Manually Versus Digitally Fabricated Removable Partial Dentures
Primary Purpose
Partially Edentulous Patients
Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
CAD/CAM fabricated RPD's
traditional fabricated RPD's
Sponsored by
About this trial
This is an interventional treatment trial for Partially Edentulous Patients focused on measuring edentulous
Eligibility Criteria
Inclusion Criteria:
- patients in need of a classic removable partial denture (RPD)
Sites / Locations
- University Hospital Ghent
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
CAD/CAM fabricated dentures
traditional fabricated dentures
Arm Description
group receiving Computer-Aided Design/Computer-Aided Manufacturing (CAD/CAM)fabricated removable partial dentures (double blind)
group receiving traditional fabricated dentures (double blind)
Outcomes
Primary Outcome Measures
fit of framework
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
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
Every 6 months, for 5 years, the RPD placement will be followed up.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01191073
Brief Title
Manually Versus Digitally Fabricated Removable Partial Dentures
Official Title
A Study on the Fit and Behaviour of Computer-aided Design and Rapid Prototyping Fabrication of Removable Partial Dentures
Study Type
Interventional
2. Study Status
Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
June 2011 (Actual)
Primary Completion Date
September 2015 (Actual)
Study Completion Date
December 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Ghent
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Partially Edentulous Patients
Keywords
edentulous
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Non-Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CAD/CAM fabricated dentures
Arm Type
Experimental
Arm Description
group receiving Computer-Aided Design/Computer-Aided Manufacturing (CAD/CAM)fabricated removable partial dentures (double blind)
Arm Title
traditional fabricated dentures
Arm Type
Active Comparator
Arm Description
group receiving traditional fabricated dentures (double blind)
Intervention Type
Device
Intervention Name(s)
CAD/CAM fabricated RPD's
Intervention Description
group receiving Computer-Aided Design/Computer-Aided Manufacturing (CAD/CAM)fabricated removable partial dentures (double blind)
Intervention Type
Device
Intervention Name(s)
traditional fabricated RPD's
Intervention Description
group receiving traditional fabricated dentures (double blind)
Primary Outcome Measure Information:
Title
fit of framework
Description
After casting "fit of the framework" between two identical reomvable partial dentures (same design, looks, material...) fabricated in a different way.
Time Frame
9 months
Secondary Outcome Measure Information:
Title
placement of RPD + control of placement
Description
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.
Time Frame
3 to 5 days
Title
re-evaluation of the RPD placement
Description
Every 6 months, for 5 years, the RPD placement will be followed up.
Time Frame
every 6 months, for 5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
patients in need of a classic removable partial denture (RPD)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lieve Van Zeghbroeck, MD, PhD
Organizational Affiliation
University Ghent
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Ghent
City
Ghent
ZIP/Postal Code
9000
Country
Belgium
12. IPD Sharing Statement
Learn more about this trial
Manually Versus Digitally Fabricated Removable Partial Dentures
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