Denture, CompleteMILLPRINTNCT04873219
Milled Versus Printed CAD/CAM Complete Dentures
A study testing manufacturing a complete dental prosthesis in people with Denture, Complete and Jaw, Edentulous, run by University of Geneva, Switzerland at 1 site in Switzerland.
Trial summary
A crossover clinical trial investigates two novel CAD/CAM techniques for complete removable dental prostheses for edentulous patients, milling and rapid prototyping (3D-printing) in a clinical setting of an undergraduate student clinic. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Denture, Complete, Jaw, Edentulous
- What is being tested?
- manufacturing a complete dental prosthesis
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteSwitzerland
- Study dates
- 15 Sep 2018to 1 Mar 2020
- Phase
- Interventional
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- patient of undergraduate student at the University clinics of dental medicine Geneva
- completely edentulous
- requesting novel complete dentures
Who cannot join
- not willing to sign informed consent
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University clinics of dental medicine
Geneva, Canton of Geneva, 1211
About this study
Official title: Evaluation of CAD/CAM Milled Versus Rapidly-prototyped (3D-printed) Complete Removable Dental Prostheses (CRDPs): a Double-blind Randomized Crossover Trial.
A crossover clinical trial investigates two novel CAD/CAM techniques for complete removable dental prostheses for edentulous patients, milling and rapid prototyping (3D-printing) in a clinical setting of an undergraduate student clinic. Outcome parameters concern the dentures' trueness, retention, stability, esthetics and occlusion. Secondary outcome parameters include willingness to pay and prosthetic maintenance need.
Read the detailed description
The process of fabricating complete removable dental prostheses (CRDPs) by novel CAD/CAM manufacturing technique has in the recent years gained immense popularity with clinicians as well as dental technicians worldwide. CRDPs can be manufactured by a subtractive process (milling technique) or by an additive process (rapid prototyping or 3D printing). The milling technique is the frequently employed technique for fabricating CRDPs; it is well documented in terms of precision, material properties, and a few clinical trials have even demonstrated good patient and clinician satisfaction. The rapid prototyping (3D printing) method however, is still in the developing stages for this particular application. Although both methods seem to yield clinically acceptable results, there are no studies in current literature which compare the CRDPs manufactured by the two CAD/CAM methods.
The proposed single-center, double-blind, randomized crossover clinical trial specifically aims to test the following hypothesis that:
- there is no difference between the two types of CRDPs (milled, and rapidly prototyped) in terms of trueness, denture quality, patient satisfaction, prosthodontic maintenance and adjustments requirements and incurred costs.
Fifteen pre-doctoral final year dental students and their respective completely edentulous patients will be recruited in this RCT. A traditional clinical complete denture protocol will be followed to record the clinical steps. Two sets of CRDPs will be manufactured (CAD/CAM milling and 3D printing). The CRDPs will be randomized before denture insertion and then delivered to the patient. Each CRDPs will be worn by the patient for a period of 6 weeks, before crossing over. Clinical examinations and data collection will be performed at baseline (T0), at denture insertion stage (T1), and at the end of 6 weeks (T2) for each of the investigated CRDPs. Assessments will comprise of comparison of trueness of denture intaglio surfaces against the corresponding master cast, denture quality assessments, patient satisfaction scores, prosthodontic maintenance needs and willingness-to-pay analysis and cost minimization analysis.
This RCT will contribute significantly in the development of CAD/CAM treatment concepts for fabricating complete removable dental prostheses (CRDPs). The study would highlight the differences, if any, between the two manufacturing methods for CRDPs, in terms of trueness, quality of the prostheses, clinician and patient satisfaction and also incurred costs. Clinically, the planned RCT hopes to demonstrate the feasibility of these novel treatment concepts in frail elderly edentates. A significant reduction in the treatment times, maintenance visits, and costs along with high patient satisfaction with these newer CRDPs would be added advantages when treating the elderly edentates.
