User Manual - ROE Dental Laboratory
Contents
1. At 1 MT PP001 MT HWO01 MT HHK24 MT MMH10 MT MMH20 MT MRH10 MT MRH2O MT LMK13 MT SMK13 MT DEOO1 MT GDN33 MT GDN50 Parallel Pin Hand Wrench Hand Key for Int Hex Connection Short Motor Adapter For Int Hex Connection Long Motor Adapter For Int Hex Connection Hex Ratchet Short Adapter Int Hex Connection Hex Ratchet Long Adapter Int Hex Connection Long Motor Key Adapter 0 05 Short Motor Key Adapter 0 05 Drill Extender Countersink for standard platform implant system Countersink for wide platform implant system Dimensions 3 20 2mm length 24mm length 10mm length 18mm length 25 30mm length 33 30mm length 16mm length 22mm length 30mm length 22mm length 28 70mm 3 75 4 2mm length 26mm 5 6mm length 26 8mm Material Stainless steel Stainless steel Stainless steel Stainless steel Stainless steel Stainless steel Stainless steel Stainless steel Stainless steel Stainless steel Stainless steel Stainless steel MT BT020 MT BT028 MT BT032 MT BT038 MT BT045 MT BT050 MT BT055 MT DI001 MT HHR13 MT HHRO7 MT RI030 Body Try in 2mm Body Try in 2 80mm Body Try in 3 20mm Body Try in 3 80mm Body Try in 4 50mm Body Try in 5 00mm Body Try in 5 50mm Implant Direct Indicator Long Hand Screwdriver for 0 05 H2. 56 Surgical Kit Description 58 Advanced Surgical Instrument Kit 60 Kit Contents 5 MIS offers general surgical instruments kit for two stage procedures Ongoing research and development efforts by MIS engineers and scientists have produced this kit to simplify common procedures and provide creative solutions for dealing with complex cases The surgical kit contains tools for implantation as well as spare places where drills can be placed according to the doctor s needs MK 0035 General Surgical Instruments Kit 1 Additional advantages of the surgical instrument kit The surgical kit is made of medically approved plastic The surgical kit can be fully sterilized using an autoclave with a temperature that does not exceed 134 C 273 F The surgical kit is small in size and therefore easy to store The modular trays represent the optimal solution in terms of cleaning decontamination and sterilization due to the absence of hidden surfaces The steam flow is optimized to maximize the elimination of condensation 9 Warning Damage to trays If the sterilization temperature is greater than 150 C damage on propylux components is to be expected Radel steel and silicone components may support repeated exposures to temperatures up to 180 C but the lifetime of the trays may be shortened When sterilizing cutting edges and the tray the use of inappropriate chemicals may damage the
3. MIS System Guide 2010 MIS User Manual MIS Corporation All Rights Reserved Published by MIS which reserves the right to modify the products described in this manual as well as to revise this publication at any time and without informing any person of such revision or change All rights reserved No part of this publication may be reproduced transcribed stored in an electronic retrieval system translated to any language or computer language or transmitted in any form whatsoever without the written consent of the publisher Questions comments or requests will be addressed promptly by contacting MIS specialists directly through our e mailing address service mis implants com MIS website can be accessed at www mis implants com This online site highlights current products and reflects all new discoveries and developments Note This User Manual is for educational use only MIS Implants Technologies Ltd produces an oral implant system that includes self tapping dental implants in a wide range of sizes These implants currently being used successfully worldwide provide a solution to partial and full edentulism All implants go through gamma irradiation and are supplied sterile specially designed tubes The implants are self tapping with threads designed to provide secure primary fixation and favorable distribution of the loading forces The MIS Implants system is manufactured from titanium alloys MIS Implant
4. The SEVEN implants are available in 330mm 3 75mm 4 20mm 5mm and 6mm diameters and 6mm 8mm 10mm 11 50mm 13mm and 16mm lengths Successful The SEVEN implant has a high success rate as a result of its advanced geometric design and new surface morphology Forgiving SEVEN is designed for implantation in a wide range of bone types and bone augmentation procedures Simple A specially designed final drill is supplied with every implant allowing a short and safe drilling procedure Easy Increased insertion speed is provided by a dual thread of 2 40mm combined with a self drilling capability Primary Stability The thread thickness changes from the apex to the neck with the same pitch improving the compression of the bone during insertion Micro rings on the implant s neck provide better initial stability by improving the interfacial shear strength at the crest zone Minimal Bone Resorption The surface roughness over the entire body the unique surface morphology together with the micro rings at the implants neck prevents bone resorption at the implant s neck Self Tapping SEVEN cuts its own threads during implantation minimizing friction generated heat Three spiral channels running the length of the fixture fill in with bone chips during implantation to improve integration 42 Length 6mm 8mm 10mm 11 50mm 13mm 16mm MF7 10330 MF7 11330 MF7 13330 MF7 16330 MF7 08375 MF7 10375 MF7 1137
5. During mechanical cleaning please ensure that the parts have no contact with the other parts to prevent damage After mechanical or manual cleaning all surgical appliances must be sterilized in an autoclave at a temperature of 134 C 273 F at a pressure of 315 Kpa for six 6 minutes Do not exceed the temperature of 134 C during sterilization It is not recommended to sterilize in hot air since you cannot gain adequate control over the temperature Do not sterilize rusty appliances Inspect for corrosion after sterilization 0035 Without drills MK IR35 With internal irrigation drills MK EI35 With external irrigation drills MT PPOO1 MT BT020 28 C Am MT BTO32 MT BT038 i MT BT045 1 MT BT050 MT BT055 MT DEOO1 eee MT DI001 i M Si MT HHR13 MT HHRO7 MT LMK13 5 MT GDN33 MT GDN50 R gt MT RIOSO PTA mei MT HMR10 e MT HWOO1 22 MT MRH10 TERNI MT MMH10 E MT HHK24 ccm MT MRH20 MT MMH20 60 The Surgical Kit Kit Contents Surgical Kit include tools that are designed specially for the step by step implantation process Correct preparation of the implant site ensures efficient and accurate installation The MIS surgical kit contains the following items S fun 0 ti hu
6. MET 19076 thread area ps KEE escofia cefsoafoeal Instrument VG Scientific Sigma Probe X Ray Source Monochromatic Al K amp 1486 6eV X Ray Beam Size 400 um Interpretation of Results No strange elements or traces thereof were identified This means that the surface treatment etching did not leave any undesired effects The implants were classified as normal based on the C Ti ratio Absorption of Serum Protein to Modified Titanium Surfaces a TIOS LL MACHINE BIOCOM M N Sela L Badihi G Rosen D Kohavi and D Steinberg The use of Titanium Ti implants is a innovative clinical procedure dentistry The absorbtion of biological molecules to the implant s surface triggers a sequence of events that can determine the outcome of this procedure Clinical data suggests that modified Ti surfaces play an important role in the success or failure of the implant Objective the purpose of this study was to investigate the interaction between Ti implants with different surface properties and serum proteins in order to find the optimal implant surfaces that may improve the osseointegration process and implant intake Materials amp Methods Ti disks 6mm in diameter with two types of surface modifications were compared Machined and Sandblast together with Acid Etched The disks were coated with mixtures of Human Serum Albumin conjugated with fluorescein HA
