What is the CE Mark? Today, medical devices, including orthodontic attachments, cannot be placed on the Western European market unless they bear the CE Mark. CE is an abbreviation for “ Conformité Européenne”, French for “European Conformity”. The CE mark appears on products that meet the safety standards that apply to all the countries of the European Union (EU). The European Union’s mandatory directives-MDD/93/42/EEC (Medical Device Directives, in short, Directives) govern the regulations applicable to all medical devices placed on the European Community (EC) market, facilitating the free movement of goods (and services) within its territory.
___.Products bearing the CE mark can be traded freely throughout the EU without further modification or testing. In order to gain such a mark, a device must pass a regulatory assessment determining whether it is in conformity with EU (European Union) requirements. In addition, the medical devices sold within the EU must meet the health and safety requirements. The Directives consolidate regulatory requirements in EU member countries under one system, meaning that if a device can be sold in one country, it is approved for sale in all EU countries. The Directives do not state whether the product should be for single use or re-use. If the reprocessor of a single-use device, labeled as such by the manufacturer, wishes to re-use it, the EU directives say that such re-use would render the re-processor a new manufacturer. In reprocessing the device, the reprocessor becomes subject to the same Essential Requirements of the Directives as the original manufacturer. A new CE mark would need to be applied to the reprocessed device. Furthermore, all obligations of the manufacturer would fall to the reprocessor that becomes thus a manufacturer (Ortho-Cycle Co. is, according to Florida Statute 499, a manufacturer since 1998). These obligations include tests for biocompatibility, sterility, quality control, documentation and traceability, and the reporting of adverse events. The regulatory system established by the Directives is applied with the help of accredited certification bodies. Their relevant expertise ensures that the conformity assessment procedures are followed, and that the devices conform to the relevant essential Requirements. These requirements change with the changing “State-of-the-art” of the domain, forcing manufacturers to improve their devices, when medical progress has been made1.
Should we have gotten it? Ortho-Cycle is a company though which a clinician can buy, sell and renew orthodontic attachments such as brackets, bands and tubes. The processing is based upon their cleaning (adhesive removal), inspection and sorting. A decade since the Food and Drug Administration (FDA) accepted its reprocessing and three years since its ISO 9002 certification2, Ortho-Cycle had to choose between ignoring the Directives and disregarding the CE Mark Certification, or accepting to be thoroughly tested on its compliance with the European demands. Its activity may have been legally acceptable even in the first case, as according to the Directives3 , a device is not refurbished when it is subject to:
___.- Normal repair and maintenance activities;
___.- Repair or replacement schemes
___.- New items repaired before sale or supply
___.- Refurbishing of a medical device by the user for his use
___.-Sale or supply of device, which have already been on the market, including those where
___. some repair and/or maintenance, is necessary to regain their operational condition.
___. In contrast, a fully refurbished device is one, which is placed on the market when it is completely rebuilt or made as new from used devices and is assigned a new useful life. According to the Directives, refurbishing involves:
___.- Stripping into component parts or subassemblies;
___.- Checking the suitability for re-use;
___.- Replacing components or subassemblies not suitable for re-use;
___.- Assembly of reclaimed and/or replacement components/subassemblies
___.- Testing of the assembled device against either the original or revised release criteria
___. As it is easy to see, by cleaning (adhesive dissolution) and by finishing the attachments’ surface with the help of centrifugal barrel tumbling (a method used by all orthodontic manufacturers), Ortho-Cycle’s reprocessing cannot be equated to refuirbishing, or even less so to “fully refurbishing”. Even if it would repair the attachments, which it doesn’t (only the acceptable attachments are selected), Ortho-Cycle’s reprocessed attachments couldn’t have been considered “fully refurbished”.
___.To pass this ultimate test, Ortho-Cycle has appealed to NIOM Certifications from Haslum, Norway. A division of the reputed Scandinavian Institute for Dental Materials that includes in its staff specialized scientists such as Arne Hensten- Pettersen (Director), Margret Rosa Grimsdotir, Heidi Kerosuo, Anette Kullmann, Erik Kleven, all well known though their studies published in American Journal of Orthodontics and Dentofacial Orthopedics, The Angle Orthodontist and elsewhere. While all the other orthodontic attachments reprocessing firms, and even many newbracket manufacturers didn’t bother, Ortho-Cycle Company has met the requirements of all of the following standards: 93/42/EEC (CE Mark), ISO 9002, BS EN 9002, ANI/ASQC Q9002-1994.
