CompletedNot Applicable

Accuracy of Digital Mandibular Repositioning in Occlusal Reconstruction for Patients With Disc Displacement

China48 participantsStarted 2025-06-20

Plain-language summary

This study evaluates a new, individualized treatment for adolescents with temporomandibular joint disorders (TMD) caused by bilateral, reducible disc displacement. Participants will undergo clinical and imaging examinations, including cone-beam CT (CBCT), MRI, and intraoral digital scanning to create three-dimensional models of the teeth and jaw. Based on these data, the study team will design and fabricate a personalized repositioning digital occlusal splint for each participant. Patients will be instructed on how to wear the splint and will return for regular follow-up visits to monitor symptoms and adjust the splint as needed. The study aims to improve pain, chewing function, and overall quality of life. All research-related imaging, digital scans, splint fabrication, and follow-up visits will be provided at no cost to participants. Possible risks include temporary discomfort or pressure when first wearing the splint, and the possibility that symptoms may not improve as expected. Participant safety, privacy, and data confidentiality will be strictly protected, and participants may withdraw from the study at any time without affecting their future medical care.

Who can participate

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Diagnosis of reducible temporomandibular joint (TMJ) disc displacement according to the 2014 revised criteria of the International Association for Dental Research;
. Bilateral reducible disc displacement confirmed by MRI;
. Reproducible joint clicking during mandibular opening and closing;
. Permanent dentition with full cognitive and communicative ability;
. Signed informed consent with good treatment compliance.

Exclusion criteria

. Non-reducible disc displacement, osteoarthrosis, isolated myofascial pain, or other conditions not meeting diagnostic criteria;
. Receipt of other TMJ disorder treatments within the past 3 months;

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in Temporomandibular Joint Space Ratio

Timeframe: Baseline and 3 months post-treatment

Change in Disc-Condyle Relationship Angle

Timeframe: Baseline and 3 months post-treatment

Trial details

NCT IDNCT07345104

SponsorFujian Medical University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-12-20

View on ClinicalTrials.gov More Temporomandibular Joint Disc Displacement trials