CONCEPT

BioHexTM One Piece-One StageTM Implant & Restoration System

The BioHex^TM One Piece-One Stage^TM System is the result of more than ten years of research and was developed to overcome certain challenges associated with current implant system.

This System is defined by an elegantly simple clinical protocol that enables the dentist to achieve an extremely high standard of clinical efficacy independent of skill and experience. The system consists of a unique one-piece, implant-abutment device, together with certain other novel components and certain unique methods for the placement of implants and the restoration of teeth.

The system is based upon two novel physical concepts, namely, (1) a common, or standard, hexagon-shaped abutment, and (2) a combined or “one-piece” implant and abutment. By virtue of its one-piece design, the system is at the forefront of the trend to perform single-stage implant procedures. By installing the implant and final abutment at the same time and without any further step, surgical or otherwise, the BioHex^TM system offers the only true single-stage implant and restoration procedure. Although elegantly simple in its approach, the one-piece design incorporating a standard abutment has been used to create a truly universal system that allow dental practitioners to manage the entire implant and restoration process safely and predictably.

The One-Piece, One-Stage Implant and Restoration Protocol is a prosthetically driven implant placement concept. Each step is determined by, and related to, the final prosthetic objectives. By adhering to the protocol, predictable aesthetic and functional results are assured.

Traditional dental restorative procedures require considerable skill and expertise. Typically, the procedure and the components used for each patient are highly customized. Independent placement of the implant requires selection of an appropriate abutment from hundreds of different options. Essentially, the abutment is selected to both compensate for implant placement inaccuracies and to address the final aesthetic and functional characteristics. Such compromise rarely produces optimal or desirable results for the patient.

By comparison, the One-Piece, One-Stage Implant and Restoration is based on three fundamental concepts that ensure a common procedure, common components and straightforward predictable results: (a) the position of the abutment determines the position of the implant, (b) the position and shape of the abutment determines the ultimate success of the prosthesis, both aesthetically and functionally, and (c) development and use of a common, optimally-designed abutment obviates the variations and risks involved with abutment selection, whilst ensuring optimal function, stability and aesthetic appearance.

The optimal abutment design addresses all critical parameters, including (a) strength, (b) crown retention, (c) crown resistant, (d) crown irretrievability, and (e) aesthetics. In addition, elimination of the abutment-implant interface ensures the long-term survival of the prosthesis and implant.

The One-Piece, One-Stage Implant and Restoration Protocol supports the basic principle that the primary objective of a dental implant is to replace missing Dentition. The term ‘dental implant’ is therefore a misnomer, in that it implies that the objective is merely to successfully place an implant. Under the One-Piece, One-Stage Implant and Restoration Protocol, only the visual aspects of the final prosthesis need to be customized by prescription from dentist to laboratory.

The System has demonstrated safety and reliability of its implants at success rates of over 90 percent, representing full integration of the implant with the bone. In addition, the System has also demonstrated the overall safety and reliability of its system with a current success rate of 97.44 percent, representing stability and utility of the prosthesis for all events over a five-year period. A formal clinical study, involving 172 implant patients, has been ongoing for more than 10 years. Whereas the osseointegration results are comparable to the results of other implant systems, the overall performance of this system is superior to that of any other system.

After animal and extensive biomechanical bench testing started in 1992, the BioHex^TM One Piece-One Stage^TM System was first introduced in 1995, as a two-piece device, although used as a one-piece in a single stage procedure. FDA 510(k) clearance was received in May 1997. After validation and satisfaction with respect to Good Manufacturing Practices (“GMP”), the one-piece device was introduced in October 1999, as substantially equivalent to the unified two-piece device.