Clear aligners instructions for use (IFU)

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 anesthesia 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

1. Rinse the new aligners with cold water.

2. If extractions were performed, wait for the site to heal before applying attachments.

3. Perform any required interproximal reduction (IPR) as dictated by the treatment plan.

4. 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.
• Keep aligners out of reach for both young children and pets. When not in use, store aligners in the provided case.
• Aligners worn out of sequence can delay treatment and result in complications, including patient discomfort. Always follow the prescribed order and wear aligners.
• Uncharacteristically shaped teeth 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 re-cementing or replacement. Any new fixed dental restorations placed during aligner treatment may require a revised treatment plan and new aligner(s).
• Aligner appliances are not effective for the movement of dental implants.
• Certain medications and medical conditions can affect orthodontic treatment. Patients should consult their prescribing physician before beginning treatment.
• Sensitivity and tenderness to teeth may occur during treatment, especially when moving 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. Some medications can increase this.
• Extended treatment time may occur due to poor compliance with the doctor’s instructions, wearing aligners less than the prescribed hours, missing appointments, poor oral hygiene, excessive bone growth, or broken appliances. Increased cost and/or the ability to achieve the desired results may occur.
• Irritation of the soft tissue in the mouth (gums, cheeks, tongue, and lips) may occur. Patients should consult with you if this persists.
• Some treatment plans may require “attachments” (small bumps of tooth-colored composite material) to be temporarily bonded to one or more teeth to assist with tooth movement. These are critical to proper movement and should be replaced if they fall off.
• All “attachments” should be removed upon treatment completion.
• Tooth decay, permanent stains or decalcification, and periodontal disease (inflammation of the gums) may occur if proper oral hygiene is not followed and preventive maintenance is not followed.

Patient Care and Maintenance

Daily Cleaning Protocols

• Cleaning Agents: Use a soft-bristled toothbrush and water or Dandy Aligner Cleaner.

• Water Temperature: Only use cool or cold water. Hot water can damage the aligner material

• Prohibited Substances: Do not use denture cleaner, whitening toothpaste, or mouthwash, as these cause the aligners to become dull or cloudy.

Dandy Aligner Cleaner Directions

1. Remove the aligner trays from the mouth.

2. Dispense one full pump of foam inside each tray.

3. Spread the foam evenly with the nozzle tip.

4. Place the trays back in the mouth and spit out any excess foam.

Administrative and Regulatory Information

ADA Codes

Related Information

• Aligner and Retainer Material Safety Data Sheets
• Clear Aligner Turnaround Times