Innovations of Invisalign Clear Aligners John Morton Director of Research and Technology 1 2016 Align Technology, Inc. All rights reserved. Legal Disclaimer The statements, views and opinions expressed in this program and related course materials are those of the speaker. Align Technology, Inc. may not endorse such statements, views or opinions. Attendees are responsible for legal and regulatory compliance of any marketing and referral programs. 2 2016 Align Technology, Inc. All rights reserved. The Innovation Pathway 2009 2010 2011 2013 2014 2015 Root Torque Extrusion Rotation Multiple Tooth Extrusion Open Bite Multi-plane Attachments Root Control SmartTrack Material Aligner Pressure Areas for Intrusion Precision Biteramps 1 st Premolar Extraction PowerArms 3 2016 Align Technology, Inc. All rights reserved. GEN SESSION_07-23-15 1
Biomechanical Approach Tooth Movement Force System Appliance Design 4 2016 Align Technology, Inc. All rights reserved. Biomechanical Approach Force System Biological System Tooth Movement BIOmechanics 5 2016 Align Technology, Inc. All rights reserved. Biomechanical Approach The proportion of the moment to the force controls the type of tooth movement Smith and Burstone, AJODO, 1984 6 2016 Align Technology, Inc. All rights reserved. GEN SESSION_07-23-15 2
Measurement Technology 7 2016 Align Technology, Inc. All rights reserved. Lingual Root Torque 2009 M PowerRidge Features A change in the shape of the aligner F1 F2 8 2016 Align Technology, Inc. All rights reserved. Is It Better WITH or WITHOUT the Feature? Sources of Variability Doctor s education and approach to treatment Doctor s experience Patient physiology and biological response Did the patient wear the aligners compliance Did the patient wear elastics Were other appliances used 9 2016 Align Technology, Inc. All rights reserved. GEN SESSION_07-23-15 3
Improvement in Predictability of Root Torque Median Lingual Root Torque Planned = 7.4 Degrees Range from 3 to 20 Degrees SAMPLE SIZE (TEST GROUP VS. CONTROL GROUP) P-VALUE Upper Incisors 11,857 >500 % <0.001 Lower Incisors 13,888 >500 % <0.001 Data on file at Align Technology 10 2016 Align Technology, Inc. All rights reserved. Clinical Evidence Extrusion: Laterals, Canines, Centrals Upper Central 95% CI for the Mean Upper Lateral 95% CI for the Mean Upper Canine 95% CI for the Mean Extrusive Force Extrusive Force Extrusive Force #1 #2 #3 #4 #5 #6 #7 #8 #1 #2 #3 #4 #5 #6 #7 #8 #1 #2 #3 #4 #5 #6 #7 #8 This Data is the Foundation of Optimized Attachments 11 2016 Align Technology, Inc. All rights reserved. The Active Surface of the Attachment 2009-2010 The Active Surface is the surface to which the aligner applies force The aligner is Activated to engage this surface 12 2016 Align Technology, Inc. All rights reserved. GEN SESSION_07-23-15 4
Force is Applied Perpendicular to the Active Surface 1. Point of Application of the Force 2. Direction of the Force 3. Magnitude of the Force 13 2016 Align Technology, Inc. All rights reserved. Activation Activation is a change in the shape of the aligner so it applies force to the active surface of the attachment or the tooth surface 14 2016 Align Technology, Inc. All rights reserved. Improvement in Predictability of Extrusion Median Extrusion Planned = 1.3 mm Range from 1 to 3.2 mm SAMPLE SIZE (TEST GROUP VS. CONTROL GROUP) P-VALUE Upper Canine 8,515 <0.001 33% Upper Incisors 16,438 <0.001 43% Lower Canine 3,459 <0.001 69% Lower Incisors 8,958 <0.001 123% Data on file at Align Technology 15 2016 Align Technology, Inc. All rights reserved. Clinical Evidence GEN SESSION_07-23-15 5
Improvement in Predictability of Rotation Median Rotation Planned = 12 Degrees Range from 5 to 40 Degrees SAMPLE SIZE (TEST GROUP VS. CONTROL GROUP) P-VALUE Upper Canine 81,194 <0.001 118% Upper Premolars 10,401 <0.001 60% Lower Canine 56,100 <0.001 88% Lower Premolars 14,472 <0.001 79% Data on file at Align Technology 16 2016 Align Technology, Inc. All rights reserved. Clinical Evidence Root Control : Angulation 2011 The shape of the aligner is altered to produce the forces and moments This is NOT a couple; the forces are not equal 17 2016 Align Technology, Inc. All rights reserved. Improvement in Predictability of Root Tip Median Root Tip Planned = 1.5 mm Range from 1 to 4.6 mm (measured at root center) SAMPLE SIZE (TEST GROUP VS. CONTROL GROUP) P-VALUE Upper Canine 26,588 80% <0.001 Upper Premolars 19,856 56% <0.001 Lower Canine 27,986 94% <0.001 Lower Premolars 12,439 88% <0.001 Upper Central 24,492 100% <0.001 Upper Lateral 25,994 88% <0.001 Data on file at Align Technology 18 2016 Align Technology, Inc. All rights reserved. Clinical Evidence GEN SESSION_07-23-15 6
