1. What is Invisalign treatment with mandibular advancement, and what are the key features?

   • Invisalign treatment with mandibular advancement, the first clear aligner solution for Class II correction in growing tween and teen patients. This new offering combines the benefits of the most advanced clear aligner system in the world with features for moving the lower jaw forward while simultaneously aligning the teeth. Invisalign treatment with mandibular advancement offers a simpler, more efficient and patient-friendly treatment option than functional appliances to treat teen Class II patients.
     
     The main features are: the precision wings placed between the 1st molar and premolars (variations may occur; wings could be positioned as forward as the 1st premolar), made from SmartTrack^® material, and strengthened with specialized design that reinforces structural integrity.

2. Was Invisalign treatment with mandibular advancement clinically evaluated?

   • Yes, a multicenter prospective IRB clinical study was completed with 80 patients in North America. Preliminary results from 42 cases thus far show statistically significant correction of Class II malocclusion in growing teen patients.
     
     To date, over 15,000 patients from North America, Europe, and Asia-Pacific have received Invisalign treatment with mandibular advancement.

3. Which Invisalign doctors were involved in the clinical study?

   • Dr. Sam Daher/Dr. Lam, Dr. Sandra Tai, Dr. Regina Blevins, Dr. Gary Brigham, Dr. Donna Galante, Dr. Barry Glaser, Dr. Mark Holt, Dr. Bill Kottemann, Dr. Sandra Selnick.

1. Why doesn’t the aligner in the area of the precision wings cover the gingiva when seated?

   • The raised gingival cutline at the precision wings is designed to ensure patient comfort by preventing impingement of the gingiva when the precision wings engage.

2. What material is the precision wings?

   • SmartTrack material.

3. Which product packages include the mandibular advancement feature option?

   • It is available with the following following new product portfolio packages:
     • Invisalign Comprehensive package under Teen and Adult patient types
     • Invisalign Comprehensive Phase 2 package (discounted package for patients who have undergone Phase 1 treatment)
     • Invisalign First Comprehensive package
     • For existing Invisalign patients that began treatment prior to July 1, 2018, MA is available on the old Invisalign Teen product only.

4. What is the price of the mandibular advancement feature?

   • There is no additional costs associated with the mandibular advancement feature.

5. What ClinCheck software is compatible with Invisalign treatment with mandibular advancement product?

   • ClinCheck version 5.1 or later is required for Invisalign treatment with mandibular advancement. It’s a manual (not-silent) upgrade.

6. What’s the aligner wear frequency with Invisalign treatment with mandibular advancement?

   • Default is weekly wear, but the doctors can follow their protocols and adjust on a case-by-case basis during setup. (Adjustments may affect the default protocol of 2mm incremental advancements at every 8 stages (2 months) with weekly aligner changes.)

7. In cases in which compliance indicator cannot be placed on the buccal aspect of the aligner because of precision wings, is there any alternative?

   • Yes, the compliance indicator can be placed in the lingual side of the aligner.

8. What are the linear grooves that surround the precision wings in the aligners?

   • The linear grooves are features to enable the manufacturability of precision wings. These are cosmetic artifacts and do not affect the force system on the teeth.
     
     They are generated dynamically on every aligner avoiding attachments and can go up to distal side of canines.

1. What’s the range of cases that can be treated with Invisalign treatment with mandibular advancement?

   • Mild to severe Class II cases.

2. For what type of patients can Invisalign treatment with mandibular advancement be used?

   • It is ideal for growing patients in permanent dentition or stable late mixed dentition who present with retrognathic Class II malocclusions. However, there is no age limit as long as permanent 1st molar is erupted and there are no erupting teeth under the precisions wings.

3. Can Invisalign treatment with mandibular advancement be used in extraction cases?

   • It can be used for extraction cases, as long as extraction site is not under precision wings. However, no pontics are available for premolar extraction cases.

