How Well Does Invisalign Work
How Well Does Invisalign Work
How Well Does Invisalign Work
Introduction: The purpose of this prospective clinical study was to evaluate the efficacy of tooth movement
with removable polyurethane aligners (Invisalign, Align Technology, Santa Clara, Calif). Methods: The study
sample included 37 patients treated with Anterior Invisalign. Four hundred one anterior teeth (198 maxillary
and 203 mandibular) were measured on the virtual Treat models. The virtual model of the predicted tooth
position was superimposed over the virtual model of the achieved tooth position, created from the
posttreatment impression, and the 2 models were superimposed over their stationary posterior teeth by
using ToothMeasure, Invisalign’s proprietary superimposition software. The amount of tooth movement
predicted was compared with the amount achieved after treatment. The types of movements studied were
expansion, constriction, intrusion, extrusion, mesiodistal tip, labiolingual tip, and rotation. Results: The mean
accuracy of tooth movement with Invisalign was 41%. The most accurate movement was lingual constriction
(47.1%), and the least accurate movement was extrusion (29.6%)— specifically, extrusion of the maxillary
(18.3%) and mandibular (24.5%) central incisors, followed by mesiodistal tipping of the mandibular canines
(26.9%). The accuracy of canine rotation was significantly lower than that of all other teeth, with the exception
of the maxillary lateral incisors. At rotational movements greater than 15°, the accuracy of rotation for the
maxillary canines fell significantly. Lingual crown tip was significantly more accurate than labial crown tip,
particularly for the maxillary incisors. There was no statistical difference in accuracy between maxillary and
mandibular teeth of the same tooth type for any movements studied. Conclusions: We still have much to
learn regarding the biomechanics and efficacy of the Invisalign system. A better understanding of Invisalign’s
ability to move teeth might help the clinician select suitable patients for treatment, guide the proper
sequencing of movement, and reduce the need for case refinement. (Am J Orthod Dentofacial Orthop 2009;
135:27-35)
I
n 1998, Align Technology (Santa Clara, Calif) past decade, Invisalign has been used to treat over
introduced Invisalign, a series of removable poly- 300,000 people worldwide,3,4 most of them above 19
urethane aligners, as an esthetic alternative to fixed years of age.5
labial braces. The Invisalign system uses CAD/CAM As Invisalign continues to grow in consumer demand
stereolithographic technology to forecast treatment and and professional use, questions regarding the efficacy of
fabricate many custom-made aligners from a single this system remain. How well do removable aligners
impression.1 Each aligner is programmed to move a move teeth? Align Technology reports that 20% to 30% of
tooth or a small group of teeth 0.25 to 0.33 mm every patients treated with Invisalign might require either mid-
14 days.2 This unique method of tooth movement has course correction or refinement impressions to help
involved more adults with orthodontic therapy. In the achieve the pretreatment goals.2 However, many orth-
odontists report that 70% to 80% of their patients require
From the School of Dentistry, University of Illinois, Chicago. midcourse correction, case refinement, or conversion to
a
b
Private practice, South Riding, Va, and White Plains, Md. fixed appliances before the end of treatment.6,7
Assistant professor and clinical chair, Department of Orthodontics.
