Manually Versus Digitally Fabricated Removable Partial Dentures

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2012 by University Ghent
Sponsor:
Information provided by (Responsible Party):
University Ghent
ClinicalTrials.gov Identifier:
NCT01191073
First received: August 26, 2010
Last updated: February 10, 2012
Last verified: February 2012
  Purpose

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.


Condition Intervention Phase
Partially Edentulous Patients
Device: CAD/CAM fabricated RPD's
Device: traditional fabricated RPD's
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Study on the Fit and Behaviour of Computer-aided Design and Rapid Prototyping Fabrication of Removable Partial Dentures

Resource links provided by NLM:


Further study details as provided by University Ghent:

Primary Outcome Measures:
  • fit of framework [ Time Frame: 9 months ] [ Designated as safety issue: No ]
    After casting "fit of the framework" between two identical reomvable partial dentures (same design, looks, material...) fabricated in a different way.


Secondary Outcome Measures:
  • placement of RPD + control of placement [ Time Frame: 3 to 5 days ] [ Designated as safety issue: No ]
    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.

  • re-evaluation of the RPD placement [ Time Frame: every 6 months, for 5 years ] [ Designated as safety issue: No ]
    Every 6 months, for 5 years, the RPD placement will be followed up.


Estimated Enrollment: 50
Study Start Date: June 2011
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients in need of a classic removable partial denture (RPD)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01191073

Contacts
Contact: Lieve Van Zeghbroeck, MD, PhD Lieve.Vanzeghbroeck@ugent.be

Locations
Belgium
University Hospital Ghent Recruiting
Ghent, Belgium, 9000
Contact: Lieve Van Zeghbroeck, MD, PhD       Lieve.Vanzeghbroeck@ugent.be   
Principal Investigator: Lieve Van Zeghbroeck, MD, PhD         
Sponsors and Collaborators
University Ghent
Investigators
Principal Investigator: Lieve Van Zeghbroeck, MD, PhD University Ghent
  More Information

No publications provided

Responsible Party: University Ghent
ClinicalTrials.gov Identifier: NCT01191073     History of Changes
Other Study ID Numbers: 2009/655
Study First Received: August 26, 2010
Last Updated: February 10, 2012
Health Authority: Belgium: Ethics Committee

Keywords provided by University Ghent:
edentulous

Additional relevant MeSH terms:
Mouth, Edentulous
Mouth Diseases
Stomatognathic Diseases
Tooth Diseases

ClinicalTrials.gov processed this record on August 25, 2014