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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01191073
Other study ID # 2009/655
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 2011
Est. completion date December 2015

Study information

Verified date November 2021
Source University Ghent
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 50
Est. completion date December 2015
Est. primary completion date September 2015
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - patients in need of a classic removable partial denture (RPD)

Study Design


Related Conditions & MeSH terms


Intervention

Device:
CAD/CAM fabricated RPD's
group receiving Computer-Aided Design/Computer-Aided Manufacturing (CAD/CAM)fabricated removable partial dentures (double blind)
traditional fabricated RPD's
group receiving traditional fabricated dentures (double blind)

Locations

Country Name City State
Belgium University Hospital Ghent Ghent

Sponsors (1)

Lead Sponsor Collaborator
University Ghent

Country where clinical trial is conducted

Belgium, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
Secondary 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
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