• Traditional orthodontic treatments for younger patients may not deliver the positive patient experience that doctors strive to deliver and can be time consuming and disruptive to patient lifestyles. Invisalign First clear aligners give these younger patients the same premium orthodontic experience that teens and adults currently receive with Invisalign clear aligner therapy.

• Patients must have erupted permanent first molars and at least any two incisors (permanent or primary) that are at least 2/3rd erupted. Patients should also have at least two primary (C or D or E) or unerupted permanent teeth (3 or 4 or 5) per quadrant in at least 3 quadrants.
• The applicability of the product is driven by the clinical dental inclusion criteria rather than the physical age.

• Invisalign First clear aligners are designed for developing dental arch form and creating space for permanent erupting dentition.
  
  They can also be used to address conditions such as dental arch development, expansion, spacing/crowding, A-P correction, aesthetic alignment, tooth protrusions or interferences.
  
  Invisalign First Phase 1 treatment is also designed to improve efficiency of Phase 2 treatment.
  
  Please note that Invisalign First clear aligners currently do not have specially designed solutions to address Class III, palatal expansion and some habitual problems.

• No. Invisalign First clear aligners are a sub-brand with a specialized product offering specifically targeting younger patients. The clear aligner product features are designed to address younger patients’ unique orthodontic needs to develop arch form and create space for erupting dentition. Align has offerings within our product portfolio for adults and teens. Additionally, the clinical applicability of Invisalign First features are not relevant for adult and teen cases.

• Yes. However, the doctor will not be able to get unique features designed to treat Phase 1 patients that are only available in the Invisalign First package. These features include dental expansion solution, expanded eruption capability, primary teeth detection and a set of Phase 1 specific clinical preferences.

• Invisalign First treatment has been designed to treat Phase 1 cases. There are 5 primary clinical reasons to believe:

  1. Treatment for a broad range of malocclusions:

     • Primary applicability: Develop arch form and maintain space for erupting dentition.
     • Common conditions include, but not limited to are: arch development, expansion, spacing/crowding, A-P correction, aesthetic alignment, and tooth protrusions or interferences.

  2. Predictable dental arch expansion:

     • New and improved staging patterns:
       • Molar move first staging pattern: Molars move first, followed by simultaneous expansion of canines and all posterior teeth (default)
       • Simultaneous staging pattern (improved)
     • SmartForce^® attachments:
       • Optimized expansion support attachments that are automatically placed by software. The attachment is applied when dental arch expansion is programmed. It adjusts and re-sizes based on the buccal tooth surface.
     • SmartStage^® technology:
       • Applied to both new and improved staging patterns. It maximizes treatment efficiency by producing the contacts and forces that support the tooth movement needed for arch expansion.

  3. Short clinical crown support:

     • To improve retention on short clinical crowns, new optimized retention attachments are automatically placed by software.
     • The attachments adjust and re-size based on the buccal tooth surface, allowing for the largest attachments to be placed for the ease of bonding.

  4. Support for erupting permanent dentition:

     • Improved and expanded eruption compensation (EC) features makes it possible to treat patients in early to late mixed dentition:
     • EC is now also available for incisors (in addition to canines and premolars)
     • Advanced proprietary eruption compensation algorithm enables highly accurate space holding for teeth to naturally erupt into the aligners. Available for upper incisors, canines, and premolars. EC for lower incisors is available but with non-algorithm calculation.

  5. Prescription and treatment planning support for Phase 1 treatment:

     • Prescription form includes primary teeth grids and questions customized for Phase 1 treatment
     • Clinical preferences specific for Phase 1 treatments, including primary teeth grids
     • ClinCheck Pro^™ software: new attachment tooltips, messaging and support of Phase 1 primary tooth numbering

• No. The only Invisalign First feature that is also available in the Invisalign aligners adult and teen portfolio is optimized retentive attachments that can be manually requested for 3, 4, 5, 6, 7 via special instructions in Rx form or via comments in ClinCheck Pro software.

What is the average treatment length with the Invisalign First clear aligners?

• In the Limited Market Release, the average length of Phase 1 treatment for primary orders is 36 aligners (+/- 9 stages as per standard deviation), 9 months of treatment.

• Yes, as long as the patient inclusion criteria is met. Invisalign First clear aligners have expanded eruption compensation for 1, 2, 3, 4, 5 and eruption—tab for 6 and 7.

