Clinical trial NCT04873219: Milled Versus Printed CAD/CAM Complete Dentures
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
Overall status: COMPLETED
Phase: NA
Conditions: Denture, Complete
Jaw, Edentulous
Keywords: Computer-Aided Design
Computer-Assisted Manufacturing
Lead sponsor: University of Geneva, Switzerland
Sponsor class: OTHER
First posted: 2021-05-05
Enrollment: 15
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: double blind single center cross-over design
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Trueness of intaglio surface
timeFrame: Change from Baseline intaglio surface at 6-weeks
Secondary outcomes:
measure: Clinician's denture quality
timeFrame: Change from Baseline denture retention and stability at 6-weeks
measure: denture satisfaction Instrument
timeFrame: Change from Baseline denture satisfaction at 6-weeks
measure: denture preference
timeFrame: after both dentures have been worn for 6 weeks
measure: prosthetic maintenance
timeFrame: at 6 weeks
measure: willingness to pay
timeFrame: at 6-weeks
Other outcomes:
Locations:
city: Genève
country: Switzerland
facility: University clinics of dental medicine
state: Geneva
Study officials:
affiliation: clinique universitaire de médecine dentaire
name: Frauke Mueller, Prof Dr Dr
role: PRINCIPAL_INVESTIGATOR
References: