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

This study has been terminated.
Sponsor:
Collaborator:
Etablissement Français du Sang
Information provided by:
University Hospital, Grenoble
ClinicalTrials.gov Identifier:
NCT00295126
First received: February 20, 2006
Last updated: March 11, 2008
Last verified: March 2008
  Purpose

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
Jaw, Edentulous
Tooth Loss
Maxillary Diseases
Procedure: cellular therapy : Autologous platelet concentrate (APC)
Phase 2
Phase 3

Study Type: Interventional
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.

Resource links provided by NLM:


Further study details as provided by University Hospital, Grenoble:

Primary Outcome Measures:
  • Radiological outcome measure : the bone height under the sinus on the two sides.

Secondary Outcome Measures:
  • 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.

Estimated Enrollment: 20
Study Start Date: May 2003
Study Completion Date: November 2007
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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00295126

Locations
France
University Hospital of Grenoble
Grenoble, Isere, France, 38043
Sponsors and Collaborators
University Hospital, Grenoble
Etablissement Français du Sang
Investigators
Principal Investigator: Georges Bettega, Dr Univesity Grenoble Hospital, Stomatology Department
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00295126     History of Changes
Other Study ID Numbers: DCIC 01 12
Study First Received: February 20, 2006
Last Updated: March 11, 2008
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by University Hospital, Grenoble:
Edentulous
Tooth Loss
APC
Autologous platelet concentrate

Additional relevant MeSH terms:
Jaw, Edentulous
Maxillary Diseases
Mouth, Edentulous
Tooth Loss
Jaw Diseases
Musculoskeletal Diseases
Stomatognathic Diseases
Mouth Diseases
Tooth Diseases
Periodontal Diseases

ClinicalTrials.gov processed this record on July 20, 2014