4. Can the doctor use vertical elastics during the course of treatment with Invisalign with mandibular advancement?

   • Yes. As long as precision cuts are not placed on the area where precision wings are located. Precision cuts can be requested through the mandibular advancement section of the Rx form, under the question “Precision Cuts for Vertical Elastics.”

5. What’s the recommended age range for when the feature can be used?

   • Mandibular advancement is recommended for patients 11-16 years old in growth spurt. Clinical results will vary outside of the recommended age range.

6. Since at least 1.5mm of space will be applied between upper and lower, will anterior segments not have contact during the mandibular advancement phase?

   • The 1.5 mm disengagement (virtual) means that there can be contact, because there is space for the thickness of upper and lower aligners.

7. According to the typodont of mandibular advancement, anterior segments are contacting. Does this mean anterior segments are contacting during the mandibular advancement phase in the intra-oral condition?

   • The contact will happen in the part of the arches with the narrowest distance when the mandible is closing in the advanced position. Normally in anterior teeth.

8. Should the doctors be concerned about TMJ?

   • Pilot doctors did not report about TMJ issues so far. Comparing it with other functional appliances the TMJ concerns may be similar or even less, because we program multiple small advancements instead of a “big jump”.

9. Is the velocity protocol same for mandibular advancement phase and non-mandibular advancement phase (pre-mandibular advancement phase and additional aligners after mandibular advancement phase)?

   • We are recommending one week wear without making adjustments to the velocity. Velocities will be calculated as per standard process for ClinCheck treatment plan setup.

10. Default setting of mandibular advancement is weekly aligner, but what about warranty period?

    • We have been messaging one week wear, so no changes to warranty policies.

11. Is it okay to offer the warranty aligner as long as the aligner wearing period is less than 2 weeks?

    • Warranty is based on number of aligner, so still applies to 1, 2 and 3 for fitting issues. Other issues are warranty defects.

12. Can chewies be used with mandibular advancement aligners with precision wings?

    • If it is due to assist posterior intrusion, it is not recommended, to maintain the integrity of the precision wings. If it is being used to improve the fitting of the aligners, use the chewy on the anterior segment to make sure that there is no full closure and avoid smashing the precision wings.

13. Why, during mandibular advancement phase, sometimes there aren’t any tooth movements programmed during the last aligners of treatment and the “Staging” tab in ClinCheck software shows the lower arch with active aligner movements on all teeth until the end of the mandibular advancement phase?

    • There may not be any tooth movements programmed, however, the aligners are activated with the precision wings working to place the mandible in the advanced position.

14. Is it possible to close the space of an anterior tooth extraction and advance the mandible simultaneously with mandibular advancement?

    • According to our protocol, a pontic can be placed but the space cannot be closed during pre-mandibular advancement or mandibular advancement phase.

15. Will Align support deep bite overcorrection/overtreatment?

    • We do not recommend planning for deep bite overreaction or overtreatment as this could adversely impact software calculation of appropriate wing placement for optimal engagement. With the U.S. launch of mandibular advancement, we have improved our software to take into account this potential clinical delay in anterior intrusion and programmed the precision wing overlap accordingly.

16. Does Align support requests for other advancement options or amounts?

    • Yes, on the Rx form, there are now two options under mandibular advancement staging. Doctors can choose either A. 2mm incremental advancements at every 8 stages to the end of mandibular advancement phase setup position (recommended option) or B. Single advancement to the end of mandibular advancement phase setup position. If doctors would like to request other advancements amounts (i.e. uniform 1mm jumps, uniform 3 mm jumps, uniform 4 mm jumps, 2 jumps, 3 jumps or 4 jumps) they can do so through “Special Instructions” in the Rx form and during ClinCheck modifications.
      
      Please note that if wing placement fails with 2 mm incremental advancement, we will attempt a single advancement (for cases where total A-P correction is less than or equal to 6 mm) or two uniform advancements (for cases where total A-P correction is greater than 6 mm).

17. What happens to cases that fail wing placement with the default protocol of 2mm incremental advancements at every 8 stages?