7. Packaging Implant Mountless Package Handling Make sure using physical and visual examination that the implant is of the right type and dimensions for the specific procedure for each patient MIS SE EN Screw Type INTERNAL HEX sseointegrated Dental Impla Fig 1 Open the box by pressing on the marked dotted line and remove the outer tube from the box Fig 2 Open the outer tube by pressing down on the lid and turning the tube counter clockwise Fig 3 Remove the inner tube from the outer tube Open the inside tube s cap on the end containing the implant and mount 108 Fig 4 Remove the implant label from the outer tube and use for tracking purposes Fig 5 Hold the inner tube so that the implant is on the top and open the cap Use one of the following three options to remove the implant from the inner tube Fig 6A contra angle hand piece Fig 6B ratchet wrench Fig 6C A hand wrench 110 Fig 7 Commence implantation procedure Fig 8 Open the other end of the smaller tube Remove the cover screw from the other side of the inner tube using the MT HHR13 key Fig 9 Attach the cover screw to the implant using the MT HHR13 key Cover Screw Inner Tube with Titanium Implant Final Drill Outside Tube 112 Templates MIS provides X ray transparencies for measurements and comparisons This helps th
8. This package contains 10 implants it can be used as stand or as drawer This packaging is designed for ease of use by the dentist and the distributor Mountless MIS BIOCOM and SEVEN implants are supplied without mounts These successful implants remain unchanged but are supplied without the blue mounts and are packaged in distinctive and easily recognizable boxes These boxes include pull tab for quick and easy opening and new titanium sleeve inside the tube for maximum sterilization This change improves the handling speed and safety of the implants The BIOCOM and SEVEN mountless implants have their own tools available as a set MK 0037 or purchased separately Taking the implant in and out of the tube Insertion of the adaptor Implant 104 For easy identification of implant diameter the cap of each outer tube is color coded as follows Implant diameter Implant length mm Implant platform Standard Wide Narrow OnePiece 105 Between the outer tube and the inner tube there are two stickers Printed on these stickers are the lot number the catalog number and the expiration date Catalog No 3 75x11 50 Type of implant amp connection MF4 11375 BIOCOM int hex implant dia 3 75 L 11 50mm Implant diameter amp length Lot 123456 el 2005 12 D 2010 12 Lot No Date of manufacture CE Mark Use by date 106
9. to motor Connection to ratchet Implant hex position Hex adapter O 2 10mm O 2 45mm Ratchet key MT MRH10 MT MRH20 MT NRH20 Motor key MT MMH10 MT MMH20 The Friction fit abutment assembly contents MT IE172 MT IE161 The friction fit extractors MT IET 1 standard wide and the MT IE161 narrow are specifically designed to separate the friction fit abutments from the implant The extractors are color coded Blue for standard abutments and Yellow for narrow abutments Int connection Int connection abutment extractor abutment extractor NP MT IE172 MT IE161 Extractor key The extractor key is the extractor of friction fit abutments from the implants Axis force activated on implant axis take out the abutment from the implant For standard wide implants Platform Switching Friction fit For narrow implants SOS Broken Screw Kit MT TF172 MT RT001 MT HW001 The SOS Broken Screw Kit has been designed to assist the surgeon during the delicate operation of removing broken screw SOS Broken Screw Kit MK 0041 SOS Tools These tools are recommended for insertion of the implant Thread Form MT TF172 1 Connect the retriever to the micromotor B Adjust the micromotor to low speed 15 25 RPM max torque and in reverse mode Retriever Hand Wrench MT RTOO1 MT HWOO1 e A Apply pressure with the retriever on the top
10. 4 Long term deleterious effects of implants on health The risks may include Inadvertent perforation of the nasal and maxillary sinus local and systemic infections perforation into soft tissue spaces and nerve injury Temporary conditions that might result from implant placement may include pain and swelling speech problems and gingivitis Long term problems may include nerve local or systemic bacterial infections and infections in susceptible individuals including those with body part replacement Existing natural dentition may be compromised by improper implant placement The following outline lists organ systems with corresponding pathophysiological problems that may influence risks a Cardiovascular failure Coronary artery disease Arrhythmias b Respiratory chronic obstructive pulmonary disease c Gastrointestinal Hepatitis Malabsorption Inflammatory bowel disease d Genitourinary chronic renal failure e Enducrine Diabetes Thyroid disease Pituitary adrenal disordes f Hematological Anemia Leukemia Bleeding clotting disorders g Musculoskeletal Arthritis Osteoporosis h Neurological Stroke Palsy Mental retardation 9 Important Warning Lack of adequate practitioner training is a major risk factor in the success of the implant procedure and might endanger patient health Therefore no implantation should be performed without prior adequate training from a certified instit
11. Do not drill without irrigation and do not exceed 47 Note Any procedure recommended by MIS cannot replace the judgment and experience of the surgeon BiOCOM Calculation of the gap between final drill tio and implant insertion depth Gap Biocom Implant Drills 3 30mm 2 80mm 0 2mm 3 75mm 3 20mm 0 3mm 4 20mm 3 80mm 0 4mm 5mm 4 50mm 0 5mm 6mm 5 50mm 0 6mm 14 Drills Drill Indications SEVEN Calculation of the gap between the final drill tio and implant insertion depth Seven Implant Drills 3 30mm 152 20 j3 20mm 3 75mm 22 80 3 60mm 4 20mm 3 30 4 10mm 5mm 4 10 4 90mm O6mm 5 10 25 90mm 13 Drills Preparation of the Fixture Site Marking Drill The Marking Drill is used for creating a reference point in the center ofthe ridge to mark the drilling location for further drilling The Marking Drill is usually inserted to a depth of 1mm without the use of force Recommended drilling speed is 1200 1500 RPM The Marking Drill supplied is 34mm in length and 1 90 mm in diameter Marking Drill MT TD110 Spade Drill Spade Drill has diameter of Recommended drilling speed 1200 1 9mm and sharp tip Spade Drills 1500 Rom The Spade Drill is 27 5mm are mostly used in Flapless procedures in length and made of stainless steel 76 Drills Preparation of the Fixture Site Pilot Drill The Pilot Drill is the first invasive drill th
12. MF4 13375 MF4 16375 MF4 11420 MF4 13420 MF4 16420 MF4 11500 MF4 13500 MF4 16500 MF4 11600 MF4 13600 All implants include the cover screw 34 Recommended insertion torque is 35 60 Ncm 3 30mm 1200 900 500 200 Drill Speed RPM 1500 1200 700 500 15 25 Diameter 0190 9 on 280 2280 0330 9330 Countersink MT GDN33 for bone type 1 amp 2 7 3 75mm 1200 900 500 400 200 Drill Speed RPM 1500 1200 700 700 500 15 25 Diameter 0190 22 on 8280 0320 0320 9375 0375 Countersink MT GDN33 for bone type 1 amp 2 by MIS cannot replace the judgment and the experience ofthe surgeon Y Any procedure recommended 35 Recommended insertion torque is 35 60 Ncm 4 20mm 1200 900 500 400 400 200 Drill Speed RPM 1500 1200 700 700 600 500 15 25 Diameter 01 90 Q2 G2 0280 03 20 03 80 03 80 420 9420 Countersink MT GDN33 for bone type 1 amp 2 5mm 1200 900 500 400 400 400 200 Drill Speed RPM 1500 1200 700 700 600 600 500 15 25 Diameter 01 90 2 Q2 0280 03 20 203 80 0450 0450 05 05 Countersink MT GDN50 for bone type 1 amp 2 36 Recommended insertion torque is 35 60 Ncm 6mm Drill Speed RPM 1200 1500 900 1200 700 700 600 600 500 Diameter 190 02 2 Countersink MT GDN50 for bone type 1 amp 2 0550 25 50 200 500 15 25 38 The MIS self tapping SEVEN implants ar
