3D Printed vs. Milled Occlusal Splints in Dentistry

NCT07236294 | Not Yet Recruiting DMC

• 1 other identifier: 2024-17704
• Study Type: observational
• Target: 24
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Wear Comfort; Retention; Stability

Keywords

3D printed splints; Milled splints; Prospective clinical randomized crossover study; Retention; Stability; comfort

Outcome Measures

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)

  "From enrollment to the end of treatment at 6 weeks"

Secondary Outcomes (7)

• 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

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Radboud University Medical Center: lead

Study Officials

• Sabine Mechelse, drs.

  Radboud University Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sabine Mechelse, MSc

CONTACT

0031648136263; sabine.mechelse@radboudumc.nl

Stanimira Kalaykova- Sparreboom, dr.

CONTACT

stanimira.kalaykova@radboudumc.nl

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Weeks
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 22, 2025
• First Posted: November 19, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): May 8, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: November 19, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Beginning 3 months and ending 3 years after the publication of results.
• Access Criteria: 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.