Ignite Creation Date:
2025-12-25 @ 2:17 AM
Ignite Modification Date:
2026-01-22 @ 3:13 PM
Study NCT ID:
NCT04027660
Status:
UNKNOWN
Last Update Posted:
2020-04-21
First Post:
2019-07-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Outcome of Immediate Zirconia Implants
Sponsor:
Implantology Institute
Organization:
Study Overview
Official Title:
Volumetric (Hard and Soft Tissue) Alterations in Immediate Zirconia Implants
Status:
UNKNOWN
Status Verified Date:
2020-04
Last Known Status:
ACTIVE_NOT_RECRUITING
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 is to study bone and soft tissue response to zirconia immediate implants.Volumetric changes will be measured before tooth extraction and after final crow placement.
Detailed Description:
Bone remodeling around immediate implants is a reality in clinical and literature arena. much is known about titanium implants but little in zirconia implants
In patients that require a tooth extraction anywhere in the oral cavity except 3rd molars are candidates fo the study. Once clinical conditions are establish and medical clearance is ok, the decision for an immediate implant is taken.
Patient will undergo for an intraoral Scanner (IOS, Trios 3Shape) to get an STL file of the previous situation.
On the day of surgery an atraumatically tooth extraction is performed (without rasing a flap) and a Zirconia implant is inserted on the alveolar socket.
The jumping gap (distance from crystal bone to implant body will be filled with a zenograft type of biomaterial) no sutures or membrane will be used.
A provisional crown or an individualized healing abutment will be placed. After 3 month healing an IOS will be made for crown fabrication and a second STL file generated.
After 15 days final crown will be placed, and 3 month after a 3rd IOS made to get the 3rd and final STL file.
An STL software will then make the correlation between the volume behavior in those 3 stages.
The control group, patients go for tooth extraction but no immediate implant and undergo with a classic protocol for implant placement. In this case the STL files are taken pre-operatory, before implant placement 3 month after tooth extraction, 2 month after implant placement (at final impression level), and 3 month after crown placement.
In patients that require a tooth extraction anywhere in the oral cavity except 3rd molars are candidates fo the study. Once clinical conditions are establish and medical clearance is ok, the decision for an immediate implant is taken.
Patient will undergo for an intraoral Scanner (IOS, Trios 3Shape) to get an STL file of the previous situation.
On the day of surgery an atraumatically tooth extraction is performed (without rasing a flap) and a Zirconia implant is inserted on the alveolar socket.
The jumping gap (distance from crystal bone to implant body will be filled with a zenograft type of biomaterial) no sutures or membrane will be used.
A provisional crown or an individualized healing abutment will be placed. After 3 month healing an IOS will be made for crown fabrication and a second STL file generated.
After 15 days final crown will be placed, and 3 month after a 3rd IOS made to get the 3rd and final STL file.
An STL software will then make the correlation between the volume behavior in those 3 stages.
The control group, patients go for tooth extraction but no immediate implant and undergo with a classic protocol for implant placement. In this case the STL files are taken pre-operatory, before implant placement 3 month after tooth extraction, 2 month after implant placement (at final impression level), and 3 month after crown placement.
Study Oversight
Has Oversight DMC:
False
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?: