Clinical Performance of CAD/CAM Occlusal Splints Fabricated With or Without Wax Bite Registration in Healthy Adults

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 occlusion. 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 at insertion.

Inclusion criteria: * Subjects aged 18-45 years * Subjects being healthy (ASA 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 willing to provide written informed consent for their participation in the study Exclusion Criteria: * 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 disorder 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 * Subjects who are pregnant or lactating * Subjects enrolled in another investigational clinical trial