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Clear aligners
Intervention
A clear plastic device in the shape of teeth
An Invisalign aligner

Clear aligners, also known as clear aligner treatment sold under the brandnames Invisalign and ClearCorrect are orthodontic devices that uses incremental transparent aligners to adjust teeth as an alternative to dental braces. A 2014 systematic review concluded that there is not evidence to determine the effectiveness of these therapies.[1] Opinion is that they are effective for moderate crowding of the front teeth, but are less effective than conventional braces for several other issues.[n 1]

Clear aligners treatment involves an orthodontist or dentist taking a mold of the patient's teeth, which is used to create a digital tooth scan. The computerized model suggests stages between the current and desired teeth positions, and aligners are created for each stage. Each aligner is worn for 20 hours a day for two weeks.[3] These slowly move the teeth into the position agreed between the orthodonist/dentist and the patient. The average treatment time is 13.5 months.[4]

Invisalign is manufactured by Align Technology, a multinational medical-device company headquartered in San Jose, California. The company was founded in 1997 by Zia Chishti, and Invisalign was approved by the Food and Drug Administration the following year. $140 million in venture capital was raised from 1997 to 2000, and another $130 million was raised in an initial public offering in 2001. Chishti was ousted from the company in 2002. In 2005 he developed Orthoclear, a similar product, which resulted in several legal disputes. As of 2014, according to Align Technology, 2.4 million people around the world had been treated with Invisalign, and 80,000 dentists had been trained how to use it.[2]

Dental use[edit]

Clear aligners are likely useful for moderate-degree, front teeth, teeth crowding. [2] In those with teeth that are either too far forward, too far backward, or rotated in the socket, the aligners are likely not as effective as conventional braces.[2] Additionally the teeth more often become misaligned again.[2] A 2013 Cochrane review found no high-quality evidence with respect to the management of the recurrence of lower front teeth misalignment following prior treatment.[5]

Clear aligners are probably more noticeable than lingual braces.[2] They are, however, likely more comfortable. They can be removed, which makes cleaning of the teeth easier, and they are faster for the dentist to apply.[2]

Application[edit]

A 3D representation of a person's teeth in the Invisalign software

Treatment begins with taking x-ray, photographs, a bite registration, and polyvinyl siloxane impressions of the person's teeth and gums. The dentist/orthodontist completes a written evaluation that includes diagnosis and treatment plan.[6][7][8][9] Dental impressions are scanned in order to create a digital 3D representation of the teeth.[7][8] Technicians move the teeth to the desired location with the program Treat, which creates the stages between the current and desired teeth positions.[8][9][10] Anywhere from six to forty-eight aligners may be needed. Each aligner moves teeth .25 to .33 millimeters.[6][3]

A computer graphic representation of the projected teeth movements, created in the software program ClinCheck, is provided to the doctor and patient for approval or modification before aligners are manufactured.[6][8][10] The aligners are modeled using CAD-CAM (computer-aided-design and computer-aided-manufacturing) software and manufactured using a rapid prototyping technique called stereolithography.[7][8] The molds for the aligners are built in layers using a photo-sensitive liquid resin that cures into a hard plastic when exposed to a laser.[7] The aligners are made from an elastic thermoplastic material that applies pressure to the teeth to move into the aligner's position.[10][11][12] Patients that need a tooth rotated or pulled down may have a small, tooth-colored[13] composite attachment bonded onto certain teeth.[10] More attachments can make the aligners less aesthetically pleasing.[8] Reproximation, (also called interproximal reduction or IPR and colloquially, filing or drilling), is sometimes used at the contacts between teeth to allow for a better fit.[14][15]

Each aligner is intended to be worn 20 hours a day for two weeks.[3] On average the treatment process takes 13.5 months.[4] Treatment time varies based on the complexity of the planned teeth movements.[3] Refinements may be ordered by the doctor during the treatment process.[16] The aligner is removed for brushing, flossing and eating.[17] Once the treatment period has concluded, the patient is advised to continue wearing a retainer at night for the foreseeable future.[16]

When the Invisalign system was first developed, many of the aligner manufacturing processes were carried out by hand, and computer technicians had to modify each tooth in the computerized model individually.[7]

History[edit]

Origins[edit]

