Document No.

: 01

Revised: 01/28/11

File Name: FDA Proposal

Design Verification Proposal

Food and Drug Administration
Submitted under guidelines established by 21 CFR 820.30

Analysis of Anaerobic Adhesives Role in Abutment Screw Preload Preservation

Team Abutment

January 28, 2011

Caitlin Devaney Rishi Kripalani Chris Riley Kevin Wilkins

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File Name: FDA Proposal

Report Title: Analysis of Anaerobic Adhesives Role in Abutment Screw Preload Preservation
Product: Adhesive Subject: Dental Implants

1. EXECUTIVE SUMMARY
One mechanism of failure for dental implants is the loosening of abutment screws by unthreading from the implant over time. This is believed to be the result of insufficient friction forces on the threading between the abutment screw and the implant. In order to alleviate this problem, greater friction must be applied in the event of unthreading. The effect of anaerobic adhesives will be investigated as a solution to this problem. A number of different anaerobic adhesives will be tested on sets of identical implant and abutment hardware. The samples will be set to the same preload and the adhesive will be allowed to cure. The screws will be removed and breakaway torque will be measured. The goal is to achieve the highest breakaway torque possible for the abutment screw which will indicate the highest resistance to screw unthreading. Most importantly, the search for a significant difference in breakaway torques serves as an indication of product lifetime extension.

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2. DESIGN AND DEVELOPMENT PLANNING

2.1. Introduction 2.1.1. For patients with a single missing anterior tooth, single dental implant restorations are a common procedure to alleviate functional and aesthetic concerns. Most dental implants are composed of three main components. These are the Implant, the abutment, and the crown. The abutment interfaces with the implant through several mechanisms. However, the use of a single titanium screw that provides sufficient axial force to retain the abutment is by far the most common type of retention mechanism. Most restorations are designed to be permanent; the crown is installed using a heavy duty dental cement to prevent motion of the crown relative to the abutment. The cement is difficult, if not impossible to remove without damaging the crown once the cement has cured. This poses a significant problem in the case of a loosened abutment screw, a complication which occurs in 5-10% of implant cases. The cause of the loosening of the screw has been cited as a result of cyclic mastication forces that can reduce frictional forces on the screw by reducing the normal force on the threads. 2.1.2. ln order to prevent loosening, the screw must be preloaded, providing an elastic retention force. It is important to establish proper preload forces on the screw. Otherwise, the lifespan of the product may drop severely. The preload is determined from the yield strength of the screw. It is best for the screw to be torqued such that it is stressed to 75-90% of the material's yield strength. This provides a maximum tensile force to retain the screw. Torque specs are provided by the manufacturers of implants. However, torque does not necessarily correlate to preload force. Small inconsistencies in surface finish can provide resistance to rotation of the screw, and thus inconsistencies in the preload force. There are currently several different types of abutment screws in use to combat this problem. Gold coated screws exhibit a lower coefficient of friction than titanium. These screws are also designed such that their soft coatings plastically deform and fill the gaps in the screw thread to provide more friction. This substantially increases the cost of the screw, and it has not been definitively proven to decrease the rate of failure. Teflon coated screws are also in use and are designed to allow

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the surgeon to achieve a more precise preload. The low frictional forces assist in installing the screw at the proper preload; however this property also makes it easier for the screw to unthread. 2.1.3. An issue in current technology of this application comes in the form of small variations in the surface finish and fit of the screws. The same property of titanium that makes it ideal for osseointegration (the porous oxide layer) increases friction on the surface of the screw threads. Because of these surface textures, torque measurements do not necessarily accurately reflect the preload. A high friction surface requires a higher torque to get the elastic deformation required. When dealing with a rough surface finish, torques that exceed shear recommendations may often become necessary. However, doing so creates a risk of breaking the screw. The ideal situation would involve a screw with little friction on installation, and great friction on attempted removal. 2.2. Problem Statement 2.2.1. A new technology is needed to prevent the recession of titanium abutment screw threading within dental implants of central and lateral incisors. Cyclic compressive loads from a lifetime of use can overcome frictional threading forces and consequently reduce the abutment screw preload. 2.3. Project Goals, Solution and Objectives 2.3.1. Our team goal is to find an adhesive that will exhibit a low coefficient of friction on installation of the abutment screw, and significantly increase the torque needed to break the screw loose. For the given application, mechanical testing is isolated from a biological environment. Thus, biocompatibility will not be addressed. 2.3.2. The design solution to be investigated involves the use of an anaerobically curing sealant that will provide lubrication of the screw upon installation. This will allow for more accurate preloading. After setting, the sealant should provide a significant increase in frictional force between the screwabutment interface to increase the force needed to loosen the screw. 2.3.3. The objectives needed to achieve the outlined goals include identification of appropriate testing methods, identification of a superior material currently not in use, the acquirement and fabrication of test samples, and the design and construction of testing apparatus.

