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

Tooth Loss Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00295126
• Other study ID #: DCIC 01 12
• Status: Terminated
• Phase: Phase 2/Phase 3
• First received: February 20, 2006
• Last updated: March 11, 2008
• Start date: May 2003
• Est. completion date: November 2007

Study information

• Verified date: March 2008
• Source: University Hospital, Grenoble
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 20
• Est. completion date: November 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Jaw, Edentulous
• Maxillary Diseases
• Mouth, Edentulous
• Tooth Loss

Intervention

Procedure:
• cellular therapy : Autologous platelet concentrate (APC)

Locations

Country	Name	City	State
France	University Hospital of Grenoble	Grenoble	Isere

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Grenoble	Etablissement Français du Sang

Country where clinical trial is conducted

France, 

References & Publications (4)

Carlson ER. Bone grafting the jaws in the 21st century: the use of platelet-rich plasma and bone morphogenetic protein. Alpha Omegan. 2000 Aug-Sep;93(3):26-30. — View Citation

Kassolis JD, Rosen PS, Reynolds MA. Alveolar ridge and sinus augmentation utilizing platelet-rich plasma in combination with freeze-dried bone allograft: case series. J Periodontol. 2000 Oct;71(10):1654-61. — View Citation

Lebeau J, Savariaux C, Perrier P, Bettega G, Raphaël B. [Functional evaluation of intraoral reconstructive surgery. A valuable tool: articulatory evaluation of the acoustic signal]. Rev Stomatol Chir Maxillofac. 2000 Apr;101(2):60-4. French. — View Citation

Robiony M, Polini F, Costa F, Politi M. Osteogenesis distraction and platelet-rich plasma for bone restoration of the severely atrophic mandible: preliminary results. J Oral Maxillofac Surg. 2002 Jun;60(6):630-5. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Radiological outcome measure : the bone height under the sinus on the two sides.
Secondary	Radiological outcome measure : the bone density
Secondary	Clinical outcome measure : assessment of the alveolar crest quality, possible orals complications, and complications at the removal site.
Secondary	Histological outcome measures : with bone core boring at the implant site.
Secondary	All these measurements will be matched for each patient on both sides.