Manually Versus Digitally Fabricated Removable Partial Dentures

A Study on the Fit and Behaviour of Computer-aided Design and Rapid Prototyping Fabrication of Removable Partial Dentures

In the clinical trial, the Computer Aided Design/Computer Aided Manufacturing (CAD/CAM) fabricated removable partial dentures (RPD's) are evaluated on casts and clinically compared with a traditional fabricated RPD for 50 consecutive patients.

During 5 years the patients are in a follow-up program in order to judge long-term stability, loss of retention, fractures, … of both groups of dentures.

Study Overview

• Status: Completed
• Conditions: Partially Edentulous Patients
• Intervention / Treatment: Device: CAD/CAM fabricated RPD's; Device: traditional fabricated RPD's

Detailed Description

The classic removable partial denture (RPD) is a denture fabricated in CrCo using the "lost wax" technique. This hand-made way of working makes the final result vulnerable, not always predictable and not reproducible.

Computer Aided Design/Computer Aided Manufacturing (CAD/CAM) techniques have been introduced in dentistry, particularly to fabricate crowns and bridges (fixed partial dentures). There is little research in the field of removable partial framework fabrication. This may be in part be attributed to the lack of suitable dedicated software.

In the technical part of the study, existing software and hardware is adjusted to maximize the automation in the application of computer-aided technologies to surveying of digital casts and pattern design and the subsequent production of sacrificial patterns using removable partial (RP) technologies.

In the clinical trial the CAD/CAM fabricated RPD's are evaluated on casts and clinically and compared with a traditional fabricated RPD for 50 consecutive patients. For every patient, two RPDs are made in the same material (CrCo).The clinical parameters (fit, stability, retention, support, friction) are double blind evaluated by two dentists. At the end of the treatment, the patient can choose one of them.

Both RPDs are fabricated in the same time frame for the fabrication of the "classic" RPD. There are for the patient no extra sessions scheduled.

During 5 years the patients are in a follow-up program in order to judge long-term stability, loss of retention, fractures, … of both groups of dentures.

Hypothesis1: CAD/CAM fabricated RPD's can meet the clinical standards for RPD's.

Hypothesis 2: Dentists do not observe a difference between the classic and CAD/CAM fabricated RPD.

Hypothesis 3: Patients do not see/feel any difference between the classic and CAD/CAM fabricated RPD.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Ghent, Belgium, 9000
    • University Hospital Ghent

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• patients in need of a classic removable partial denture (RPD)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CAD/CAM fabricated dentures; group receiving Computer-Aided Design/Computer-Aided Manufacturing (CAD/CAM)fabricated removable partial dentures (double blind)	Device: CAD/CAM fabricated RPD's; group receiving Computer-Aided Design/Computer-Aided Manufacturing (CAD/CAM)fabricated removable partial dentures (double blind)
Active Comparator: traditional fabricated dentures; group receiving traditional fabricated dentures (double blind)	Device: traditional fabricated RPD's; group receiving traditional fabricated dentures (double blind)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
fit of framework	After casting "fit of the framework" between two identical reomvable partial dentures (same design, looks, material...) fabricated in a different way.	9 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
placement of RPD + control of placement	There will be a placement of a removable partial denture, and after 3 to 5 days, this placement will be re-checked as a follow up.	3 to 5 days
re-evaluation of the RPD placement	Every 6 months, for 5 years, the RPD placement will be followed up.	every 6 months, for 5 years

Collaborators and Investigators

• Sponsor: University Ghent
• Investigators: Principal Investigator: Lieve Van Zeghbroeck, MD, PhD, University Ghent

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2011
• Primary Completion (Actual): September 1, 2015
• Study Completion (Actual): December 1, 2015

Study Registration Dates

• First Submitted: August 26, 2010
• First Submitted That Met QC Criteria: August 27, 2010
• First Posted (Estimate): August 30, 2010

Study Record Updates

• Last Update Posted (Actual): December 1, 2021
• Last Update Submitted That Met QC Criteria: November 18, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Keywords: edentulous
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Mouth Diseases; Tooth Diseases; Mouth, Edentulous
• Other Study ID Numbers: 2009/655