfer of Jaw Positions Bilateral AI-segmented medial pole points of the condyles and the right infraorbital point were annotated in cross-sectional views.A virtual articulator was added and registered to the facebow's reference planes and hinge axis. (3)Determination of Therapeutic Position Sagittal joint spaces (anterior/superior/posterior) were measured on cross-sectional views. The composite mandibular model was repositioned to the target occlusion using the "Move Mesh" function based on: Optimal mean joint space measurements and physiological condylar position.
Repositioning splint therapy with jaw position determined by ai-assisted virtual patientProcedure or surgery
The jaw position was determined by the following steps:
- AI-Based Segmentation and Reconstruction of Virtual Patients: CBCT DICOM data was imported into an ai-based craniomaxillofacial bone segmentation system to reconstruct 3D models of the jaws and dentition. The trajectory of mandibular movement was recorded by an electronic facebow.
- Virtual Transfer of Jaw Positions Bilateral AI-segmented medial pole points of the condyles and the right infraorbital point were annotated in cross-sectional views.A virtual articulator was added and registered to the facebow's reference planes and hinge axis. (3)Determination of Therapeutic Position Sagittal joint spaces (anterior/superior/posterior) were measured on cross-sectional views. The therapeutic position was determined based on: Optimal mean joint space measurements, physiological condylar position and optimal trajectory of mandibular movement.
| Study group | Role | What they receive |
|---|---|---|
| receive repositioning splint therapy with jaw position determined by mechanical articulator | Experimental | Participants will receive repositioning splint therapy with jaw position determined by mechanical articulator method for 3-6 months. Receives: Procedure: Repositioning splint therapy with jaw position determined by mechanical articulator |
| receive repositioning splint therapy with jaw position determined by ai-assisted virtual articulator | Experimental | Participants will receive repositioning splint therapy with jaw position determined by ai-assisted virtual articulator. Receives: Procedure: Repositioning splint therapy with jaw position determined by ai-assisted virtual articulator |
| receive repositioning splint therapy with jaw position determined by ai-assisted virtual patient | Experimental | Participants will receive repositioning splint therapy with jaw position determined by ai-assisted virtual patient Receives: Procedure: Repositioning splint therapy with jaw position determined by ai-assisted virtual patient |
What is being measured
The primary outcome is the main question the study is designed to answer.
Condylar position as assessed by CBCT measurements
Condylar position of the three groups will be assessed after each treatment based on the measurements of sagittal joint spaces (anterior/superior/posterior) on CBCT's cross-sectional views.
Measured: 3-6 months
Condylar repositioning rate as assessed by CBCT measurements
Using Mimics software, post-treatment condylar positions were analyzed and measured. The proportions of affected-side condyles reposition to the Gelb 4/7 position were compared across the three therapeutic jaw position determination methods.
Measured: 3-6 months
Secondary outcomes (3)
Fricton index as assessed by comprehensive physical examination to participants
Fricton index consists of dysfunction index and palpation index, which can quantify mandibular function and movement, palpation of muscles and other indicators, and is widely used to evaluate the clinical efficacy of temporomandibular disorders.
Measured: 3-6 months
Dysfunction index as assessed by by comprehensive physical examination to participants
Dysfunction index refers to the comprehensive Index that reflect temporomandibular joint tenderness and functioning problems.
Measured: 3-6 months
Palpation index as assessed by by comprehensive physical examination to participants
Palpation index refers to the comprehensive index that reflect muscle tenderness problems.
Measured: 3-6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2025
- Study start20 Jul 2025
- Primary completion20 Aug 2026 (estimated)
- Study completion20 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Temporomandibular Disorder (TMD)Studies of the same condition, open and under way.
