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This crossover study aims to evaluate the wear comfort, retention, and stability of 3D-printed and milled occlusal splints in healthy subjects.
The main question it aims to answer is:
Research questions
- How do healthy subjects experience the wear comfort, fitting, retention and stability of a printed and milled occlusal splint? and how do clinicians experience the fitting, retention and stability of the splints?
By systematically assessing self-reported outcomes, this research seeks to contribute valuable insights into the practical applications of both technologies. The findings may not only enhance our understanding of patient preferences but also guide future developments in the design and manufacturing of occlusal splints, ultimately improving patient care in dental practice.
The main study parameter is to assess the participant self-reported findings regarding the comfort, retention, stability and fit of the milled and printed splint and in addition to the hygiene and discoloration of the splint over time.
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| Measure | Description | Time Frame |
|---|---|---|
| Comfort | Self reported wear comfort by filling in a questionnaire. This scale measures the comfort of the occlusal splint, where "Very uncomfortable" represents the worst experience (lowest score) and "Very comfortable" represents the best experience (highest score). Minimum Value: Very uncomfortable, Maximum Value: Very comfortable. Higher Scores Mean: Better comfort (more comfort) | "From enrollment to the end of treatment at 6 weeks" |
| Measure | Description | Time Frame |
|---|---|---|
| Stability | Two dentists will evaluate the splints outside of the mouth using a standardized assessment form (pre-tested) focussing on stability. The splints will then be placed in the mouth of the subject and reassessed based on the same parameter. Description: This is a custom-developed 5-point Likert-type scale designed to assess the experience of splint stability. Dentists rate how stable or mobile the occlusal splint feel. Scale Values:
Participants also rate stability on the same way. They rate how stable or mobile the occlusal splint felt during use. |
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Inclusion Criteria:
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The population for this prospective clinical randomized crossover trial, will consist of young adult participants aged 18 to 45, which study Dentistry, or are a co-worker or patient at the Dentistry Department of Radboudumc Nijmegen.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sabine Mechelse, MSc | Contact | 0031648136263 | sabine.mechelse@radboudumc.nl | |
| Stanimira Kalaykova- Sparreboom, dr. | Contact | 0031243092911 | stanimira.kalaykova@radboudumc.nl |
| Name | Affiliation | Role |
|---|---|---|
| Sabine Mechelse, drs. | Radboud University Medical Center | Principal Investigator |
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Specific IPD datasets, such as those underlying published results, will be shared. However, this sharing will occur under strict conditions to ensure data security and participant confidentiality. The data will be pseudonymized, using a secure key management system to separate identifiers from research data. Access will require appropriate agreements, ensuring compliance with ethical and legal standards, and will be granted only for research purposes aligning with the study's objectives.
Beginning 3 months and ending 3 years after the publication of results.
To ensure confidentiality and compliance, access to IPD will be restricted to authorized personnel involved in the research process, including the Principal Investigator (PI), specific research team members, external collaborators, and regulatory authorities. Access is based on each individual's role and necessity for the research. The PI will have full access to the IPD, pseudonymized data, and supporting documents for data management and reporting. Research team members, such as co-investigators, assistants, and statisticians, will have access to the data necessary for their assigned tasks. Access will be controlled through formal data requests, Data Use Agreements, and secure platforms. Pseudonymization ensures participant confidentiality while enabling the sharing of valuable research data for scientific progress.
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| From enrollment to the end of treatment at 6 weeks |
| Perceived Retention of Occlusal Splint on Model | This 5-point Likert-type scale measures the perceived retention (fit and tightness) of the splint when seated on the dental model, used to assess passive fit. Scale Values:
Scores 1-2 ("Too loose") and 4-5 ("Too tight") indicate deviations from optimal retention, which may be considered suboptimal and might require adjustment. | From enrollment to end of treatment at six weeks |
| Perceived Retention of Occlusal Splint During Wear | A custom 5-point Likert-type scale measuring how well the occlusal splint stays in place during use, based on patient-reported experience. The scale evaluates whether the retention is too loose or too tight, or within acceptable/optimal limits. Scale Values:
| From enrollment to the end of treatment at six weeks. |
| Perceived Fit of the Occlusal Splint on the Model and in the Mouth | This 5-point Likert-type scale evaluates the fit of the occlusal splint both on the dental model and in the patient's mouth. It assesses how well the splint is perceived to conform to the desired shape and fit, both passively on the model and during wear. Scale Values:
Directionality: Higher scores represent better fit (i.e., optimal adaptation and minimal discomfort). | From enrollment to end of the treatment at six weeks. |
| Perceived Fit of the Occlusal Splint on Teeth | This 5-point Likert-type scale measures how well the patient feels the occlusal splint fits on their teeth. This includes subjective experiences regarding comfort and fit quality. Scale Values:
Directionality: Higher scores indicate a better fit (i.e., a more comfortable and effective splint). | From enrollment to end of the treatment at six weeks |
| Cleanability | This 5-point Likert-type scale measures how easy or difficult it is for the patient to keep the occlusal splint clean. It evaluates the patient's experience of cleaning the splint and the effort involved in maintaining its cleanliness. Scale Values:
Directionality: Higher scores indicate that the splint is easier to clean, suggesting better material or design for cleanliness. | From enrollment to the end of treatment at 6 weeks. |
| Occlusion | Articulating paper is used to check the occlusion. The contact marks of the paper help identify areas of contact between the splint and natural teeth, and the distribution of these contacts is assessed.
| From enrollment to the end of treatment at 6 weeks. |