Milled Versus Printed CAD/CAM Complete Dentures

Study Overview
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Brief Summary
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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
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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.

Official Title
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Evaluation of CAD/CAM Milled Versus Rapidly-prototyped (3D-printed) Complete Removable Dental Prostheses (CRDPs): a Double-blind Randomized Crossover Trial.

Conditions
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Jaw, Edentulous, Denture, Complete

Intervention / Treatment
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* Device: manufacturing a complete dental prosthesis


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: double blind single center cross-over design
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: CAD/CAM milled complete denture<br>the dentures were milled out of a block of pre-polymerized PMMA resin (Avadent, Global dental Science, Netherlands) | Device: manufacturing a complete dental prosthesis<br>* dental treatment to replace missing teeth<br>* Other names: complete denture manufacturing;|
| Experimental: CAD/CAM rapid prototyped complete denture<br>the dentures will be 3D-printed from a liquid PMMA, including the teeth (NexDent, Netherlands) | Device: manufacturing a complete dental prosthesis<br>* dental treatment to replace missing teeth<br>* Other names: complete denture manufacturing;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Trueness of intaglio surface | fit of the dental prosthesis as evaluated by superimposition of scanned intaglio surfaces at baseline and at 6-weeks | Change from Baseline intaglio surface at 6-weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinician's denture quality | denture quality questionnaire (Alfadda et al. 2014) | Change from Baseline denture retention and stability at 6-weeks | 
| denture satisfaction Instrument | patient's denture satisfaction questionnaire (Allen et al. 2001) | 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 | after both dentures have been worn for 6 weeks | 
| prosthetic maintenance | described adjustments and repair of the denture during the observation period | at 6 weeks | 
| willingness to pay | open ended contingency valuation method to evaluate the amount the patient would pay for the denture | at 6-weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Computer-Aided Design, Computer-Assisted Manufacturing