RadboudUMC
Nijmegen, Gelderland, 6525 EX, Netherlands
NCT Number: NCT07236294
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.
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Notify Me18 year–45 year
All sexes
Observational
Nijmegen, Gelderland, 6525 EX, Netherlands
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: "From enrollment to the end of treatment at 6 weeks"
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)
Time frame: From enrollment to the end of treatment at 6 weeks
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.
Time frame: From enrollment to end of treatment at six weeks
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.
Time frame: From enrollment to the end of treatment at six weeks.
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:
Time frame: From enrollment to end of the treatment at six weeks.
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).
Time frame: From enrollment to end of the treatment at six weeks
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).
Time frame: From enrollment to the end of treatment at 6 weeks.
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.
Time frame: From enrollment to the end of treatment at 6 weeks.
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.
Radboud University Medical Center
Other
Material and Clinical Assessment of 3D-printed vs. Milled Occlusal Splints: A Study on Performance and Durability in Dental Applications
Acronym: Splints
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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