Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT06412159 |
| Other study ID # |
KFSIRB200-130 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
January 1, 2023 |
| Est. completion date |
February 1, 2024 |
Study information
| Verified date |
May 2024 |
| Source |
Kafrelsheikh University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Purpose: To compare the overall accuracy and fit of different components for mandibular
metallic removable partial denture (RPD) frameworks fabricated by selective laser melting
using combined analog-digital, and fully digital impression techniques.
Material and methods. Two RPD frameworks were fabricated for each of the 18 participants
using each of the 2 techniques of the 18 participants enrolled, were of mandibular Kennedy
class I, the first technique was the combined analog-digital workflow had the analog steps
include: a physical impression was made using polyvinyl siloxane, stone casts were made, then
the stone cast was scanned with a laboratory scanner to generate a digital cast. The 3Shape
CAD software was then used to design a digital RPD, which was fabricated from a
cobalt-chroumum alloy by selective laser melting. The second technique was fully digital
where an intraoral digital scanner was used to make a definitive scan, which was sent to the
3Shape software for digitally designing the RPD framework and subsequent selective laser
melting for fabrication. For both frameworks in the same participant, the same design was
used for consistency. To assess the accuracy of fit, based on STL data analysis (intra-oral
digital superimposition evaluation), a color map was constructed using non metrology
software, and overall fit accuracy and the misfit (distance between each framework component
and the reference intra-oral scan) were measured at rest, guiding plane and lingual plate
areas.
Description:
Eighteen mandibular bilateral partially edentulous participants aged from 50 to 65 years
having mandibular Class I Kennedy classification were selected randomly from the outpatient
clinic of the prosthodontic department. The clinical study was explained to the patients and
they accept it and an informed consent were signed by all them
For each patient, two different cobalt chromium removable partial denture frameworks were
constructed; the first one was fabricated using combined analog-digital workflow (group 1)
and the other framework was fabricated using completely digital workflow (group 2) and
comparing them through evaluation of:
1. Over all accuracy
2. Accuracy of fit of occlusal rests and major connector and Guiding plane/plate relation.
Two techniques were used to fabricate 18 RPD frameworks in total. Fabrication of cobalt
chromium removable partial denture framework using combined analog-digital workflow (group 1)
The Removable partial denture frameworks for group 1 were fabricated as follow:
The first technique was a combined analog-digital technique, in which a physical definitive
impression was made and a stone cast was fabricated. a physical impression was made using
polyvinyl siloxane impression material. , and a stone cast was poured using Type IV stone .
In an edentulous area, border molding was first accomplished using a green modeling plastic
impression compound . The impression and stone cast were evaluated critically to ensure
quality. The stone cast was then scanned using a laboratory scanner to produce a virtual 3D
master model. The 3Shape CAD software was used to design a digital RPD . The RPD framework
was designed with an lingual plate mandibular major connector, RPI retentive clasps on the
first premolars.
The definitive STL design file was then sent to the Dental Laboratory, to be selective laser
melted in Co-Cr alloy
