An interventional study of Digital occlusal splints (CAD/CAM) and Conventional occlusal splints in Bruxism, sponsored by Pontificia Universidade Católica do Rio Grande do Sul. Completed at 1 site in Brazil. Open to participants aged 20 Years to 55 Years. Per ClinicalTrials.gov, last updated 2025-06-12.
Sponsored by Pontificia Universidade Católica do Rio Grande do Sul · Not applicable, Interventional, and Treatment
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.
151 studies on the registry are indexed under Bruxism; 39 are open to participants now.
This study's enrollment of 20 is below the median of 39 across 94 interventional studies indexed under Bruxism.
Browse Bruxism studies →Pontificia Universidade Católica do Rio Grande do Sul is the lead sponsor of 23 studies on the registry; 4 are open to participants now.
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Exclusion Criteria:
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)
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
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
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
Number of occlusal contacts
The number of occlusal contacts will be measured using the OccluSense® device
Time frame: Immediately after the initial installation
Time Required for Splint Adjustment
The time required to adjust each splint during the fitting process
Time frame: Immediately after the initial installation and adjustment
Participant satisfaction after installation
Patients will assess their overall satisfaction with the splints using a 5-point Likert scale, with 1 meaning the lowest score of satisfaction and 5 meaning the highest score of satisfaction.
Time frame: Immediately after the initial installation and adjustment
Participant satisfaction after 30 days
Patients will assess their overall satisfaction with the splints using a 5-point Likert scale, with 1 meaning the lowest score of satisfaction and 5 meaning the highest score of satisfaction.
Time frame: After 30 days of use
Splint comfort after installation
Patients will assess comfort with the splints using a 5-point Likert scale, with 1 indicating the lowest level of comfort and 5 indicating the highest level of comfort.
Time frame: Immediately after the initial installation and adjustment
Splint comfort after 30 days
Patients will assess comfort with the splints using a 5-point Likert scale, with 1 indicating the lowest level of comfort and 5 indicating the highest level of comfort.
Time frame: After 30 days of use
Splint stability after installation
Patients will assess the stability of the splints (retention) during use using a 5-point Likert scale, with 1 indicating the lowest level of stability (frequent movement) and 5 indicating the highest level of stability (no movement).
Time frame: Immediately after the initial installation and adjustment
Splint stability after 30 days
Patients will assess the stability of the splints (retention) during use using a 5-point Likert scale, with 1 indicating the lowest level of stability (frequent movement) and 5 indicating the highest level of stability (no movement).
Time frame: After 30 days of use
Plan to share: No — Not planned. Sharing of anonymized data may be considered under exceptional circumstances through direct contact with investigators.
No publications or documents are linked to this record.
Ran from Aug 2024 to primary completion in Jan 2025, 5 months.
Of 59 non-industry interventional studies with no phase under Bruxism, half reached primary completion within 8 months of starting (the median), counting those still running; a quarter within 3 and three quarters within 13. This study's 5 months is below that.
Counting every sponsor, half of 60 studies reached it within 7 months; a quarter within 3 and three quarters within 13.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.
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Pontificia Universidade Católica do Rio Grande do Sul