    • If the total A-P correction is less than or equal to 6 mm, the software will implement a single jump. If total A-P correction is greater than 6mm, we will implement two uniform jumps. If precision wings still cannot be placed, the case will be setup with class II elastic simulation.

18. Is it possible for doctors to request custom staging during the pre-mandibular advancement or mandibular advancement phase?

    • No, customized staging requests are not possible.

19. What happens to cases that have an initial severe deep bite > 7 mm?

    • There is no limitation on the maximum amount of deep bite that is applicable for mandibular advancement treatment. Our software will auto configure pre-mandibular advancement movements for cases with a severe deep bite > 7 mm for successful precision wing placement. However, based on our clinical analysis, cases starting with a severe deep bite should proceed at doctor’s discretion, as results depend on anterior intrusion and leveling the curve of Spee.

20. What happens if a primary molar (D or E) exfoliates during the mandibular advancement phase?

    • On the primary order: The exfoliation of D or E may compromise the stability of precision wings, which is why we recommend that patients have D’s and E’s present with primary root structure, with or without congenitally missing 4s or 5s which have approximately 1 year from exfoliation, so that the mandibular advancement appliance can be worn for at least 1 year without exfoliation or loss.
      
      On the secondary order: Customers can order eruption compensation on additional aligners (AA). It will be the doctor’s judgement to see if ordering AA is needed or not. If the doctor doesn’t need to preserve the space of D and E are they are exfoliated, then ordering AA would help to get the eruption compensation (EC) that fits the size of premolars. Or if the aligner edge is irritating the gingiva, then ordering AA with EC would be more comfortable for the patients. Doctors should take new scans and records to submit with the AA order.

21. Can customers request lingual attachments for teeth that are under the precision wings?

    • Yes, customers can request lingual attachments through “Special Instructions” and during ClinCheck modifications. Monitor for any unwanted tipping of the teeth under the precision wings that may have lingual attachments especially if the patient inadvertently bites on the precision wings. If you notice any buccal tipping, debond the lingual attachment and continue treatment as necessary.

22. Can the mandibular advancement feature be used to address respiratory, sleep apnea, or TMJ problems?

    • Invisalign with mandibular advancement was designed for Class II correction in growing patients. Invisalign with mandibular advancement is not for usage with respiratory, sleep apnea, or TMJ problems and in some markets is considered off label use for these indications.

23. I see a large interarch space in ClinCheck treatment plan—why is this?

    • The interarch space in the ClinCheck treatment plan may look increased in deep bite cases with programmed anterior intrusion (as compared to other mandibular advancement treatment plans). This is intentional to enable greater wing engagement throughout all stages of mandibular advancement treatment.
      
      Please note that interarch opening and wings in ClinCheck setup are a virtual representation without an articulator. Clinically, the interarch opening will vary based on the patient bite and how the wings engage intraorally.

24. Can mandibular advancement be used with Invisalign First?

    • Mandibular advancement was designed to perform at its best when the patient is a peak growth phase and with stable dentition (or non-exchanging dentition) under the precision wings throughout treatment. Our recommended age range for use of Invisalign treatment with mandibular advancement is from 11-16 years old.
      
      Often in Invisalign First cases, dentition under the precision wings can be exfoliating if primary teeth or erupting if permanent teeth. In order to maintain the integrity of the aligners, Align’s recommendation is to defer using Invisalign treatment with mandibular advancement with stable dentition under the precision wings.
      
      In addition, there is a possibility that complete Class II correction may not be achieved within the allotted time period for additional aligners covered under Invisalign First (18 months). Therefore for additional aligner coverage, it is recommended to select Invisalign Comprehensive in cases where the doctor would like to use Invisalign treatment with mandibular advancement.

25. Does Align^® support requests for symmetrical placement of wings on the left and right sides?

    • No, we do not support this, and doctors cannot directly specify on which teeth the precision wings are placed. Due to positions of the teeth, sometimes the wings may be placed forward closer to the 4/5 on one side and closer to 5/6 on the other side. This happens due to tooth positions and tooth size differences on both sides of the arch and tooth movements that are going on within the case. We have reduced the frequency of precision wings moving around the arch; however, as the teeth are also moving within the arch, unlike traditional appliances, some movement of the precision wings is expected. The placement of the wings slightly forward on one side vs. the other should not cause any clinical asymmetry nor affect clinical performance as the mandible is still being brought forward per the ClinCheck setup.