Is the CE Mark a proof of quality? With the introduction of the Directives (4-6), the Essential Requirements for industrial goods to be placed on the European Communion market changed significantly. In the past, goods other than medical devices could be CE marked as soon as their safety was established. However, the new Essential requirements asked for proof of device’s performance, as declared in the manufacturers labeling. Thus, the performance of a medical device became a legal pre-condition for application of the CE mark. As a result, the performance of a medical device now has to be demonstrated, documented and clinically evaluated, and the risk to benefit ratio assessed. This new development has lead to a quite clear distinction between the value of the CE mark applied to medical devices and CE marks applied to other industrial goods. Whereas non-medical devices only need to be safe and do not actually have to work, medical devices bearing a CE mark according to the Directives need to be both safe and effective. These legal requirements for medical devices are equivalent to quality aspects, which means that the CE mark on medical devices is de facto a quality mark. The European Commission, national Competent Authorities (CAs), manufacturers and consultants all agree with the conclusion that CE-marked medical devices are “good” devices4, “the ethical problems associated with the re-use of medical devices can be considered within the conventional triangle of benefit, risk and cost. There are few reasons to believe that the benefit to a patient from a properly refurbished device will be any less than that to be expected from a new device. The central issue is the balance between possible attributable risks of refurbishing the re-used device and the possible advantages in terms of cost”.
___.From the cost point of view, in Ortho-Cycles’s case, a comparison of the price of high quality, new attachments (minimum one dollar) versus that of their recycling (maximum 30 cents) is significant. In general, according to the Directives, orthodontic attachments are considered to present a medium risk (Class IIa): a counsel for the American Association of Orthodontists (AAO), has shown that “even if a bracket could become detached and the patient could swallow it, this will not result in an injury to the patient”5.Later, in response to a NBC-TV broadcast, AAO’s President, Dr. D. Poulton, has stated, “these brackets are safe and effective” 6.
References
1. NIST GCR 01-815, A Guide to the EU Medical Device Directive, Web Site http://www.newapproach.org
2.Kuftinec M, Matasa CG, ISO 9002 Certification, Am. J. Orthod. Dentofac. Orthop. 2000; 118: 583-585
3.Recommendation NB-MED/2.1/Rec5, Council Directives 90/385/EEC, 93/42/EEC and 98/79/EC
4. Hill R, The Regulatory Affairs Journal (Devices) (http://pjbpubs.co.uk/raj/). According to a Policy Conference at the European Heart House (Ryden L, European Heart Journal (1998) 19, 1628-1631 Policy Document Re-use of devices in cardiology, Proceedings from a Policy Conference at the European Heart House, 5-6 February, 1998
5. Bowers SA, Legislation and legislation update, Recycled brackets, Am/ J. Orthod. Dentofac. Orthop. 1993: 103: 194-195
6.AAO Annual Report, 1997-1998.
Brackets’ shape influences friction
___.In our previous studies we have shown that most research on the sliding mechanism were focused on the materials of which the bracket and the wire are made. The highest friction, however, is generated by the interaction elastomer-metal, as the coefficient of friction of the latter is some ten times larger than the others. While some manufacturers have understood this, creating brackets such as Shoulder by GAC, or Synergy by RMO, there are others who seem to disregard it. The purpose of this study is to relate bracket shape with the friction generated by the elastomeric ligature.
___.Most research have concentrated on the friction generated by hard materials, avoiding the influence of the elastomers. Thus, Stoner’s article1 shows that “Because of appliance inefficiency, sometimes applied force is dissipated by friction or improper application and it is difficult both to control and determine the amount of force that is being received by the individual tooth”. The same feeling is shared by Meling et al.2: “Ligation with elastomeric or stainless steel ligatures creates additional frictional forces, the significance of which is difficult to forecast as they depend on the material used”. Bazakidou et al.3, after showing that the highest frictional forces exhibited by the system elastomer/ stainless steel were 95.8g + 28.4 for the arch wire 0.016” x 0.022” and 83.7g + 17.8 for the 0.017” x 0.025”, noted that “For all brackets, there was no trend noted between mode of ligation and friction”.
___.This study has as ita purpose to demonstrate that various shapes of the edgewise brackets lead to significant variations in friction due to the way these are elastomer-ligated.
