Page 1 of 7 RBM dental implants by CST Process Technical Release September 2012 Summary Finish Line operates technologically validated RBM (Resorbable Blasting Media) Process, based on its CST (Comprehensive Surface Treatment) Process. From now, our customers may benefit from well known advantages of RBM implants. RBM surface is featured by extensively developed roughness and zero biocompatibility obstructions, thanks to using of biocompatible Calcium Phosphate blasting media. Calcium Phosphates are easily dissolved, leaving well textured surface completely free of contaminants. As one of the leaders, Lifecore Co, put it on its page www.trycare.co.uk/techdata_pdfs/106.pdf, RBM surface is roughened using only biocompatible media (calcium phosphate ceramic) that is fully resorbable, permitting its removal after manufacturing. The result is a clean, textured, pure titanium surface. Additionally, RBM does not need strong acids for removing of blasting media remains, which contributes to implants biocompatibility as well. Finish Line's RBM surface undergoes completing surface treatment by citric acid, also compatible to live textures. Finish Line RBM CST Process uses an apatite born Calcium Phosphate having approximate chemical composition of Ca 3 (PO 4 ) (Tri-Calcium Phosphate), blasted at automatic blasting machine allowing uniform and repeatable surface of implants. The cleaning, washing-out and washing stages include using of Ultrasonic Bathes with De-Ionized Water of high purity, air drying is carried out in clean room class 10,000, while quality control at all stages of the treatment is performed including on-line SEM-EDS control and periodical XPS and optical profilometry tests. Finish Line RBM implants demonstrate high surface performances, and when checked by advanced physical instruments (SEM, EDS, XPS, Optical Profilometer) are revealed to be fully identical to the surface performances of implants manufactured by the leaders in the field: 1. The surface structure (morphology) of the Finish Line RBM dental implants, as exposed by SEM microphotographs, is featured by highly developed surface porosity. 2. The surface roughness of the Finish Line RBM dental implants is well-defined and uniform. The main roughness parameter Ra has good acceptable value of about 1.9 microns. 3. The surface purity of the Finish Line RBM dental implants, as exposed by SEM microphotographs and checked by EDS-SEM instrument, is nearly absolute: no inclusions or contaminations are detected, any point of the surface is revealed to be pure Titanium alloy. 4. The surface chemical composition of the Finish Line RBM dental implants, as analyzed by XPS instrument, represents well acceptable values of the main elements usually found on the dental
Page 2 of 7 implants surface underwent blasting and blasting media cleaning. Content 1. Challenge. Finish Line has entered RBM implants club 2. RBM CST Process 3. RBM implants comparative tests 3.1. SEM general view 3.2. SEM surface structure (morphology) 3.3. Roughness by optical profilometer 3.4. Surface chemistry & purity 3.4.1. By SEM EDS 3.4.2. By XPS 4. Conclusions. Finish Line customers may benefit from RBM implants advantages 1. Challenge. Finish Line has entered RBM implants club Finish Line operates technologically validated RBM (Resorbable Blasting Media) Process, based on its CST (Comprehensive Surface Treatment) Process. By using this process, our customers may benefit from well known advantages of RBM implants. RBM surface is featured by extensively developed roughness, not less than in case of hard Alumina blasting, while overcoming the last in terms of biocompatibility, thanks to using of biocompatible Calcium Phosphate blasting media. Furthermore, opposite to Alumina and other hard blasters, Calcium Phosphates are easily dissolved, leaving well textured surface completely free of contaminants. Additionally, RBM does not need strong acids for removing of blasting media remains, which contributes to implants biocompatibility as well. Finish Line's RBM surface undergoes completing surface treatment by citric acid, also compatible to live textures. 2. RBM CST Process Following years of experience in developing, engineering and industrial running of its aluminablasting-double-etching CST Process, successfully operated during several years for manufacturing hundred of thousands dental implants, Finish Line has entered the RBM processing as well, to contribute to the world spreading of this novel process and to allow its customers to benefit from it. The RBM CST Process as presently validated is detailed in the appropriate Finish Line documents and consists of the following main stages of the implants treatment: Washing from machining remains, including Ultrasonic Bathes and steam cleaning
Page 3 of 7 Calcium Phosphates Blasting for formation of surface morphology, using automatic blasting machine allowing uniform and repeatable blasted surface of implants After blasting washing Dissolution of the blasting media in diluted inorganic acid solutions not attacking Titanium Surface conditioning through replacement of inorganic acids by citric acid Ultimate washing, finally in Ultrasonic Bathe with DIW of high purity Air drying in clean room class 10,000 Quality control at all stages of the treatment, including on-line SEM-EDS control and periodical XPS and optical profilometry tests. The blasting media used in the Process is an apatite born Calcium Phosphate having approximate chemical composition of Ca 3 (PO 4 ) (Tri-Calcium Phosphate) with hardness estimated as 5 by the Mohs' scale of hardness, as compared to 9 for Alumina. The <300 μm particles of the apatite blasting media are presented on the microphotograph below: 3. RBM implants comparative tests In this chapter we present results of tests of Finish Line RBM implants, which show their full identity to RBM implants of leaders in the field. 3.1. SEM general view SEM (Scanning Electron Microscope) general view, magnificationx10 Lifecore Biomedical RBM Implant www.trycare.co.uk/techdata_p dfs/106.pdf Finish Line RBM implant Sample APA-S040912 Finish Line RBM implant Sample 0812-1a-gamma
