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Milled Versus Printed CAD/CAM Complete Dentures (MILLPRINT)

Primary Purpose

Denture, Complete, Jaw, Edentulous

Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
manufacturing a complete dental prosthesis
Sponsored by
University of Geneva, Switzerland
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Denture, Complete focused on measuring Computer-Aided Design, Computer-Assisted Manufacturing

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • patient of undergraduate student at the University clinics of dental medicine Geneva
  • completely edentulous
  • requesting novel complete dentures

Exclusion Criteria:

  • not willing to sign informed consent

Sites / Locations

  • University clinics of dental medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

CAD/CAM milled complete denture

CAD/CAM rapid prototyped complete denture

Arm Description

the dentures were milled out of a block of pre-polymerized PMMA resin (Avadent, Global dental Science, Netherlands)

the dentures will be 3D-printed from a liquid PMMA, including the teeth (NexDent, Netherlands)

Outcomes

Primary Outcome Measures

Trueness of intaglio surface
fit of the dental prosthesis as evaluated by superimposition of scanned intaglio surfaces at baseline and at 6-weeks

Secondary Outcome Measures

Clinician's denture quality
denture quality questionnaire (Alfadda et al. 2014)
denture satisfaction Instrument
patient's denture satisfaction questionnaire (Allen et al. 2001)
denture preference
the patient will decide which denture he/she prefers to keep after the clinical trial
prosthetic maintenance
described adjustments and repair of the denture during the observation period
willingness to pay
open ended contingency valuation method to evaluate the amount the patient would pay for the denture

Full Information

First Posted
December 1, 2020
Last Updated
April 29, 2021
Sponsor
University of Geneva, Switzerland
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1. Study Identification

Unique Protocol Identification Number
NCT04873219
Brief Title
Milled Versus Printed CAD/CAM Complete Dentures
Acronym
MILLPRINT
Official Title
Evaluation of CAD/CAM Milled Versus Rapidly-prototyped (3D-printed) Complete Removable Dental Prostheses (CRDPs): a Double-blind Randomized Crossover Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
September 15, 2018 (Actual)
Primary Completion Date
September 15, 2019 (Actual)
Study Completion Date
March 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Geneva, Switzerland

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Denture, Complete, Jaw, Edentulous
Keywords
Computer-Aided Design, Computer-Assisted Manufacturing

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
double blind single center cross-over design
Masking
ParticipantCare ProviderInvestigator
Masking Description
neither the patients, nor the operator knew which type of denture was inserted
Allocation
Randomized
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CAD/CAM milled complete denture
Arm Type
Active Comparator
Arm Description
the dentures were milled out of a block of pre-polymerized PMMA resin (Avadent, Global dental Science, Netherlands)
Arm Title
CAD/CAM rapid prototyped complete denture
Arm Type
Experimental
Arm Description
the dentures will be 3D-printed from a liquid PMMA, including the teeth (NexDent, Netherlands)
Intervention Type
Device
Intervention Name(s)
manufacturing a complete dental prosthesis
Other Intervention Name(s)
complete denture manufacturing
Intervention Description
dental treatment to replace missing teeth
Primary Outcome Measure Information:
Title
Trueness of intaglio surface
Description
fit of the dental prosthesis as evaluated by superimposition of scanned intaglio surfaces at baseline and at 6-weeks
Time Frame
Change from Baseline intaglio surface at 6-weeks
Secondary Outcome Measure Information:
Title
Clinician's denture quality
Description
denture quality questionnaire (Alfadda et al. 2014)
Time Frame
Change from Baseline denture retention and stability at 6-weeks
Title
denture satisfaction Instrument
Description
patient's denture satisfaction questionnaire (Allen et al. 2001)
Time Frame
Change from Baseline denture satisfaction at 6-weeks
Title
denture preference
Description
the patient will decide which denture he/she prefers to keep after the clinical trial
Time Frame
after both dentures have been worn for 6 weeks
Title
prosthetic maintenance
Description
described adjustments and repair of the denture during the observation period
Time Frame
at 6 weeks
Title
willingness to pay
Description
open ended contingency valuation method to evaluate the amount the patient would pay for the denture
Time Frame
at 6-weeks

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: patient of undergraduate student at the University clinics of dental medicine Geneva completely edentulous requesting novel complete dentures Exclusion Criteria: not willing to sign informed consent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frauke Mueller, Prof Dr Dr
Organizational Affiliation
clinique universitaire de médecine dentaire
Official's Role
Principal Investigator
Facility Information:
Facility Name
University clinics of dental medicine
City
Genève
State/Province
Geneva 4
ZIP/Postal Code
1211
Country
Switzerland

12. IPD Sharing Statement

Plan to Share IPD
No

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Milled Versus Printed CAD/CAM Complete Dentures

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