13. Perform a visual inspection Use approved agents only Dispose of damaged instruments Gees ee N Check ton Breakouts in blades compatibility Bent instruments Cleaning Corrosion Remove all residues Sterilization Use an ultrasonic bath Use anticorrosive cleaning agent Thoroughly rinse away cleaning and disinfecting agents with running water Use distilled water to prevent water spots All dental instruments should be sterilized Use only sterile packages The device is not sterile The device must be sterilized before use by autoclave at a temperature of 134 C 273 F Drying at a pressure of 315 Kpa for a 6 minute duration Do not exceed 134 C during sterilization Dry only with compressed air hot air absorbent paper tissue Storage Store in a dry dust proof area Keep instruments separated from chemicals 102 Implant Packaging 104 Implant Color Code 105 Sticker Description 106 Implant Mountless Package Handling 102 MIS puts great effort into providing end users with safe simple and up to date packages Our products pass very strict tests so that we can provide doctors with the best tools available The single implant package The implant package consists of three sections an outer carton containing the instructions an outer plastic tube and inner plastic tube We recommend that the instructions be read carefully Mountless package 10 Implants Package
14. implant surface as indicated by the various test results Light Microscopy Materials and Methods Micro CT The sample was analyzed by micro CT before histological treatment was analyzed by micro X ray micro computed tomography SkyScan 1072 Belgium The X ray source was operated at 100 kV and a current of 98 yA The sample was rotated 180 with a rotation step of 0 90 an acquisition time of 5 6 s per scan and a pixel size of 118 um Three dimensional reconstructions were then performed with the 3D Creator SkyScan software Histology Embedding Samples were fixed in a 10 formalin solution dehydrated in ascending graded ethanol 0 80 90 95 10096 and pure acetone and then impregnated and embedded in PMMA methyl methylmetacrylate The Polymerization was obtained with a temperature increase from 20 to 80 X ray microtography Results and Discussion The histotology and microscopy results show the following osseointegration contact areas between the bone and implant surfaces Light Microscopy Full osteointegration was observed Bone contact was achieved both in the front of the wire and at the top of the implant Bone ingrowth with bone trabeculae was also observed Micro CT Bone osseointegration was observed along all the 3D axes Bone trabeculae are directly in contact with the wires Conclusion In conclusion it appears that larger bone ingrowth and bone contact was observed
15. in the implants Overview 20 Implant System 22 UNO 30 BIOCOM 38 SEVEN 20 The MIS leading implants UNO BIOCOM and SEVEN A A A A UNO UNO BIOCOM SEVEN ONE PIECE NARROW MIS has developed range of unique implants and tools to assist in the simplification of the implantation process and to ensure both efficiency and success while minimizing risks The innovative design of our implants combined with our simple and fast insertion procedures provides an easy to use system that ensures successful results The wide range of MIS implant lines provides a variety of clinical solutions for the reconstruction of a single tooth screw retained or cemented fixed bridges and overdentures Furthermore MIS Note The selection of MIS implants and procedures is a recommendation only and cannot replace the judgment and the experience of the surgeon This recommedation shoud be used as a guide only implants can be used in any surgical and bone augmentation procedures from the simplest to the most intricate MIS implants are made of high quality materials under very strict quality control procedures with a 10096 inspection rate All MIS implants are made of biocompatible medical grade titanium and their surfaces undergo dual acid etching procedures Implants m Each of these unique implants is specifically engineered for use in narrow ridges and tight spaces The insertion of the UNO implant
16. is a quick and simple one stage procedure Due to their innovative geometries and advanced surface morphology these unique implants offer high primary stability These versatile implants can be used to restore single crowns and anterior cemented bridges UNO NARROW lt UNO ONE PIECE o e E EE mE Abutment with squared crown Deep threads 0 6mm Dual thread of 2mm Cutting Apex Two spiral channls Implant length Surface A acid etched B sandblasted and acid etched Maximum anguled position 10 0 6mm 1 2 3 4 5 6 2 External Hexagon 2 7 mm Deep threads 0 6mm Cutting Apex Two spiral channls Implant length Dual thread of 2mm Surface sandblasted and acid etched Features Versatility The MIS UNO is indicated for use in narrow ridges and tight places such as maxillary lateral and mandibular incisors The MIS UNO s versatility enables the clinician to use mono block screw type implant Especially designed for narrow ridges and tight spaces The geometric is encompassed in the unique design Bone to implant contact maximized Enables a fast thread form free insertion the implant for single tooth partial denture and over denture restorations Long lasting Due to innovative geometry and advanced and initial stability surface treatment the MIS UNO provides high initial stability and a long lasting restorative result Advantages Surface Simple The surface
17. what is involved and the influence of heavy smoking gt 10 day uncontrolled diabetes untreated periodontal disease and bad oral hygiene habits Step 4 Treatment Plan Patient cooperation The various treatment alternatives under consideration should be presented and explained to the patient i e complete removable prostheses retained by ball or Step 3 bar attachments screw retained fixed or X ray Examination removable crowns or bridges cemented Diagnostic measures crowns or bridges etc The final choice of treatment must be decided upon with Panoramic and tomographic radiographs should the patient It is important to obtain patient be obtained Vertical and horizontal approval of the treatment plan 52 bone shape and dimension and take into consideration both functional and aesthetic requirements The implant is supplied in a sealed and sterilized package An implant whose sterility has been compromised should not be used An implant in a partially opened or defective package should not be used Attention should be paid to the expiration date Step 5A Surgical Phase The shape size and lot number of the implant should be noted use the This stage must be done under a strict infection attached label Implant placement should control protocol Preoperative antibiotics are be performed in accordance with the recommended Routine blood tests should implant placement procedure described be performed an