• Yes, Invisalign First treatment is compatible with the Mandibular Advancement feature but is only available for order where MA is sold and with certain dentition inclusion criteria rules to ensure aligner fit and integrity

  • MA inclusion criteria:

    1. The teeth under and adjacent to the precision wings must be present and stable throughout the Mandibular Advancement phase of treatment.
    2. CDEs or 4’s and 5’s should be stable (i.e. not expected to exfoliate or be erupting during the MA phase). Eruption compensation is not available for premolars during the primary MA phase of the treatment. Please note that EC for premolars in only available on secondary orders, including AA orders.
    3. Invisalign First clear aligners patient inclusion criteria also applies: The use of Invisalign First clear aligners requires that patients have erupted permanent first molars and at least any two incisors that are at least 2/3rd erupted. Patients also must have at least 2 primary (C or D or E) or unerupted permanent teeth (3 or 4 or 5) per quadrant in at least 3 quadrants.

• Yes, Align will support continuation of Mandibular Advancement treatment and provide eruption compensation features for premolars in additional aligner orders. However, please note that the performance of the aligners may be compromised.
• Note: Eruption compensations for premolars are not available for primary orders.

• Similar to Invisalign clear aligners, Invisalign First clear aligners are designed to achieve up to 8mm of dental arch expansion. On average, doctors in the limited market release have been planning between 4-6mm of dental arch expansion to reach their treatment objectives. Note that doctors can select the amount of desired arch expansion in the clinical preferences section in the Rx form.

• Both attachments are automatically placed by software. They are adjusted and re-sized based on the buccal tooth surface, allowing for the largest attachments to be placed for ease of bonding.

  • There are 2 main differences:

    1. The first difference is when these attachments are activated: the optimized expansion attachment is activated when dental arch expansion is programmed, while optimized retention attachment is applied when no dental arch expansion is programmed
    2. The second difference is teeth applicability—please refer to the table below:

• Treatment time can vary patient to patient and depending on the doctor’s discernment of the treatment plan, Phase 1 treatment can take anywhere from approximately 6-18 months.

• There are two staging patterns: 1. Molars move first and 2. Simultaneous expansion. Molars move first is the default in clinical preferences that can be easily changed by the Doctor.

• Yes. To improve retention on short clinical crowns, new optimized retention attachments are automatically placed by software.
  • Attachments are automatically placed by software on permanent first molar, primary second molar (or second premolar).
  • The attachments adjust and re-size based on the buccal tooth surface, allowing for the largest attachments to be placed for the ease of bonding.
  • Attachments will be only placed if no other optimized attachments are placed due to presence of an applicable tooth movements or if it does not conflict with your clinical preferences.

• Yes. Improved and expanded eruption compensation (EC) features make it possible to treat patients in early to late mixed dentition.
  • Eruption compensation is now also available for incisors (in addition to canines and premolars).
  • Advanced proprietary eruption compensation algorithm enables highly accurate space-holding for teeth to naturally erupt into the aligners. Available for upper incisors, canines, and premolars.
  • Eruption compensation for lower incisors is available but with non-algorithm calculation.
  • Doctors select which teeth for which they would like eruption compensation on the Rx.

• Weekly aligner changes (without slowing down velocity) are recommended; however, the decision to prescribe weekly aligner changes is at the doctor’s discretion based on patient needs. As a reference, some doctors in the Limited Market Release changed aligners anywhere between 4-7 day range.

• Yes. iTero element will have a new case type added called “Invisalign First treatment” to enable easier ordering process for Invisalign First treatment. Please note that iOSim will not be available for Invisalign First clear aligners.

• Phase 1 Limited Market Release cases are in progress. Finished cases will be available in May 2018 and later to assess the max amount of expansion achieved. Invisalign First clear aligners were designed for up to 8mm and doctors in the limited market release planned between 4-6mm with dental arch development/dental expansion.

• Doctors can order additional aligners to reach the desired expansion amount or achieve any movements that were planned that fit within the AA policy for the Invisalign First comprehensive package (AA policy: 18 months). The AA policy has been designed to support any secondary orders, and it is not meant to cover Phase 2 treatment.

• Compliance indicators are available as a customizable add-on for Invisalign First clear aligners and the Phase 2 portfolio.

• The doctor should use the eruption compensation feature of the Invisalign First clear aligners; however, doctors can order pontics through special instructions.

• The doctor has the option to purchase a discounted Comprehensive Phase 2 Package. Alternatively, the doctor has the option to purchase any of the products within the product portfolio but the discount is only applicable to the Comprehensive Phase 2 Package.

• Yes, there is a time limit to complete Phase 1 treatment in order to still be eligible for a discount on Phase 2 treatment.
  • In order to be eligible for a discounted Comprehensive package, treatment with Invisalign First clear aligners should be completed within the past 10 years, as measured from the shipment date of the initial aligners associated with the most recent Invisalign First treatment.

