Ignite Creation Date:
2024-05-05 @ 6:36 PM
Last Modification Date:
2024-10-26 @ 9:35 AM
Study NCT ID:
NCT00519571
Status:
UNKNOWN
Last Update Posted:
2008-05-09
First Post:
2007-08-20
Brief Title:
Evaluation of the Safety and Efficacy of Using ImplantLock Device - Dental Implant Accessory
Sponsor:
Innovative Implant Solutions
Organization:
Innovative Implant Solutions
Study Overview
Official Title:
Evaluation of the Safety and Efficacy of Using ImplantLock Device - Dental Implant Accessory
Status:
UNKNOWN
Status Verified Date:
2008-05
Last Known Status:
NOT_YET_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:
To investigate the safety and effectiveness of the ImplantLock device and its contribution to 80 mm long root-form endosseous implants stability under immediately applied continuous functional loading
Detailed Description:
Primary Endpoints
Serious adverse events occurrence rate during implantation procedure or following implantation related to the ImplantLock device will be documented in Serious Adverse Event Form
Adverse events occurrence rate during implantation procedure or following implantation related to the ImplantLock device will be documented in Adverse Event Form
Secondary Endpoints
Determine 80 mm long endosseous implant stability while using ImplantLock Device Stability will be routinely assessed
Determine the ability to immediately apply continuous functional loading on 80 mm long endosseous implant while using ImplantLock Device The ability to immediately apply continuous functional loading will be routinely assessed
Serious adverse events occurrence rate during implantation procedure or following implantation related to the ImplantLock device will be documented in Serious Adverse Event Form
Adverse events occurrence rate during implantation procedure or following implantation related to the ImplantLock device will be documented in Adverse Event Form
Secondary Endpoints
Determine 80 mm long endosseous implant stability while using ImplantLock Device Stability will be routinely assessed
Determine the ability to immediately apply continuous functional loading on 80 mm long endosseous implant while using ImplantLock Device The ability to immediately apply continuous functional loading will be routinely assessed
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