Clear aligners are orthodontic devices that are a transparent, plastic form of dental braces used to adjust teeth.
Clear aligners have undergone changes, making assessment of effectiveness difficult. A 2014 systematic review concluded that published studies were of insufficient quality to determine effectiveness. Experience suggests they are effective for moderate crowding of the front teeth, but less effective than conventional braces for several other issues and are not recommended for children. In particular they are indicated for "mild to moderate crowding (1–6 mm) and mild to moderate spacing (1–6 mm)", in cases where there are no discrepancies of the jawbone. They are also indicated for patients who have experienced a relapse after fixed orthodontic treatment.
Clear-aligner treatment involves an orthodontist or dentist, or with home-based systems, the person themselves, 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 22 hours a day for one or two weeks.
Clear aligners are more noticeable than lingual braces, but they can be removed, which makes cleaning of the teeth easier, and they are faster for the dentist to apply. Dental impressions are scanned in order to create a digital 3D representation of the teeth. Anywhere from six to eighty aligners may be needed during the first set of aligners. Each aligner moves teeth .25 to .33 millimeters.
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. Patients that need a tooth rotated or pulled down may have a small, tooth-colored composite attachment bonded onto certain teeth. More attachments can make the aligners less aesthetically pleasing.
Each aligner is intended to be worn an optimal 22 hours a day for one to two weeks. On average the treatment process takes 13.5 months, although treatment time varies based on the complexity of the planned teeth movements. Once the treatment period has concluded, the patient is advised to continue wearing a retainer at night for the foreseeable future.
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.
Sales began in the U.S. in 1999. Align paid OrthoClear $20 million and OrthoClear agreed to end its operations. It has been reported that in 2017 its clear align system had been used to treat about 80,000 patients. In 2001, Pumphrey started using Invisalign. He decided to switch to OrthoClear, because of the way OrthoClear manufactured its aligners and because of its reduced lab fees. When manufacture of Orthoclear ceased, Pumphrey had 400 patients in treatment. With no other options available, he started his own company to complete his patients' clear aligner treatment.
Direct-to-consumer brands
SmileDirectClub
SmileDirectClub, based in Nashville, Tennessee, was launched in 2014 as an alternative to in-office clear aligners. The company offered direct-to-consumer clear aligner service which can be used from home, without having to see a dentist. This allowed them to price aligners at half of the other competitors. Unlike Invisalign or traditional clear aligners competitors, no brackets were placed on patient's teeth in office and the teeth were expected to move via the plastic aligner alone. The company faced criticism from the orthodontic community because of no involvement of a physical dentist. Similar startups have also launched in different parts of the world. In September 2023, SmileDirectClub filed for bankruptcy, before shutting down completely in December 2023, leaving thousands of customers without any support.
Smile White
Smile White is a UK-based company that offers clear aligners. In June 2023, the brand was acquired by dentists Hussein and Hassan Dalghous, known on TikTok as TwinDentists.
Direct to consumer clear aligner services
Following SmileDirectClub, multiple companies provide aligner treatment to patients by mailing their aligners and monitoring the treatment through a digital platform. The American Association of Orthodontists, the largest society representing orthodontists in the United States and abroad, released consumer alert explaining potential risks associated with such services.
Society and culture
Lawsuits
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.
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.
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.
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.
In September 2023, SmileDirectClub filed for bankruptcy. While SmileDirectClub initially sought Chapter 11 bankruptcy protection to restructure its finances, it was unable to secure the necessary funding and ultimately shut down its operations in December 2023.
In October 2024, Dentsply Sirona voluntarily suspended the sale and marketing of its Byte clear aligners and impression kits as it conducts a review of regulatory requirements.
Costs
The cost of clear aligners is typically lower than their all-metal counterparts because of the materials and technology used. Prices are rarely impacted by factors such as the duration of the treatment and the extent of the issues requiring correction, as much as specific details of the treatment plan, time/age of treatment, location, the experience of the orthodontist. In countries such as Australia, Canada, United States and United Kingdom prices are fairly similar across providers at circa $2,000/£1,500.
Notes
References
External Link
- 10 Tips to Wear Invisalign Correctly for Faster Results