c
Associate professor, Department of Orthodontics. There are few substantive controlled clinical trials
d
Associate professor, Department of Restorative Dentistry. pertaining to Invisalign. Lagravère and Flores-Mir8
e
Postgraduate student. conducted a systematic review of the literature about
Reprint requests to: Neal D. Kravitz, University of Illinois, Department of
Orthodontics, 801 S Paulina St, MC 841, Chicago, IL 60612; e-mail, nealkravitz@ the Invisalign system and found that it did not offer
gmail.com. scientific evidence regarding the indication, efficacy,
Submitted, March 2007; revised and accepted, May 2007. limitations, or treatment effects of Invisalign. To date,
0889-5406/$36.00
Copyright © 2009 by the American Association of Orthodontists. published data have primarily included case reports,
doi:10.1016/j.ajodo.2007.05.018 commentaries, material studies, surveys, descriptive
27
28 Kravitz et al American Journal of Orthodontics and Dentofacial Orthopedics
January 2009
technical articles, 1 abstract, 2 restrospective compar- align. The amount of tooth movement predicted by
ative cohort studies, and only 2 clinical trials.3 ClinCheck (Align Technology, Santa Clara, Calif) was
In the first cohort study, Djeu et al9 retrospectively compared with the amount achieved after Invisalign
compared the treatment results of Invisalign patients to treatment. Tooth movement was evaluated on Tooth-
those with conventional fixed appliances, using the Measure, Invisalign’s proprietary virtual model super-
American Board of Orthodontics (ABO) objective imposition software. The types of tooth movement
grading system. The authors reported that the Invisalign studied were expansion, constriction, intrusion, extru-
group scored a mean 13 points higher and achieved a sion, mesiodistal tip, labiolingual tip, and rotation.
passing rate 27% lower than did the fixed appliance
group. Invisalign scores were significantly lower for MATERIAL AND METHODS
correcting posterior torque, occlusal contacts, antero- The sample comprised 401 anterior teeth (198
posterior occlusal relationships, and overjet. maxillary, 203 mandibular) measured from the virtual
In a follow-up study, Kuncio et al4 compared the models of 37 participants (14 men, 23 women). Each
postretention dental changes of patients treated with patient was treated with Anterior Invisalign in the
Invisalign and conventional fixed appliances, using the Department of Orthodontics at the University of Illinois
ABO objective grading system. The Invisalign group at Chicago. The participants included 23 whites, 9
consisted of patients treated in the 2005 treatment Hispanics, 2 blacks, 2 East-Indians or Middle Easterns,
outcome study.9 The authors reported that patients and 1 Asian. Their mean age was 31 years. Sample
treated with Invisalign had more relapse than those Invisalign treatment included 30 dual arch, 3 maxillary
treated with fixed appliances, particularly in the max- arch only, and 4 mandibular arch only. The mean
illary anterior teeth. number of aligners per treatment was 10 maxillary and
In the first clinical trial, Bollen et al10 compared the 12 mandibular. The mean amounts of anterior inter-
effects of material stiffness and activation frequency on proximal reduction (IPR) were 1.3 mm in the maxilla
the ability to complete Invisalign treatment. The au- and 1.6 mm in the mandible. The frequency of anterior
thors concluded that subjects with a 2-week activation IPR was 180 of 401 teeth (45%). Tooth attachments
frequency, no planned extractions, and low peer assess- varied in shape, size, and position according to the
ment rating score were more likely to complete their doctor’s prescription. The frequency of anterior tooth
initial series of Invisalign aligners. The overall comple- attachments was 68 of 401 teeth (17%).
tion rate of initial aligners for patients who had 2 or The patients were selected from the Department of
more premolars extracted was only 29%. All subjects Orthodontics at the University of Illinois at Chicago by
who completed their initial series of aligners required 2 orthodontists: the faculty member supervising the
case refinement or conversion to fixed appliances. treatment and the faculty member assigned to oversee
In the second clinical trial, Clements et al11 com- all participants (B.K.). The one supervising the treat-
pared the effects of material stiffness and activation ment first determined whether the malocclusion could
frequency on the quality of treatment measured by be appropriately treated with anterior Invisalign. Pa-
changes in peer assessment rating scores. The authors tients deemed acceptable were then screened by the
concluded that the aligners were most successful in overseer. Only after approval from both faculty mem-
improving anterior alignment, moderately successful at bers was the patient selected for the study.