- More trials run by Fujian Medical UniversityThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fujian Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hao Yu, Fujian Medical University
- Investigators
- Hao Yu, PhD, MD, Principal investigator, Fujian Medical University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07090772
- Sponsor's protocol ID
- 2025ECSS057
- Status last verified
- Jul 2025
- First submitted
- 21 Jul 2025
- Last updated
- 29 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 29 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Different Therapeutic Jaw Position Determining Methods in Repositioning Splint Therapy for Temporomandibular Joint Disk Displacement Without Reduction：A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT07090772
- Acronym / sponsor ID
- 2025ECSS057
- Conditions
- Temporomandibular Disorder (TMD)
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Fujian Medical UniversityUniversity, hospital or other
- Study start
- 20 Jul 2025 (actual)
- Primary completion
- 20 Aug 2026 (estimated)
- Study completion
- 20 Aug 2026 (estimated)
- First posted
- 29 Jul 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.
The goal of this clinical trial is to learn if different therapeutic jaw position determining methods influence the efficacy of repositioning splint therapy for temporomandibular joint disk displacement without reduction. The main questions it aims to answer are:
Does different therapeutic jaw position determining methods influence the efficacy of repositioning splint therapy for temporomandibular joint disk displacement without reduction? Researchers will compare the efficacy of repositioning splint therapy made with different therapeutic jaw position determining methods for temporomandibular joint disk displacement without reduction.
Participants will:
Take repositioning splint made with different therapeutic jaw position determining methods every day for 3-6 months.
Visit the clinic once every 3 weeks for checkups and tests.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| receive repositioning splint therapy with jaw position determined by mechanical articulator | Experimental | Procedure: Repositioning splint therapy with jaw position determined by mechanical articulatorParticipants will receive repositioning splint therapy with jaw position determined by mechanical articulator method for 3-6 months. |
| receive repositioning splint therapy with jaw position determined by ai-assisted virtual articulator | Experimental | Procedure: Repositioning splint therapy with jaw position determined by ai-assisted virtual articulatorParticipants will receive repositioning splint therapy with jaw position determined by ai-assisted virtual articulator. |
| receive repositioning splint therapy with jaw position determined by ai-assisted virtual patient | Experimental | Procedure: Repositioning splint therapy with jaw position determined by ai-assisted virtual patientParticipants will receive repositioning splint therapy with jaw position determined by ai-assisted virtual patient |
Who may qualify
- Ages
- 13 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Aged 13-50 years, with permanent dentition, possessing full autonomy in behavior and expression;
- Meeting the 2014 Diagnostic Criteria for Temporomandibular Disorders (DC/TMD) diagnostic standards for irreducible temporomandibular joint disc displacement;
- MRI-confirmed unilateral irreducible disc displacement: At maximum intercuspation: Posterior band of disc located anterior to the 11:30 position, intermediate zone anterior to condyle; At maximum mouth opening: Intermediate zone remains anterior to condyle.
Key exclusion criteria (4 listed)
- Systemic diseases, psychiatric disorders, or impaired consciousness;
- Pain-only disorders without articular pathology signs;
- Mandibular hypoplasia, TMJ tumors, or prior TMJ trauma;
- History of definitive TMJ disorder treatment.
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 |
|---|---|---|
| Repositioning splint therapy with jaw position determined by mechanical articulatorThe therapeutic jaw position will be determined by the following steps: 1. Pre-treatment Jaw Position Recording Participants were seated upright with relaxed posture, eyes facing forward, and the Frankfort plane parallel to the floor. Intercuspal position (ICP) was recorded using silicone registration material. Edge-to-edge position of central incisors was recorded for protrusive position. Left/right lateral positions were recorded with opposing canines aligned. 2. Transfer of Jaw Positions Following the manufacturer's protocol for the Artex CR mechanical facebow (Amann Girrbach, Austria) to transfer Participants' jaw positions. 3. Determination of Therapeutic Position The Glenoid fossa was divided into 7 grids in the oblique-sagittal plane using Gelb's method, identifying grid 4 (Gelb 4/7) as the target condylar position.Condylar displacement knobs were set per VTO analysis. Incisal pin height was increased to establish vertical dimension. | Procedure or surgery | receive repositioning splint therapy with jaw position determined by mechanical articulator |
