Autogenous bone graft has been considered the gold standard in Guided Bone Regeneration (GBR) technique used for bone augmentation. However, there are disadvantages associated with autograft use such as limited amount of available bone and increased morbidity for the patient at the sampling site. Several biomaterials have been used as a replacement of the autogenous bone. Viral-inactivated bone allograft powder is an alternative that has proven efficacy and tolerance. This study aims to assess the non-inferiority of viral-inactivated allogeneic bone paste compared to a viral-inactivated cortico-cancellous allogenic bone powder in achieving the ideal bone volume.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
86
BIOBank bone paste (PPT322)
BIOBank cortico-cancellous bone powder (PPT6)
Clinique Rive Gauche
Toulouse, France
RECRUITINGBone volume obtained
The primary endpoint is binary in nature (yes / no) and assessed radiographically by the CBCT: To assess, 4 to 6 months post-transplant, if the bone volume obtained at the time of implant placement corresponds to the desired bone volume before the transplant. Measured by an independent Evaluator, blind to the treatment received.
Time frame: 4 to 6 months post-bone grafting
Duration of surgery
measured in minutes
Time frame: immediate post-operative
Ease of manipulation
assessed by the operating surgeon using a Visual Analogue Scale from 0 (Not easy at all) to 10 (Very easy)
Time frame: immediate post-bone grafting
Absolute gain in bone volume
measured in mm by a radiographic distance
Time frame: 4 months post-bone grafting
Primary osteointegration (implants stability)
measured by Implant Stability Quotient (ISQ) using Resonance frequency analysis (RFA)
Time frame: 4 months post-bone grafting
Peri-implant marginal bone height
measured in mm
Time frame: 4 months post-bone grafting
Survivorship of the implant
binary variable yes / no
Time frame: 3-4 months post-implant
Need for a new bone augmentation simultaneously with implant placement
Binary yes/no
Time frame: 4 to 6 months post-bone grafting (implant placement)
Insufficient primary stability of the implant
Implant Stability Quotient (ISQ) less than 35N
Time frame: 4 to 6 months post-bone grafting (implant placement) and 3-4 months post-implant
Occurrence of complications related to the transplant
binary yes / no
Time frame: 7-10 months post-bone grafting
Nature of possible complications or a thematic grouping in the inter-group comparison
All complications appeared from the bone grafting until the end of the study will be described overall and by arm and grouped by thematic if relevant.
Time frame: 7-10 months post-bone grafting
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