Conventional vs Digital CAD/CAM Splints for Bruxism

NCT06518447 | Completed

• 1 other identifier: 59319422.3.0000.5336
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Bruxism

Keywords

occlusal splints; computer-aided design; bruxism

Outcome Measures

Primary Outcomes (1)

• Number of occlusal contacts

  The number of occlusal contacts will be measured using the OccluSense® device

  Immediately after the initial installation

Secondary Outcomes (7)

• Time Required for Splint Adjustment

  Immediately after the initial installation and adjustment

• Participant satisfaction after installation

  Immediately after the initial installation and adjustment

• Participant satisfaction after 30 days

  After 30 days of use

• Splint comfort after installation

  Immediately after the initial installation and adjustment

• Splint comfort after 30 days

  After 30 days of use

Study Arms (2)

Digital occlusal splints (CAD/CAM)

EXPERIMENTAL

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.

Device: Digital occlusal splints (CAD/CAM)

Conventional occlusal splints

ACTIVE COMPARATOR

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.

Device: Conventional occlusal splints

Interventions

Digital occlusal splints (CAD/CAM) DEVICE

Consists of occlusal stabilization intra-oral splints fabricated using a fully digital workflow, involving intraoral scanning, virtual design, and 3D printing to ensure precise fit and comfort.

Also known as: Digital intra-oral device

Digital occlusal splints (CAD/CAM)

Conventional occlusal splints DEVICE

Consists of occlusal stabilization splints fabricated using traditional analog methods, including physical impressions, plaster models, and manual processing with heat-cured acrylic resin to achieve the desired occlusal arrangement.

Also known as: Conventional intra-oral device

Conventional occlusal splints

Eligibility Criteria

• Age: 20 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pontificia Universidade Católica do Rio Grande do Sul: lead

Study Sites (1)

Faculdade de Odontologia. Pontifícia Universidade Católica do Rio Grande do Sul.

Porto Alegre, Rio Grande do Sul, 90619-900, Brazil

Location

MeSH Terms

Conditions

Bruxism

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases; Habits; Behavior

Study Officials

• Marcio L Grossi, PhD

  Pontifícia Universidade Católica do Rio Grande do Sul

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Participant Masking: Patients will not be informed whether they are receiving the conventional stabilization splint or the CAD/CAM splint. The splints will be marked with small, inconspicuous letters (A for Group A and B for Group B) during the fabrication process to minimize the possibility of the patients identifying which type of splint they are using. Additionally, both splints will be polished similarly to ensure no noticeable differences in appearance or texture. Researcher Masking: The primary researcher conducting patient evaluations and data analysis will be blinded to the group assignments. This researcher will not be involved in the fabrication or fitting of the splints, thereby maintaining an objective perspective during assessments.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 3, 2024
• First Posted: July 24, 2024
• Study Start: August 1, 2024
• Primary Completion: January 31, 2025
• Study Completion: January 31, 2025
• Last Updated: June 12, 2025

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)