Wear ComfortSplintsNCT07236294
3D Printed vs. Milled Occlusal Splints in Dentistry
An observational study of Wear Comfort and Retention, run by Radboud University Medical Center at 1 site in Netherlands.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Wear Comfort, Retention, Stability
- How many people
- 30 participants
- Where
- 1 siteNetherlands
- Study dates
- 5 Jan 2026to 7 Jul 2026
- How long will I take part?
- 6 Weeks
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Material and Clinical Assessment of 3D-printed vs. Milled Occlusal Splints: A Study on Performance and Durability in Dental Applications
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:
Read more
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.
Read the 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.
- Conditions
- Wear Comfort, Retention, Stability
- Keywords
- 3D printed splints, Milled splints, Prospective clinical randomized crossover study, Retention, Stability, comfort
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: "From enrollment to the end of treatment at 6 weeks"
Secondary outcomes (7)
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:
- = Very unstable / significant movement
- = Unstable / some movement
- = Neutral / no notable instability or discomfort
- = Stable / little to no discomfort
- = 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.
Measured: From enrollment to the end of treatment at 6 weeks
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:
- = Much too loose
- = Loose, but acceptable
- = Optimal
- = Slightly tight, but acceptable
- = 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.
Measured: From enrollment to end of treatment at six weeks
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:
- = Much too loose
- = Loose, but acceptable
- = Optimal
- = Slightly tight, but acceptable
- = Very good Score Range: Minimum = 1, Maximum = 5 Directionality: Higher scores indicate a better outcome (i.e. better retention and patient satisfaction during wear).
Measured: From enrollment to the end of treatment at six weeks.
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:
- = Very poor
- = Poor
- = Average
- = Good
- = Very good Score Range: Minimum = 1, Maximum = 5
Directionality:
Higher scores represent better fit (i.e., optimal adaptation and minimal discomfort).
Measured: From enrollment to end of the treatment at six weeks.
Perceived Fit of the Occlusal Splint on Teeth
This 5-point Likert-type scale measures how well the patient feels the occlusal splint fits on their teeth. This includes subjective experiences regarding comfort and fit quality.
Scale Values:
- = Very poor fit
- = Poor fit
- = Average fit
- = Good fit
- = Very good fit Score Range: Minimum = 1, Maximum = 5
Directionality:
Higher scores indicate a better fit (i.e., a more comfortable and effective splint).
Measured: From enrollment to end of the treatment at six weeks
Cleanability
This 5-point Likert-type scale measures how easy or difficult it is for the patient to keep the occlusal splint clean. It evaluates the patient's experience of cleaning the splint and the effort involved in maintaining its cleanliness.
Scale Values:
- = Very difficult to clean
- = Difficult to clean
- = Neutral
- = Easy to clean
- = Very easy to clean Score Range: Minimum = 1, Maximum = 5
Directionality:
Higher scores indicate that the splint is easier to clean, suggesting better material or design for cleanliness.
Measured: From enrollment to the end of treatment at 6 weeks.
Occlusion
Articulating paper is used to check the occlusion. The contact marks of the paper help identify areas of contact between the splint and natural teeth, and the distribution of these contacts is assessed.
- = Very Poor Occlusion. Few or no contacts, or contacts are isolated in a small area, which may create uneven pressure and discomfort.
- = Poor Occlusion. A small number of scattered contacts, or large areas without contact. There are visible areas where the occlusion is uneven.
- = Neutral Occlusion. Contacts are generally evenly distributed but may be slightly uneven in certain areas. Some contact marks, but no clear high spots or excessive force.
- = Good Occlusion Most contacts are evenly distributed. A few areas may show slightly heavier marks but are within an acceptable range comfort and function.
- = Very Good Even pressure across the splint, indicating optimal fit. Higher scores (4-5) indicate better occlusion.
Measured: From enrollment to the end of treatment at 6 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2025
- Study start5 Jan 2026
- Primary completion7 Jul 2026
- Study completion7 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wear ComfortStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
- Target duration
- 6 Weeks
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sabine Mechelse, drs., Principal investigator, Radboud University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07236294
- Sponsor's protocol ID
- 2024-17704
- Acronym
- Splints
- Status last verified
- Jan 2026
- First submitted
- 22 Jul 2025
- Last updated
- 12 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Specific IPD datasets, such as those underlying published results, will be shared. However, this sharing will occur under strict conditions to ensure data security and participant confidentiality. The data will be pseudonymized, using a secure key management system to separate identifiers from research data. Access will require appropriate agreements, ensuring compliance with ethical and legal standards, and will be granted only for research purposes aligning with the study's objectives.
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Material and Clinical Assessment of 3D-printed vs. Milled Occlusal Splints: A Study on Performance and Durability in Dental Applications
- ClinicalTrials.gov ID
- NCT07236294
- Acronym / sponsor ID
- Splints / 2024-17704
- Conditions
- Wear Comfort, Retention, Stability
- Keywords
- 3D printed splints, Milled splints, Prospective clinical randomized crossover study, Retention, Stability, comfort
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Study start
- 5 Jan 2026 (actual)
- Primary completion
- 7 Jul 2026 (actual)
- Study completion
- 7 Jul 2026 (actual)
- First posted
- 19 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 6 Weeks
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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)
7 secondary outcomes
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2026.
- Individual participant dataSharing planned: Yes. Specific IPD datasets, such as those underlying published results, will be shared. However, this sharing will occur under strict conditions to ensure data security and participant confidentiality. The data will be pseudonymized, using a secure key management system to separate identifiers from research data. Access will require appropriate agreements, ensuring compliance with ethical and legal standards, and will be granted only for research purposes aligning with the study's objectives.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sabine Mechelse, drs. principal investigator
Radboud University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Wear Comfort and Retention, run by Radboud University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comfort (time frame: "From enrollment to the end of treatment at 6 weeks"). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2026.