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2.4.

Testing Justification and Overview 2.4.1. The test to be conducted involves the measurement of the breakaway torque of the adhesive at a constant preload. Finding the breakaway torque of the adhesive and comparing this quantitative data to the abutment and implant breakaway torque will help conclude whether or not the addition of the adhesive would be beneficial. This will also indicate whether the addition could handle more torque than the abutment and implant configuration alone. 2.4.2. Testing is required to verify that the preventative measure proposed has a measureable reduction in abutment screw torsion during installation. 2.4.3. If proven positive, the use of anaerobic adhesives during abutment fastening should be approved by the FDA as a preventative measure against loss of screw preload, creating a subsequent extension in product lifetime.

2.5.

Important Terminology 2.5.1. Osseointegration (n): connection of a structural medial implant to living bone without the presence of living tissue at the interface. Abutment (n): A component connecting the prosthetic dental implant to the crown, often correcting for shape and axial misalignment. Anaerobic adhesive (n): An adhesive that is kept in the uncured state by oxygen, as in air, and that cures in the absence of oxygen when exposed to metal ions, especially copper or iron. (ASTM standard D5363-03) Breakaway torque (n): the initial torque required to break the bonds, measured at the first movement between the nut and the bolt when unscrewing an unseated assembly. (ASTM standard D5363-03) Prevailing torque (n): the torque measured after the initial breakage of the bond measured at 180 degrees rotation of the nut. (ASTM standard D5649-01)

2.6.

Organizational Responsibilities 2.6.1. The responsibilities associated with this project must be addressed. In doing so, each individual will be accountable for a task that best matches their strengths and capabilities. Upkeep and revision of the experimental design, standard operating procedure and bill of materials will be addressed by

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Kevin Wilkins; progress tracking/scribing and report editing will be addressed by Chris Riley; project timeline and task organization will be addressed by Caitlin Devaney; and data collection and analysis will be addressed by Rishi Kripalani. 2.7. Document Tracking, Deliverables and Timeline 2.7.1. All submitted reports will be filed in PDF format on the group forum of the e-learning software platform used. This Modular Object-Oriented Dynamic Learning Environment (Moodle) provides a medium for transparent, reliable, and accessible documentation. Data collection will be stored in signed and dated lab journals until final publishing. 2.7.2. We aim to publish the project test results in Science Direct," a well known research paper database easily accessible by the general public. 2.7.3. The following is a brief summary of project milestones: MILESTONE Proposal submittal Bill of Material creation Attain Bill of Materials Testing begins Data collection complete Data analysis complete Report submittal COMPLETION DATE January 28th, 2011 February 4th, 2011 February 20th, 2011 February 23rd, 2011 February 28th, 2011 March 3rd, 2011 March 11th, 2011

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3. DESIGN INPUTS
3.1. User and Patient Needs The needs of the user (oral surgeon) generally include a sense of confidence in the product. The product also must interfere minimally in the already well-established procedure of installing the implant. For the new product to be successful it must increase the ease, efficiency, and reliability of the procedure. For the given application, the user requires a product that will lubricate the implant with minimal viscosity. The product must also be easily stored and have a long shelf life. As for the patient, the product must not fail over the course of its expected lifespan. This level of reliability would prevent the patient from additional pain, expenses and inconvenience. In case of the implant's failure, it would be beneficial for the patient if the product is easily removed. 3.2. Performance Requirements 3.2.1. The functional requirements of the product include a shear stress around 620 pascals per newton of force applied onto the tooth and a compressive stress around 20000 pascals per newton of force applied onto the tooth. Also, the adhesive used should have a viscosity between 10 to 25 mPa.s, and for the product to be anaerobic. 3.2.2. The service environment of the product consists of a metal on metal surface that is isolated from any biological fluid. The adhesive used must stand up to the temperature of the human body with minor fluctuations. 3.2.3. The testing of the product adheres to ASTM standards: D5363-03 Standard Specification for Anaerobic SingleComponent Adhesives and D5649-01 Standard Test Method for Torque Strength of Adhesives Used on Threaded Fasteners. 3.3. Design Input Assessment Plan Interviews will be completed with a patient and an oral surgeon directly and/or via email to determine that the design inputs are accurate reflections of reality. Also, numerous case studies dealing with the surgical procedure, abutment failure, and coated abutments and screws will be reviewed. Appropriate ASTM standards will also be studied to determine testing procedures and specifications that fit this application's design.

