3D-BONE

1 Positioning of the PEEK replica and preparation of the cortical screw site

2 Positioning of the biomaterial graft

3 Fixing of the graft with the cortical screw

4 Graft fixed at vestibular level

CONE BEAM CT AND PRODUCTION OF A 3D VIRTUAL BONE MODEL

The fundamental requirement is a Cone Beam CT of the jaw, with a special focus on the area with the defect. The process starts with the acquisition of the patient’s tomographic examina- tion. The DICOM file is sent by the clinician to the BTK TEAM using the Web, for the beginning of the design phase (http://upload.btk.dental/btk3d).

DIGITAL PROCESSING OF THE 3D-BONE STRUCTURE

Based on the patient’s situation, the device is designed using the CAD modelling software within the framework of a fully digitalized work flow. The morphological and dimen- sional features of the device and the position of the holes for the cortical screws are specifically designed so as to fit the patient’s anatomy, while preserving the noble structures.

CHECK AND APPROVAL BY THE PRESCRIBING CLINICIAN

The clinician receives a three-dimensional digital model of the requested custom-made block, can check its compliance and authorize its production. Alternatively, the virtual graft is remodelled as needed until it is approved. To authorize production, the clinician sends a prescription of the custom-made device.

PRODUCTION OF THE GRAFT AND OF THE REPLICA

The graft is made out of a BTK synthetic bone block. It is produced by subtractive technology, using a dedicated machine for the biomaterial: an extremely precise multi- axis milling machine. At the same time, BTK produces the graft replica in biocompatible material.

CHECKING, PACKAGING AND STERILIZATION

Upon completion of the manufacturing phase, production standards are scrupulously checked by means of compliance tests. Then the device is cleaned in a ultrasonic automatic machine and packed in a clean room under controlled atmosphere. The product is sterilized by means of GAMMA RAYS following a validated sterilization process.

In addition to the custom-made bone graft, we deliver a replica made of PEEK, a biocompatible material.
It is a copy of the graft and already has the holes for the cortical screws.
It is very useful in the first surgical phases:

1. Simulation of the surgery on the model, before performing actual surgery.
2. Correct management of flaps and soft tissues.
3. Checking of the fitting.
4. Surgical guide for drills, to make the holes for the cortical screws.

Figliuzzi M, Mangano FG, Fortunato L, De Fazio R, Macchi A, Iezzi G, Piattelli A, Mangano C. Vertical ridge augmentation of the atrophic posterior mandible with custom-made, com- puter-aided design/computer-aided manufacturing using porous hydroxyapatite scaffolds. J Craniofac Surg. 2013 ;24(3):856-9.
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Mangano FG, Zecca PA, van Noort R, Apresyan S, Iezzi G, Piattelli A, Macchi A, Manga- no C. Custom-Made Computer-aided-design/computer-aided manufacturing biphasic calci- um-phosphate scaffold for augmentation of an atrophic mandibular anterior ridge. Hindawi Publishing Corporation – Case Rep Dent. 2015; 941265. Epub 2015.
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Lobo SE, Livingston Arinzeh T. Biphasic calcium phosphate ceramics for bone regeneration and tissue engineering applications. Materials 2010, 3, 815-826.
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Mangano F, Zecca P, Pozzi-Taubert S, Macchi A, Ricci M, Luongo G, Mangano C. Maxillary sinus augmentation using computer-aided design/computer-aided manufacturing (CAD/CAM) technology. Int J Med Robot. 2013 9(3):331-8. Epub 2012.
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Mangano F, Macchi A, Shibli JA, Luongo G, Iezzi G, Piattelli A, Caprioglio A, Mangano C. Maxillary ridge augmentation with custom-made CAD/CAM scaffolds. A 1-year prospective study on 10 patients. J Oral Implantol. 2014, 40(5):561-9. Epub 2013.
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Kunihiro O, Tsuyoshi M, Hisao M, Akira G, Kazuomi S, Hideki Y. Corrective osteotomy using customized hydroxyapatite implants prepared by preoperative computer simulation. Int J Med Robot. 2010; 6: 186–193. ORIGINAL ARTICLE Published online 2010 in Wiley InterScience (www.interscience.wiley.com).
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Macchi A, Mangano C, Inversini M, Norcini A, Binaghi E. Scaffolds individualizzati (Cus- tom-Made) nella rigenerazione ossea dei mascellari. Custom-Made scaffolds in maxillary bone regeneration. IMPLANTOLOGIA ORALE 4, 2006.