Horizontal Bone Augmentation of Alveolar Ridge: A Randomized Controlled Clinical Trial. - Trial NCT06420713
Access comprehensive clinical trial information for NCT06420713 through Pure Global AI's free database. This phase not specified trial is sponsored by University of Sao Paulo and is currently Completed. The study focuses on Platelet-rich Fibrin,Bone Substitutes,Atrophic Maxilla,Cone-beam Computed Tomography,Bone Regeneration. Target enrollment is 28 participants.
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Study Focus
Horizontal Bone Augmentation of Alveolar Ridge
Interventional
procedure
Sponsor & Location
University of Sao Paulo
Timeline & Enrollment
N/A
Oct 20, 2019
May 09, 2024
Primary Outcome
Micro-CT and Histometric analyses
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.
ICD-10 Classifications
Data Source
ClinicalTrials.gov
NCT06420713
Non-Device Trial