Milled Versus Printed CAD/CAM Complete Dentures

Jaw, Edentulous Clinical Trial

— MILLPRINT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04873219
• Other study ID #: MDGPA_03
• Status: Completed
• Phase: N/A
• Start date: September 15, 2018
• Est. completion date: March 1, 2020

Study information

• Verified date: April 2021
• Source: University of Geneva, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. Outcome parameters concern the dentures' trueness, retention, stability, esthetics and occlusion. Secondary outcome parameters include willingness to pay and prosthetic maintenance need.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: March 1, 2020
• Est. primary completion date: September 15, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Denture, Complete
• Jaw, Edentulous

Intervention

Device:
• manufacturing a complete dental prosthesis
dental treatment to replace missing teeth

Locations

Country	Name	City	State
Switzerland	University clinics of dental medicine	Genève	Geneva 4

Sponsors (1)

Lead Sponsor	Collaborator
University of Geneva, Switzerland

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Clinician's denture quality	denture quality questionnaire (Alfadda et al. 2014)	Change from Baseline denture retention and stability at 6-weeks
Secondary	denture satisfaction Instrument	patient's denture satisfaction questionnaire (Allen et al. 2001)	Change from Baseline denture satisfaction at 6-weeks
Secondary	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
Secondary	prosthetic maintenance	described adjustments and repair of the denture during the observation period	at 6 weeks
Secondary	willingness to pay	open ended contingency valuation method to evaluate the amount the patient would pay for the denture	at 6-weeks