18. 3 30 05 90 04 90 04 10 03 60 03 20 05 10 05 10 03 30 02 80 02 20 81 Drills Drill Cutting Capability Drilling Energy md Standard stainless steel MIS stainless steel Number of holes Test conditions Drill diameter 2 mm Test bench force transducer Piezo Drill speed 600 RPM drill feed obtained by DC motor Drill sed Opa controlled by displacement potentiometric transducer Drill material fiberglass Conclusion The MIS stainless steel drills with special sharpening have greater endurance and efficiency in drilling They minimize the heat generated during the Cutting action 82 Features of Ceramic drills include reduced vibration pleasant smooth operation and continuous substance removal whether used in implantology or oral surgery The MIS Ceramic drills are made of a high performance ceramic mix of partly stabilized yttrium and aluminium ceramic The mixture of these two established materials provides MIS Ceramic drills with an above average bending strength of 2 000 MPa In comparison the bending strength of zirconium oxide ceramic used among other things in the manufacturing of root posts is 1 200 Mpa Advantages Metal free biocompatible corrosion free MT CRD21 MT CRD20 MT CRD28 Marking Drill Pilot Drill Twist Drill 2 10mm 2mm 02 80mm Dimensions length 28 5mm length 33 5mm length 35mm Material Zircon dioxide Zircon dioxide Zircon dioxi
19. 5 MF7 13375 MF7 16375 MF7 06420 MF7 08420 MF7 10420 MF7 11420 MF7 13420 MF7 16420 MF7 06500 MF7 08500 MF7 10500 MF7 11500 MF7 13500 MF7 16500 5mm 3 implant wide platform MF7 06600 MF7 08600 MF7 10600 MF7 11600 MF7 13600 6mm p Screw type implant wide All implants include the cover screw and final drill platform 43 Recommended insertion torque is 35 60 Nem omm 1200 900 500 200 Drill Speed RPM 1500 1200 700 400 15 25 Diameter 01 90 02 Q2 0240 Q2 20 3 30 23 20 3 75mm 1200 900 500 200 300 Drill Speed RPM 1500 1200 700 400 500 15 25 Diameter 1 90 2 02 Q2 80 2 80 0280 83 75 03 60 03560 Final drill For bone type 1 amp 2 Countersink MT GDN33 For bone type 3 amp 4 Any procedure recommended by MIS cannot replace the judgment and the experience of the surgeon 44 Recommended insertion torque is 35 60 Ncm 4 20mm 1200 900 500 400 200 200 Drill Speed RPM 1500 1200 700 700 400 500 15 25 Diameter 0190 02 02 0280 03 20 0330 0420 04 20 0410 Final drill For bone type 1 amp 2 Countersink MT GDN33 For bone type 3 amp 4 5mm 1200 900 500 400 400 200 200 Drill Speed RPM 1500 1200 700 700 600 400 500 15 25 Diameter 1 90 22 02 0280 0320 380 0410 85 5 4 90 OR Final drill For bone type 1 amp 2 Countersink MT GDN50 For bone type 3 amp 4 6mm Drill Speed RP
20. M 1200 900 1500 1200 Recommended insertion torque is 35 60 Ncm 400 700 400 600 400 600 Diameter Final drill For bone type 1 amp 2 Countersink MT GDN50 For bone type 3 amp 4 1 90 2 2 0320 03 80 04 50 200 200 400 500 15 25 0510 06 26 05 90 OR 48 Indications amp Contraindications 50 Step by Step Protocol Indications Adequate bone is needed to support the implant with width and height being the primary dimensions of concern The obligatory bone dimension for implant placement in chosen site may be extracted for adequate radiological techniques used in implant dentistry In addition very careful evaluation has to be made as to the location of vital blood vessels nerves maxillary sinus soft tissue spaces and their relation to the site planned for implant placement Contraindications The contraindications customary in oral surgery with other implant materials should be observed These include patients taking corticosteroids anticoagulants or anticonvulsant and those receiving radiation or other Immunosuppressive therapy Lactating or pregnant women are not candidates nor are patients with abnormal laboratory values for BUN 48 creatinine or serum calcium Patients with diabetes or cardiovascular disease are contraindicated Hypertension above 110 170 mmHg osteoportic crush fractures respiratory disease thyroid or parathyr
21. S FITC Following incubation the coat was removed from the disks by SDS See eee II nun METTET A Albumin IGG Fibronectin Fibrinogen SEVEN A Confocal Scanning Laser Microscope was used to visualize and measure the HAS FITC coat and the degree of protein removal from the Ti surfaces Results The Confocal Microscope images revealed a significantly higher amount of HAS FITC coat on the rough disks as compared with the machined disks Furthermore under similar experimental conditions less HAS FITC could be removed from the rough disks than from the machined disks Conclusions Absorption of aloumin to the rough treated Ti surface is both qualitatively and quantitatively far more intense as compared with the machined surfaces Further studies of the chemical and physical characterization of the modified Ti surfaces are underway Moreover additional serum proteins as well as oral microorganisms are being examined for their interactions with the modified Ti surfaces Hebrew University Jerusalem Israel IADR August 03 2004 Overview 16 Overview Histology MIS implants undergo routine testing including histology and microsity tests in order to evaluate the amount and quality of bone integrated on the implant as well as other indications for osseointegration The osseointegration s success IS determined through the many contact areas of the implant surface The following report characterizes the MIS
22. at is used for preparation of the fixture site The Pilot Drill is used to drill to the desired depth and angle of implantation according to the implant length 8mm 10mm 11 5mm 13mm and 16mm Recommended drilling speed is 900 1200 RPM The Pilot Drill is important because it determines the initial drilling angle A parallel pin should be used to check the drilling angle When placing more than one implant place a parallel pin in each completed hole before proceeding to the next site Align the Pilot Drill parallel to the previous pin when available bone permits The Pilot Drill is 37mm long and 2 mm in diameter Pilot Drill MT TD200 Checking drill depth Implant site depth probe MT BTI10 After the implantation site is drilled it is recommended to check its depth and suitability to the required implant length The Implant Site Depth Probe MT BTI10 is used for this Made of stainless steel Drills Preparation of the Fixture Site Final The Final Drill is the last drill used before inserting the implant The choice of Final Drill is determined by the implants diameter The different diameters are 2 80mm 3 20mm 3 50mm 380mm 4 50mm 5mm 5 50mm The recommended drilling speed is 400 700 Rpm 700 Rpm for small diameter and 400 Rpm for large diameter 2 80mm 3 20mm gt 3 80mm SSS 4 50mm IL 5 5 50mm pm cm The Final Drills are standard drills used for standard
23. coholism any respiratory urinary gastro intestinal neurological hematological endocrine or other systemic disorders and patients taking bisphosphate medication as a treatment for osteoporosis mucocutaneus disorder It is recommended in cases with questionable medical histories to consult with the patient s general practitioner and or appropriate specialist before any surgical procedure dimensions of the implant site should be measured and charted The anatomical relationships of neighboring teeth and proximity to the anatomical structures such as the mandibular canal maxillary sinus and base of the nose must be evaluated Bone inclination and shape should also be taken into account Surgical guide with radioopage markers is recommended for the tomographic radiographs and for the surgery in complicated cases Step 2 Dental Conditions and Oral Hygiene A complete and thorough intraoral examination must be performed and recorded This must include an evaluation of the dentition oral hygiene smoking and patient attitude to oral health Implant procedures should not be performed on patients with active osteolitic periodental conditions active periodontal disease inflammatory or infectious areas at the implant site Extreme bruxing and clenching forces should be taken into consideration It should be emphasized that acceptance of a treatment plan that includes dental implants must be preceded by a detailed explanation of
