Ignite Creation Date:
2024-06-16 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06420713
Status:
COMPLETED
Last Update Posted:
2024-06-11
First Post:
2024-05-14
Brief Title:
Horizontal Bone Augmentation of Alveolar Ridge
Sponsor:
University of Sao Paulo
Organization:
University of Sao Paulo
Study Overview
Official Title:
Use of Xenogeneic Bone Graft Associated With Autogenous Bone Graft or Leukocyte-and-Platelet-Rich Fibrin L-PRF for Horizontal Bone Augmentation of Alveolar Ridge A Randomized Controlled Clinical Trial
Status:
COMPLETED
Status Verified Date:
2024-06
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 objective of this randomized controlled clinical trial was to evaluate the effects of particulate xenogeneic bone grafts associated with autogenous bone graft or Leukocyte-and-Platelet-Rich Fibrin L-PRF for horizontal alveolar ridge augmentation Twenty-eight patients presenting edentulous regions and requiring horizontal bone augmentation prior to dental implant placement were included in this study and randomly divided into two groups according to the proposed guided bone regeneration GBR treatment
Fourteen surgical sites corresponding to Group A received bone regeneration with particulate autogenous bone tissue associated with deproteinized bovine bone graft Bio-Oss Small Geistlich AG Wolhusen Switzerland In Group B fourteen surgical sites were regenerated with deproteinized bovine bone graft Bio-Oss Small associated with L-PRF In both groups the grafted region was protected by a collagen membrane Bio-Gide Compressed Geistlich AG Wolhusen Switzerland fixed to the buccal and palatal bone plates using titanium pins
Cone-beam computed tomography CBCT scans were performed preoperatively immediately after the GBR surgical procedure after 8 months of GBR healing and immediately after dental implant placement to measure linear and volumetric changes in the alveolar ridge At the time of dental implant placement after an average period of 8 months following the guided bone regeneration procedures bone biopsies were taken from the grafted area for histological histomorphometric and micro-CT analysis
After a period of 6 months the dental implants were reopened to receive implant-supported prosthetic rehabilitation Implant stability was assessed using resonance frequency analysis at the time of implant placement in the grafted area and after an average of 6 months during the reopening surgical stage Patient pain perception following bone regeneration procedures was assessed using a visual analog scale All obtained data were statistically analyzed
Fourteen surgical sites corresponding to Group A received bone regeneration with particulate autogenous bone tissue associated with deproteinized bovine bone graft Bio-Oss Small Geistlich AG Wolhusen Switzerland In Group B fourteen surgical sites were regenerated with deproteinized bovine bone graft Bio-Oss Small associated with L-PRF In both groups the grafted region was protected by a collagen membrane Bio-Gide Compressed Geistlich AG Wolhusen Switzerland fixed to the buccal and palatal bone plates using titanium pins
Cone-beam computed tomography CBCT scans were performed preoperatively immediately after the GBR surgical procedure after 8 months of GBR healing and immediately after dental implant placement to measure linear and volumetric changes in the alveolar ridge At the time of dental implant placement after an average period of 8 months following the guided bone regeneration procedures bone biopsies were taken from the grafted area for histological histomorphometric and micro-CT analysis
After a period of 6 months the dental implants were reopened to receive implant-supported prosthetic rehabilitation Implant stability was assessed using resonance frequency analysis at the time of implant placement in the grafted area and after an average of 6 months during the reopening surgical stage Patient pain perception following bone regeneration procedures was assessed using a visual analog scale All obtained data were statistically analyzed
Detailed Description:
None
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