Materials and methods
___.The method and installation used was the same as in our previous studies4.In these, we have shown that it is possible to measure static friction by equating friction to the deadening effect produced by a wire sliding through the couple bracket-elastomer. In this installation, an end of a spring was solidly attached, while the other was attached to a hook to which weights were attached.This lower, mobile end had a pointer sliding along a graph. The wire was forced to slide vertically through various brackets which were ligated or not. In this way, a deadened scale was generated in which the bracket, ligated or not, was the brake. Each bracket was tested at least five times, with and without ligature, and the distance read on the scale (mm) versus the weight (g) was recorded. The difference between the two almost parallel lines obtained was marked with F (gr) and represents additional friction caused by the ligation.
 |
___.Only upper (U) and lower (L) stainless steel central brackets with similar under-the-tie wing perimeter (P) were selected. These exhibit the largest differences in shape, as shown in Table I and Fig.1a & b to Fig.10 a & b). All were thoroughly cleaned, as was the straight stainless steel wire used (American Orthodontics, 0.0215"x 0.028"). The elastomeric modules were new and made by American Orthodontics (Memory die-cut chain, gray, short, code 854-253).
___.In the attempt to relate the bracket shape to the friction these oppose when ligated, several characteristics were measured. While the perimeter P of the module stretched around the bracket, in the absence of the wire, could be measured directly (with the help of a caliper), two other characteristics had to be measured indirectly. For the purpose we used enlarged photographs or flat virtual images (as shown on a computer monitor, see our previous studies5). The angle a, formed by the stretched module above the wire, see Fig. 11, was measured with a protractor on the virtual image. The distance D (between the upper edge of the wire while at the bottom of the slot and the highest points of the under-the-tie-wing area), was measured in the same way, i.e. by reporting the height of the real bracket to the virtual one. The under-the tie-wing perimeter, 2(L + W), was measured with a caliper and noted with P.
___.While measuring the friction, irregular, discontinuous sliding of the wire was often found. Such discontinuities can be easily felt even during the manual sliding of the ligated bracket along the wire. One of these was observed by examining the bracket sidewise under 10x. The die-cut module, having a rectangular section (sharp edges) can be dragged into the gap formed at the contact point of the wire with the slot wall. Some of these gaps, which act like traps in which the modules are caught, are intentionally made to enhance the wire insertion. Brackets exhibiting significant dragging were not tested. The second source of discontinuities is caused by tiny particles of elastomer which detach from the module and adhere to the wire.
Results
___.To limit the influence of additional tension in the module generated by larger under-the-tie-wing perimeters, only smaller, central brackets were used (P varying between 3.3 and 5mm). The brackets tested are shown in Fig.1 a, b to 10 a, b; Table I shows their corresponding brand, line and tooth (U for upper, L for lower). The same table shows the value of the measured friction F (gr), the angle a (degrees), under-the tie-wing perimeter P (mm) and distance D (mm). The variation of F with a and D are shown in Fig.12 and 13.
Discussion
___.While Fig.12 and 13 show only a lose dependence due to the reasons explained above, both indicate that friction is influenced the bracket shape, and especially by the distance between the bottom of the slot and the highest point of the under-the-tie-wing, Fig. 14.
___.The importance of friction on the sliding mechanism, is still controversial. While some considers its influence as insignificant, other con-sider it important.
___.Insignificant. ”Tests of a limited sample of stainless steel arch wires and brackets typically used in sliding mechanics revealed that frictional resistance was effectively reduced to zero each time minute relative movements occurred at the bracket/arch wire interfaces. Factors such as the degree of dental tipping, relative arch wire/slot clearances, and method of tying, did not have a measurable effect on frictional resistance in the simulated dynamics of the oral environment"6. Our previous work was considered in no way of emulating the dynamics of the oral cavity, being misleading: “Failure to do this by many investigators in the past has produced a total misconception as to the part friction may or may not play in “sliding mechanics”7.
