Milled Versus Printed CAD/CAM Complete Dentures

NCT04873219 | Completed

• 1 other identifier: MDGPA_03
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Denture, Complete; Jaw, Edentulous

Keywords

Computer-Aided Design; Computer-Assisted Manufacturing

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Clinician's denture quality

  Change from Baseline denture retention and stability at 6-weeks

• denture satisfaction Instrument

  Change from Baseline denture satisfaction at 6-weeks

• denture preference

  after both dentures have been worn for 6 weeks

• prosthetic maintenance

  at 6 weeks

• willingness to pay

  at 6-weeks

Study Arms (2)

CAD/CAM milled complete denture

ACTIVE COMPARATOR

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

Device: manufacturing a complete dental prosthesis

CAD/CAM rapid prototyped complete denture

EXPERIMENTAL

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

Device: manufacturing a complete dental prosthesis

Interventions

manufacturing a complete dental prosthesis DEVICE

dental treatment to replace missing teeth

Also known as: complete denture manufacturing

CAD/CAM milled complete denture; CAD/CAM rapid prototyped complete denture

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• not willing to sign informed consent

Sponsors & Collaborators

• University of Geneva, Switzerland: lead

Study Sites (1)

University clinics of dental medicine

Geneva, Canton of Geneva, 1211, Switzerland

Location

MeSH Terms

Conditions

Jaw, Edentulous

Condition Hierarchy (Ancestors)

Jaw Diseases; Musculoskeletal Diseases; Stomatognathic Diseases; Mouth, Edentulous; Mouth Diseases; Tooth Diseases

Study Officials

• Frauke Mueller, Prof Dr Dr

  clinique universitaire de médecine dentaire

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: neither the patients, nor the operator knew which type of denture was inserted
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof Dr med dent Dr hc Frauke Müller

Model Details: double blind single center cross-over design

Study Record Dates

• First Submitted: December 1, 2020
• First Posted: May 5, 2021
• Study Start: September 15, 2018
• Primary Completion: September 15, 2019
• Study Completion: March 1, 2020
• Last Updated: March 30, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)