3D Printed vs. Milled Occlusal Splints in Dentistry

NCT ID: NCT07236294

Last Updated: 2025-11-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

24 participants

Study Classification

OBSERVATIONAL

Study Start Date

2026-01-01

Study Completion Date

2026-09-01

Brief Summary

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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

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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.

Conditions

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Wear Comfort Retention Stability

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Radboud University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sabine Mechelse, drs.

Role: PRINCIPAL_INVESTIGATOR

Radboud University Medical Center

Central Contacts

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Sabine Mechelse, MSc

Role: CONTACT

0031648136263

Stanimira Kalaykova- Sparreboom, dr.

Role: CONTACT

Other Identifiers

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2024-17704

Identifier Type: -

Identifier Source: org_study_id

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