• The 10-year time period was selected based on the eruption timeframe of exfoliating primary teeth and erupting permanent teeth to ensure that Phase 2 can be started in late mixed-permanent dentition.

• Doctors are able to order Vivera® retainers and Invisalign retainers. Commercially available retainers (e.g. Hawley, Theroux) are also available.
  
  At this time, Vivera and Invisalign retainers do not have eruption compensation capability to support patients during the course of exfoliating / erupting dentition. Therefore, Vivera and Invisalign retainers usage between Phase 1 and Phase 2 treatments might be very limited and used only during a limited time period when stable dentition is present.

• No, both products have unlimited stages.

• Single arch pricing will be available for the Invisalign First Comprehensive package.
  
  Single arch pricing is not available for the discounted Comprehensive Phase 2 package.

• A doctor who uses Invisalign First clear aligners for Phase 1 treatment can receive a discount on Invisalign Comprehensive if he/she chooses to use that product for the patient’s Phase 2 treatment.

• Yes, eruption compensation and eruption tabs are available at no additional cost.

• Unlimited AA are available free of charge for 18 months for the Comprehensive Phase 1 Package.

• Phase 1 treatment has limited treatment objectives. Phase 1 is not necessarily designed to finish the occlusion and it is completed when the doctor and patient treatment objectives are met, thus the treatment length is typically shorter than Phase 2.

• Unlimited AA are available free of charge for 3 years, and for a fee for 2 years.

• Invisalign First Comprehensive package: 18 months after the shipment date of the initial set of aligners.
• Discounted Comprehensive Phase 2 package: 5 years after the shipment date of the initial set of aligners.

• Yes, the discount is transferrable by patient. In order for the discount to apply, Invisalign records must be transferred to the doctor scheduled to conduct Phase 2 treatment.

• Doctors can order Invisalign First clear aligners by selecting the “child” option in IDS. This will direct the doctor to the Invisalign clear aligner options, from which the doctor can access the Invisalign First Comprehensive package offering. Refer to the new “How to Order” slick for additional information.

• Yes, only if the primary order is Invisalign First clear aligners.
  • Secondary orders that are allowed for Invisalign First treatment:
    1. Warranty
    2. Additional Aligners
    3. Replacements

• The doctor will be able to see a new Status on the Patient file and Patient List page in IDS under the “In Treatment” tab showing that patient is eligible for Phase 2 treatment after Phase 1 treatment expiration date (TED) is reached. Phase 1 Patients shall not be automatically archived after TED is reached.

• Upgrade:
• Doctor can upgrade from Comprehensive Phase 2 Package that has 3 years unlimited AA policy to Invisalign Comprehensive Package that has 5 years unlimited AA policy
• Downgrade:
• No automated downgrade switch is allowed
• Downgrade from Comprehensive Phase 2 Package to Express and Lite Packages can only be manually requested through comments during ClinCheck^® review
• Switches not permitted:
• Switch from Invisalign First Comprehensive Product to any Phase 2 product in the portfolio
• Switch between Comprehensive Phase 2 Package and Assist Package

Doctors have switching control for all products in the new portfolio

• All switches up to a higher stage product can be managed through SWITCH or comments in ClinCheck Web^®/ClinCheck Pro^™
• All switches down to a lower stage product can be managed through comments in ClinCheck Web/ClinCheck Pro

• Before July 1, 2018, we recommend completing any prescriptions that are in progress.
• Before July 1, 2018, please upgrade to the latest version of ClinCheck ProTM. If you are not using the latest ClinCheck Pro software available on all of the computers used for treatment planning in your practice, please upgrade now. Utilizing the latest version of ClinCheck Pro assures you have the latest treatment planning features including those being introduced in the new Invisalign product portfolio.

To download and install the latest version of ClinCheck^® visit: https://resources.invisalign.com/us/Support/Pages/ClinCheckPro.aspx

To view the version of ClinCheck Pro installed on your computer:

• Open ClinCheck Pro [See visual]
• Click on the “ClinCheck Pro” menu in the upper left corner
• Click on “Help” from the ClinCheck Pro menu
• Click on “About ClinCheck Pro” from the Help Menu
• A screen will load that shows the current version of ClinCheck

Each computer in your office should be upgraded to a ClinCheck Pro version starting with 5.3 or 5.4. If an older version is in use, visit the following page on the Invisalign Doctor Site to download the latest version of ClinCheck Pro: https://resources.invisalign.com/us/Support/Pages/ClinCheckPro.aspx

Treating with the new Invisalign First Comprehensive Package will require the use of the latest version of ClinCheck Pro software.

The ordering process workflow on the Invisalign Doctor Site will be redesigned as of July 1, 2018. Please see above section which provides an overview of this new workflow.