26. Why can’t doctors get precision wings in some mandibular advancement cases?

    • Despite best efforts, please expect that in a marginal percentage of cases, precision wings for mandibular advancement cannot be placed due to a combination of several factors that prevents successful placement at one or more stages of treatment: clinical crown height, posterior interarch opening and interarch width discrepancy. If precision wings cannot be placed, the case will be setup with Class II elastic simulation.

27. Does Align support requests for longer precision wings?

    • No, we cannot support requests for changes to the size or shape of the precision wings.

28. Are there any considerations for dolichofacial patients?

    • Dolichofacial and vertical growth patients may benefit from the support of vertical elastics to ensure wing engagement.

29. What can doctors do to ensure optimal wing engagement?

    • If the wings stop engaging during mandibular advancement treatment, here are some potential approaches:
      • Supplement with vertical elastics to help with engagement
      • Patient re-education (position forward, do not bite on wings, etc.)
      • Additionally, some doctors have reported success with the use of Class II elastics at the beginning of treatment for 4-6 weeks to help patients habituate to posturing forward.

Records

1. What type of photos are mandatory for mandibular advancement treatments? Must additional mandibular advancement photos (in edge to edge position) be submitted?

   • The required photos are in maximum intercuspation (centric occlusion). Photos in edge to edge position are not mandatory.

2. Out of the 6 additional photos for mandibular advancement, which is the most important photo (which view) for the technician to setup CC?

   • The intraoral lateral view photos in centric occlusion (right and left).

3. When uploading additional mandibular advancement photos in edge to edge position, will the technician setup the edge to edge position accordingly?

   • If additional edge to edge photos were submitted, the edge to edge corrected position will be set according to the end of mandibular advancement software parameters, unless otherwise specified by the doctor.

4. Why do the models have to be set in centric occlusion at initial position (stage 0). Would it be possible to set the initial bite (stage 0) in the corrected position (edge to edge)?

   • No, centric occlusion photos are mandatory. Initial bite set will need to be centric occlusion, the software will position the corrected position according to the end of mandibular advancement software parameters.

5. If the doctor submitted additional photos with edge to edge position, why in ClinCheck software he/she can only visualize the centric occlusion photos?

   • Edge to edge position photos provided by the doctor are not mandatory. If additional edge to edge photos were submitted, they can be used by the technician during setup based on the doctor’s special instruction. However, these photos are not intended for visualization in ClinCheck.

6. Regarding eruption compensation requests in prescription form, will the system grey out the option of placing them on bicuspids or cuspids when selected to treat with mandibular advancement?

   • None will be greyed out. All will be available for this section. If 5s or 4s are not fully erupted, we won’t apply mandibular advancement.

Pre-mandibular advancement phase

1. What is the purpose of the pre-mandibular advancement phase, and why is it needed?

   • Pre-mandibular advancement is automated to move teeth just enough to allow for precision wing placement. Otherwise, Align does not recommend delaying the start of the mandibular advancement phase if the patient is at the appropriate, critical growth period for success. The following types of pre-mandibular advancement phase movements are auto-configured by the software for successful precision wing placement:
     • In class II, div 2 cases: procline incisors and create at least 2 mm overjet for first jump
     • Derotate molars to a minimum of 20 degrees
     • For severe deep bite > 7 mm, leveling the curve of Spee and intrude anteriors to a minimum of 7 mm overbite
     • For posterior crossbite, improve posterior buccal overjet so that it is within the -2 mm to 4 mm range for precision wing placement

2. Is it possible to perform distalization / mesialization during the pre-mandibular advancement phase?

   • No, in the pre-mandibular advancement phase, customized staging requests are not possible. Pre-mandibular advancement phase is intended for adjustments to tooth positions to increase success of precision wing placement. (Please note: up to 1 mm of distal or mesial movement may occur to improve setup as necessary.)