Multi-Plane Movement 2011 3D movement control An attachment and a pressure point combined to produce the optimal force system 19 2016 Align Technology, Inc. All rights reserved. Treatment of Open Bite 2011 Extrusion of the anteriors as a unit Reaction forces are delivered to the posteriors 20 2016 Align Technology, Inc. All rights reserved. Activations are Unequal 21 2016 Align Technology, Inc. All rights reserved. GEN SESSION_07-23-15 7
SmartTrack Material Force 14-day Aligner Stress Relaxation SmartTrack 2013 Low constant force Excellent thermoforming Returns to its original shape Springback; more NiTi like in performance Time Force measured in simulated oral environment (100% RH @ 37 degrees C) 22 2016 Align Technology, Inc. All rights reserved. SmartTrack Material 2013 Low constant force Excellent thermoforming Returns to its original shape Springback; more NiTi like in performance 23 2016 Align Technology, Inc. All rights reserved. Treatment of Deep Bite FORCE 2014 Single tooth intrusion Intrusion of the anteriors as a unit Reaction forces are delivered to the posteriors; bicuspids extruded to level curve of Spee if necessary 24 2016 Align Technology, Inc. All rights reserved. GEN SESSION_07-23-15 8
Treatment of Deep Bite Optimized Biteramps Disocclude the posteriors 25 2016 Align Technology, Inc. All rights reserved. The Innovation Pathway to G6 2009 2010 2011 2013 2014 2015 Root Torque Extrusion Rotation Multiple Tooth Extrusion Open Bite Multi-plane Attachments Root Control SmartTrack Material Aligner Pressure Areas for Intrusion Precision Biteramps 1 st Premolar Extraction PowerArms 26 2016 Align Technology, Inc. All rights reserved. Invisalign G6 2015 First premolar extraction 27 2016 Align Technology, Inc. All rights reserved. GEN SESSION_07-23-15 9
Invisalign G6 is Powered by Three Critical Elements SmartTrack Aligner material provides gentle, more constant forces to improve control of tooth movements SmartForce Attachments and features engineered to deliver the force systems necessary to achieve predictable tooth movements SmartStage Technology 28 2016 Align Technology, Inc. All rights reserved. SmartStage Technology An advanced algorithm that determines the shape of the aligner at every stage so that the aligner engages with the tooth and the active surface of the attachments to apply the necessary force system 29 2016 Align Technology, Inc. All rights reserved. Invisalign G6 First Premolar Extraction Solution Designed to maximize posterior anchorage Designed to maintain root parallelism during retraction Designed for vertical control The aligner design is based on the principle of Differential Moments to maximize posterior anchorage 30 2016 Align Technology, Inc. All rights reserved. GEN SESSION_07-23-15 10
Newton s Laws An aligner programmed to close the extraction space produces equal and opposite forces on the crowns of the anterior and posterior teeth (the aligner is in equilibrium) 31 2016 Align Technology, Inc. All rights reserved. Producing the Counter-Moment The Invisalign G6 solution is designed to control the force and the moment and produce BODILY MOVEMENT during retraction The counter-moment is produced by Aligner Activations which deliver force to the crown of the tooth and the Optimized Retraction Attachment M 32 2016 Align Technology, Inc. All rights reserved. Controlling the Posteriors Center of Resistance Activations are made to the aligner to apply force to the surface of the tooth and apply force to the Optimized Anchorage Attachments Force from Aligner 33 2016 Align Technology, Inc. All rights reserved. GEN SESSION_07-23-15 11
Differential Moments 34 2016 Align Technology, Inc. All rights reserved. Aligner Activations More Aligner Activations are applied to counter the extrusion and loss of inclination anticipated when closing of a first premolar extraction site and maximum anchorage is desired Aligner Activations 35 2016 Align Technology, Inc. All rights reserved. Power Arms 36 2016 2015 Align Technology, Inc. All rights reserved. GEN SESSION_07-23-15 12
Facilitating the Use of Power Arms 37 2016 Align Technology, Inc. All rights reserved. Facilitating the Use of Power Arms A force applied at the center of resistance results in bodily movement of the tooth F 38 2016 Align Technology, Inc. All rights reserved. Facilitating the Use of Power Arms Space exists to allow the tooth to move 39 2016 Align Technology, Inc. All rights reserved. GEN SESSION_07-23-15 13
Summary of Invisalign 2015/2016 Fundamental biomechanics is being used to advance the Invisalign System The G series of features and solutions have shown to improve tooth movement (better with than without) SmartTrack material is a highly advanced polymer developed by Align specifically for orthodontics and the Invisalign System SmartForce features, SmartTrack material, and SmartStage technology together enable doctors to achieve excellent outcomes with Invisalign aligners 40 2016 Align Technology, Inc. All rights reserved. Thank You! 41 2016 2015 Align Technology, Inc. All rights reserved. GEN SESSION_07-23-15 14