3D Printed vs. Milled Occlusal Splints in Dentistry
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-45
SponsorRadboud University Medical Center
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Subjects being healthy (ASA <IV)
Subjects with healthy, complete dentitions (except for extractions of wisdom teeth, or tooth extractions for the purpose of orthodontic treatment in the past)
Subjects willing and able to participate in the study
Subjects willing to provide written informed consent for their participation in the study
Disqualifiers
Subjects with dental issues other than the inclusion criteria
Subjects with a history of autoimmune disorder
Subjects with known allergies to acrylic materials
Subjects with severe allergies manifested by a history of anaphylaxis or those with severe, chronic allergies (e.g., asthma) and subjects with an active infection of any kind at the time of enrollment
Trial population
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.
Trial design
Design model
Other
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
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)
Time frame
"From enrollment to the end of treatment at 6 weeks"Secondary outcomes
1
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: 1. = Very unstable / significant movement 2. = Unstable / some movement 3. = Neutral / no notable instability or discomfort 4. = Stable / little to no discomfort 5. = Very stable / no movement or discomfort at all Score Range: Minimum = 1, Maximum = 5 Higher scores indicate a better outcome (i.e. greater stability and comfort during wear). 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 the end of treatment at 6 weeks2
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: 1. = Much too loose 2. = Loose, but acceptable 3. = Optimal 4. = Slightly tight, but acceptable 5. = Too tight Score Range: Minimum = 1, Maximum = 5 A score of 3 ("Optimal") indicates the ideal result, where the occlusal splint has a good fit and retention on the model. 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 end of treatment at six weeks3
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: 1. = Much too loose 2. = Loose, but acceptable 3. = Optimal 4. = Slightly tight, but acceptable 5. = Very good Score Range: Minimum = 1, Maximum = 5 Directionality: Higher scores indicate a better outcome (i.e. better retention and patient satisfaction during wear).
Time frame
From enrollment to the end of treatment at six weeks.4
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: 1. = Very poor 2. = Poor 3. = Average 4. = Good 5. = Very good Score Range: Minimum = 1, Maximum = 5 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.Locations
Sponsors and contacts
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Source ClinicalTrials.gov
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