___.Highly important. In engineering, repetitive “minute relative movements” bear a dreaded name, fretting. Entire symposia, especially in aeronautics, are dedicated to their destructive effects on closely joint contacts and cables8. A NASA study states: "The fretting of steel against steel started with coefficients of friction between 0.60 and 0.70. This was followed by... a reduction in the coefficient of friction to between 0.53 and 0.61. An essentially stable coefficient of friction was reached after approximately 20 cycles, giving values that rose slowly to between 0.58 and 0.65 at 300 cycles"9. Recent research in orthodontics10 show for the coefficient of friction in fretting similar, high values: "Implementation of the centered positioning method resulted in a friction force ranging from 0.89 N to 0.97 N at a 200 µm displacement amplitude and 1 Hz frequency, corresponding to a coefficient of friction ranging from 0.45 to 0.49... When the centered positioning method was not used, significantly higher values for the coefficient of friction were found for both bracket-wire combinations". According to engineering handbooks11, the static coefficient of friction for steel on steel (clean) is 0.58 (compare with that of rubber/elastomers on solids which is between 1 and 4, the highest known!).
While this experimenter has no clinical background, he belives that, even if not closely duplicating the phenomena occuring in the mouth, static analyses of friction of the materrials involved can provide useful clues to their understanding.
Conclusions
___.From all materials, elastomers exhibit the highest friction (Fricare, Latin for “to rub”), and the brackets are the instrument through which it is applied. It increases whenever the module is overstretched (wide under-the-tie-wing perimeter) and/or exerts a pressure over the wire (sharp angles). The last condition results from larger distances between the bottom of the slot and the highest point of the under-the-tie-wing ligating area.
___.Separated, die-cut ligatures are an important source of friction as these may drag the elastomer between the wire and the slot wall. This phenomenon typically occurs at the insertion end of the slot which is often chamfered. In contrast, interconnected (raised above the slot entrance)and round modules have less chances to be entrapped, and thus to increase friction.
___.While still disputed, fretting, or the repetitive “minute relative movements”, are different forms of a phenomenon which can cause serious problems by over soliciting the anchorage.
References
1. Stoner MM, Force control in clinical practice, Am. J. Orthod. Dentofac Orthop. 1960; 46: 163-8
2. Meling TR, Odegaard JM, Holthe K, Segner D, The effect of friction on the bending stiffness of orthodontic beans: a theoretical and in vitro study, 1997; 112: 41-9
3.Bazakidou E, Nanda R,Duncanson MG, Jr., Sinha P, Evaluation of frictional resistance in esthetic brackets, Am. J. Orthod. Dentofac Orthop. 1997; 112: 138-144
4. Matasa CG, A do-it-yourself friction testing, The Orthodontic Materials Insider, Sept. 1995; (3):1-7 Edgewise-Friktionstest fir Jedermann, Informationene aus Orthodontie und Kieferorthopadie, 1995:27(4): 535-548; A do-it-yourself bracket-ligature -arch wire testing, Scientific poster presented at the 96th American Assoc of Orthodontists Annual Meeting in Denver, CO, May 1996; La friccion entre la bracket de arco de canto, la ligadura y el alambre. II. Test de friccion para todos, Rev Esp Ortod 1996; 26:189-198
5. Elastomers can generate high friction, Poster at the 101th AAO Annual Session, Toronto, May 2001; Weighing...friction, The Orthodontic Materials Insider, June 2001, 13 (2):1-8
6. Braun S, Bluestein M, Moore BK, Benson G, Am J Orthod Dentofacial Orthop 1999; 115: 619-27
7. Brown S, Personnal communication, July 2001
8. Second International Symposium on Fretting Fatigue, Department of Mechanical Engineering, University of Utah, Salt Lake City, August 31 - September 2, 1998; 23rd Annual Meeting of the Holm Conference on Electrical Contacts, Chicago, 1977.
9. Bailey JM, Godfrey D, Lewis Flight Propulsion Laboratory, Cleveland, OH Coefficient of friction and damage to contact area during the early stages of fretting . II Steel, iron, iron oxide and glass combinations, National Advisory Committee for Aeronautics Technical Note 3144, 1954
10.Verbeke G, Chatzicharalampous E, Carels C, Frictional behavior of stainless steel bracket-wire combinations subjected to small oscillating displacements", Am J Orthod Dentofacial Orthop 2001; 120: 371-7
11. Minshall H, Coefficient of friction, in: Weast RC, ed., CRC Handbook of Chemistry and Physics, 59th ed., 1978-1979, W. Palm Beach, FL: F-21
THANKS FOR YOUR INPUT !
