ArticleTrials2024
3D printed versus milled stabilization splints for the management of bruxism and temporomandibular disorders: study protocol for a randomized prospective single-blinded crossover trial.
Article in Trials, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers, 1 of them a synthesis that pooled it.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
12 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Pooled it
- Effectiveness of a Novel Mono-Block Splint Versus a Twin-Block Splint for Anterior Disc Displacement With Reduction: A Randomised Controlled Trial.Journal of oral rehabilitation · 2026Trial
- Fully digital workflow versus conventional methods for fabricating the Michigan appliance in patients with temporomandibular joint disorder. A randomized controlled clinical trial.BMC oral health · 2026Trial
- Application of fully digital occlusal splints in painful temporomandibular disorders: a randomized controlled clinical study.Head & face medicine · 2026Trial
- Comparative Efficacy of Digital 3D-Printed and Conventional Stable Occlusal Splints in the Treatment of Temporomandibular Disorders.Journal of oral rehabilitation · 2025Trial
- Impact of Printing Orientation and Printer Type on the Accuracy of 3D-Printed Dental Splints.Materials (Basel, Switzerland) · 2026Article
- Dental publications on the treatment of temporomandibular disorders: A bibliometric analysis.F1000Research · 2026Review
- A retrospective evaluation of the clinical efficacy of occlusal splint therapy combined with manual therapy in patients with anterior disc displacement without reduction.Journal of oral & facial pain and headache · 2025Article
- Three-Dimensionally Printed Splints in Dentistry: A Comprehensive Review.Dentistry journal · 2025Review
- Retention of 3-D-Printed, Milled, and Conventionally Fabricated Occlusal Splints.Medical science monitor : international medical journal of experimental and clinical research · 2025Article
- Review
- Study on the Combined Application of Occlusal Splint and Intra-Articular Injection of Hyaluronic Acid in the Treatment of Non-Reducible Anterior Disc Displacement of the Temporomandibular Joint.Therapeutics and clinical risk management · 2025Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
10 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundNowadays, stabilization splints for the management of bruxism and temporomandibular disorders (TMD) can be produced utilizing a digital workflow comprising a digital impression of the teeth, digital splint design, and computer-aided manufacturing of the splints. The latter is usually a milling process, however, more recently 3D printing gained popularity due to its better cost and time efficiency. It remains unknown whether 3D printed stabilization splints are inferior to milled splints regarding clinical outcomes.
methodsThis clinical trial assesses the non-inferiority of 3D printed occlusal splints compared to milled occlusal splints in a monocentric prospective randomized single-blinded crossover trial with two cohorts. One cohort includes 20 participants with bruxism, the other 20 participants with pain-related TMD, i.e., myalgia, myofascial pain, or arthralgia of the jaw muscles/the temporomandibular joint(s) diagnosed according to the Diagnostic Criteria for Temporomandibular Disorders (DC/TMD). Michigan-type stabilization splints are fabricated in a digital workflow by milling or 3D printing using CE-marked materials within their intended purpose. The participants wear a milled and a 3D printed splint in a randomized order for 3 months each, with follow-up visits after 2 weeks and 3 months. Investigated outcome parameters are oral health-related quality of life (OHRQoL) evaluated by the Oral Health Impact Profile (OHIP-G14), participant satisfaction as rated on a visual analog scale, therapeutic efficacy, and technical result of the splints. In this context, therapeutic efficacy means antagonist wear and-in the TMD group-reduction of pain/disability assessed by the Graded Chronic Pain Scale (GCPS v2.0) and clinical assessment following the DC/TMD standard, while technical outcome measures splint fit, wear and fracture rate. DISCUSSION: The trial will provide important information on the clinical outcome of 3D printed stabilization splints in comparison to milled splints and will, therefore, enable an evidence-based decision in favor of or against a manufacturing process. This, in turn, will guarantee for a maximum of the patient's OHRQoL during splint therapy, therapeutic efficacy, and longevity of the splints.
trial registrationGerman Clinical Trials Register (DRKS) DRKS00033904. Registered on March 15, 2024.
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