Partially Edentulous Patients
Conditions
Keywords
edentulous
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.
Interventions
DEVICECAD/CAM fabricated RPD's
group receiving Computer-Aided Design/Computer-Aided Manufacturing (CAD/CAM)fabricated removable partial dentures (double blind)
DEVICEtraditional fabricated RPD's
group receiving traditional fabricated dentures (double blind)
Sponsors
University Ghent
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* patients in need of a classic removable partial denture (RPD)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| fit of framework | 9 months | After casting fit of the framework between two identical reomvable partial dentures (same design, looks, material...) fabricated in a different way. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| placement of RPD + control of placement | 3 to 5 days | 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 | Every 6 months, for 5 years, the RPD placement will be followed up. |
Countries
Belgium
Outcome results
None listed