- Conditions
- Denture, Complete, Jaw, Edentulous
- Being tested
- manufacturing a complete dental prosthesis
- Keywords
- Computer-Aided Design, Computer-Assisted Manufacturing
- Medical subject headings
- Jaw, Edentulous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
manufacturing a complete dental prosthesisDevice
Also called complete denture manufacturing
dental treatment to replace missing teeth
| Study group | Role | What they receive |
|---|---|---|
| CAD/CAM milled complete denture | Active comparator | the dentures were milled out of a block of pre-polymerized PMMA resin (Avadent, Global dental Science, Netherlands) Receives: Device: manufacturing a complete dental prosthesis |
| CAD/CAM rapid prototyped complete denture | Experimental | the dentures will be 3D-printed from a liquid PMMA, including the teeth (NexDent, Netherlands) Receives: Device: manufacturing a complete dental prosthesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Trueness of intaglio surface
fit of the dental prosthesis as evaluated by superimposition of scanned intaglio surfaces at baseline and at 6-weeks
Measured: Change from Baseline intaglio surface at 6-weeks
Secondary outcomes (5)
Clinician's denture quality
denture quality questionnaire (Alfadda et al. 2014)
Measured: Change from Baseline denture retention and stability at 6-weeks
denture satisfaction Instrument
patient's denture satisfaction questionnaire (Allen et al. 2001)
Measured: Change from Baseline denture satisfaction at 6-weeks
denture preference
the patient will decide which denture he/she prefers to keep after the clinical trial
Measured: after both dentures have been worn for 6 weeks
prosthetic maintenance
described adjustments and repair of the denture during the observation period
Measured: at 6 weeks
willingness to pay
open ended contingency valuation method to evaluate the amount the patient would pay for the denture
Measured: 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 posted5 May 2021
- Study start15 Sep 2018
- Primary completion15 Sep 2019
- Study completion1 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Denture, CompleteStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- double blind single center cross-over design
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Geneva, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Frauke Müller, University of Geneva, Switzerland
- Investigators
- Frauke Mueller, Prof Dr Dr, Principal investigator, clinique universitaire de médecine dentaire
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04873219
- Sponsor's protocol ID
- MDGPA_03
- Acronym
- MILLPRINT
- Status last verified
- Mar 2025
- First submitted
- 1 Dec 2020
- Last updated
- 30 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of CAD/CAM Milled Versus Rapidly-prototyped (3D-printed) Complete Removable Dental Prostheses (CRDPs): a Double-blind Randomized Crossover Trial.
- ClinicalTrials.gov ID
- NCT04873219
- Acronym / sponsor ID
- MILLPRINT / MDGPA_03
- Conditions
- Denture, Complete, Jaw, Edentulous
- Keywords
- Computer-Aided Design, Computer-Assisted Manufacturing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University of Geneva, SwitzerlandUniversity, hospital or other
- Study start
- 15 Sep 2018 (actual)
- Primary completion
- 15 Sep 2019 (actual)
- Study completion
- 1 Mar 2020 (actual)
- First posted
- 5 May 2021 (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.
A crossover clinical trial investigates two novel CAD/CAM techniques for complete removable dental prostheses for edentulous patients, milling and rapid prototyping (3D-printing) in a clinical setting of an undergraduate student clinic. Outcome parameters concern the dentures' trueness, retention, stability, esthetics and occlusion. Secondary outcome parameters include willingness to pay and prosthetic maintenance need.
Detailed description
The process of fabricating complete removable dental prostheses (CRDPs) by novel CAD/CAM manufacturing technique has in the recent years gained immense popularity with clinicians as well as dental technicians worldwide. CRDPs can be manufactured by a subtractive process (milling technique) or by an additive process (rapid prototyping or 3D printing). The milling technique is the frequently employed technique for fabricating CRDPs; it is well documented in terms of precision, material properties, and a few clinical trials have even demonstrated good patient and clinician satisfaction. The rapid prototyping (3D printing) method however, is still in the developing stages for this particular application. Although both methods seem to yield clinically acceptable results, there are no studies in current literature which compare the CRDPs manufactured by the two CAD/CAM methods.
