Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| EVAMED | OTHER |
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BIOBank bone paste (PPT322) | Experimental | Allogeneic bone paste derived from human living donor femoral heads |
|
| BIOBank cortico-cancellous bone powder (PPT6) | Active Comparator | Allogeneic bone powder derived from human living donor femoral heads (used in current practice) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BIOBank bone paste | Biological | BIOBank bone paste (PPT322) |
| |
| 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 |
| 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) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Grégoire EDORH | Contact | +33 1 64 42 00 75 | gedorh@biobank.fr |
| Name | Affiliation | Role |
|---|---|---|
| Bruno Courtois, Dr | Clinique Rive Gauche (TOULOUSE) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinique Rive Gauche | Recruiting | Toulouse | 31100 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41159915 | Derived | Courtois B, L'Homme A, Labadie MP. Allogeneic bone paste versus bone powder for oral guided bone regeneration: A randomized, noninferiority trial. J Periodontol. 2026 Mar;97(3):411-421. doi: 10.1002/jper.11385. Epub 2025 Oct 29. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D001862 | Bone Resorption |
| D009057 | Stomatognathic Diseases |
| ID | Term |
|---|---|
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
Not provided
Not provided
Randomized non-inferiority, two-arm, parallel, single-blind and monocentric clinical trial:
Not provided
Not provided
Statistician will also perform trial analyses with treatment masking
| BIOBank cortico-cancellous bone powder |
| Biological |
BIOBank cortico-cancellous bone powder (PPT6) |
|
| 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 |