Zia Chishti conceived of the basic design of InvisAlign while an adult orthodontics patient. During his treatment with a retainer intended to complete his treatment, he posited a series of such devices could effect a large final placement in a series of small movements. He partnered with Kelsey Wirth to seek developers.[6][18] Chishti and Wirth joined fellow Stanford students Apostolos Lerios and Brian Freyburger to co-found Align Technology in 1997.[18] They obtained funding from Kleiner Perkins Caufield and Byers and began development in a garage in Menlo Park, California.[7] Lerios and Freyburger were graduate students working with Marc Levoy in the computer graphics lab at Stanford. They researched capturing the geometry of objects in CAD models, and the use of 3D printers to replicate the object calling it the 3D Fax project. Their use of these technologies allowed them to develop the programming that designed incremental retainers.[18] The Invisalign system was approved by the Food and Drug Administration in 1998[6][19] and sales began in the U.S. in 1999.[8][17]

Establishment[edit]

Woman wearing Invisalign

Orthodontists were resistant to adopting Invisalign at first, in particular because the founders had no orthodontic credentials or expertise, but the product became popular among consumers.[6] In 2000 Align Technology planned a $31 million television advertising campaign that The New York Times said would be “the most aggressive consumer advertising plan the dental profession has ever seen.”[20] The company raised about $140 million in funding over four rounds from 1997 to 2000.[18][20][21] $130 million in additional funding was raised in 2001 through an initial public offering on NASDAQ.[18][22] By 2001, 75 percent of the 8,500 orthodontists in North America had been trained on the Invisalign system.[18][23] That same year, Align Technology made Invisalign available to general dentists following a class-action lawsuit that alleged making the system available only to orthodontists resulted in unfair competition for dentists.[18][23]

In the early 2000s, Align Technology was spending nearly all of its revenues on marketing and advertising, and losing about $18 million per year.[24][25] Cofounders Wirth and Chishti resigned from Align Technology in 2001 and 2003 respectively,[19] with Thomas Prescott replacing Chishti as CEO in March 2002. Prescott re-focused the company on North America and cut the marketing budget to about one-third its original size.[24][25]

In 2005, Chishti and others created competitor OrthoClear.[19] This resulted in a legal dispute regarding alleged patent infringement by OrthoClear[26] and a series of lawsuits whereby both Align and OrthoClear alleged the other had engaged in false advertising, defamation and trademark infringement, among other things. The “longstanding round of bitter litigation” was settled in 2006.[19][27] Align paid OrthoClear $20 million and OrthoClear agreed to end its operations.[26]

The Invisalign system grew from 80,000 patients in 2002 to 175,000 in 2004. It won several awards for stereolithography, medical design and fast growth. Align Technology was profitable for the first time in 2003. In 2005 the company expanded into Japan[24] and acquired General Orthodontic, an orthodontics firm that supported doctors prescribing the Invisalign system.[28][24] Later that year the Harvard School of Dental Medicine began requiring that its orthodontic graduate students complete Invisalign certification before they graduate.[24] By 2008 more than 500,000 patients had used Invisalign,[16] which grew to two million by 2012.[28]

Recent developments[edit]

In 2007 the Academy of General Dentistry approved Align Technology's Program Approval for Continuing Education (PACE) program.[28] The company also created the AlignTech Institute, which provides educational resources to doctors.[29] In 2009, Align Technology began to require that doctors prescribing Invisalign complete at least ten cases per year and ten hours of training in order to maintain their Invisalign provider status. In January 2010, 20,000 doctors had their certification suspended for not meeting the requirements, but a class action lawsuit regarding providers that paid for training under the original rules resulted in some certifications being re-instated.[30] In March 2011, Align Technology acquired Cadent System, Inc., a dentist firm, for $190 million.[31]

Manufacturers[edit]

Align Technology[edit]

Align Technology
Public
Traded as ALGN
Industry Orthodontic
Founded 1997
Founder Zia Chishti and Kelsey Wirth
Headquarters San Jose, California, United States
Key people
Joe Hogan, Chief Executive Officer
Products Invisalign, iTero Scanner and Orthocad products
Revenue $560 million[28]
Number of employees
3,200[28]
Website www.aligntech.com