The proposed single-center, double-blind, randomized crossover clinical trial specifically aims to test the following hypothesis that:
- there is no difference between the two types of CRDPs (milled, and rapidly prototyped) in terms of trueness, denture quality, patient satisfaction, prosthodontic maintenance and adjustments requirements and incurred costs.
Fifteen pre-doctoral final year dental students and their respective completely edentulous patients will be recruited in this RCT. A traditional clinical complete denture protocol will be followed to record the clinical steps. Two sets of CRDPs will be manufactured (CAD/CAM milling and 3D printing). The CRDPs will be randomized before denture insertion and then delivered to the patient. Each CRDPs will be worn by the patient for a period of 6 weeks, before crossing over. Clinical examinations and data collection will be performed at baseline (T0), at denture insertion stage (T1), and at the end of 6 weeks (T2) for each of the investigated CRDPs. Assessments will comprise of comparison of trueness of denture intaglio surfaces against the corresponding master cast, denture quality assessments, patient satisfaction scores, prosthodontic maintenance needs and willingness-to-pay analysis and cost minimization analysis.
This RCT will contribute significantly in the development of CAD/CAM treatment concepts for fabricating complete removable dental prostheses (CRDPs). The study would highlight the differences, if any, between the two manufacturing methods for CRDPs, in terms of trueness, quality of the prostheses, clinician and patient satisfaction and also incurred costs. Clinically, the planned RCT hopes to demonstrate the feasibility of these novel treatment concepts in frail elderly edentates. A significant reduction in the treatment times, maintenance visits, and costs along with high patient satisfaction with these newer CRDPs would be added advantages when treating the elderly edentates.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- double blind single center cross-over design
| Arm | Type | Receives |
|---|---|---|
| CAD/CAM milled complete denture | Active comparator | Device: manufacturing a complete dental prosthesisthe dentures were milled out of a block of pre-polymerized PMMA resin (Avadent, Global dental Science, Netherlands) |
| CAD/CAM rapid prototyped complete denture | Experimental | Device: manufacturing a complete dental prosthesisthe dentures will be 3D-printed from a liquid PMMA, including the teeth (NexDent, Netherlands) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- patient of undergraduate student at the University clinics of dental medicine Geneva
- completely edentulous
- requesting novel complete dentures
Key exclusion criteria (1 listed)
- not willing to sign informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| manufacturing a complete dental prosthesisAlso: complete denture manufacturingdental treatment to replace missing teeth | Device | CAD/CAM milled complete denture, CAD/CAM rapid prototyped complete denture |
Primary outcome
Trueness of intaglio surface
Time frame: Change from Baseline intaglio surface at 6-weeks
fit of the dental prosthesis as evaluated by superimposition of scanned intaglio surfaces at baseline and at 6-weeks
5 secondary outcomes
Clinician's denture quality
Time frame: Change from Baseline denture retention and stability at 6-weeks
denture satisfaction Instrument
Time frame: Change from Baseline denture satisfaction at 6-weeks
denture preference
Time frame: after both dentures have been worn for 6 weeks
prosthetic maintenance
Time frame: at 6 weeks
willingness to pay
Time frame: 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 30 Mar 2025.
- Individual participant dataSharing planned: No
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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.
Frauke Mueller, Prof Dr Dr principal investigator
clinique universitaire de médecine dentaire
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing manufacturing a complete dental prosthesis in people with Denture, Complete and Jaw, Edentulous, run by University of Geneva, Switzerland at 1 site in Switzerland.
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 3 inclusion and 1 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 30 Mar 2025. 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 Switzerland. 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?
Trueness of intaglio surface (time frame: Change from Baseline intaglio surface 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 30 Mar 2025; AzTrials last refreshed its copy on 30 Oct 2026.