improving the midline and overjet, and least successful The inclusion criteria for patient selection were the
in improving buccal occlusion, transverse relationships, following. (1) The patient qualified for anterior Invis-
and overbite. Single mandibular incisor extraction sites align with less than 5 mm of anterior crowding or
reported significantly greater space closure than either spacing and adequate buccal interdigitation. Patients
maxillary or mandibular premolar extraction sites. with posterior edentulous spaces were included if
The landmark studies of Bollen et al10 and Clements treatment did not entail space closure. Patients who
et al11 marked the beginning of independent prospec- would have mandibular incisor extractions were in-
tive clinical research regarding Invisalign. However, cluded in this study. Only 1 participant was treated with
neither study used aligners that were identical to mandibular incisor extraction. (2) The patient was at
Invisalign’s current aligner material or evaluated the least 18 years of age to allow for proper consent. (3) No
efficacy of tooth movement with Invisalign. Further special instructions could be requested on ClinCheck to
clinical trials are needed to assess the strengths and alter the sequence or the speed of tooth movement.
limitations of Invisalign treatment. Clinicians were allowed to request or refuse IPR,
The purpose of this prospective clinical study was proclination, attachments, and overcorrections on Clin-
to evaluate the efficacy of tooth movement with Invis- Check at their discretion. (4) No auxiliaries other than
American Journal of Orthodontics and Dentofacial Orthopedics Kravitz et al 29
Volume 135, Number 1
Fig 1. A, The final stage of tooth movement (red oval), corresponding to the predicted tooth
position. The posttreatment Treat model was then selected from the data bank to be transferred into
ToothMeasure (yellow arrow). B, Highly matched stationary posterior teeth were selected for
superimposition by clicking on the appropriate boxes (yellow arrow). The accuracy of posterior
superimposition and the efficacy of anterior tooth movement can be seen with the color-coded DI
legend.
Invisalign attachments could be used during treatment, superimposed on the zero stage of the posttreatment
and the tray could not be altered with scissors or model. The final stage of the pretreatment model
thermopliers. corresponded to the predicted tooth position. The zero
These subjects were instructed to wear each aligner stage of the posttreatment model corresponded to the
22 hours a day, 7 days a week for 2 to 3 weeks. All achieved tooth position. The 2 models were superim-
patients were asked to complete a daily compliance log posed over their untreated stationary premolars and
during treatment, recording the number of hours the molars (Fig 1). ToothMeasure provided a matching
aligners were worn each day. results report on the accuracy of the pretreatment and
After completing the initial series of aligners, post- posttreatment impressions. Posterior teeth that poorly
treatment polyvinyl siloxane impressions were mailed matched between the 2 impressions were not selected
to Align Technology. Two Align technicians assigned for superimposition (Fig 2). For patients with missing
to our study e-mailed the pretreatment and posttreat- posterior teeth, the remaining teeth were used for
ment virtual Treat models back to our department, superimposition.
where they were deidentified and stored. Pretreatment Once the 2 models were superimposed, ToothMeasure
digital models were transferred into ToothMeasure to performed an efficacy analysis report, which showed
score the discrepancy index (DI) by using a modified quantitative measurements for the predicted and achieved
ABO objective grading system. Because treatment movements. The percentage of accurate tooth move-
involved correction of the anterior teeth exclusively, ment was determined by the following equation: per-
the DI was scored only on overjet, overbite, anterior centage of accuracy ⫽ 100% ⫺ [(|predicted-achieved|/
open bite, and crowding. |predicted|) ⫻ 100%]. The equation accounted for
ToothMeasure is a software application developed by directionality and ensured that the percentage of accu-
Align Technology used internally to provide measure- racy never exceeded 100% for teeth that achieved
ments on scanned computer models. The software mea- movements beyond their predicted value. The tooth
sures the shape of each tooth, intra-arch values (tip, torque movements evaluated were labial expansion, lingual
[labiolingual tip], rotation, crowding, and alignment), and constriction, intrusion, extrusion, mesiodistal tip, labio-
interarch values (overjet, overbite, occlusal contacts, oc- lingual tip, and rotation. Translational tooth movements
clusal relationship, and discrepancy). It enables 1 operator (expansion, constriction, intrusion, extrusion, and me-
(N.D.K.) to reproducibly superimpose 2 digital models on siodistal tip) were measured in millimeters. Rotational
user-selected reference points, such as untreated teeth, tooth movements (labiolingual tip and rotation) were
palatal rugae, and dental implants. Teeth can be superim- measured in degrees.
