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Clinical Evaluation of 3D-Printed Stabilization Splints for Probable Bruxism: An Exploratory Cohort Analysis of a
Kerstin Rabel1, Marie Linke1, Tobias Linke2
1Department of Prosthetic Dentistry, Center for Dental Medicine, Medical Center ‑ University of Freiburg, Faculty of Medicine, University of Freiburg, Hugstetterstr. 55, 79106 Freiburg, Germany.
Objectives:
In addition to established milling procedures, 3D printing is increasingly used to fabricate stabilization splints. However, comparative clinical evidence remains limited. This exploratory cohort analysis compared patient-reported, clinical and technical outcomes of milled and 3D-printed splints in patients with probable bruxism diagnosed through case history and clinical examination using the German Bruxism Screening Index.
Methods:
17 participants with probable bruxism completed the trial and wore a milled and a 3D-printed splint in a randomized order for three months each, with follow-ups after two weeks and three months. Outcomes assessed were oral health-related quality of life (OHRQoL), treatment efficacy (antagonist wear), technical result (splint fit at insertion, wear, fracture), and participant satisfaction (wearing comfort, splint retention, preferred splint). T-tests, Wilcoxon signed-rank tests and regression models were used for statistical analysis.
Results:
Statistical analysis revealed no significant differences between 3D-printed and milled splints regarding OHRQoL, antagonist wear, splint wear and splint retention. 3D-printed splints required less adjustment prior to insertion and were preferred by most participants due to their higher wearing comfort.
Conclusion:
In this exploratory cohort, outcomes observed over three months per splint were compatible with the clinical use of both manufacturing approaches. The findings concerning splint adjustment and wearing comfort were attributed to the specific splint design used in this trial rather than to the manufacturing process. However, the evaluation of long-term results of milled and 3D-printed splints requires trials with extended follow-up periods and splint designs specific to the manufacturing process.
Clinical Significance:
Short-term findings of the present trial suggest that 3D-printed stabilization splints are a clinically feasible alternative to milled splints for patients with probable bruxism. Comparable patient-reported oral health-related quality of life, clinical and technical outcomes support their clinical use, but long-term performance requires further investigation.
