Occlusal splints are commonly used to manage sleep bruxism, temporomandibular disorders, and tooth wear. Traditionally, a wax bite registration is used during the fabrication of CAD/CAM occlusal splints to determine the vertical dimension and occlusal relationship. New digital techniques allow the splint to be designed without a wax bite registration by virtually increasing the vertical dimension based on maximal intercuspation.
This randomized crossover study compares these two fabrication workflows in healthy volunteers. Participants will wear both splints in random order. The study will evaluate patient-reported comfort and clinical performance, including occlusal contacts, force distribution, splint stability, and the occlusal adjustments required during insertion
Subjects aged 18-45 years
Subjects with an ASA physical status classification of I-III.
Subjects with healthy complete dentitions (except for congenitally missing teeth (agenesis), extractions of wisdom teeth, or tooth extractions for the purpose of orthodontic treatment in the past)
Subjects willing and able to participate in the study
Subjects presenting with active dental disease, extensive restorations affecting the occlusion, or other oral conditions that may interfere with the assessment of the occlusal splints
Subjects with a history of autoimmune disorders
Subjects with known allergies to acrylic materials
Subjects with severe allergies manifested by a history of anaphylaxis or those with severe, chronic allergies (e.g., asthma) and subjects with an active infection of any kind at the time of enrollment
Crossover
Occlusal splint fabricated using a virtual increase of the vertical dimension
DeviceIntervention 1: CAD/CAM occlusal splint fabricated using a virtual increase of the vertical dimension CAD/CAM-milled occlusal splint fabricated from PMMA using a fully digital workflow. The splint is designed by virtually increasing the vertical dimension based on the participant's maximal intercuspation, without the use of a conventional wax bite registration. Participants will wear the splint overnight for 3 weeks (minimum 6 hours per night).
Occlusal splint fabricated using a conventional wax bite registration
DeviceIntervention 2: CAD/CAM occlusal splint fabricated using a conventional wax bite registration CAD/CAM-milled occlusal splint fabricated from the same PMMA material using a conventional wax bite registration to determine the vertical dimension and occlusal relationship during the digital design process. Participants will wear the splint overnight for 3 weeks (minimum 6 hours per night).
Participant-reported comfort
Self-reported wear comfort by filling in a questionnaire. This scale measures the comfort of the occlusal splint (0-10), where "very uncomfortable" represents the worst experience (lowest score) and "very comfortable" represents the best experience (highest score). Minimum Value: very uncomfortable, Maximum Value: very comfortable. Higher Scores Mean: better comfort (more comfort)
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