In response to our last issue, we received relatively few letters showing interest for visiting it on the Internet (where it is published as an addition to www.Orthocycle.com), and hundreds asking us to continue to publish it on paper. To convince us to do it, the writers made comments such as one can see in the following pages.
___.DG, Wilmington, DE, USA: "I just finished reading my September 2001 issue of “Insider”. I urge you to continue publication of this valuable informative newsletter. I suspect that I have used Ortho-Cycle Co. for at least twenty years, possibly even longer. The newsletter reinforces my resolve to use recycled brackets. It continually “debunks” statements by manufacturers as to why one should not use recycled brackets. In addition, it gives valuable information comparing one bracket manufacture to another, particularly when it comes to retention and often deformation qualities."
___.R.G.M. Cape Town, S. Africa: "Thank you for your newsletter which I have enjoyed reading over the years."
___.L.K., Needham & Ashland, MA, USA: "It is written concisely. In fact, it has made me a better dentist. Because of you I know my Metallurgy and I know why I do, what I do, when doing ortho. I also like the fact you cite and list your references."
___.J.S., Bristol, UK: "I do feel that “The Insider” is of use; I use it as quite a nice little update for postgraduates."
___.J.E.,Wynberg, South Africa: "In South Africa, as in many parts of the world, there are individuals who are against recycling and often claim that inferior orthodontic is being done because of this. The numerous informative and scientifically based articles over the years have assisted me refuting these claims. In contrast I know that the brackets are sterilized and checked for accuracy while this service is not available from the original manufacturers."
___.B.W.A., Worthington, Windom & Jackson, MN: “The Insider” is one of the few publications that I always read cover-to-cover when it is sent out. I have found it a tremendous source of information that other journals are unwilling to research and publish. Please keep up your good work."
___.Prof. D.B., Brasilia, Brasil: "Thank you very much for honoring me with the opportunity to always receive such an interesting periodical. Accept my congratulations for the seriousness and firmness by which you defended your position in favour of recycling the orthodontic brackets."
___.P.V., Stockholm, Sweden: "I like your "Insider" very much. I like specially your simple ways to evaluate quality, like the way you evaluate slot in size in the September issue."
___.Professor W. T, Bradenton, FL, USA: "I have always enjoyed the unique messages and science in the newsletter. Although not presently using recycled brackets, we have done so with no problems and have shipped out some for use in needed countries. There is a place for recycled brackets in orthodontics here and aboard, and we appreciate your dedication to making the process highly professional and the system compatible with fine orthodontic materials."
___.Professor C.W.D., Brussels, Belgium: "It would be a great loss to the orthodontic profession if we would no longer receive your publication. Your publication is a unique source of information. The articles are usually extremely interesting, well documented and well written. It is probably the only professional publication I read from A to Z every time I get it in the mail. So please don’t let us down, but continue publishing it."
___.J.P.F., Manuka & Quaenbeyan, NSW, Australia: "It is an informative publication on dental materials, which is an interest of mine. I am particularly pleased to see your articles on metal sensitivity."
___.C.S., Auckland, New Zealand: "I very much appreciate receiving and reading your Newsletter. The information and views contained within each edition are a refreshing change to the “blurb” published by the various Orthodontic Manufacturers. Thanks again for your past (and hopefully, your continued future) efforts."
___.Professor J.K.H., Sydney & Mormon, NSW, Australia: "I have always enjoyed your publication “Insider” I would be most grateful if you could continue to forward me a copy of this innovative and technical journal. As my father was a metallurgist, I find it a publication that is always to read."
___.J.LW, Auckland, New Zealand: "Since about 1987 I have used your service and I have recycled my own brackets regularly trough your factory. Great service and great savings and wise. Your “Insider” has been welcomed as good reading and helpful guidance."
___.A.B.K., Oregon City & Woodburn, OR, USA: “In reference to your request for feelings about “the Insider” in your Sept.2001, I would be perfectly content to read it on the web site.”
___.M.S., Wanganui, New Zealand: “I write in reply to your request on the back of the September “The Insider”. It fills a gap that the professional journals do not cover, and the manufacturers are not going to.”
___.M.J.C., North Rockhampton, Q, Australia: “Please do not stop sending the “Insider”, as I find it always of tremendous interest.”
___.J.D.V., San Luis Obispo, CA, USA: “My vote is to continue your publication of the Insider. It is excellent, I read it cover to cover, and I have received valuable information from almost every issue.