24. d blood pressure and pulse on pages 20 43 checked emergenoy resuscitation apparatus should be available Premedication may be considered for an apprehensive patient or before extensive procedures The sale of this implant is restricted by law to licensed dentists This surgical procedure should only be performed by someone with appropriate training Initial planning is of the utmost importance dentist performing the prosthetic stage of the treatment should be an active participant together with the surgeon when making decisions affecting the choice of the implant the type of the prosthesis and the three dimensional positioning of the implant At this is a prosthetic driven procedure the Step 5B Implant Selection Choice of the correct MIS implant should be based on previous evaluations of 12 24 Step 6 Evaluating Osseointegration After a post operative integration period of 12 weeks in the mandible and 24 weeks in the maxilla the implants may be exposed Osseointegration is evaluated clinically in conjunction with radiographs Step 7 Restoration The final restoration is provided according to the treatment plan taking into account occlusal and aesthetic requirements MIS superstructures must be used for MIS implants Step 8 Follow up The follow up includes an annual check up including peripical radiograph re evaluation and patient education in maintenance and pedantic oral hygiene
25. de ceramics ceramics ceramics 83 Drills Drills Maintenance Correct and careful maintenance of MIS drills is extremely important Damage to drill tips can cause significant impairment of drill function The following are detailed instructions for proper maintenance Instructions for Maintenance of Drills Prior to First Time Surgical Use Stage 1 Light Cleaning and Rinsing Drills should be dipped in detergent rinsed and dried Stage 2 Sterilization Drills should be sterilized in an autoclave at 134 C 273 F at a pressure of 315 Kpa for a 6 minute duration Do not exceed 134 C during sterilization Stage 3 During Use Drills should be soaked in a sterile saline solution until the cleaning stage Instructions for Cleaning and Storage of Drills After Use Stage 1 Cleaning Drills should be brushed with detergent to remove any remaining blood or tissue Stage 2 Ultrasonic Cleaning Drills should be cleaned in an ultrasonic bath with appropriate detergent Note During ultrasonic cleaning contact between drills should be avoided Stage 3 Rinsing Drills should be rinsed under running water and dried Stage 4 Lubrication Required if more than 4 weeks of storage is expected Drills should soak for 10 seconds in dental oil then removed from the solution and left to dry for 30 seconds without rinsing or towel drying then placed in the surgical kit Stage 5 Sterilization Drills should b
26. e sterilized in an autoclave at 134 C 273 F at a pressure of 315 For a 6 minute duration Do not exceed 134 C during sterilization Stage 6 Storage Use At this stage kits are ready for long term storage drills can be used immediately upon opening the kit Recommendations Cutting tools should be used for a maximum of 30 drillings Sterilized water should be used in order to avoid surface stains Drills 86 Specialized Surgical Tools 98 Screw Tests 99 General Information 86 MIS provides a variety of surgical tools to assist the surgeon during the implantation operation The wide variety of MIS tools are specially designed with the purpose of facilitating a safe simple and short implantation procedure Torque wrench MT RI040 Features The Torque wrench is designed for tightening or loosening screws and for implant insertion It also ensures the optimal transmission of force during implant insertion The Torque scale ranges from 15 45 Ncm with an accuracy of plus or minus 5 The scale on the opposite side can be used as a reverse torque The maximal load as indicated by the scale on the wrench body should not be exceeded There is also a scale on the opposite side Advantages It provides a removal torque check before implant loading User Instructions 1 Connect the torque wrench A to the desired key 2 Place the torque wrench in the mouth 3 While
27. e specially designed for implantation in a wide range of bone types and bone augmentation procedures Their geometric design includes dual threads three spiral channels stemming from the apex micro rings on the implant neck and a changing thread thickness along the implant All MIS SEVEN implants are supplied with a single use final drill for reducing the heat produced during drilling which results in an improved osseointegration 99 245mm 0 1mm 240mm Standard wide 2 45mm Int hex connection Conical body Surface sandblasted acid etched Three spiral channels Domed apex Standard wide Dual thread of 2 40mm Micro rings 0 1x0 3mm zo o BE IBN 40 210mm 0 3mm Narrow 2 10mm Int hex connection Conical body Surface sandblasted acid etched Two spiral channels Domed apex Narrow Dual thread of 2mm Micro rings 0 1x0 3mm NO 01 BW 5 Leck Features The SEVEN implant is designed to suit a wide range of bone types and bone augmentation procedures A specially designed drill ensures short and safe drilling procedures A double thread of 240mm increases the implants insertion speed It has self tapping capability lt has three spiral channels for improved integration The micro rings 01x0 3mm on the implants neck reduce the shear stress in the crest zone The changes in the thickness of the thread 0 15 0 4 mm improve bone compression
28. e surgeon in the selection of the appropriate implant type diameter and length according to each individual case The following X ray templates are available 1 For BIOCOM implants Cat No MC BIOIN 2 For SEVEN implants Cat No MC SEVIN j U amp U 4 a i ef 07 ue ve ME A vi U All transparencies include a ruler 1 100 in mm and radiographic implant transparency scale of i 100 real and 125 113 Symbols Key to the symbols on labels and instruction leaflets LOT Batch code Manufacturer Catalog number Do not resterilize Single use Do not use if package is damaged Attention see instructions for use Authorised representative in the European community e Date of manufacture By prescription only STERILE R Sterilized using gamma irradiation ed R T Use by All rights reserved No part of this publication may be reproduced transcribed stored in an electronic retrieval system translated into any language or computer language or be transmitted in any form whatsoever without the prior written consent of the publisher Warning Only a licensed dentist should use these products eu LOcdN OW MIS Implants Technologies Ltd www mis implants com MIS s Quality System complies with international quality standards ISO 13485 2003 Quality Management System for Medical Devices ISO 9001 2008 Quality Ma
29. ex Short Hand Screwdriver for 0 05 Hex Ratchet Wrench 64 Dimensions 2 00mm length 28 5mm 2 80mm length 28 5mm 3 20mm length 28 5mm 3 80mm length 28 5mm 4 50mm length 28 5mm 5 00mm length 28 5mm 5 50mm length 28 5mm length 15mm length 22mm length 16mm length 75 Material Stainless steel Stainless steel Stainless steel Stainless steel Stainless steel Stainless steel Stainless steel Titanium Stainless steel Stainless steel Stainless steel 65 MK EI35 Advanced Surgical Kit with external irrigation drills MT TDN19 Marking drill 190mm external irrigation MT TDN20 Pilot drill 2mm external irrigation MT TDN28 Twist drill 2 80mm external irrigation MT TDN32 Twist drill 3 20mm external irrigation MT TDN38 Twist drill 3 80mm external irrigation MT TDN45 Twist drill 4 50mm external irrigation MT TDN50 Twist drill 5mm external irrigation MT TDN55 Twist drill 550mm external irrigation MK IR35 Advanced Surgical Kit with internal irrigation drills MT TD110 Marking drill 190mm MT TD200 Pilot drill 2mm MT TD280 Twist drill 280mm MT TD320 Twist drill 320mm MT TD380 Twist drill 380mm MT TD450 Twist drill 4 50mm MT TD500 Twist drill 5mm MT TD550 Twist drill 5 50mm MK 0035 Advanced Surgical kit supplied without drills 68 70 15 81 82 83 Use of MIS Drills Color Code Drill I
