Ignite Creation Date:
2024-05-06 @ 7:49 PM
Last Modification Date:
2024-10-26 @ 3:14 PM
Study NCT ID:
NCT06146153
Status:
COMPLETED
Last Update Posted:
2024-04-02
First Post:
2023-11-18
Brief Title:
Intra Oral Scanning of Edentulous Arches
Sponsor:
October University for Modern Sciences and Arts
Organization:
October University for Modern Sciences and Arts
Study Overview
Official Title:
Impact of Various Palatal Vault Configurations of Edentulous Arches on Scan Accuracy An Invivo Clinical Study
Status:
COMPLETED
Status Verified Date:
2024-04
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:
the aim of this study is to compare the influence of different palatal vault configurations on the accuracy and scan speed of IO scans in cases of completely edentulous arches The null hypothesis is that there is no difference in scanning time and trueness and precision of IO scans between class I II and III palatal vault configurations
Detailed Description:
A reference model will be created for each of the three groups with different palatal vault configurations PVS material DMG Silagum Germany will be used for impressions in a one-step process by an experienced operator and type IV plaster Heraeus Germany will be used to produce the models These models will then bedigitized by an experienced operator using an extraoral scanner Trios 3 3Shape Copenhagen Denmark The STL scan file of the maxillary model will be imported into CAD software Meshmixer Autodesk San Rafael CA USA to generate a reference file Reference markers will then be added to the digital files to aid the superimposition process during digital subtraction operationsFor intraoral scans the entire maxilla of each patient will be digitally captured using an intraoral scanner TRIOS POD 3Shape Copenhagen DenmarkAccording to ISO standards specifically ISO 5725-1 the accuracy of digital impressions obtained with intraoral scanners IOS will be evaluated according to two main parameters trueness and precision
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