Ignite Creation Date:
2024-05-06 @ 8:15 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06317090
Status:
COMPLETED
Last Update Posted:
2024-03-19
First Post:
2023-06-06
Brief Title:
Vertical GBR LPRF Block vs Autogenous Bone With DBBM
Sponsor:
Universitaire Ziekenhuizen KU Leuven
Organization:
Universitaire Ziekenhuizen KU Leuven
Study Overview
Official Title:
Vertical Guided Bone Regeneration LPRF Block vs a Mixture of Autogenous Bone With Deproteinized Bovine Bone Mineral A Split-mouth RCT Study With 25 Months Follow-up
Status:
COMPLETED
Status Verified Date:
2024-03
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:
split-mouth RCT 25 months follow up GBR protocol with LPRF as grafting material in the test group and autogenous bone with DBBM as grafting material in the control group
Detailed Description:
6 patients were included in this split-mouth RCT In control sites a horizontal GBR procedure was performed using a titanium reinforced dPTFE membrane with a graft consisting of 50 autogenous bone and 50 DBBM In test sites a titanium reinforced dPTFE membrane was used with a graft consisting of an LPRF block This was left to heal for 9 months Subsequently an implant was placed At time of implant placement a bone biopsy was taken After 4 months of osseointegration the abutment connection was performed 1 year after loading of the implants a final check was done CBCT scans were taken at intake immediately after reconstruction 9 months after reconstruction before implant placement and 1 year after loading of the implants
Primary outcome measure is the bone volume as measured on the CBCT scans Secondary outcome measures are bone quality in the biopsy buccal bone thickness around the oral implant number and type of complications cumulative survival rates of the implants 1 year after loading
Primary outcome measure is the bone volume as measured on the CBCT scans Secondary outcome measures are bone quality in the biopsy buccal bone thickness around the oral implant number and type of complications cumulative survival rates of the implants 1 year after loading
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