Comfort, Occlusal Analysis, Occlusal Splints, Occlusion
Conditions
Keywords
Milled splints, Prospective clinical randomized crossover study
Brief summary
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
Detailed description
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.
Interventions
DEVICEOcclusal splint fabricated using a virtual increase of the vertical dimension
Intervention 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).
DEVICEOcclusal splint fabricated using a conventional wax bite registration
Intervention 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).
Sponsors
Radboud University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Participant-reported comfort | From enrollment to the end of treatment at 7 weeks | 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) |
Countries
Netherlands
Contacts
CONTACTSabine Mechelse, MSc
CONTACTStanimira Kalaykova-Sparreboom, dr.
PRINCIPAL_INVESTIGATORSabine Mechelse, MSc
Radboud University Medical Center
Outcome results
None listed