Construction And Preliminary Clinical Evaluation Of Digital Stabilization Occlusal Splint System

Purpose:The purpose of this study was to build an effective digital workflow for stabilization occlusal splint with additive manufacturing(AMT)methods and to assess the adaptability in clinic.Methods:Part Ⅰ: The construction of digital workflow.Mandibular movement and neuromuscular jaw relation were collected and recorded using the mandibular movement analysis system.The digital model of the upper and lower jaws were established using a dental 3D scanner.CAD design of digital occlusal stabilization splint was completed using a computer aided design software.Using rapid prototyping printing software to complete the production of digital stabilization occlusal splint.Part Ⅱ: Assessment of clinical adaptability.Set up a clinical evaluation form and adaptation evaluation.The clinical evaluation form includes objective evaluation(Tscan occlusion analyzer evaluation indexes)and subjective evaluation(basic performance and subject perception indexes).Ten volunteer subjects were selected.Digital stabilization occlusal splints were produced as digital group(DG)and conventional stabilization occlusal splints were produced as control group(CG)simultaneously.And a self-cross-control method was adopted to measure the clinical evaluation form and the adaptation when the splints of the two groups were clinically worn.SPSS medical statistical software used independent sample t test and MannWhitney U test to complete statistical analysis of clinical evaluation form between DG and CG;used independent sample t test and ANOVA test to complete statistics of adaptation between DG and CG.Results:Part Ⅰ: The digital workflow of the stabilization occlusal splint was built successfully.The digital stabilization occlusal splint manufactured by this digital workflow has good performance and comfort.Part Ⅱ: In the comparison of the mean values of the 13 scoring items between DG and CG in the clinical evaluation form,except that the mean values of the retention scores in DG were lower than those in CG,the other items scored higher in DG than those in CG.There were statistically significant differences between the two groups in terms of surface smoothness,seating,stability,and abnormal stress on the teeth(P<0.05).In the comparison of the subjects themselves,the digital occlusal stabilization splints scores were higher than the conventional occlusal stabilization splints in all subjects.There were significant differences among subject 03,06,08,and 10(P <0.05).In comparison of T-scan objective evaluation,basic performance,subject evaluation,and total scores,DG was significantly better than CG(P <0.05).Comparing in the adaptation,the measured mean values of DG and CG were 636.29μm and 704.2μm respectively,with statistical differences(P <0.05).In DG,the adaptation of the upper right incisor,the upper right canine and the upper left second molar were significantly better than that in CG(P <0.05).Conclusions:1.Digital stabilization occlusal splint workflow is feasible.2.The preliminary clinical evaluation results of the digital stabilization occlusal splint are better than the conventional stabilization occlusal splint.3.Long-term clinical evaluation of digital occlusal splint is still needed in further research.