Allogeneic Bone Paste Versus Allogeneic Bone Powder
Primary Purpose
Bone Resorption, Dental Diseases
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
BIOBank bone paste
BIOBank cortico-cancellous bone powder
Sponsored by
About this trial
This is an interventional treatment trial for Bone Resorption
Eligibility Criteria
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
Sites / Locations
- Clinique Rive GaucheRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
BIOBank bone paste (PPT322)
BIOBank cortico-cancellous bone powder (PPT6)
Arm Description
Allogeneic bone paste derived from human living donor femoral heads
Allogeneic bone powder derived from human living donor femoral heads (used in current practice)
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Duration of surgery
measured in minutes
Ease of manipulation
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
measured in mm by a radiographic distance
Primary osteointegration (implants stability)
measured by Implant Stability Quotient (ISQ) using Resonance frequency analysis (RFA)
Peri-implant marginal bone height
measured in mm
Survivorship of the implant
binary variable yes / no
Need for a new bone augmentation simultaneously with implant placement
Binary yes/no
Insufficient primary stability of the implant
Implant Stability Quotient (ISQ) less than 35N
Occurrence of complications related to the transplant
binary yes / no
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.
Full Information
NCT ID
NCT04141215
First Posted
October 23, 2019
Last Updated
March 1, 2022
Sponsor
Biobank
Collaborators
EVAMED
1. Study Identification
Unique Protocol Identification Number
NCT04141215
Brief Title
Allogeneic Bone Paste Versus Allogeneic Bone Powder
Official Title
Allogeneic Bone Paste Versus Allogeneic Bone Powder in Pre-implant Guided Bone Regeneration in Oral Surgery: a Randomized Non-inferiority Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 15, 2019 (Actual)
Primary Completion Date
November 30, 2022 (Anticipated)
Study Completion Date
November 30, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Biobank
Collaborators
EVAMED
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bone Resorption, Dental Diseases
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
ParticipantOutcomes Assessor
Masking Description
Statistician will also perform trial analyses with treatment masking
Allocation
Randomized
Enrollment
86 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
BIOBank bone paste (PPT322)
Arm Type
Experimental
Arm Description
Allogeneic bone paste derived from human living donor femoral heads
Arm Title
BIOBank cortico-cancellous bone powder (PPT6)
Arm Type
Active Comparator
Arm Description
Allogeneic bone powder derived from human living donor femoral heads (used in current practice)
Intervention Type
Biological
Intervention Name(s)
BIOBank bone paste
Intervention Description
BIOBank bone paste (PPT322)
Intervention Type
Biological
Intervention Name(s)
BIOBank cortico-cancellous bone powder
Intervention Description
BIOBank cortico-cancellous bone powder (PPT6)
Primary Outcome Measure Information:
Title
Bone volume obtained
Description
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
Secondary Outcome Measure Information:
Title
Duration of surgery
Description
measured in minutes
Time Frame
immediate post-operative
Title
Ease of manipulation
Description
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
Title
Absolute gain in bone volume
Description
measured in mm by a radiographic distance
Time Frame
4 months post-bone grafting
Title
Primary osteointegration (implants stability)
Description
measured by Implant Stability Quotient (ISQ) using Resonance frequency analysis (RFA)
Time Frame
4 months post-bone grafting
Title
Peri-implant marginal bone height
Description
measured in mm
Time Frame
4 months post-bone grafting
Title
Survivorship of the implant
Description
binary variable yes / no
Time Frame
3-4 months post-implant
Title
Need for a new bone augmentation simultaneously with implant placement
Description
Binary yes/no
Time Frame
4 to 6 months post-bone grafting (implant placement)
Title
Insufficient primary stability of the implant
Description
Implant Stability Quotient (ISQ) less than 35N
Time Frame
4 to 6 months post-bone grafting (implant placement) and 3-4 months post-implant
Title
Occurrence of complications related to the transplant
Description
binary yes / no
Time Frame
7-10 months post-bone grafting
Title
Nature of possible complications or a thematic grouping in the inter-group comparison
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Grégoire EDORH
Phone
+33 1 64 42 00 75
Email
gedorh@biobank.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bruno Courtois, Dr
Organizational Affiliation
Clinique Rive Gauche (TOULOUSE)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinique Rive Gauche
City
Toulouse
ZIP/Postal Code
31100
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bruno Courtois
Phone
+33 5 62 89 99 30
Email
brunocourtois.co@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
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Allogeneic Bone Paste Versus Allogeneic Bone Powder
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