Page 4 of 7 Conclusion: all three implants have gained identically clean micro porous homogeneous surface 3.2. SEM surface structure (morphology) SEM (Scanning Electron Microscope) surface structure (morphology) Lifecore Biomedical (*) Finish Line RBM Implants RBM Implant Samples APA-S040912 and magnificationx500 0812-1a-gamma, magn.x2000 Osstem(**) RBM Implant Magnification X 4000 2000 1000 Conclusion: all implants have identical surface, featured by intensively developed morphology with sharp boundaries, having no especial geometry (*)www.trycare.co.uk/techdata_pdfs/106.pdf (**)www.chirurgiaorale.altervista.org/ostem/ostem/rbm_reserch.pdf
Page 5 of 7 3.3. Roughness by optical profilometer Test's results of roughness measurement by optical profilometer, for Finish Line RBM implant, sample APA-P2-040912 Following are comparative results of the main roughness parameter Ra value, for dental implant surface of various companies: Company Lifecore Osstem Finish Line Implant RBM implant RBM implant RBM implant Source (*) (**) Above test results Ra, microns 1.3 1.3-1.8 1.9
Page 6 of 7 Test instrument or way of derivation Ra is calculated following the Lifecore web page definition: "Lifecore s RBM surface offers approximately 250% greater surface roughness (Ra) than a traditional machined surface", the last is roughly estimated as of 0.5 microns The Ra value as defined at the Osstem web page from the above profile image Veeco Optical Profilometer Conclusion: the surface of Finish Line RBM implants has homogeneous roughness with Ra statistical value of 1.9 microns, within a range declared as optimal by leaders in the field. (*)www.trycare.co.uk/techdata_pdfs/106.pdf (**)www.chirurgiaorale.altervista.org/ostem/ostem/rbm_reserch.pdf 3.4. Surface chemistry & purity 3.4.1. By SEM EDS Surface chemistry & purity of Finish Line RBM implants as tested by SEM-EDS (Scanning Electron Microscope and Energy Distribution Spectrum) Finish Line RBM APA-S-040912 0812-1a-gamma 0812-3a-beta sample identification: SEM microphotograph, magnification X500: EDS (*): Conclusion: SEM microphotographs show absolutely clean porous surface of the implants, while EDS chemical analysis at any point of the surface show regular chemical composition of Ti-Al-V alloy with no contaminations (*)The spectra were obtained from the random points on the surface as seen by the microphotograph, while absolutely identical spectra were revealed on any point of the tested surface. The high pick on the spectrum is responsible for Ti, the left small is responsible for Al, and the right small one for V. 3.4.2. By XPS
Page 7 of 7 Chemical composition of dental implants surface as tested by X-ray Photoelectron Spectroscopy (XPS) Company Finish Line Finish Line Implant RBM implant, sample APA- X-040912, top section RBM implant, sample APA- X-040912, screw section RBM implant Source XPS test for this research XPS test for this research Element concentration, atomic %, as defined at the measure point by XPS Ti O C Al V N Ca Zn Si P 15.97 17.41 54.47 55.76 22.05 21.37 Osstem (*) 0..2 60.5 02.2 2 2 0.0 2.0 2 0.2 0.2 Conclusions: 1.Main chemical components detected on the surface (Ti, O, C) are of identical level for both Finish Line and Osstem implants (Al and V at the Finish Line implant are on the usual level for Ti6Al4V alloy, while their absence in the Osstem case may point out on using of pure Titanium for implants' manufacturing). 2. Traces of Ca and P are remains of biocompatible blasting media (Calcium Phosphate) used in both cases. 3. Other negligible traces are common for both cases and constitute remains of materials used at various stages of the surface treatment process. 3.25 3.08 (*)www.chirurgiaorale.altervista.org/ostem/ostem/rbm_reserch.pdf 0.34 0.60 0.94 0.61 4. Conclusions. Finish Line customers may benefit from RBM implants advantages 1. The surface structure (morphology) of the Finish Line RBM dental implants, as exposed by SEM microphotographs, is identical to that of the leading companies in the field and is featured by highly developed surface porosity. 2. The surface roughness of the Finish Line RBM dental implants is well-defined and uniform. The main roughness parameter Ra has good acceptable value of 1.9 microns, which falls in the range of this parameter as declared by the leaders in the field. 3. The surface purity of the Finish Line RBM dental implants, as exposed by SEM microphotographs and checked by EDS-SEM instrument, is nearly absolute: no inclusions or contaminations are detected, any point of the surface is revealed to be pure Titanium alloy. 4. The surface chemical composition of the Finish Line RBM dental implants, as analyzed by XPS instrument, represents well acceptable values of the main elements usually found on the dental implants surface underwent blasting and blasting media cleaning, and is fully identical to that of the leaders in the field. 0.56 0.53 0.67 0.65 0.85 0 0.91 0