30. exerting finger pressure on the handle B turn the torque wrench slowly in a clockwise direction C until the desired torque is reached Material Stainless steel Sterilize before use in autoclave up to 134 C 273 F 134 C Sterilization The device is not sterile The device must be sterilized before use by autoclave at a temperature of 134 C 273 F and at a pressure of 315 Kpa for a 6 minute duration Do not exceed 134 C during sterilization 88 Implant site depth probe MT BTI10 u Bone depth 775 70 Bone depth RE Implant size 78 Features easy and accurate measurement ofthe an apical ball that ensures a fast tactile hole drilled in the bone this simple procedure examination of the cavity when checking helps define the optimal size of implant to implant length use in each case Dimensions 1 80 2 0mm length Depth of measurement 8mm 10mm 11 5mm 100mm 13mm and 16mm The depth probe includes The MIS general surgical kit MK 0035 contains several unique surgical instruments as well as tools that can be adjusted for direct connection to the implant Implant Direction Indicator MT DI001 This surgical instrument reveals the condition of a particular implant by showing the implant direction The implant indicator is connected directly to the implant and shows the direction of the implant The implant indicator contains groove marks indicating gingival
31. face Overview At 5 all of the following aspects have been considered Macrostructure The geometric design of the body and thread profile of the implant act to increase the primary stability and to distribute the axial forces of occlusion Microstructure The surface roughness and microgeometry of titanium are achieved by sandblasting and acid etching This process increases the surface envelope of the implant Blasted surfaces demonstrate more bone to implant surface contact when compared with machined surfaces This advanced geometric design and surface morphology are the factors that create successful implants Surface cleaning The implant surface consists of titanium oxide Ti O2 which can reach a thickness of 100 microns and is in turn covered with an additional one molecule thick layer of contaminants containing sodium silicon magnesium fluorine etc The cleaning process is multi staged in order to ensure the quality of the product The success of the implant is determined its geometric shape by its microscopic texture and its surface quality 13 Overview Overview Roughness Measurements Roughness or rugosity is a measure of the small scale variations in the height of a physical surface A rough texture allows the trapping of different elements and increase the envelope surface A high tendency for high roughness improves mechanical anchorage and increases the envelope s
32. heights each groove mark indicates 2 mm of gingival height Implant Direction Indicator MT DIOO1 90 MIS provides key designed specifically for the extraction of mountless standard or wide implants placed in very soft bone or in sinus lift procedures The key can be manipulated manually or with a ratchet The connection between the key and the implant is facilitated by means of a screw that attaches to the thread of the implant This allows for a firm for a firm connection between implant and key and for a safe and simple implant extraction Key Screw Hex adapter to Ratchet Implant Hex position A A The key consists of two parts the MT HMR10 MT HMRO5 body and the screw The key is composed of stainless steel It is recommended to dismantle the two key parts body and screw before sterilization Direct Hand And Ratchet Hex Key MT HMRO5 MT HMR10 Step Step B i EA A By Hand By Ratchet Tightening the screw to the implant Ratchet connected to top of the key in order to pull implant 92 Tools for Int hex Connection MIS provides two tools that connect directly to the implant hexagon and indicate the hexagonal location of the implant The upside that connects directly to the internal hexagon is 2 45mm for standard wide platform and 2 10mm for narrow platform The insection tools for implants are also suitable for hand ratchet and motor Connection
33. ing and has a unique wide thread design as well as tapered threads at the apical part Internal Hexagon 2 45 mm Cutting Flutes Domed Apex Surface sandblasted and acid etched Thread lead 0 8 mm Features The BIOCOM implants are self tapping with threads that are designed to provide secure primary fixation A wide range of restoration parts a Suitable for two stage implant procedures Available in 3 30mm 3 5mm 4 20mm 5mm and 6mm diameters and lengths of 6mm 8mm 10mm 11 50mm 13mm and 16mm See page 25 Surface The surface roughness and microgeometry of Titanium Alloy Ti GAI AV ELI are achieved by sand blasting and acid etching Blasted surfaces demonstrate more bone to implant surface contact compared with machined surfaces 32 Self Tapping Thethree cutting flutes are designed to engage the bone immediately during placement and ensure multi directional locking The tapping head cuts into the bone with far less friction due to the relief design of the cutting edge Length 4 20mm Screw type implant standard platform Gbmm Screw type implant wide platform Screw type implant wide platform 6mm MF4 06420 MF4 06500 MF4 06600 8mm MF4 08375 MF4 08420 MF4 08500 MF4 08600 33 10mm MF4 10330 MF4 10375 MF4 10420 MF4 10500 MF4 10600 11 50mm 13mm 16mm MF4 11330 MF4 13330 MF4 16330 MF4 11375
34. lity of the drill allows for up to 30 uses During drilling the temperature must not exceed 47 C Each drill has a podium on which the drill stopper can be locked in place Drill Stopper MIS provides drill stoppers that give the dental surgeon simple and accurate depth control The sleeves are available for standard implants in 8 10 11 5 13 and16mm with a different ring color for each diameter color coded drill matches sleeve color Fi Drill stoppers Hun IS _ OUT Proceeding IN Proceeding Laser mark Color code D LA N li T Depth Groove Internal irrigation uU n MT TD320 MT TDS20 Twist drill 3 20mm Pilot Short drill 2mm 70 Drills Color Code Color code is used for easy identification of drills or implants diameters as follows White Implant 26 Drill 5 05 50 12 Drills Drill Indications LS The calculation presented refers to the height between the actual drilling depth and the implants apex and shows the difference in length after final drilling This calculation is important for planning the drilling depth Geometrical difference between the drill s tip and the implant The diameter marking drill is used with continuous and out motion at the desired location on the alveolar crest as predetermined with the aid of radiograph
35. nagement System and CE Directive for Medical Devices 93 42 EEC MIS s products are cleared for marketing in the USA and CE approved
36. ndications Preparation of Fixture Site Drill Cutting Capability Ceramic Drills Drill Maintenance 68 Drills Using MIS Drills The implant placement procedure includes the use of several drills with different diameters and characteristics The great variety of drills offered by MIS provide drilling solutions for all the various stages and processes of the implantation site preparation MIS drills include drills with internal and external irrigation as well as conical and ceramic drills Most MIS drills are groove marked for depth control and are color coded for immediate identification of drill diameter All drilling is carried out under internal irrigation with saline Features MIS drills are designed to be used with all MIS implants The drills are available in 3 varieties In each diameter size there are drills with an internal irrigation hole without an irrigation hole and a short drill Each diameter is color coded and a different color is marked on the middle part of the drill The groove marks on the drills specify the depth of the insertion 6mm 8 mm10mm 11 5mm l3mm and16mm The short twist drills have a 6mm mark included MT TDS20 MTTDS55 for our line of 6mm implants The short drills will have marks at 6mm 8mm and 10mm The drills may be used for depths of 11 5mm with the mark being found at the junction of the color mark and above the 10mm mark All MIS drills have a 120 C cutting degree The sharpness and high qua
