Dentaltown August 2022 - 18

All aligners
are not alike.
Discover clear aligners with excellent
clarity, strength, and gentle,
consistent teeth-moving forces1,2
REALIGN YOUR EXPECTATIONS. VISIT HCP.MYORAFIT.COM
INDICATION:
The OraFit™ Custom Clear Aligner System is indicated for use in the
alignment of permanent teeth through orthodontic treatment of
misalignment and malocclusion.
IMPORTANT SAFETY INFORMATION:
Contraindications: The OraFit™ Custom Clear Aligner System is
contraindicated for patients who:
* Are allergic to plastics
* Have active periodontal disease.
Warnings:
* In rare occurrences, patients may be allergic to the thermoplastic
polyurethane materials of the aligners. Advise patients that if
swelling or extreme redness occurs, discontinue use immediately
and consult you or other health care professional.
* In rare occurrences, patients with hereditary angioedema (HAE)
may experience local swelling and can be triggered by dental
procedures or appliances. If extreme swelling occurs, advise
patients to discontinue use immediately and consult a health
care professional.
* Because the aligners are worn in the mouth, accidental
swallowing or aspiration of the appliance may occur and may
be harmful.
Precautions / Risks:
* Aligners worn out of sequence by patients can result in delayed
treatment and complications, including discomfort.
* Uncharacteristically shaped and missing teeth can potentially
extend treatment time and may affect the potential to achieve
desired results.
* Existing fixed dental restorations (crowns, bridges) may
become dislodged during aligner wear and may require recementing
or replacement. Any new fixed dental restorations
placed during aligner treatment may result in the need for a
revised treatment plan and new aligner(s).
* Aligner appliances should not be used for the movement of
dental implants or fixed bridgework.
* Patients may experience sensitivity and tenderness during
treatment, especially when moving forward from one aligner
step to the next.
* Aligner wear may temporarily affect speech, resulting in a
slight lisp. Patients typically adapt quickly to the aligners within
a week or two.
* Patients may experience an increase in salivation or dryness
of the mouth.
* Irritation of the soft tissue in the mouth (gums, cheeks, tongue
and lips) may occur.
* In the presence of severe crowding, interproximal reduction
(IPR) may be required to produce enough space for proper
tooth movement. Risk associated with IPR as part of treatment
should be taken into account.
* All teeth should be at least partially covered by aligners to
avoid supra-eruption of teeth.
ATTENTION: THIS IS NOT ALL YOU NEED TO KNOW. Please see the
Instructions for Use for detailed directions for use and daily care
/ maintenance, as well as full precautions and risk information.
References: 1. Keller KJ. Stress Relaxation in Orthodontic Aligner Plastics: an In Vitro Comparison Study. Master's thesis. University of Nebraska Medical Center; 2020. Accessed March 10, 2022.
https://digitalcommons.unmc.edu/etd/504 2. What's Zendura FLX all about? ZenduraDental. Accessed March 10, 2022. https://www.zenduradental.com/pages/properties
OraFit is a trademark of Bausch Health Companies Inc. or its affiliates. © 2022 Bausch Health Companies Inc. or its affiliates. OFT.0057.USA.22
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Dentaltown August 2022

Table of Contents for the Digital Edition of Dentaltown August 2022