3. Could the doctor request for more than 24 aligners on pre-mandibular advancement phase?

   • The pre-mandibular advancement phase is 4 stages minimum. There is currently no maximum restriction on the pre-mandibular advancement phase.

Mandibular advancement phase

1. In what phase of treatment is Class II corrected?

   • Class II is corrected during the mandibular advancement phase simultaneously with anterior teeth alignment.

2. How long is mandibular advancement phase?

   • Minimum of 26 weeks with 4 transitional aligners.

3. What’s the default setup for incremental mandibular advancements?

   • 2mm incremental mandibular advancements (or jumps) in 8 stages but last jump may be up to 2.5mm in 12 stages minimum or more stages depending on the overjet amount (note: this includes holding time of at least 12 stages/3 months in the corrected position), total minimum of 26 stages excluding transitional aligners with precision wings for corrected position.

4. Does Align support requests for variable advancement during the mandibular advancement phase?

   • Our software does not currently support variable advancement, such as 3 mm in the first jump, but 2 mm for the second jump.

5. How specifically can the doctor request for asymmetric advancement on each side?

   • Considering the lower arch as a “unit”, the doctor cannot specify the amount of correction on each side. The software will automatically program it.

6. Can the doctor request a setup final position, without matching the midlines?

   • This request is possible. Under the “Mandibular Advancement” section of the Rx form, for the question “Asymmetrical Movement of the Lower Arch,” doctors can select “Do not shift the lower arch to improve midlines during the mandibular advancement phase” so that software will not attempt to shift the lower arch transversely to improve midlines.

7. Can one jump be programmed if requested?

   • Yes, under the “Mandibular Advancement” section of the Rx form, for the question “mandibular advancement staging,” doctors can select “Single advancement to the end of mandibular advancement phase setup position” to request single advancement (with the caveat that patient comfort may be impacted in cases with significant A-P discrepancy).

8. Are we able to modify the amount of mandibular advancement?

   • Yes, by adjusting the end of mandibular advancement position.

9. Does final position of mandibular advancement phase have to be edge to edge? What if the doctor does not want to finish mandibular advancement-phase with edge to edge position, can it be adjusted?

   • No, final position does not have to be edge to edge. This final position can be adjusted. Under the “Mandibular Advancement” section of the Rx form, for the question “End of mandibular advancement phase setup position,” doctors can select “Lower arch 1 mm beyond edge to edge position” or “Lower arch 2 mm beyond edge to edge position” as alternatives to the default “Edge to edge position.”

Transitional aligners

1. Why is transitional phase needed?

   • Transitional phase is needed to allow further holding of the correction with transitional aligners (4 aligners by default) and time to transition to the next set of aligners for post-mandibular advancement phase. No tooth movement is programmed to ensure the fit of the next series of aligners as records are taken and submitted before the start of transitional phase.

1. Can lingual attachments be placed on canines and incisors?

   • Yes, as long as they don’t interfere with precision wings, they can be placed.

2. In cases with short clinical crowns, what sort of attachment will the technicians place to increase retention?

   • Technicians are not placing attachments to add retention. The software is automatically placing optimized retention attachments when possible.

3. Why is the software usually making 12 aligners for the last jump (holding period) during mandibular advancement? Even when there is no need to balance or when it balances mandibular advancement for more than 26 aligners?

   • The last jump (holding period) is 12 aligners by default to hold the patient at the final jaw position for 3 months. This 12 stages is independent of amount of advancement in the last jump that can vary from case to case.

4. Is there a limitation to the maximum amount of overjet applicable for mandibular advancement?

   • No, there is no limitation in the maximum amount of overjet.

5. What is the limit of transitional aligners a doctor can request?

   • Not more than 15 transitional aligners.