As of 2012, 92 percent of Align Technology's revenues were from sales of Invisalign, 76 percent of which came from the US market.[28] The company also produces iTero scanner products and OrthoCAD digital services.[28] It supports several different types of Invisalign treatment plans. In addition to the default "Full" version, there is a Teen version with wear indicators and replacements for lost aligners. An Assist version provides additional tools and services to assist the doctor and several Express versions have fewer aligners at a lower cost for minor adjustments.[28] Align Technology also produces retainers used after treatment under the Vivera brand.[28]

The Invisalign Express 10, which uses 10 aligners, was introduced in 2005.[32] The Vivera brand retainers were developed in 2007 and Invisalign Teen was released the following year.[28] Invisalign 1.5 was released in 2009. It was followed by Invisalign G3 in 2010 and G4 in 2011. Invisalign G3 and G4 were designed for more complex treatments. An Invisalign Express 5 version, which uses 5 aligners, was introduced in 2012.[26] In February 2014, Align Technology released a G5 product designed to treat deep bites.[33]

Support, software engineering, pre-production and administrative functions are done from Align Technology's headquarters in California. The manufacturing of Invisalign aligners is performed in Mexico[18] and treatment plans are created in Costa Rica. Align Technology also operates separate subsidiaries in Hong Kong and Australia that sell Invisalign in their respective markets.[29] Align Technology provides training and certification to doctors,[8][34] as well as equipment and aligners related to the Invisalign system.[28]

ClearCorrect[edit]

ClearCorrect
Private
Industry Dental lab
Founded 2006
Headquarters Round Rock, Texas, USA
Key people
Willis Pumphrey Jr., Founder Jarrett Pumphrey, CEO
Products Clear aligners
Website clearcorrect.com

ClearCorrect, LLC is a company established in 2006, the Round Rock, Texas based company distributes their product throughout the United States and in 2011 was named the fastest-growing health company in America by Inc. magazine.[35][36]

ClearCorrect was founded in Houston, Texas by Willis Pumphrey, Jr. in 2006[37][38] In 2001, Pumphrey started using Invisalign, a clear aligner product manufactured by Align Technology. Align was founded by Zia Chishti and Kelsey Wirth, both MBA graduates of Stanford University.[39] In 2005, Zia Chishti started another company called OrthoClear.[40] Pumphrey decided to switch to OrthoClear, due to the way OrthoClear manufactured their aligners and also because of their reduced lab fees.[41] In October, 2006 an agreement was made between Invisalign and Orthoclear in which OrthoClear agreed to stop all production of clear aligners.[40] At the time Pumphrey had 400 patients in treatment with OrthoClear. With no other options available, Pumphrey started his own company to complete his patients' clear aligner treatment.[42]

Society and culture[edit]

Legal[edit]

The litigious history in the clear aligner market prompted ClearCorrect to be proactive in addressing patent issues between itself and Align Technology. Align had previously filed a complaint with the U.S. International Trade Commission against OrthoClear Inc., In the end an agreement was made between Align and OrthoClear in which Align paid OrthoClear $20 million for its intellectual property and OrthoClear agreed to stop accepting cases in the United States.[40]

In February 2009, ClearCorrect filed a declaratory judgment against Align Technology. ClearCorrect claimed that some of Align’s patents were invalid, and thus ClearCorrect’s product did not infringe on Align’s patents.[42] ClearCorrect voluntarily dismissed the suit in April 2009, after Align stated to the court that it had no intention of suing ClearCorrect for patent infringement.[42][43]

On February 28, 2011, Align Technology filed two lawsuits against ClearCorrect. Align alleged that under California’s Unfair Practices Act, that ClearCorrect sold products for a price below the average production cost, with the purpose of "destroying competition in the market for clear aligner systems." Align also claimed that ClearCorrect infringed eight of Align's patents.[44]

On May 12, 2011 ClearCorrect filed a countersuit against Align Technology, denying allegations that it is infringing on Align patents. In the countersuit, ClearCorrect alleged that Align's allegations are invalid and accused Align of patent misuse and double patenting. The countersuit cited much of the evidence raised in Align's previous patent case against Ormco, which resulted in a federal court ruling that 11 of Align's patent claims were invalid.[45]

Cost[edit]

Disadvantage of Invisalign in comparison to conventional orthodontic treatment include cost and technical limitations in handling complex cases.[46] In a typical case, conventional braces may cost $4,000 in the United States, while Invisalign would cost $5,600; insurance may cover $1,000 of either treatment.[47] In the UK, Invisalign generally costs £2,500 – £4,500, according to the company. [48]