I continue to use your services and am a strong admirer of both your integrity and expertise. PS: I would gladly pay for a subscription.”
___.Consultant D.C.T., Shropshire, UK: “I would certainly be sorry to see this publication discontinued as it frequently carries practical information on various aspects of orthodontic brackets and adhesives, which is hard to obtain from any other source. A good example is your delightfully simple article on evaluation of slot size in September 2001 issue.”
___.Professor G.C., Quakertown, PA, USA: “Thank you for sending the latest edition of the Insider. As requested, I am indicating interest in continuing to receive the information included within your publication. I feel your publication has illuminated a variety of important issues relating to Biomaterial Science and the field of Orthodontics. This information is helpful to me in the capacity as a practicing orthodontist as well as an educator at the University of Pennsylvania.”
___.Professors T.M.G. & R.L.V., Chicago, IL: “Thank you for your outstanding contribution to the new “Orthodontics: Principles and Techniques”. We appreciate all the blood, sweat and tears that go into this dedicated effort for the graduate orthodontic students of the coming millennium! This is a superb example of teamwork!”
___.Professor W.A.B., Columbus, OH: “Thank you for your chapter contribution on the characterization of used orthodontic brackets for our new book in vivo Aging of Dental Biomaterials, which is scheduled for publication in 2001 by Quintessence.”
___.J.B., Woodmere, New York, NY, USA: “I like the Insider because of its frequent erudition.”
___.K.G.G., White Bear Lake, MN, USA: “I have always enjoyed your informative and well written articles you provide in your mailed Bulletin. Please continue this Insider.”
___.J.A.K., Boca Raton, FL, USA: “Yes, I would like to continue to receive your newsletter. I find it very informative especially in areas that are not typically explained, as the science of bond and metal technology.”
___.P.M.R., Rochester, NH, USA: “I find “the Insider” to be well written, informative and certainly filling a gap in my education and orthodontic literature. …Dr. Matasa should be commended for his research and articles.”
___.M.H.S., Cote St. Luc, Quebec, Canada: “I find “The Insider” newsletter most informative and honest. Keep up the excellent work.”
___.J.E.V., Pasadena & Houston, TX, USA: “I find the Orthodontic Materials Insider very informative and I always enjoy reading it.”
___.R.F.R., Hyannis & Orleans, MA, USA: “I hope very much that you will be able to continue to publish the “Insider”: I enjoy it very much.”
___.D.P, Vancouver, Richmond & Delta, BC, Canada: “Firstly, we’d like to congratulate your company’s Silver Anniversary and thank you for the many newsletters sent our way over the past.”
___.Consultant N.WTH. Bristol, UK: “I certainly wish to continue to receive this information. I would be very happy to do this via the Web, so as long as your Website continues to post these articles.”
___.Prof. M.R., Innsbruck, Austria: “Yes indeed, you are a star! All through the last years I was amazed by the huge scientific activities you were busy in. Now finding you in Graber’s new book is something special indeed. It will be fascinating to read it as well as going through your special article on Angle, the innovator. Your web site is impressive!”
___.I.P.C., Bournemouth, Dorset, England: “I enjoy reading a magazine rather than an anonymous VDU screen, and I find it extremely convenient when your magazine arrives through the post. Quite simply I do not have to look for it, it is there in front of me. I would encourage you to continue posting it, and I would like to say how much I appreciate its style and contents in the past.”
___.F.G.R.,Pleasanton, California: “Please continue publishing the Insider. I have used your recycling service for probably 10 years or so and am very pleased with the service. I never hesitate to explain in great detail to patients why I do when asked with the “you mean these brackets have been in someone else’s mouth before?” question. I always look forward to reading the Insider while the ADA journal often sits around for some time before it gets read (if it gets read). Your newsletter is truly scientific and not just a poorly disguised ad.”
___.Dear Dr. Matasa:
___.Greetings, from one orthodontically-inolved chemical engineer to another. It is past due that I write you a letter of appreciation for contributions you have made, unknowingly, to what I do. First some personal background: I graduated Clemson University in 1957 with a B. S. (ChE) degree, worked as an engineer for six years and then began my second career, eventually becoming an MSD orthodontist at the University of Washington. Proudly, Clemson is on the rise. Founded in 1889 in South Carolina, it has been recognized as Time Magazine’s 2001 Public College of the Year, and last July was listed in the Kaplan/Newsweek College Catalog as one of the top schools in the nation overall. My other alma mater, is well known for producing many, splendid academicians and for other contributions to orthodontics over five decades.