6. Is Class II always corrected during mandibular advancement phase?

   • No the full Class II to Class I correction may not always fully correct depending on the severity of the case or the patient compliance, or growth. Sometime, a second mandibular advancement phase might be needed. Alternatively, an additional aligner with Class II elastics is needed to fine tune the correction.

7. Can I adjust the length of the phases or make any other special requests?

   • Yes. See the list below:
     • Adjust the length of phases in Invisalign with mandibular advancement treatment (default is 26 weeks)
     • Doctor can request to setup the jaw advancement to 1mm or 2 mm beyond edge to edge (default is set edge to edge position)
     • Can adjust the number of jaw jumps
     • Doctor can request more transitional aligners (default is 4)

1. If a doctor makes a modification in ClinCheck software (ClinCheck Pro^™ and ClinCheck Web^® versions) and adds attachments or precision cuts on teeth that are under precision wings, which cannot be done, will the doctor receive a comment explaining the reason why the feature could not be placed?

   • Yes, every time a doctor instruction cannot be followed, there has to be a comment that explains the situation.

2. Will by default all attachments be automatically removed during transitional phase aligners on ClinCheck plan of mandibular advancement? Does this need to be requested?

   • Transitional aligners are copying the last mandibular advancement phase, if such has attachments, then there will be attachments. Attachment removal can be requested for transitional aligners.

3. Why do precision wings move from stage to stage and there are differences per side (right and left)? Why do they jump from premolars to molars in one stage?

   • Precision wings change location due to changes in tooth movements and multiple other factors. Tooth movements and the precision wings height and placement, are determined by the software.
     
     This is the comment that will be placed:
     
     Precision wings are automatically placed by the software depending on the tooth and jaw position at each stage. Therefore, there can be differences in the wing height and position at each stage due to the corresponding changes in the tooth and/or jaw positions. At this time, we are not able to manually adjust the height or position of the wings.

4. Can I get aligners with no tooth movement in any arch and with mandibular advancement (like passive aligners with precision wings)?

   • Transitional aligners are intended to hold the mandible in an advanced position while waiting for standard Invisalign aligners or additional aligners to be delivered. No additional tooth movements are programmed or allowed on these aligners. If doctors need transitional aligners, please plan and request for them on the initial order.
     
     If tooth movements have been completed and the doctor requires more aligners for advancing the mandible, they can ask for additional aligners, which include tooth movements.

Mandibular advancement phase with additional aligners (AA)

1. If the residual overjet is less than 2mm after the initial treatment with or without mandibular advancement, can the doctor request for mandibular advancement treatment during additional aligner phase?

   • Yes.

2. When the amount of mandibular advancement is just 2mm or less, why mandibular advancement phase still need to have 26 stages.

   • According to our protocol for primary mandibular advancement orders, at least 26 stages are required to apply mandibular advancement to a treatment plan. There is no minimum stage length for secondary orders.

3. Are new impressions required for additional aligner with mandibular advancement if primary order was treated with mandibular advancement?

   • No, they are not. However, it is recommended to send them.
     
     We can proceed with old impressions as long as the patient is wearing the initial stages or up to the middle of the treatment and if the reason for submission is 1,2,3 aligner fit issues/change in the number of jumps/change the amount of transitional aligners/same treatment plan but requests changes in attachments, features for example. If this is not the case, we request the doctor to send new records.
     
     Also, we cannot proceed with mandibular advancement treatment if doctor submits AA order for single arch only (treat lower only) or if they submit AA order for both arches but send new impression/scan for one arch only. We need to treat both arches and we need 2 new impressions.

1. What happens to Rx form that are in progress prior to the November 2018 roll out of the new mandibular advancement questions on the Rx form?

   • If mandibular advancement is selected, you will see the new mandibular advancement questions, with answers set to the Align default responses. Customers should review the new section carefully and select the desired responses (preferences).

2. For additional aligner orders, will all the prior selections for mandibular advancement setup be defaulted from the primary order?

   • No, for additional aligner orders, the mandibular advancement questions will be set to Align default responses. Please review the options carefully to select your desired responses.