Ignite Creation Date:
2024-05-05 @ 4:40 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00295126
Status:
TERMINATED
Last Update Posted:
2008-03-14
First Post:
2006-02-20
Brief Title:
REPI a Randomized Open Label Trial Evaluating the Use of APC in Pre-Implantation Reconstruction of Maxilla
Sponsor:
University Hospital Grenoble
Organization:
University Hospital Grenoble
Study Overview
Official Title:
Use of Autologous Platelet Concentrate in Pre-Implantation Reconstruction of Maxilla
Status:
TERMINATED
Status Verified Date:
2008-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a randomized open label trial that evaluates the efficacy of an autologous platelet concentrate APC in pre-implantation reconstruction of maxilla
The sinus occlusion will be performed under general anaesthetic On one side by the usual technique with hipbone transplant the other side will be restored with APC mixed with autologous bone tissue removed from the surgery site
The side selection will be determined by the randomization
The sinus occlusion will be performed under general anaesthetic On one side by the usual technique with hipbone transplant the other side will be restored with APC mixed with autologous bone tissue removed from the surgery site
The side selection will be determined by the randomization
Detailed Description:
Rational
Maxillary Edentulous is one of the more frequent handicaps that cause many problems for dental prosthesis Dental implants are currently the most convenient solution but require sufficient bone sinus height
The filling of the sinus can be made by two ways
Either with autologous bone removed from hipbone or cranial bone This method has several drawbacks such as the multiplicity of the surgery sites
Or with alloplasty materials that are subject to uncertain osseointegration and that are very expensive
The aim of this study is to show the interest of an autologous platelet concentrate APC in this surgery We will use the osteogenic property of platelets associated with a small quantity of spongy bone removed from the surgery site
It has been previously demonstrated that platelets contain growth factors in particular PDGF platelet derivated growth factors TGF-α1 and 2 transforming growth factors and IGF-1 insulin like growth factor These molecules have receptors on spongy bone enhance mitosis osteoblast differentiation angiogenesis and induce the inhibition of osteoclats
Method
The sinus filling will be performed under general anaesthetic On one side by the usual technique with hipbone transplant the other side will be restored with APC mixed with autologous bone tissue removed from the surgery site
The side selection will be determined by the randomization For each patient a waiting period of 6 months is required before dental implants
Twenty patients will be enrolled in this single-centre study with a follow-up of one year
Main objective
- To demonstrate that the osteogenesis with APC mixed with a small quantity 1 to 2 cm2 of autologous bone tissue removed from the surgery site has a sufficient quality to allow the dental implants
Secondary Objectives
To compare the osteogenesis with the current procedure hipbone transplant
To estimate the kinetic of osteogenesis using successive radiography
Maxillary Edentulous is one of the more frequent handicaps that cause many problems for dental prosthesis Dental implants are currently the most convenient solution but require sufficient bone sinus height
The filling of the sinus can be made by two ways
Either with autologous bone removed from hipbone or cranial bone This method has several drawbacks such as the multiplicity of the surgery sites
Or with alloplasty materials that are subject to uncertain osseointegration and that are very expensive
The aim of this study is to show the interest of an autologous platelet concentrate APC in this surgery We will use the osteogenic property of platelets associated with a small quantity of spongy bone removed from the surgery site
It has been previously demonstrated that platelets contain growth factors in particular PDGF platelet derivated growth factors TGF-α1 and 2 transforming growth factors and IGF-1 insulin like growth factor These molecules have receptors on spongy bone enhance mitosis osteoblast differentiation angiogenesis and induce the inhibition of osteoclats
Method
The sinus filling will be performed under general anaesthetic On one side by the usual technique with hipbone transplant the other side will be restored with APC mixed with autologous bone tissue removed from the surgery site
The side selection will be determined by the randomization For each patient a waiting period of 6 months is required before dental implants
Twenty patients will be enrolled in this single-centre study with a follow-up of one year
Main objective
- To demonstrate that the osteogenesis with APC mixed with a small quantity 1 to 2 cm2 of autologous bone tissue removed from the surgery site has a sufficient quality to allow the dental implants
Secondary Objectives
To compare the osteogenesis with the current procedure hipbone transplant
To estimate the kinetic of osteogenesis using successive radiography
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None