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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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

Other trials in Switzerland

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.

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 groups in NCT04873219
Study groupRoleWhat they receive
CAD/CAM milled complete dentureActive comparatorthe 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 dentureExperimentalthe 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.

  1. 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)
  1. Clinician's denture quality

    denture quality questionnaire (Alfadda et al. 2014)

    Measured: Change from Baseline denture retention and stability at 6-weeks

  2. denture satisfaction Instrument

    patient's denture satisfaction questionnaire (Allen et al. 2001)

    Measured: Change from Baseline denture satisfaction at 6-weeks

  3. 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

  4. prosthetic maintenance

    described adjustments and repair of the denture during the observation period

    Measured: at 6 weeks

  5. 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.

  1. First posted5 May 2021
  2. Study start15 Sep 2018
  3. Primary completion15 Sep 2019
  4. Study completion1 Mar 2020

Resources

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)
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

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.

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