Status:
TERMINATED
REPI : a Randomized Open Label Trial Evaluating the Use of APC in Pre-Implantation Reconstruction of Maxilla
Lead Sponsor:
University Hospital, Grenoble
Collaborating Sponsors:
Etablissement Français du Sang
Conditions:
Jaw, Edentulous
Tooth Loss
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief 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 unde...
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 b...
Eligibility Criteria
Inclusion
- Age above 18 years
- ASA1 class of anesthetic risk
- SA3 or SA4 of the Misch classification
Exclusion
- 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
Key Trial Info
Start Date :
May 1 2003
Trial Type :
INTERVENTIONAL
End Date :
November 1 2007
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00295126
Start Date
May 1 2003
End Date
November 1 2007
Last Update
March 14 2008
Active Locations (1)
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1
University Hospital of Grenoble
Grenoble, Isere, France, 38043