REPI : a Randomized Open Label Trial Evaluating the Use of APC in Pre-Implantation Reconstruction of Maxilla
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.
Procedure: cellular therapy : Autologous platelet concentrate (APC)
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Use of Autologous Platelet Concentrate in Pre-Implantation Reconstruction of Maxilla.|
- Radiological outcome measure : the bone height under the sinus on the two sides.
- Radiological outcome measure : the bone density
- Clinical outcome measure : assessment of the alveolar crest quality, possible orals complications, and complications at the removal site.
- Histological outcome measures : with bone core boring at the implant site.
- All these measurements will be matched for each patient on both sides.
|Study Start Date:||May 2003|
|Study Completion Date:||November 2007|
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00295126
|University Hospital of Grenoble|
|Grenoble, Isere, France, 38043|
|Principal Investigator:||Georges Bettega, Dr||Univesity Grenoble Hospital, Stomatology Department|