A study of a clear dental aligner system for orthodontic treatment

Use of a Clear Aligner System to treat orthodontic malocclusion. The clear aligner system is an alternative to braces and allows for better oral hygiene as the aligner can be removed to allow for brushing of teeth and rinsing with mouthwash. After a 3D scan and x-rays of the teeth, a virtual model of the desired treatment outcome is created and a series of aligners is designed to achieve that outcome. Each aligner is reused on a daily basis, being removed for a maximum of 2 hours each day while consuming liquids other than water, while eating and to brush, floss and rinse to maintain good oral hygiene. The aligner is also worn at night. After use, the aligner should be cleaned by rinsing in accordance with the participant instructions for use and care of the aligner. The participant is instructed by their orthodontist to change aligners every 1-2 weeks at home. These devices are custom-made for each participant and may be used in conjunction with accessories such as buttons and elastics. Modifications to the aligner design and treatment plan can be done as deemed necessary by the treating orthodontist. This information is captured in the CRFs and patient compliance is partly indicated by the reconciliation of the returned, used, aligners. Treatment is projected to last approximately 12 months. Participants will visit their orthodontist quarterly while on treatment and each visit is expected to be approximately 30-45 mins in duration including 3D scans, and safety reporting. The initial and final treatment visits may take up to 30 minutes longer to accommodate x-rays, extra-oral photographs and questionnaire..