37. ndition before corrosion evaluation and is a determining factor in the electrochemical behavior of this alloy A study of titanium and its alloys demonstrated that the biocompatibility of metal implants was related to their electrochemical characterization The results showed thatthe presence of cells on metals led to an increase in the impedance and polarization resistance Rp values of the metals SEM micrographs and an equivalent circuit confirmed this behavior Modification of the surface by thermal treatment improves corrosion resistance as a protective titanium layer is formed on the surface Another quality that makes titanium uniquely suited to implants is that the titanium oxide layer is stable over a very large range of physiologic pH and therefore there is no release of free ions into the tissue Titanium alloys increase the mechanical strength by 30 40 over pure titanium 4 over pure titanium Titanium alloys increase the mechanical strength by 30 40 Overview Overview Finite Elements Test The finite elements method FEM provides additional information about implants Implants analysis by FEM is a test that is commonly used for the localization and prediction of mechanical system failures structure analysis enables the determination of effects such as deformations strains and stresses which are caused by applied structure loads The safety factor is calculated using the maximum
38. of the broken screw B While maintaining the pressure activate the motor This action should release the screw If the screw is still not released apply intermittent pressure on the screw i In the case of a damaged thread A The thread form has to be used carefully B Be sure to align the thread form parallel to the thread axe Thread in the clockwise direction and for every complete turn release the pressure of the thread form by turning it 30 in reverse direction and repeat D In instances where greater torque is in needed the hand wrench or ratchet may be used 98 Tensile test of dental screws 1900 Ti screw 2mm 1600 Gold screw 2mm 1400 1200 1000 Load N 800 600 400 200 0 02 04 06 08 1 12 14 16 Displacement mm Fatigue test of dental screw 1600 1400 Ti screw 2mm 1200 1000 Test conditions 20 screws 2 of titanium grade 5 Loading frequency 30Hz 800 600 400 200 0 1 E 03 1 E 04 1 E 05 1 E 06 5 E 06 1 E 07 Max force N Test results indicate that the fatigue limit ofthe tested screw is 530N andthe screw will not break even after 5 million cycles gt Number of cycles 99 Surgical Tools General Information The wide variety of MIS surgical tools requires several maintenance guidelines Instrument maintenance for surgical tools Disinfection Examination Immerse instruments immediately after use
39. oid disease should be excluded from treatment Patients with diagnosed malignanoy in the past five years and those with nodular enlargements tenderness or unexplained lumps or masses of the head or neck should not be treated Implanting procedures should not be performed on persons with active osteolitic inf lammatory or infectious processes in the implantation site The following outline lists the contraindications Debilitating or uncontrolled disease Pregnancy Hemophilia Granulocytopenia or other bleeding problems steroid use Prophylactic antibiotics Brittle diabetes Ehler Danlos syndrome OsSteoradionecrosis renal failure Organ transplantation anticoagulation therapy Unexplained hypersensitivity Fibrous dysplasia Regional enteritis Other Contraindications Conditions diseases or treatments that severely compromise healing including radiation therapy Poor patient motivation Psychiatric disorders that interfere with patient understanding and compliance with the necessary procedure Unrealistic patient expectations Unattainable prosthodontic reconstruction Inability of patient to manage oral hygiene Patient hypersensitivity to specific components of the implants Risks Risks associated with the surgical procedure fall into four broad categories 1 Immediate anesthetic and surgical risks 2 Psychological and psychiatric risks 3 Medical threats to long term retention
40. procedures When drilling the site they may be used as the last drill However in certain cases there may be an additional instrument used for final preparation of the site Use of a Final Drill is determined by the specific procedure according to bone and implant type Implant Length Options Short Long 3 30mm 28 4mm 37 5mm 3 75mm 28 5mm 37 6mm 4 20mm 28 7mm 38 7 5mm 28 9mm 38 2mm 6mm 28 9mm 38 2mm Drills Checking drill depth After the implantation site is drilled a check of its depth and suitability to the required implant length is recommended The Implant Site Depth Probe MT BTI10 is used for this aim 19 Drills Preparation of the Fixture Site Countersink MT GDN33 MT GDN50 The Countersink is used to widen the crest to prevent pressure on the implant s neck Depth marks of 3 75mm 4 20mm 5Smm and 6mm appear on the Countersink to indicate the suitable implant diameter The recommended drilling speed is 200 500 RPM Standard Wide MT GDN33 i MT GDN50 Drills SEVEN Special Final Drill A specially designed final drill is recommended for use in bone types 1 and 2 for 6mm 8mm 10mm 11 50mm 13mm and 16mm SEVEN implants in order to prevent pressure on the implant s neck The special final drill is supplied with every implant allowing short and safe drilling procedure The recommended drilling speed is 200 400 Rpm Final Drill for implant diameters G 5 4 20 03 75 0
41. roughness and microgeometry of Titanium Alloy Ti 6AI 4V ELI are achieved by sand blasting and acid etching Blasted MIS specially designed tools and simple procedure ensure a worry free restoration for the clinician surfaces demonstrate more bone to implant surface contact compared with machined Easy surfaces An innovative design with increased insertion speed making the MIS UNO an easy implant to insert Stability The MIS UNO design ensures maximum strength and stability for the implant and restorative parts Length Narrow essem UNO Ball Anchor Screws 21 10mm 11 50mm 13mm 16mm MO1 10300 MO1 11300 MO1 13300 MO1 16300 MO1 10350 MO1 11350 MO1 13350 MO1 16350 MO2 10300 MO2 11300 MO2 13300 MO2 16300 MB NR005 MB NRO15 MB NRO025 3mm 1200 900 700 Drill Speed RPM 1500 1200 900 15 20 Diameter 1 90 2 22 22 40 3 50mm 1200 900 700 400 Drill Speed RPM 1500 1200 900 700 15 20 Diameter 1 90 2 2 2 40 3 3 50 29 1200 900 700 Drill Speed RPM 1500 1200 900 15 25 Diameter 1 90 2 2 2 40 3 Any procedure recommended by MIS cannot replace the judgment and the experience of the surgeon 30 MIS BIOCOM implants are titanium cylinder screw type implants with an internal hexagon connection They are designed for both two stage or single stage procedures The implant is self tapp
