Allogeneic Bone Paste Versus Allogeneic Bone Powder

Study Overview
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Brief Summary
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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.

Official Title
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Allogeneic Bone Paste Versus Allogeneic Bone Powder in Pre-implant Guided Bone Regeneration in Oral Surgery: a Randomized Non-inferiority Clinical Trial

Conditions
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Bone Resorption, Dental Diseases

Intervention / Treatment
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* Biological: BIOBank bone paste
* Biological: BIOBank cortico-cancellous bone powder


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient aged ≥ 18 years old Patient able to read, understand and give written consent to participate in the study Patient affiliated with a social security system or beneficiary of such a system Partially edentulous patient with 1 to 2 intercalary missing teeth or a terminal gap with distal vertical and lateral support bone volume Presence of a bone deficit requiring horizontal and / or vertical bone augmentation (stage 4 or 5 of the Benic and Hammerle classification) treated by GBR for delayed placement of up to 4 dental implants Possibility of acquisition by CBCT for the required protocol visits Exclusion Criteria: General contraindication to bone graft and implant surgery Pregnant woman or planned pregnancy during the study period or breast-feeding woman; Patient who has had a bone augmentation by GBR during the previous 12 months, in the area targeted for filling with the allogeneic material Patient who received less than 3 months ago a CBCT acquisition at the operative site Patient simultaneously requiring more than one GBR augmentation in the same quadrant Patient with signs of local infection at the targeted graft site Systemic, metabolic or autoimmune disease that may adversely affect healing of soft and bone tissue (eg, unbalanced type 1 or type 2 diabetes) Use of treatments (chemotherapy or radiotherapy) or drugs (bisphosphonates, chronic steroids) known to potentially interfere with tissue healing Patient presenting a dental plaque objectified by an oral examination (Loe SILNESS ≥ 2 on more than 50% of the dental surfaces) Patient smoker of more than 10 cigarettes a day Any other condition that, in the investigator's opinion, would be detrimental to the safety of the patient or fail to meet the requirements of the protocol

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized non-inferiority, two-arm, parallel, single-blind and monocentric clinical trial: BIOBank bone paste (PPT322), derived from human living donor femoral heads BIOBank cortico-cancellous bone powder (PPT6), derived from human living donor femoral heads, used in current practice as reference treatment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BIOBank bone paste (PPT322)<br>Allogeneic bone paste derived from human living donor femoral heads | Biological: BIOBank bone paste<br>* BIOBank bone paste (PPT322)<br>|
| Active Comparator: BIOBank cortico-cancellous bone powder (PPT6)<br>Allogeneic bone powder derived from human living donor femoral heads (used in current practice) | Biological: BIOBank cortico-cancellous bone powder<br>* BIOBank cortico-cancellous bone powder (PPT6)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bone 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. | 4 to 6 months post-bone grafting | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of surgery | measured in minutes | 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) | immediate post-bone grafting | 
| Absolute gain in bone volume | measured in mm by a radiographic distance | 4 months post-bone grafting | 
| Primary osteointegration (implants stability) | measured by Implant Stability Quotient (ISQ) using Resonance frequency analysis (RFA) | 4 months post-bone grafting | 
| Peri-implant marginal bone height | measured in mm | 4 months post-bone grafting | 
| Survivorship of the implant | binary variable yes / no | 3-4 months post-implant | 
| Need for a new bone augmentation simultaneously with implant placement | Binary yes/no | 4 to 6 months post-bone grafting (implant placement) | 
| Insufficient primary stability of the implant | Implant Stability Quotient (ISQ) less than 35N | 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 | 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. | 7-10 months post-bone grafting |