Clear Dental Aligners
Clear dental aligners (referred to from here on as clear aligners) are a series of custom-made, removable plastic trays designed to gradually move teeth into a desired position.
Clear aligners are an alternative to traditional braces and are available by prescription from a licensed practitioner, such as a dentist or orthodontist.
The FDA reviews and authorizes clear aligners before being marketed and sold in the United States. The FDA has not authorized clear aligners that are sold directly to consumers without a prescription and supervision by a dentist or orthodontist. Using clear aligners without proper professional supervision may increase the risk of complications.
What Should I Know Before Choosing Clear Aligners?
Clear aligners are commonly used to treat mild to moderate orthodontic issues, including crowded teeth, gaps between teeth, and bite problems. More complex orthodontic conditions may require traditional braces or other treatments.
Clear aligners are prescription devices, meaning they are only safe to use under the supervision of a licensed practitioner, such as a dentist or orthodontist. In-person examination by a dentist or orthodontist can help lower the risks of uneven bite, unintended tooth movement, pain, and tooth loss. After starting treatment, periodic in-person visits can help ensure that your teeth are moving safely and as planned.
How Do Clear Aligners Work?
Clear aligner treatment generally involves the following steps:
Step 1 - Evaluation and Planning: Your dentist or orthodontist will look at your teeth, bite, dental history, and may take X-rays. Digital scans or impressions are used to create a 3D model of your mouth and develop a treatment plan.
Step 2 - Making Your Clear Aligners: A series of customized aligners will be made just for you. Each aligner is designed to gradually shift specific teeth over the course of your treatment.
Step 3 - Wearing Your Aligners: Patients typically wear each clear aligner for one to two weeks before progressing to the next set. For best results, aligners should be worn for at least 20 hours per day or as directed by your dentist or orthodontist.
Step 4 - Progression: Each new set of clear aligners will move your teeth a little closer to their final position. Your dentist or orthodontist will periodically evaluate and monitor your progress. How long your treatment takes will depend on how much your teeth need to shift.
Step 5 - Maintaining your Results: After your last set of clear aligners, your dentist or orthodontist may recommend using a retainer to keep your teeth in place and prevent teeth from shifting back.
Benefits of Clear Aligners
Patients may choose clear aligners over traditional braces for different reasons, such as:
- Less noticeable appearance
- Clear aligners can be removed for eating, brushing, flossing, and cleaning of the clear aligners
- Easier oral hygiene compared to traditional braces
- More comfortable for some patients
- Fewer dietary restrictions
Potential Risks and Limitations
Clear aligners may not be appropriate for every patient. Potential risks and disadvantages include the following:
- May not effectively treat more complex orthodontic conditions
- Clear aligners can be lost or damaged
- Temporary speech changes may occur
- Some patients may experience irritation or allergic reactions to clear aligner materials
- Treatment may not progress as intended if clear aligners are not worn as directed
- Existing dental treatments such as crowns, fillings and implants may loosen or become dislodged and require repair or replacement
- Adverse events such as swelling and laceration (cut or scrape)
What About Online Companies That Sell Clear Aligners Directly to Consumers?
The FDA has not authorized clear aligners that are marketed directly to consumers without supervision by a dentist or orthodontist. The lack of appropriate professional supervision may increase the risk of complications.
Some individual treatment plans may include remote monitoring and virtual dental visits (tele-dentistry). While virtual visits can be a useful part of dental care, periodic, in-person visits to see a dentist or orthodontist can help reduce the risks of an uneven bite, unintended tooth movement, pain, and tooth loss, and ensure your treatment is progressing appropriately.
The FDA has received reports involving non-authorized direct-to-consumer clear aligners in which patients experienced:
- New or worsening dental pain
- Jaw pain
- Bite problems
- Worsening tooth misalignment
- New gaps between teeth
If you are using clear aligners and experience new or worsening symptoms, contact your dentist or orthodontist for an evaluation.
How Do I Know if the FDA has Authorized a Clear Aligner?
You can ask your dentist or orthodontist about the product being used.
You can also search the FDA’s 510(k) database using the product code NXC to determine whether a product has received FDA authorization.
Some companies may say they are FDA-registered, but this is not the same as FDA-authorized. FDA-registered means a manufacturer has simply listed its facility and products with the FDA, whereas FDA-authorized means the FDA has actively reviewed the specific product and cleared or approved it for public use.
Information for Patients
If you are considering clear aligners:
- Make sure you receive an evaluation by a dentist or orthodontist, preferably in-person to determine whether clear aligners are appropriate for you
- Discuss the benefits and risks with your dentist or orthodontist
- Follow instructions regarding wear time and follow-up visits
- Attend recommended appointments during treatment
- Tell your dentist or orthodontist if you experience pain, bite problems, or other unexpected symptoms
Reporting Problems with Clear Aligners
Report serious adverse events to both FDA and the manufacturer. If you suspect a problem associated with a clear aligner, report it through FDA's MedWatch program.
If you can, include the following information:
- Unexpected side effects or adverse events
- Whether additional dental treatment is needed to address the problem
- Name of manufacturer and device
- Device-related concerns (related to fit and function)
- Material integrity issues (problems with the material of the device)
- Tissue reactions (allergies or sensitivities)