Notes[edit]

  1. ^ Daniel A. Kuncio (The New York State Dental Journal), 2014: "Invisalign has been proven to resolve moderate anterior tooth crowding predictably, but treatment outcome studies have highlighted Invisalign’s weaknesses compared to conventional braces in treating anterior-posterior discrepancies, large rotational movements and the extrusion of teeth. More post-treatment relapse of anterior dental alignment has also been found in Invisalign cases."[2]

References[edit]

  1. ^ Rossini, G.; Parrini, S.; Castroflorio, T.; Deregibus, A.; Debernardi, CL. (Nov 2014). "Efficacy of clear aligners in controlling orthodontic tooth movement: A systematic review.". Angle Orthod. doi:10.2319/061614-436.1. PMID 25412265. The quality level of the studies was not sufficient to draw any evidence-based conclusions. 
  2. ^ a b c d e f g Kuncio, Daniel A. (March 2014). "Invisalign: current guidelines for effective treatment.". The New York State Dental Journal 80 (2): 11–4. PMID 24851387. 
  3. ^ a b c d Malik, Ovals; McMullin, Allbhe; Waring, David (April 2013). "Invisible Orthodontics Part 1: Invisalign". Dental Update. PMID 23767109. 
  4. ^ a b Fogel, Joshua; Janani, Raymond (2010). "Intentions and behaviors to obtain Invisalign". Journal of Medical Marketing 10 (2): 135–145. doi:10.1057/jmm.2009.50. ISSN 1745-7904. 
  5. ^ Yu, Y; Sun, J; Lai, W; Wu, T; Koshy, S; Shi, Z (6 September 2013). "Interventions for managing relapse of the lower front teeth after orthodontic treatment.". The Cochrane database of systematic reviews 9: CD008734. doi:10.1002/14651858.CD008734.pub2. PMID 24014170. 
  6. ^ a b c d e f Basavaraj Subhashchandra Phulari (30 June 2013). History of Orthodontics. JP Medical Ltd. p. 1. ISBN 978-93-5090-471-8. 
  7. ^ a b c d e f Tuncay, Orhan (2006). The Invisalign System. Quintessence Publishing Co, Ltd. ISBN 1850971277. 
  8. ^ a b c d e f g h Rakosi, Thomas; Graber, Thomas M. (2010). Orthodontic and Dentofacial Orthopedic Treatment. Thieme. ISBN 978-3-13-127761-9. 
  9. ^ a b Bishop, A.; Womack, R.; Derakhshan, M. (September–October 2002), "An esthetic and removable orthodontic treatment option for patients: Invisalign", The Dental Assistant: 14, PMID 12387123 
  10. ^ a b c d Melsen, Birte (3 February 2012). Adult Orthodontics. John Wiley & Sons. pp. 353–. ISBN 978-1-4443-5574-1. 
  11. ^ Cowley, Daniel (August 1, 2012), Effect of Gingival Margin Design on Retention of Thermoformed Orthodontic Aligners, University of Nevada, retrieved March 11, 2014 
  12. ^ Alexander, Justin (2012), Effect of Reducing the Incremental Distance of Tooth Movement per Aligner while Maintaining Overall Rate of Movement on Self-Reported Discomfort in Invisalign Patients (PDF), Saint Louis University, retrieved March 11, 2014 
  13. ^ Joffe, L. (2003). "Invisalign(R): early experiences". Journal of Orthodontics 30 (4): 348–352. doi:10.1093/ortho/30.4.348. ISSN 1465-3133. PMID 14634176. 
  14. ^ Humber, PV (2008), "A Snapshot of Invisalign", Aesthetic Dentistry Today 2 (1): 85–88, retrieved 2011-01-28 
  15. ^ Boyd, RL (August 2008), "Esthetic orthodontic treatment using the invisalign appliance for moderate to complex malocclusions", Journal of Dental Education 72 (8): 948–67, PMID 18676803, retrieved January 28, 2011 
  16. ^ a b c Sultan, Aisha (January 21, 2008). "Braces offer 'invisible' fix". St. Louis Post-Dispatch. Retrieved January 9, 2014. 
