Ignite Creation Date:
2024-05-06 @ 6:51 PM
Last Modification Date:
2024-10-26 @ 2:55 PM
Study NCT ID:
NCT05804253
Status:
COMPLETED
Last Update Posted:
2023-04-07
First Post:
2023-03-14
Brief Title:
Maxillary Sinus Grafting With Deproteinized Porcine or Bovine Bone Mineral
Sponsor:
Camlog Oral Reconstruction Foundation
Organization:
Camlog Oral Reconstruction Foundation
Study Overview
Official Title:
Clinical Radiographic and HistologicalHistomorphometric Analysis of Maxillary Sinus Grafting With Deproteinized Porcine or Bovine Bone Mineral a Randomized Controlled Clinical Trial
Status:
COMPLETED
Status Verified Date:
2023-03
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:
The present study aimed to compare the histomorphometrically evaluated new bone formation the radiographically measured graft stability and the clinical implant outcome between maxillary sinuses grafted either with deproteinized porcine bone mineral DPBM or deproteinized bovine bone mineral DBBM Conclusions From a clinical point of view the present results demonstrate that DPBM provides for comparable bone formation and stable graft dimension and high implant success rates combined with healthy peri-implant condition
Detailed Description:
Materials and Methods Thirty maxillary sinuses in 28 participants were initially included and randomly assigned to the test group TGDPBM n15 or the control group CGDBBM n15 After a healing period 6 months bone core biopsies were axially retrieved in the molar site for histological histomorphometrical analysis of new bone formations In addition radiographically measured graft stability as well as the clinical implant outcome implant survivalsuccessperi-implant health were assessed at the 1-year and 3-year follow-up evaluations
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