Material and Clinical Assessment of 3D-printed vs. Milled Occlusal Splints: A Study on Performance and Durability in Dental Applications
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Comfort
Study Overview
Brief Summary
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.
Detailed Description
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.
Study Design
- Study Type
- Observational
- Observational Model
- Other
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 45 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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
Exclusion Criteria
- •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
- •Subjects who are pregnant or lactating
- •Subjects enrolled in another investigational clinical trial
Outcomes
Primary Outcomes
Comfort
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)
Secondary Outcomes
- Stability(From enrollment to the end of treatment at 6 weeks)
- Perceived Retention of Occlusal Splint on Model(From enrollment to end of treatment at six weeks)
- Perceived Retention of Occlusal Splint During Wear(From enrollment to the end of treatment at six weeks.)
- Perceived Fit of the Occlusal Splint on the Model and in the Mouth(From enrollment to end of the treatment at six weeks.)
- Perceived Fit of the Occlusal Splint on Teeth(From enrollment to end of the treatment at six weeks)
- Cleanability(From enrollment to the end of treatment at 6 weeks.)
- Occlusion(From enrollment to the end of treatment at 6 weeks.)