FDA Clears Aligner Treatment With Mandibular Advancement

Richard Gawel


The Food and Drug Administration (FDA) has cleared Invisalign treatment with mandibular advancement for commercial availability in the United States. According to Align Technology, Invisalign treatment with mandibular advancement is the first clear aligner solution for Class II correction in growing tween and teen patients that combines the benefits of clear aligner treatment with features for moving the jaw forward while simultaneously aligning the teeth. The company further says that this solution offers a simpler, more efficient, and patient-friendly treatment option than functional appliances typically used to treat teen Class II patients.

“Class II malocclusion is the largest opportunity in the teen segment, representing close to 45% of the 9 million teen case starts worldwide each year,” said Raphael Pascaud, Align Technology chief marketing officer. “We believe that Invisalign treatment with mandibular advancement offers significant benefits to both doctors and their patients and is an effective alternative for Class II elastics and other traditional functional appliances like twin blocks.” 

In Class II treatment, doctors align the teeth and advance the lower jaw to improve the patient’s profile. Invisalign treatment with mandibular advancement is designed to replicate the action of commonly used functional appliances for Class II correction through new “precision wings” that hold the mandible in a forward position while simultaneously correcting malocclusion and crowding issues. Traditionally, doctors often correct the mandible position and straighten the teeth in separate phases, resulting in a longer overall treatment time.

“I think Invisalign treatment with mandibular advancement targets every deficiency we have with the old functional system,” said Dr. Sam Daher, an orthodontist with practices in Vancouver, British Columbia. “I like the fact that we can start Invisalign treatment early. We don’t have to wait until the adult teeth are in completely. We target kids right at the beginning of the growth spurt, between the ages of 11 and 12. We’re getting excellent results with these kids. I really think it’s because kids are motivated to wear their aligners to get rid of their overbites.”

Invisalign treatment with mandibular advancement can replace Class II elastics and functional appliances while offering significant benefits to the doctor and patient, Align Technology says. For example, the single-appliance solution is easy to use and saves the cost and time of adjustments and repairs, the company reports. Its mechanism of action also replicates that of functional appliances across a range of mild to severe cases. The simultaneous Class II correction and anterior teeth alignment may be more efficient than traditional treatment approaches, with patient-pleasing anterior alignment occurring earlier.

Invisalign treatment with mandibular advancement will be commercially available in the United States on November 19.

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