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4. PROPOSED SOLUTION
4.1. Conceptual Design Description As stated earlier, the main issue concerning the loosening of abutment screws originates with the screw-abutment interface (titanium is commonly used for both components). Too much friction at this interface results in resistance on the screw threads during pretorqueing, but not on the screw head. As a result of these nonuniform torsional forces the head tends to experience shear, and the observed pretorque measurement is often inaccurate. This then poses the risk of abutment screws loosening, as the observed pretorque measurement is larger than the actual amount. Thus, it appears that the screw has been properly installed with enough force used to hold it properly in place when in fact the force that has been applied is less than is needed. Loosening of the abutment screws cause dental implants to fail, often leading to inconvenience and high costs paid by the patient. However, there is a solution to this problem. Reducing the friction within the screw-implant interface would allow for reduced resistance on the screw threads and would thus allow for a more uniformly applied torsional force to the screw. This would both yield a more accurate pretorque measurement and would reduce the amount of shear stress experienced by the screw head. To both reduce the frictional resistance on the screw threads and hold the screw more securely in place after the dental procedure is conducted, a polymeric adhesive may be applied to the screw threads. The adhesive used will act to lubricate the screw-implant interface prior to curing, as well as hold the screw firmly in place after it has hardened. 4.2. Design Performance Applying a polymeric adhesive to the screw-implant interface will provide a lubricating surface while the screw is being installed. After this, the adhesive will begin to cure. The addition of the adhesive will prevent future loosening of the screw after the procedure, increasing the lifespan of the implant. In implementing this solution, it will be necessary to find an appropriate material for use in the dental procedures. Many epoxies are already in use in the dental industry. Some applications include the adhering of braces, crowns and other implants to a patients teeth, jaw bone and soft tissues. For the environment associated with the stated application, the material used must abide several functional requirements. The adhesive must cure anaerobically and allow enough time prior to curing for the screw to be installed. The adhesive used must have moderate tensile and

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compressive strength as the screw will be subject to shear, compressive and tensile forces. Such implants will undergo cyclic loading caused by chewing. This constitutes the need for a material with a fatigue strength large enough to minimize its deterioration over time. In addition to these requirements, the adhesive used must have a service temperature greater than that which may be experienced in the human body. Upon reviewing these requirements, it becomes clear that a polymeric epoxy would be well suited for the given application. Epoxies have service temperatures above that observed in the human body. Also, many have adequately high yield and compressive strengths. Epoxy resin, for example, has a Youngs modulus of 2.35 to 2.47 GPa. This is well above the levels of stress that would be experienced by the adhesive. Many dental epoxies rely on the exposure of ultraviolet light to cure. This property is owed to the presence of photoinitiators commonly found in Bis-GMA dental composite resins. Because of this, it would not be difficult to find an epoxy with which the amount of time between implementation of the abutment screw and curing of the epoxy could be controlled. The need for an anaerobic adhesive fits the application well. Anaerobic epoxies are often used to secure screws, as well as other joints in a number of industries. Knowing this, focus then shifts to find such an epoxy that is biocompatible. 4.3. Patient Safety Assurance In order to ensure the patients safety and the continued success of the implant, the use of biocompatible materials is essential in most dental applications. In abiding this requirement, the abutment screw adhesive must be safe for use in the body. Luckily, modern dentistry already boasts a number of safe, dental adhesives. Among these are composite resins, commonly composed Bis-GMA monomers. While early composite resins were quite prone to failure due to a lack of strength, improvements throughout the 1990s improved the mechanical properties of the adhesives to extents adequate for use in dental implants. This was due to the inclusion of dentin primers. In addition to the reduced risk of failure, much of the mass in composite resins consists of inert materials. Allergies to composite resins are rare, as well.

