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

Occlusal splints are widely used in the management of sleep bruxism, temporomandibular disorders, and tooth wear. The increasing implementation of CAD/CAM technology has improved the efficiency and reproducibility of occlusal splint fabrication. Conventionally, the vertical dimension and occlusal relationship are determined using a wax bite registration. Recent developments in digital dentistry now allow the vertical dimension to be increased virtually based on the patient's maximal intercuspation, eliminating the need for an additional wax bite registration.

Although both fabrication workflows are currently used in clinical practice, there is limited clinical evidence comparing their performance. It remains unclear whether omitting the conventional wax bite registration affects the initial clinical performance of CAD/CAM occlusal splints at insertion, before any occlusal adjustments are performed. Potential differences may exist in patient comfort, splint stability, occlusal contacts, force distribution, and the number of occlusal adjustments required. In addition, little is known about differences in patient-reported outcomes, including comfort, perceived occlusion, stability, and overall satisfaction during the period of splint use.

Inclusion criteria

• 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 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 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
• Subjects who are pregnant or lactating
• Subjects enrolled in another investigational clinical trial