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

March 11, 2008 updated by: University Hospital, Grenoble

Use of Autologous Platelet Concentrate 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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment

20

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Isere
      • Grenoble, Isere, France, 38043
        • University hospital of Grenoble

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Radiological outcome measure : the bone height under the sinus on the two sides.

Secondary Outcome Measures

Outcome Measure
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Grenoble

Collaborators

Etablissement Français du Sang

Investigators

  • Principal Investigator: Georges Bettega, Dr, Univesity Grenoble Hospital, Stomatology Department

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2003

Study Completion (Actual)

November 1, 2007

Study Registration Dates

First Submitted

February 20, 2006

First Submitted That Met QC Criteria

February 20, 2006

First Posted (Estimate)

February 22, 2006

Study Record Updates

Last Update Posted (Estimate)

March 14, 2008

Last Update Submitted That Met QC Criteria

March 11, 2008

Last Verified

March 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DCIC 01 12

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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