Ignite Creation Date:
2024-05-05 @ 4:46 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00318487
Status:
COMPLETED
Last Update Posted:
2022-12-21
First Post:
2006-04-11
Brief Title:
Bilateral Sinus Floor Augmentation in Conjunction With Immediate Implant Loading - Study on 3i Dental Implants
Sponsor:
University Hospital Ghent
Organization:
University Hospital Ghent
Study Overview
Official Title:
Bilateral Sinus Floor Augmentation in Conjunction With Immediate Implant Loading - A Clinical and Histomorphometric Follow-Up Study on 3i Dental Implants
Status:
COMPLETED
Status Verified Date:
2022-12
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:
Fifteen 15 patients completely edentulous in the maxilla will be treated with 8 dental implants The total treatment will be done in 2 stages to allow within the same group a study of two different approaches Miniscrews that can be functionally loaded will be provided by 3i with the design and surface textures as wanted by the study sponsor
Detailed Description:
The department of oral surgery in Ghent has a lot of patients for bilateral sinus lift procedures The group of patients should have enough bone for installation of 4 dental implants in the area 14-24 In this region 4 implants will be installed and immediate loading with a provisional acrylic metal reinforced bridge will be provided The survival and success of the implants immediate functional loading will be studied interest point 1 Two different implant surfaces are used in the study to be compared interest point 2 in relation to peri-implant parameters radiographical healing and success criteria at the same time bilateral sinus lifting is performed One sinus is filled with a mixture of iliac crest bone and Bio-Oss Geistlich Germany and the second sinus is filled with calvarial skull bone and Bio-oss The latter bone combination is appreciated clinically by the surgeons since it leads to a subjectively better implant stability This however remains to be investigated This study can compare both harvesting techniques and evaluate clinical treatment outcome interest point 3 Normally there is a certain waiting time after sinus lifting before dental implants are installed Recently however some literature abstracts indicate that immediate placement of the implants in the sinus lifted bone can be successful However this is not done with immediate functional loading We propose to install in total 6 miniscrews 2 in each sinus lift area Four will be loaded immediately and connected rigidly to the other 4 normal sized implants Actually the immediate loaded bridge will be supported in total by 4 normal and 4 miniscrew implants Four months after loading the 4 loaded miniscrews are removed with a trephine drill in order to examine soft-tissue healing bone-implant contact and bone healing by means of histomorphometry Since the implants are in cortical bone sinus lifted bone it will be possible to examine the given implant surface under immediate loading in both bone conditions interest point 4 Immediately after removing the miniscrews they are replaced by the normal sized implants One side will be randomly assigned for immediate non-functional loading the other side will be assigned to a non-loaded condition With this latter design we can mimic the partial sinus lift condition as it is often done 4 months after sinus lifting - the classical procedure At the time of exposing the implants of the 2-stage procedure the miniscrews are removed This gives us an idea of bone healing of an implant installed 4 months after sinus lifting and kept additionally unloaded for 4 months This gives us histology of immediately loaded implants in healed sinus lifted bone interest point 5
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None