Ignite Creation Date:
2024-05-06 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 12:44 PM
Study NCT ID:
NCT03496428
Status:
COMPLETED
Last Update Posted:
2019-10-30
First Post:
2018-03-31
Brief Title:
Customized Impressions in Dental Implants - Soft Tissues Changes
Sponsor:
Implantology Institute
Organization:
Implantology Institute
Study Overview
Official Title:
Customized Impressions in Dental Implants - Soft Tissues Changes
Status:
COMPLETED
Status Verified Date:
2019-08
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:
Six patients with a single unit implant in the anterior maxilla from premolar to premolar after at least 3 months with provisional implant supported restoration will be submitted to definitive implant impressions
Informed consents and local ethical committee clearance will be obtained Patients will be submitted to a silicon impression with a customized impression coping from which a conventional cast will be obtained and scanned with D2000 3Shape and to an intraoral scan with Trios 3Shape Standard Tessellation Language STL files will be obtained from both procedures and imported to reverse engineering software Geomagic Control X 3D Systems and the distance between both scans will be calculated in a colored 3D map From this map two outcomes will be analyzed the changes in soft tissues around implants with the two techniques primary outcome and the discrepancy between both scans in the teeth adjacent to the implants secondary outcome
Informed consents and local ethical committee clearance will be obtained Patients will be submitted to a silicon impression with a customized impression coping from which a conventional cast will be obtained and scanned with D2000 3Shape and to an intraoral scan with Trios 3Shape Standard Tessellation Language STL files will be obtained from both procedures and imported to reverse engineering software Geomagic Control X 3D Systems and the distance between both scans will be calculated in a colored 3D map From this map two outcomes will be analyzed the changes in soft tissues around implants with the two techniques primary outcome and the discrepancy between both scans in the teeth adjacent to the implants secondary outcome
Detailed Description:
Custom-guided tissue healing with o provisional restoration is the most predictable way to achieve natural anatomically shaped tissue and optimal esthetics Several authors describe the use of an anatomically contoured provisional restoration to start to guide the soft tissue healing in an ideal natural morphology that replicates the tooth form Being that after shaping the tissue to ideal anatomic form and health the exact duplication of the soft tissue contour should be obtained so that laboratory can duplicate it in the final restoration Nowadays gold-standard describes the use of a customized impression coping that replicates the provisional soft tissue contour by the use of and analog-silicone index upon which a gypsum cast is created
The use of computer-aided designcomputer-assisted manufacture CADCAM technologies to manufacture prosthetic frameworks on dental implants is noticeably increasing This method requires the use of an STL file which can be acquired intra-orally or extraorally using a stone cast poured from a conventional implant impression using a customized implant impression coping
Several studies have already described the accuracy of STL data and that evaluating STL models can be done by best fit algorithms in appropriate softwares
In this pilot study the investigators aim to evaluate soft tissue profile changes in single unit implants in the aesthetic area using a customized impression coping with conventional methods and the intraoral impression with an intraoral scanner Trios 3Shape Additionally position discrepancies of adjacent teeth between the two techniques will be assessed
This pilot study will include 6 patients with single unit implant which will be recruited according inclusion criteria and submitted to the two different impression techniques Conventional stone cast will be scanned with a laboratory scanner D2000 3Shape with a described deviation of 5μm Two STL files will be obtained per patient and by established methods with a reverse engineering software Geomagic Control X 3D Systems discrepancies between them assessed
Differences in axis x y z and overall distances will be assessed in the soft tissues 18 points and in adjacent teeth 26 points according established methods per patient Additionally 3D colored maps will be produced to ascertain volumetric changes between techniques T-test and Wilcoxon signed-rank test will be used and the level of statistical significance set at P005 Sample size determination will be performed based on obtained results
The use of computer-aided designcomputer-assisted manufacture CADCAM technologies to manufacture prosthetic frameworks on dental implants is noticeably increasing This method requires the use of an STL file which can be acquired intra-orally or extraorally using a stone cast poured from a conventional implant impression using a customized implant impression coping
Several studies have already described the accuracy of STL data and that evaluating STL models can be done by best fit algorithms in appropriate softwares
In this pilot study the investigators aim to evaluate soft tissue profile changes in single unit implants in the aesthetic area using a customized impression coping with conventional methods and the intraoral impression with an intraoral scanner Trios 3Shape Additionally position discrepancies of adjacent teeth between the two techniques will be assessed
This pilot study will include 6 patients with single unit implant which will be recruited according inclusion criteria and submitted to the two different impression techniques Conventional stone cast will be scanned with a laboratory scanner D2000 3Shape with a described deviation of 5μm Two STL files will be obtained per patient and by established methods with a reverse engineering software Geomagic Control X 3D Systems discrepancies between them assessed
Differences in axis x y z and overall distances will be assessed in the soft tissues 18 points and in adjacent teeth 26 points according established methods per patient Additionally 3D colored maps will be produced to ascertain volumetric changes between techniques T-test and Wilcoxon signed-rank test will be used and the level of statistical significance set at P005 Sample size determination will be performed based on obtained results
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