Overview: This guide provides the indications, safety warnings, clinical directions, and patient maintenance protocols for the Dandy Clear Aligners System and retainers.
Indications and Clinical Use
Aligner System Indications
The Dandy Clear Aligners System is used for the alignment of permanent teeth during orthodontic treatment of misalignment and malocclusion.
Retainer System Indications
Dandy retainers are used to prevent teeth from shifting positions after the completion of orthodontic treatment.
Safety and Contraindications
Patient Contraindications
Do not use Dandy Clear Aligners if the patient meets these criteria:
Known allergy to plastic materials.
Presence of active periodontal disease.
Health Warnings
Allergic Reactions: Thermoplastic polyurethane may cause rare allergic reactions. Discontinue use if swelling or redness occurs.
Hereditary Angioedema (HAE): Dental appliances can trigger local swelling in patients with HAE.
Aspiration Risk: Accidental swallowing or aspiration of the aligner may occur because the aligner is worn in the mouth.
Precautions and Potential Risks if the Aligner System is Continued
- In the presence of severe crowding, interproximal reduction (IPR—reducing the thickness of enamel on the tooth) may be required to produce enough space for proper tooth movement and alignment. The risks associated with IPR as part of treatment should be considered.
- The health of the gums and bone, both of which support the patient’s teeth, can be affected by wearing aligners.
- Throughout the course of treatment, the bite will change and may result in temporary patient discomfort in the jaw joint. Although rare, patients may experience joint pain, headaches, or ear problems. Patients should inform their doctor if any of these symptoms occur.
- At the end of the treatment, it may be necessary to adjust the bite.
- All teeth should be at least partially covered by aligners to avoid supra-eruption of the teeth.
- Aligner wear can aggravate teeth, including previously traumatized or significantly restored teeth. In rare occurrences, additional dental treatment might be required, such as, but not limited to, endodontic treatment, additional restorative treatment, or the tooth may be lost.
- Root resorption (shortening of the root of the tooth) can occur during any orthodontic treatment, including aligner appliances, and could threaten the longevity of the teeth.
- Supplemental treatment, in addition to aligner appliances, may be required for severe open bite, overjet, excessive crowding, or skeletal jaw disproportions. All surgery and anaesthesia risks must be considered before treatment if oral surgery is required.
- Other fixed and/or removable orthodontic appliances may be required for more complicated treatment plans where aligners alone will not be adequate to achieve the desired outcome.
- Once treatment has been completed, teeth may shift positions if the proper and consistent wearing of retainers is not followed.
- Upon completion of aligner treatment, some cases may require enhancement with additional aligners, traditional orthodontic treatment, and/or cosmetic restorations such as veneers or crowns to achieve ideal results. Successful treatment outcomes are not guaranteed.
Clinical Instructions for Doctors
Initial Setup and Fitting
Rinse the new aligners with cold water.
If extractions were performed, wait for the site to heal before applying attachments.
Perform any required interproximal reduction (IPR) as dictated by the treatment plan.
Seat the Step #1 aligner and check for tissue impingement or bleaching. Trim and polish the aligner if necessary.
Treatment Progression and Follow-up
Wear Schedule: Patients should wear aligners for 20–22 hours daily.
Step Duration: Exchange aligners for the next step in the sequence approximately every two weeks.
Monitoring: Conduct monthly appointments to check interproximal contacts, aligner fit, and general progress.
Advise patients of the following
- Keep aligners away from hot water and harsh chemical solutions.