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5. DESIGN VERIFICATION PLAN

5.1. Design of Experiment 5.1.1. This experiment will determine the effect of polymeric adhesives on the breakaway torques for titanium implant abutment screws. The adhesives tested include: BIS-GMA, PMMA, Compound Resin, and Loctite 290. This experiment will test a number of single implants sets, composed of the implant, the abutment and the abutment screw. Each implant will be installed and bonded to a common medium. Each adhesive will be tested in addition to a control group of dry screws. There will be five samples for each group. 2 L of adhesive will be applied to each of the implant theads shortly before installation of the abutment screw. The screws will be tightened by hand until contact is made between the head of the screw and the top of the abutment. Each screw will be turned the same number of revolutions to ensure that the same preload is applied to each screw. The installation torque will be recorded. The samples will then be allowed to fully cure for a period of up to three days. After the curing period is complete, the bolts will be removed and the breakaway torque will be measured. 5.1.2. The preload will be kept consistent by keeping the elongation the same. This will be achieved by setting the angle of all screws to match the angle of the control screws that are torqued to manufacturer specifications. 5.1.3. Removal torque is the output variable. It is expected that the increase in removal torque for the experimental samples will be in the range of 1-10 N.cm more than the installation torque specification. 5.1.4. Due to the narrow time frame and budget for this project, the study will be conducted only once. 5.2. Sample Description 5.2.1. The equipment used will be titanium alloy external hex implants, corresponding titanium abutments, and screws from Nobel Biocare. 5.2.2. The hardware in each of the abutment assemblies will be identical. The volume of adhesive will be the same for all

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samples, except in the case of the control in which there will be no adhesive. Each test will include five samples. 5.3. Test Procedures 5.3.1. The following ASTM standards will act as experimental guidelines to ensure the accuracy of measurements within material property variability: D5363-03: Standard Specification for Anaerobic SingleComponent Adhesives D5648-01: Standard Test Method for Torque-Tension Relationship of Adhesives used on Threaded Fasteners (Lubricity) D5649-01: Standard Test Method for Torque Strength of Adhesives Used on Threaded Fasteners F602-98a: Criteria for Implantable Thermoset Epoxy Plastics 5.3.2. The procedure, based on the standard D549-01, involves curing and any planned environmental conditioning. The torque strengths will be determined as follows: The bolt head is secured in the clamping device and the nut unscrewed at a speed of less than ten revolutions per minute. The breakaway torque will then be recorded, along with the prevailing torque as measured from a direct reading. The latter will apply only if a torque wrench is used. 5.3.3. Two assumptions made suggest that the proportionality of torque to preload is a continuous function, and the backing off of screw threads is the primary mechanism of failure. 5.4. Equipment 5.4.1. Testing will require accurate and precise measurement of torque. A calibrated electronic torque wrench will be used to measure the values needed to the precision required. 5.4.2. The data collected will be a breakaway torque measured to 0.1 N.cm. 5.5. Analytical Techniques 5.5.1. The variability between tested adhesives reduces the overall precision in the experiment, limiting the analysis to a confidence level of 95% ( = 0.05). 5.5.2. A one-way analysis of variance (ANOVA) will be used to determine significant variations in mean differences of prevailing and break-way torques of abutment screw fastening

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systems. In addition, direct comparison of mean differences will be created using Tukeys studentized range test. This test will highlight the superiority of certain anaerobic adhesives to the control (no adhesive). 5.5.3. The most relevant value to collect is the loss of preload through any abutment screw torsion during the initial installation. By measuring the difference between the installation and breakaway torques of each fastening system, the efficiency of each systems installed preload can be compared directly. 5.6. Contingency Plan Under the condition of limited supplies and /or time, the experiment will be adjusted to reflect the loading concepts of the implant improvement under simplified conditions. Firstly, if unable to obtain titanium abutment screws and/or implants, metal nut and bolt assemblies of separate materials will be constructed to mimic the conditions of threading and loading of the titanium abutment-implant environment. In the event of limited or insufficient time, the cyclic loading tests within the experiment can be omitted. This aspect can be omitted because the success or failure of the short-term preload testing can be extrapolated to the long-term reliability of the adhesive. This falls under the assumption that receding threads cause the lifespan of the implant to decrease.

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