3D Printed vs. Milled Occlusal Splints in Dentistry
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Wear Comfort, Retention, Stability. Basic parameters: 18 years — 45 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Material and Clinical Assessment of 3D-printed vs. Milled Occlusal Splints: A Study on Performance and Durability in Dental Applications
Overview
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.
Primary outcome measures
- Comfort [Time frame: "From enrollment to the end of treatment at 6 weeks"]
Secondary outcome measures (7)
- Stability [Time frame: From enrollment to the end of treatment at 6 weeks]
- Perceived Retention of Occlusal Splint on Model [Time frame: From enrollment to end of treatment at six weeks]
- Perceived Retention of Occlusal Splint During Wear [Time frame: From enrollment to the end of treatment at six weeks.]
- Perceived Fit of the Occlusal Splint on the Model and in the Mouth [Time frame: From enrollment to end of the treatment at six weeks.]
- Perceived Fit of the Occlusal Splint on Teeth [Time frame: From enrollment to end of the treatment at six weeks]
- Cleanability [Time frame: From enrollment to the end of treatment at 6 weeks.]
- Occlusion [Time frame: From enrollment to the end of treatment at 6 weeks.]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Other
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07236294 · 2024-17704