Ignite Creation Date:
2024-05-19 @ 5:34 PM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06412159
Status:
COMPLETED
Last Update Posted:
2024-05-16
First Post:
2024-05-03
Brief Title:
Digital Evaluation of Accuracy for Removable Partial Denture Frameworks
Sponsor:
Kafrelsheikh University
Organization:
Kafrelsheikh University
Study Overview
Official Title:
Intra-oral Digital Evaluation of Fit Accuracy for Removable Partial Denture Frameworks Fabricated by Selective Laser Melting Using 2 Different Impression Techniques Within Subjected Study
Status:
COMPLETED
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
PurposeWithin subject study aim 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 24 participants using each of the 2 techniques of the 24 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
Material and methods Two RPD frameworks were fabricated for each of the 24 participants using each of the 2 techniques of the 24 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
Detailed Description:
Twenty four 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 major connector Guiding planeplate relation and retentive terminal of I bar clasp
Two techniques were used to fabricate 48 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 I bar 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
The Overall fit accuracy and the misfit at some areas where the accuracy measurement was performed included The restrest seat areas of right and left premolars the right and left guide planeplate area the mandibular major connector area including the superior border of lingual plate area and retentive terminal of I bar clasp
All measurements were made by a single investigator and were repeated five times The average error of measurement was approximately 0002 mm As a basis for our evaluation of misfit a distance of 0 to 005 mm was considered close contact no gap and a distance of 005 to 031 mm was defined as clinically acceptable fit
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 major connector Guiding planeplate relation and retentive terminal of I bar clasp
Two techniques were used to fabricate 48 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 I bar 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
The Overall fit accuracy and the misfit at some areas where the accuracy measurement was performed included The restrest seat areas of right and left premolars the right and left guide planeplate area the mandibular major connector area including the superior border of lingual plate area and retentive terminal of I bar clasp
All measurements were made by a single investigator and were repeated five times The average error of measurement was approximately 0002 mm As a basis for our evaluation of misfit a distance of 0 to 005 mm was considered close contact no gap and a distance of 005 to 031 mm was defined as clinically acceptable fit
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None