  17. ^ a b Isaacs, Barbara (February 25, 2001). "Good riddance to metal-mouth misery". Knight Ridder. Retrieved January 9, 2013. 
  18. ^ a b c d e f g h Coughlan, Anne; Hennessy, Julie, Invisalign: Orthodontics Unwired, Kellogg School of Management }
  19. ^ a b c d "OrthoClear, Align end lengthy legal fight". Silicon Valley Business Journal. September 28, 2006. Retrieved January 9, 2013. 
  20. ^ a b Feder, Barnaby J. (18 August 2000). "Orthodontics Via Silicon Valley; A Start-Up Uses Computer Modeling And Venture Capital to Reach Patients". The New York Times. p. 1. 
  21. ^ Liedtke, Michael (September 23, 2000). "Using new software, dentists straighten teeth without braces". Associated Press. Retrieved January 9, 2014. 
  22. ^ Liedtke, Michael (January 26, 2001). "Align Technology Raises $130 Million in IPO". Associated Press. Retrieved January 9, 2014. 
  23. ^ a b Bush, Jewel (August 14, 2001). "Stealth Braces". NYT Regional Newspapers. Retrieved January 9, 2013. 
  24. ^ a b c d e Gretchen, Antelman (2008). International Directory of Company Histories 94. St. James Press. pp. 15–18. ISBN 1-55862-615-8. 
  25. ^ a b Lau, Gloria (May 3, 2004). "It has a bracing impact on patients; Align Technology". 
  26. ^ a b c Benesh, Peter (March 19, 2007). "No More Mouthfuls of Metal". Investor's Business Daily. Retrieved January 9, 2013. 
  27. ^ "Align Technology and OrthoClear end Litigation" (PDF). Ortho Tribune. October 16, 2006. Retrieved January 7, 2013. 
  28. ^ a b c d e f g h i j k Align Technology, Inc. SWOT Analysis. (2013). 1-8.
  29. ^ a b Plunkett, Jack W. (March 1, 2009). Plunkett's Companion to the Almanac of American Employers 2009: Mid-Size Firms. Plunkett Research, Ltd. p. 134. ISBN 978-1-59392-126-2. 
  30. ^ Rasmussen, March (March 2011), Invisalign Agrees to Settlement in Class Action Lawsuit, American Dental Association, retrieved March 25, 2014 
  31. ^ "Restructuring Roundup: Align to close New Jersey facility, will cut 119 jobs". Medical Device Daily. September 9, 2011. 
  32. ^ "Medical Devices; Pricing simplified for Invisalign". Science Letter. December 27, 2005. 
  33. ^ "Treatment of deep bite malocclusions". BDJ 216 (5): 260–260. 2014. doi:10.1038/sj.bdj.2014.164. ISSN 0007-0610. 
  34. ^ Edwab, Robert R. (2003). Essential Dental Handbook: Clinical and Practice Management Advice from the Experts. PennWell Books. p. 412. ISBN 978-0-87814-624-6. 
  35. ^ [1] Inc. Company Profile Rank
  36. ^ [2] ClearCorrect honored by Inc. magazine
  37. ^ [3] Doctors welcome options
  38. ^ [4] Dental Cosmetic Center of Houston
  39. ^ [5] Invisible braces
  40. ^ a b c [6] Orthoclear, Align lengthy legal battle
  41. ^ [7] Necessity knows the law
  42. ^ a b c [8] Competing at the cutting edge
  43. ^ [9] ClearCorrect Voluntarily Dismisses Lawsuit Against Invisalign
  44. ^ [10] Align Technology Files Lawsuits Against ClearCorrect
  45. ^ [11] ClearCorrect denies patent infringement, countersues Align
  46. ^ Shalish, M.; Cooper-Kazaz, R.; Ivgi, I.; Canetti, L.; Tsur, B.; Bachar, E.; Chaushu, S. (2011). "Adult patients' adjustability to orthodontic appliances. Part I: a comparison between Labial, Lingual, and Invisalign". The European Journal of Orthodontics 34 (6): 724–730. doi:10.1093/ejo/cjr086. ISSN 0141-5387. 
  47. ^ Coughlan, Anne; Hennessy, Julie, Invisalign: Orthodontics Unwired (PDF), Kellogg School of Management 
  48. ^ "What will it cost?", invisalign.co.uk.

Further reading[edit]

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