Conventional vs Digital CAD/CAM Splints for Bruxism

Pontificia Universidade Católica do Rio Grande do Sul

Status: Not yet enrolling

Conditions: Bruxism

Treatments: Device: Digital occlusal splints (CAD/CAM); Device: Conventional occlusal splints

Study type: Interventional

Funder types: Other

Identifiers

NCT06518447

59319422.3.0000.5336

Details and patient eligibility

About

This is a randomized controlled trial with a crossover design, which intends to enroll 20 adult patients aged between 20 and 55 years with confirmed or probable sleep bruxism. Participants will be randomized to receive either a conventional stabilization splint or a CAD/CAM splint. Each patient will use one type of splint for 30 days, followed by a 15-day wash-out period, after which they will switch to the other type of splint. The study aims to compare the quality, precision, and comfort of the two types of occlusal splints. Outcomes will include manufacturing time, amount of in-mouth adjustments, adaptation, occlusal contacts, and participant satisfaction.

Enrollment: 20 estimated patients

Sex: All

Ages: 20 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult patients aged between 20 and 55 years.
• Probable or confirmed diagnosis of sleep bruxism.
• No previous treatment with occlusal splints.
• Absence of periodontal diseases and/or dental fractures.
• Patients must have a minimum of 28 teeth.

Exclusion criteria

• Patients with systemic diseases affecting the temporomandibular joint, such as rheumatoid arthritis, osteoarthritis, and osteoporosis.
• Chronic users of medications that may interfere with the study results, including analgesics, anti-inflammatory drugs, anxiolytics, antidepressants, and anticonvulsants.
• Patients with a history of temporomandibular joint surgery.
• Pregnant or breastfeeding women.
• Patients with severe dental misalignment or malocclusion that would affect splint fitting and evaluation.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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20 participants in 2 patient groups

Digital occlusal splints (CAD/CAM)

Experimental group

Description:

Patients in this arm will receive a CAD/CAM occlusal stabilization splint created using a fully digital workflow. The process includes: 1. Digital Impression: digital scan of the mouth will be performed using a 3shape® intraoral scanner. 2. Digital Design: The scanned data will be processed using Dental Wings' DWOS® software to design the occlusal splint virtually. The design will ensure the splint follows the Michigan splint type specifications. 3. Manufacturing: The designed splint will be fabricated using a Straumann® P series rapidshape P30+ 3D printer with a specific acrylic resin, Cosmos Splint. The splint will be polished to ensure comfort and fit, while maintaining the same surface texture as the conventional splint. 4. Fitting and Adjustment: The digitally fabricated splint will be fitted and adjusted as necessary to ensure proper adaptation and occlusal contacts. An Occlusense device will be used to verify and adjust the occlusal contacts during the fitting process.

Treatment:

Device: Digital occlusal splints (CAD/CAM)

Conventional occlusal splints

Active Comparator group

Description:

Patients in this arm will receive a conventional occlusal stabilization splint fabricated using traditional analog methods. The process includes: 1. Impression Taking: Impressions of the patient's upper and lower arches will be taken using alginate. 2. Model Preparation: The plaster models will be mounted on a semi-adjustable articulator using a centric relation occlusal record. A wax-up of the occlusal splint will be created following the Michigan splint type specifications. 3. Manufacturing: The wax-up will be processed and flasked with heat-cured acrylic resin to create the final splint. The splint will be polished similarly to the digital splint to ensure a consistent appearance and texture. 4. Fitting and Adjustment: The conventional splint will be fitted and adjusted to ensure proper adaptation and occlusal contacts. An Occlusense device will be used to verify and adjust the occlusal contacts during the fitting process.

Treatment:

Device: Conventional occlusal splints