Bone Resorption, Dental Diseases
Conditions
Brief summary
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.
Interventions
BIOLOGICALBIOBank bone paste
BIOBank bone paste (PPT322)
BIOLOGICALBIOBank cortico-cancellous bone powder
BIOBank cortico-cancellous bone powder (PPT6)
Sponsors
EVAMED
Biobank
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
Statistician will also perform trial analyses with treatment masking
Intervention model description
Randomized non-inferiority, two-arm, parallel, single-blind and monocentric clinical trial: 1. BIOBank bone paste (PPT322), derived from human living donor femoral heads 2. BIOBank cortico-cancellous bone powder (PPT6), derived from human living donor femoral heads, used in current practice as reference treatment
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patient aged ≥ 18 years old 2. Patient able to read, understand and give written consent to participate in the study 3. Patient affiliated with a social security system or beneficiary of such a system 4. Partially edentulous patient with 1 to 2 intercalary missing teeth or a terminal gap with distal vertical and lateral support bone volume 5. 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 6. Possibility of acquisition by CBCT for the required protocol visits
Exclusion criteria
1. General contraindication to bone graft and implant surgery 2. Pregnant woman or planned pregnancy during the study period or breast-feeding woman; 3. Patient who has had a bone augmentation by GBR during the previous 12 months, in the area targeted for filling with the allogeneic material 4. Patient who received less than 3 months ago a CBCT acquisition at the operative site 5. Patient simultaneously requiring more than one GBR augmentation in the same quadrant 6. Patient with signs of local infection at the targeted graft site 7. Systemic, metabolic or autoimmune disease that may adversely affect healing of soft and bone tissue (eg, unbalanced type 1 or type 2 diabetes) 8. Use of treatments (chemotherapy or radiotherapy) or drugs (bisphosphonates, chronic steroids) known to potentially interfere with tissue healing 9. Patient presenting a dental plaque objectified by an oral examination (Loe SILNESS ≥ 2 on more than 50% of the dental surfaces) 10. Patient smoker of more than 10 cigarettes a day 11. 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Bone volume obtained | 4 to 6 months post-bone grafting | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Ease of manipulation | immediate post-bone grafting | assessed by the operating surgeon using a Visual Analogue Scale from 0 (Not easy at all) to 10 (Very easy) |
| Absolute gain in bone volume | 4 months post-bone grafting | measured in mm by a radiographic distance |
| Primary osteointegration (implants stability) | 4 months post-bone grafting | measured by Implant Stability Quotient (ISQ) using Resonance frequency analysis (RFA) |
| Peri-implant marginal bone height | 4 months post-bone grafting | measured in mm |
| Duration of surgery | immediate post-operative | measured in minutes |
| Need for a new bone augmentation simultaneously with implant placement | 4 to 6 months post-bone grafting (implant placement) | Binary yes/no |
| Insufficient primary stability of the implant | 4 to 6 months post-bone grafting (implant placement) and 3-4 months post-implant | Implant Stability Quotient (ISQ) less than 35N |
| Occurrence of complications related to the transplant | 7-10 months post-bone grafting | binary yes / no |
| Nature of possible complications or a thematic grouping in the inter-group comparison | 7-10 months post-bone grafting | 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. |
| Survivorship of the implant | 3-4 months post-implant | binary variable yes / no |
Countries
France
Contacts
Primary ContactGrégoire EDORH
Outcome results
None listed