42. s Technologies Ltd is vigilant about maintaining the high quality of its products as well as developing new products in the fields of dental implants abutments and surgical kit components MIS s Quality System complies with international quality standards ISO 13485 2003 Quality Management System for Medical Devices ISO 9001 2008 Quality Management system and CE Directive for Medical Devices 93 42 EEC MIS s products are cleared for marketing in the USA and CE approved Overview MIS concept D Introduction Raw Material Finite Elements Test Implant Treatment Implant Surface Roughness Measurements XPS Analysis In Vitro Test Histology Overview Overview Introduction MIS is dynamic high tech research and production company It develops and manufactures a comprehensive range of dental implants that provide long lasting successful solutions to partial and full edentulism The MIS Implants system combines several advantageous elements in order to achieve good primary stability and successful osseointegration The qualities that contribute to successful osseointegration have been determined by various researchers to include choice of raw material macrostructure microstructure and surface cleaning In this chapter we present these factors and others that have been considered and or included in the implants manufacturing process MIS upholds its high standards relevant to these factors through comprehensi
43. stress failure theory for ductile materials The stress limit is specified by the tensile yield strength of the material The benefits of FEM include increased accuracy enhanced design and better insight into critical design parameters The results of these tests show that the greatest stress occurs in the neck rather than the apex of the implant 4 7 Overview 10 Overview Implant Treatment Structure Raw Material A Roughness Macro amp Micro Titanium s rough surface provides many points for mechanical anchorage and increases the envelope surface by two to three times Subtraction Advantage degradation separation of the coating Sandblast 5 The combination of the two methods induces macro and microstructure that is optimal for cell adhesion Acid Etching MIS Surface Treatment S i Overview Implant Surface The contact surface of dental implant is very important aspect of the implant s long term success This phenomenon is known as osseointegration The opposing reaction of the bone to the implant is determined by morphology chemical composition load and the characteristics of the implant surface It is achieved by topography and morphology nano surface elements and bone reaction tests Weck EX 23 AS SEM image of the bone to implant inter
44. trays The trays have to be handled carefully to avoid any breakage Never use trays with broken areas Cleaning Procedure It is not recommended to use the following for appliances made of stainless steel Cleaning and disinfection agents containing high rates of chlorine Cleaning or disinfection agents containing oxalic acid It is not recommended to use the following for an appliance or a material marked by a color code Detergents and cleaning agents containing high rates of the aforementioned chemicals e Extremely high temperature during cleaning and sterilization of the product Please Note Please conduct a visual inspection of the appliances Do not use faulty and dull appliances Clean and disinfect such appliances separately Do not allow traces residue blood secretion tissue residue to dry on the appliances Always soak in the disinfecting fluid immediately after use Use only stainless steel dedicated detergents and strictly follow the usage instructions Rinse the disinfectants and cleaning agents thoroughly with water Do not store put away appliances that are still damp or wet Use only nylon bristle brush to remove accumulated dirt residue off the appliance Clean the cavities and hollow spaces thoroughly Clean excessively contaminated appliances using an ultrasonic bathtub Do not clean disinfect even in an ultrasonic bathtub or sterilize together appliances made of different materials
45. urface by two to three times 4 10 2 05 0 00 20 AFM Test MIS Surface topography Roughness Measurement The arithmetic average of the deviation Ra is the most commonly used measure for surface roughness The microgeometry of MIS implants meets the roughness recommended in the international literature Instrument Parthometer M1 MAHR Ra 2 2um Rz 14 6um Rmax 15um Lt 5 6mm Lc 0 8mm Pc 0 5 0 5 165 c 14 Overview XPS Analysis For surface analysis the samples were irradiated without applying any standardization procedure with monochromatic X rays Survey spectra The core level binding energies of the different were recorded with a pass energy of 100 eV peaks were normalized by setting the binding allowing the surface chemical composition to energy for the Cls to 284 5 eV For each of the be determined The atomic concentrations were screws one flat edge area marked as 1 was calculated using elemental sensitivity factors analyzed in the as received state only Table 1 XPS Atomic Concentrations for LOT 83 ege Joie v 4 A Mr7 19975 thread area Jaajon aoa 935 0 16 ES CER MF7 13375 thread area 2 2778 16 11 51 31 10 21 10 05 0 78 3 60 BET Table 2 Ti Oxide Thickness nm for LOT 83 Oxide Thickness nm MF7 13375 thread area 1 Table 1 XPS Atomic Concentrations for LOT 41903 means Tes 8 BEST A Jemen
46. ute Precautions 1 The implant is supplied for one time use DO NOT RESTERILIZE 2 Use of implant does not require any unusual preoperative antibiotic prophilaxis 50 The surgical manual is designed to provide an overview of the presurgical and surgical procedures applicable to the MIS dental implant system Successful implantation requires combination of several factors This step by step protocol is provided to ensure that the correct surgical procedures are followed Step 1 Patient Selection General medical history Patients must be carefully selected for surgery Medical histories should be evaluated for indications and contra indications Medical contra indications includes immunodeficiency or immunosuppressive treatment evolving or active malignancy or following head and neck radiation poorly controlled diabetes or other hormonal disorders blood dyscrasias and serious bleeding disorders recent myocardial infarction severe cardiac insufficiency and valve pathology general bone diseases affecting the jaws hypersensitivity to specific implant components psychiatric or personality disorders that limit or interfere with patient understanding and compliance Caution amp Additional Tests Caution and additional tests should be used in the following cases patients with preexisting myocardial disorders anti coagulant therapy arrythmias and valvular pathology auto immune diseases pregnancy al
47. ve examinations and tests The implant surface is tested and has satisfied or exceeded all requirements for implants The tests are carried out in some of the world s best known research institutions The main tests that MIS implants undergo are Mechanical test XPS Analysis Roughness Surface analysis SEM Cytotoxicity Sterility Torque removal value Histology Overview Raw Material All MIS implants are made of biocompatible medical grade Titanium alloy Titanium and its alloys are highly successful materials for the fabrication of dental implants because of their favorable combination of properties such as low specific weight high strength to weight ratio high modulus of elasticity very high corrosion resistance and excellent general biocompatibility The excellent biocompatibility and osseointegration Capabilities of titanium are related to a variety of favorable properties of the material and its surface including the following A dense highly resistant passive oxide film that protects the underlying metal from further oxidation and corrosion A very low dissolution rate of the oxide film and an extremely low concentration of charged titanium corrosion products Biocompatibility is a complex property that involves physical chemical biological medical and design aspects It is important to note that the corrosion resistance of the titanium alloy is directly related to the surface co
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