___.After 32 years I still work as an orthodontist, though not so vigorously any more. Other interests (five grands, running, golfing, writing novels — and one other passion to be addressed herewith) have me still tooling along, however. And that brings me back to our commonality. I have used my engineering background in recent years to focus on designs and development (hopefully) of the orthodontic brackets of tomorrow — brackets completely aesthetic and with self-contained ligation.
___.From both an orthodontic and chemical engineering standpoint, Ortho-Cycle’s newsletter, The Orthodontic Materials Insider, has been a good resource and a genuine help to me. Following your expressed goal, “Renewal of orthodontists’ habits and tools,” it has given me, time and again, insight into tools and materials. The topics you have researched, both in the literature and in the lab, have been of interest. I have benefited from your work and engineering knowledge, and this letter, albeit it late, is a “Thank You,” joining others who have already done so as printed in your December issue several years ago.
___.Easy-to-read, and at the same time written in a scientifically accessible way, your articles have been well documented, open-minded, and show no allegiance to unfounded beliefs or so-called “sacred elephants.” I understand manufacturers, fearing competition, attacked your company, leading to a suit in court where they didn’t show up, as you reported in your Insider of March 1998. Was the credibility of your company in question? I can’t believe that was an issue. And no jurors of today would condemn recycling. That you have been selected to teach at several universities, have authored technical articles and write chapters in reputable textbooks speak for themselves about your dedication to orthodontics.
While I have never met you personally, I visit both your company and your individual web sites and see that I am not alone in appreciating your contributions. Also, I have been told your conferences and courses have been welcomed all over the world.
___.In the field of self-engaging and aesthetic/composite brackets, which preoccupies me conceptually as an engineer, you have saved me time and provided insight by showing the patent evolution of the first (Insider, December 1996) and the status of the last (June and September 1997). In addition, your issues on elastomeric ligatures and their impact on friction plus your reports on metal allergies were timely and needed. As a result, I maintain most of your publications for ready reference.
Finally, the above being said, let me respond to your question raised in the last issue: Should you continue publishing the newsletter — or just post it on the Internet? While I understand financial hardships are involved, perhaps you can continue paper editions by offering subscriptions for a fee; you have a dedicated readership. And readers might be invited to participate by submitting their original writings, suggest topics for examination and give you interesting feedback via a “Letters to the Editor” section. In the meantime I send best wishes for your continued success, and keep up the good work. Sincerely, Andrew P. Collins,DMD, PA, Durham & Roxboro, NC, USA, December 2001
TYPE A NOTE ON YOUR LETTERHEAD, AND SEND IT...
(It will cost us years of research made available
to you for free!)
___.The Orthodontic Materials Insider has reached maturity in encompassing the material-related problems haunting orthodontists. In our previous issue (celebrating a quarter century since Ortho-Cycle’s beginning and fifteen years since the publication of The Insider), one could see the long list of the many materials and devices which were discussed through the years in an unbiased way. ___.Along the years, we have established credibility, our newsletter being often equated with the reputed Clinical Research Associates (CRA) Newsletter. Years ago, its leader, Gordon J. Christiansen, DDS, MSD, PhD, actually confirmed it:“From contacts with my orthodontists friends, and reading your newsletter, I am impressed with what you have accomplished, and congratulate you for your efforts. Your and our activities appear to have many similarities”. Often called the “Consumer Report” of the orthodontists, The Insider has provided systematic information on materials at a time when only dental materials were the object of books (only very few materials and devices are common to both orthodontists and dentists). Concomittently, Ortho-Cycle’s laboratory has gradually grown, becoming a trusted research center.
___.In spite of these successes, Ortho-Cycle has continued to send, for years and for free, its newsletter to some twenty thousand orthodontists around the world. As the related financial burden has became such that even large companies couldn’t afford, in our last issue we asked our readers if we should continue to publish it, or if they would like to help us by saving us the mailing costs (Internet only). Impressed by the answers we got and despite of all the hardships involved, we have decided to continue to publish “The Insider” on paper, and mail it for free, to those who will request it in writing, using their letter head, before March 1, 2002.