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Sponsors and Collaborators: |
University Hospital, Grenoble Etablissement Français du Sang |
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Information provided by: | University Hospital, Grenoble |
ClinicalTrials.gov Identifier: | NCT00295126 |
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.
Condition | Intervention | Phase |
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Jaw, Edentulous Tooth Loss Maxillary Diseases |
Procedure: cellular therapy : Autologous platelet concentrate (APC) |
Phase II Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Safety/Efficacy Study |
Official Title: | Use of Autologous Platelet Concentrate in Pre-Implantation Reconstruction of Maxilla. |
Estimated Enrollment: | 20 |
Study Start Date: | May 2003 |
Study Completion Date: | November 2007 |
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 :
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 :
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
France, Isere | |
University Hospital of Grenoble | |
Grenoble, Isere, France, 38043 |
Principal Investigator: | Georges Bettega, Dr | Univesity Grenoble Hospital, Stomatology Department |
Study ID Numbers: | DCIC 01 12 |
Study First Received: | February 20, 2006 |
Last Updated: | March 11, 2008 |
ClinicalTrials.gov Identifier: | NCT00295126 |
Health Authority: | France: Afssaps - French Health Products Safety Agency |
Edentulous Tooth Loss APC Autologous platelet concentrate |
Mouth Diseases Mouth, Edentulous Tooth Diseases Periodontal Diseases Musculoskeletal Diseases |
Maxillary Diseases Stomatognathic Diseases Jaw, Edentulous Tooth Loss |
Jaw Diseases |