Bruxism
Conditions
Keywords
occlusal splints, computer-aided design, bruxism
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.
Interventions
DEVICEDigital occlusal splints (CAD/CAM)
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.
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.
Sponsors
Pontificia Universidade Católica do Rio Grande do Sul
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
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.
Eligibility
Sex/Gender
ALL
Age
20 Years to 55 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of occlusal contacts | Immediately after the initial installation | The number of occlusal contacts will be measured using the OccluSense® device |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Participant satisfaction after installation | Immediately after the initial installation and adjustment | 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. |
| Participant satisfaction after 30 days | After 30 days of use | 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. |
| Splint comfort after installation | Immediately after the initial installation and adjustment | 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 Required for Splint Adjustment | Immediately after the initial installation and adjustment | The time required to adjust each splint during the fitting process |
| Splint stability after installation | Immediately after the initial installation and adjustment | 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). |
| Splint stability after 30 days | After 30 days of use | 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). |
| Splint comfort after 30 days | After 30 days of use | 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. |
Countries
Brazil
Outcome results
None listed