REPI : a Randomized Open Label Trial Evaluating the Use of APC in Pre-Implantation Reconstruction of Maxilla

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Use of Autologous Platelet Concentrate in Pre-Implantation Reconstruction of Maxilla.

Conditions
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Jaw, Edentulous, Tooth Loss, Maxillary Diseases

Intervention / Treatment
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* Procedure: cellular therapy : Autologous platelet concentrate (APC)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age above 18 years ASA1 class of anesthetic risk SA3 or SA4 of the Misch classification Exclusion Criteria: Smoker Progressive sinusal lesion or previous history of maxillary sinusitis Previous history of maxillary surgery Hemopathy Contraindication to cytapheresis Progressive cardiopathy Severe cerebellar arteriopathy Infectious state Thrombopenia < 150 g/l controlled by citrate Serology : antibody anti-HVC, anti-HIV 1 & 2, anti HTLV 1 & 2 positive

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: cellular therapy : Autologous platelet concentrate (APC)|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Radiological outcome measure : the bone height under the sinus on the two sides. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Edentulous, Tooth Loss, APC, Autologous platelet concentrate