Allogeneic Bone Paste Versus Allogeneic Bone Powder

Not Applicable

• Conditions: Bone Resorption; Dental Diseases
• Interventions: Biological: BIOBank bone paste; Biological: BIOBank cortico-cancellous bone powder

• Registration Number: NCT04141215
• Lead Sponsor: Biobank

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-10-23
• Study First Submitted QC: 2019-10-24
• Study First Posted: 2019-10-28
• Study Start: 2019-11-15
• Status Verified: 2022-01
• Last Update Submitted: 2022-03-01
• Last Update Posted: 2022-03-02
• Primary Completion: 2022-11-30
• Study Completion: 2022-11-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 86

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BIOBank bone paste (PPT322)	BIOBank bone paste	Allogeneic bone paste derived from human living donor femoral heads
BIOBank cortico-cancellous bone powder (PPT6)	BIOBank cortico-cancellous bone powder	Allogeneic bone powder derived from human living donor femoral heads (used in current practice)

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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)
Duration of surgery	immediate post-operative	measured in minutes
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
Survivorship of the implant	3-4 months post-implant	binary variable yes / no
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.

Trial Locations

Locations (1)

Clinique Rive Gauche; 🇫🇷 Toulouse, France