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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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:
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| Conventional occlusal splints | Active Comparator | Patients in this arm will receive a conventional occlusal stabilization splint fabricated using traditional analog methods. The process includes:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of occlusal contacts | The number of occlusal contacts will be measured using the OccluSense® device | Immediately after the initial installation |
| Measure | Description | Time Frame |
|---|---|---|
| Time Required for Splint Adjustment | The time required to adjust each splint during the fitting process | Immediately after the initial installation and adjustment |
| Participant satisfaction after installation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marcio L Grossi, PhD | PontifÃcia Universidade Católica do Rio Grande do Sul | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculdade de Odontologia. PontifÃcia Universidade Católica do Rio Grande do Sul. | Porto Alegre | Rio Grande do Sul | 90619-900 | Brazil |
Not planned. Sharing of anonymized data may be considered under exceptional circumstances through direct contact with investigators.
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| ID | Term |
|---|---|
| D002012 | Bruxism |
| ID | Term |
|---|---|
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
| D006184 | Habits |
| D001519 | Behavior |
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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.
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| 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. |
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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.
| 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. | 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. | 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. | 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). | 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). | After 30 days of use |