The Use of Clear Aligners With Movement Enhancement Techniques
Phase: NA
Conditions: Malocclusion
Sponsor: Align Technology, Inc.

 
 
 
 
 
 
 
 
 
 
The Use of Clear Aligners with Movement Enhancement Techniques  
NCT02087163 
January 9, 2019  
 

Study Summary  
Title 
The Use of Clear Aligners with Movement Enhancement Techniques  
Objectives 
Evaluated whether movement enhancement techniques increased the rate 
and length of tooth movement, and length of total treatment time.  
Purpose 
The purpose of this study was to use clear aligners to measure tooth 
movement and length of treatment.   
Relevant Scientific 
Background 
Orthodontic tooth movement is the result of forces applied to the crown of a 
tooth and the biological remodeling of the soft and hard tissues. 
The Invisalign® System (Align Technology, San Jose, California, USA) 
accurately fabricates removable clear aligners to move teeth with relative 
precision to provide comprehensive orthodontic treatment.  Some 
practitioners advise patients to change aligners at 1-2 week wear time 
intervals in order to reduce treatment time or for other orthodontic or dental 
reasons. Animal studies in mice and rats have suggested that low magnitude, 
high frequency mechanical stimuli increases the healing of bony lesions in 
non-weight bearing bones, enhances the adaptive remodeling of condylar 
cartilage as evidenced by the advent of endochondral bone replacing 
hypertrophic cartilage, and enhances the effect of mechanical and magnetic 
forces on tooth movement.   
Design 
This was a non-significant risk, multicenter, randomized prospective study 
conducted at three sites in North America. A total of 90 adult patients who 
were eligible for Invisalign® Full treatment per the standard Invisalign® 
Instructions for Use were recruited for the study. Subjects were randomly 
placed into either a 7 day or 14 day aligner wear schedule.  
Primary Outcome 
Tooth movement change was calculated.  
• 
Participants were followed for the duration of orthodontic treatment, 
an average of 78 weeks. 
Secondary Outcome 
Length of treatment change was calculated as number of clear aligners used. 
• 
Participants were followed for the duration of orthodontic treatment, 
an average of 78 weeks.  
Treatment 
Clear aligners with movement enhancement techniques.  

Eligibility Criteria 
Inclusion Criteria: 
A subject were considered eligible if all of following inclusion criteria were 
fulfilled: 
• 
Males or females between the ages of 16-46 inclusive 
• 
Required orthodontic treatment 
• 
Had permanent dentition  
• 
No craniofacial anomaly present 
• 
No past and present signs and symptoms of periodontal disease 
• 
No significant medical history or medication that would adversely 
affect the development or structure of the teeth and jaws and any 
subsequent tooth movement 
• 
No previous orthodontic or orthopaedic relapse 
• 
No history of trauma, bruxism or parafunction 
• 
No skeletal jaw discrepancy 
• 
Angle Class I or Class II molar and canine relationship 
• 
Crowding of at least 4mm per arch 
• 
No osteoporosis drugs 
Exclusion Criteria: 
A subject was considered ineligible if any one of the following exclusion 
criteria were fulfilled: 
• 
Subjects who did not fulfill all inclusion criteria requirements  
Sites 
3 participating doctors in the North America.  
Sample Size 
90 subjects. 
Length of Study 
Approximately 4 years.  
Statistical Analysis 
Plan 
Pretreatment records were analyzed to measure the exact amount of 
crowding. A discriminate analysis was used to ensure that there was no 
significant difference between study groups in any parameters (crowding, 
overjet, overbite, crossbite, gender, age, race,) that may have impacted the 
analysis of the efficacy of the aligners and the aligners with movement 
enhancement techniques.  
A multivariate analysis was conducted to determine if time or treatment 
modality showed an effect.  
 

Rate of tooth movement, length of treatment, and length of total treatment 
time were analyzed between all study groups.  
 
A sample size of 90 was selected to determine if future studies should be 
conducted based on the outcome of this study.  
Results 
Subject Enrollment 
• 
Started: 90 
o 70 female 
o 20 male 
• 
Completed: 73 
• 
Not completed: 17 
All 73 completed subjects were included in the data analysis which was 
conducted by Align’s own statisticians. Tooth movement change was 
measured as a millimeters of change per aligner. Length of treatment change 
was measured as the number of weeks. No Adverse Events were reported.