| Repositioning splint therapy with jaw position determined by ai-assisted virtual articulatorThe jaw position was determined by the following steps: 1. AI-Based Segmentation and Reconstruction of Jaw Models CBCT DICOM data was imported into an ai-based craniomaxillofacial bone segmentation system to reconstruct 3D models of the jaws and dentition. The mandibular/maxillary bone models and dental arches were exported as .ply files. These .ply files were then imported into Exocad software. 2. Virtual Transfer of Jaw Positions Bilateral AI-segmented medial pole points of the condyles and the right infraorbital point were annotated in cross-sectional views.A virtual articulator was added and registered to the facebow's reference planes and hinge axis. (3)Determination of Therapeutic Position Sagittal joint spaces (anterior/superior/posterior) were measured on cross-sectional views. The composite mandibular model was repositioned to the target occlusion using the "Move Mesh" function based on: Optimal mean joint space measurements and physiological condylar position. | Procedure or surgery | receive repositioning splint therapy with jaw position determined by ai-assisted virtual articulator |
| Repositioning splint therapy with jaw position determined by ai-assisted virtual patientThe jaw position was determined by the following steps: 1. AI-Based Segmentation and Reconstruction of Virtual Patients: CBCT DICOM data was imported into an ai-based craniomaxillofacial bone segmentation system to reconstruct 3D models of the jaws and dentition. The trajectory of mandibular movement was recorded by an electronic facebow. 2. Virtual Transfer of Jaw Positions Bilateral AI-segmented medial pole points of the condyles and the right infraorbital point were annotated in cross-sectional views.A virtual articulator was added and registered to the facebow's reference planes and hinge axis. (3)Determination of Therapeutic Position Sagittal joint spaces (anterior/superior/posterior) were measured on cross-sectional views. The therapeutic position was determined based on: Optimal mean joint space measurements, physiological condylar position and optimal trajectory of mandibular movement. | Procedure or surgery | receive repositioning splint therapy with jaw position determined by ai-assisted virtual patient |
Primary outcome
Condylar position as assessed by CBCT measurements
Time frame: 3-6 months
Condylar position of the three groups will be assessed after each treatment based on the measurements of sagittal joint spaces (anterior/superior/posterior) on CBCT's cross-sectional views.
Condylar repositioning rate as assessed by CBCT measurements
Time frame: 3-6 months
Using Mimics software, post-treatment condylar positions were analyzed and measured. The proportions of affected-side condyles reposition to the Gelb 4/7 position were compared across the three therapeutic jaw position determination methods.
3 secondary outcomes
Fricton index as assessed by comprehensive physical examination to participants
Time frame: 3-6 months
Dysfunction index as assessed by by comprehensive physical examination to participants
Time frame: 3-6 months
Palpation index as assessed by by comprehensive physical examination to participants
Time frame: 3-6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2025.
- Individual participant dataSharing planned: No
Related trials for Temporomandibular Disorder (TMD)
Not yet recruiting
Comparing Dextrose Prolotherapy vs. Sodium Hyaluronic Acid Injections for Jaw Joint Internal Derangement
Temporomandibular Joint Internal Derangement, TMJ-ID
Recruiting
R01_Pilot Jaw Muscle Phenotypes
Chronic TMD Pain, Temporomandibular Disorder
Recruiting
Evaluation of the Effect of Adding Sodium Bicarbonate to Lidocaine in the Treatment of Myofascial Pain Syndrome
Myofacial Pain, Myofacial Pain Syndrome
Recruiting
Clinical and Electromyographic Assessment of Occlusal Splint Therapy
Temporomandibular Joint Disorders
Recruiting
An Open Label Study Assessing REN Treatment in Headache Management in Temporomandibular Disorders
Temporomandibular Disorder, Orofacial Pain
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.
Hao Yu, PhD, MD principal investigator
Fujian Medical University, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Repositioning splint therapy with jaw position determined by mechanical articulator, Repositioning splint therapy with jaw position determined by ai-assisted virtual articulator and Repositioning splint therapy with jaw position determined by ai-assisted virtual patient in people with Temporomandibular Disorder (TMD), run by Fujian Medical University at 1 site in China.
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 4 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: enrolling by invitation, as of the sponsor's last update on 29 Jul 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 China. 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?
This study is still under way. Results are not available in the source record yet.
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?
Condylar position as assessed by CBCT measurements (time frame: 3-6 months). The study lists 2 primary outcomes in all. 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 29 Jul 2025.