Comparison of Conventional,3D Printed and Novel Hybrid Stabilization Splints in the Management of… (NCT07760428) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Comparison of Conventional,3D Printed and Novel Hybrid Stabilization Splints in the Management of Temporomandibular Joint Disorders
India36 participantsStarted 2026-08-16
Plain-language summary
Occlusal splint therapy is a well-established conservative approach for the management of temporomandibular disorders (TMDs); however, variability in clinical outcomes suggests that no single splint design is universally optimal. Conventional chairside stabilization splints are widely used and allow immediate intraoral adjustments; however, they are technique-sensitive and may compromise long-term fit and patient comfort. Conversely, 3D-printed occlusal splints provide superior precision, reproducibility, and material stability; however, their uniformly rigid structure may limit initial comfort and patient compliance, particularly in patients with acute pain or muscle tenderness.
To address these limitations, the researchers intend to develop an innovative hybrid occlusal splint i.e. Dual material 3D printed stabilization splint, that integrates both hard and soft components. This design aims to combine the biomechanical stability and occlusal precision characteristic of rigid splints with the cushioning effect and enhanced comfort provided by soft splints. The objective is to improve adaptation, compliance, and the sustained therapeutic efficacy of the splint.
Who can participate
Age range
18 Years – 60 Years
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:
* Patients presenting with clinical symptoms of TMJ pain disorders were diagnosed using the DC/TMD criteria.
* Age between 18 and 60.
* The same number of original molars was used to avoid affecting periodontal proprioception and bite force.
* The Patient's consent to participate in the study.
Exclusion Criteria:
* Pregnancy
* Not willing to participate in the study
* Healing disorders or systemic diseases where healing is compromised.
* Allergic to PMMA, TPU, PETG or any other 3D printing or conventional prosthetic material.
* Patients with epilepsy or any other neurological disorders.
* Systemic Arthritis or any other osteo-degenerative disorder.
* Acute TMJ trauma or fracture in \< 30 days.
* Any obvious dental decay or periodontal disease to which fascial pain could be attributed.
* Patient with psychiatric disorder or on anti-anxiety or anti-depressant drugs.
* Patients with dental implants.
* Any systemic condition associated with widespread pain such as in fibromyalgia.
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
1
Visual Analog Scale (VAS)
Timeframe: Baseline, 1 week, 2 weeks, 4 weeks
2
Maximum Mouth Opening
Timeframe: Baseline, 1 week, 2 weeks, 4 weeks
3
Maximum Bite Force
Timeframe: baseline, 1 week, 2 weeks, 4 weeks
Trial details
NCT IDNCT07760428
SponsorPostgraduate Institute of Dental Sciences Rohtak