posed within accuracies of 0.2 mm and 1.0°.12,13 All statistical analyses were performed with SPSS
The final stage of the pretreatment model was software (SPSS, Chicago, Ill). Accuracy was deter-
30 Kravitz et al American Journal of Orthodontics and Dentofacial Orthopedics
January 2009
Fig 2. A, Poorly matched right and left second molars indicated by the matching report. B, The
second molars were deselected for superimposition (black arrows). Note the improvement in
superimposition of the remaining 6 posterior teeth and the greater deviation in the position of the
anterior teeth.
mined by the amount of tooth movement achieved movements was 41% (Table I). The highest accuracy
divided by the amount attempted. A 1-way analysis of was achieved during lingual constriction (47.1%), and
variance (ANOVA) test (P ⬍0.05) compared the mean the lowest accuracy was during extrusion (29.6%).
percentage of accuracy for each type of movement. The More specifically, the most accurate tooth movements
Scheffé test (P ⬍0.05) ascertained which teeth, within were lingual constriction of the mandibular canines
that movement, had a significant difference in accuracy. (59.3%) and lateral incisors (54.8%), followed by
Paired t tests (P ⬍0.05) compared the accuracy of rotation of the maxillary central incisors (54.2%). The
canine rotations greater than 15° and less than 15°. least accurate tooth movements were extrusion of the
Paired t tests (P ⬍0.05) also compared the accuracy of maxillary (18.3%) and mandibular (24.5%) central
labial crown tip vs lingual crown tip for each anterior incisors, followed by mesiodistal tip of the mandibular
tooth. An ANOVA test determined the significance of canines (26.9%) (Fig 3). An acceptable sample size was
the modified DI on the accuracy of each type of attained for all tooth movements, with the exception of
movement. extrusion of the mandibular lateral incisors (n ⫽ 4) and
canines (n ⫽ 3). All movements had large standard
RESULTS deviations (mean SD ⫽ 32.9).
Thirty-eight consecutively treated patients were When analyzing the accuracies of each movement,
enrolled in the clinical study. Of them, 37 completed only rotation (P ⫽ 0.001) had a significant difference in
anterior Invisalign treatment according to the research accuracy between teeth (Table II). The accuracy of
protocol. One patient could not complete his treatment rotation for the maxillary canines (32.2%) was signif-
in time for data collection. One clinician deviated from icantly lower than that of the maxillary central incisors
the protocol by using elastics to extrude a maxillary (54.2%) and mandibular lateral incisors (51.6%). The
incisor. For this patient, only the mandibular arch was accuracy of rotation for the mandibular canines
evaluated. (29.1%) was significantly lower than that of the max-
Patient compliance forms were collected at the end illary central, mandibular central (48.8%), and mandib-
of treatment; all patients reported wearing their aligners ular lateral (51.6%) incisors (Fig 4 and Table III).
for 21 to 23 hours per day. The last data collection was The accuracy of rotation for the maxillary and
in December 2006. All predicted translational move- mandibular canines was further evaluated after separat-
ments less than 0.2 mm and rotational movements less ing the sample into 2 groups: predicted rotations less
than 1.0° were eliminated from the analysis to account than 15° and predicted rotations greater than 15° (Table
for the error in model superimposition. IV). Fifteen degrees was chosen as a clinically discern-
The mean accuracy of Invisalign for all tooth able amount of malrotation. For rotations greater than
American Journal of Orthodontics and Dentofacial Orthopedics Kravitz et al 31
Volume 135, Number 1
Max central 48.5 13 37.9 51.8 32 34.0 44.7 39 30.0 18.3 12 24.8
Max lateral 49.0 14 37.3 40.4 30 34.4 32.5 22 22.1 28.4 23 33.2
Max canine 36.0 13 38.0 34.7 17 33.5 40.0 17 34.0 49.9 11 30.5
Mand central 27.4 24 31.9 46.7 14 41.5 46.6 37 29.6 24.5 11 37.0
Mand lateral 50.8 30 34.5 54.8 14 38.0 40.0 42 30.4 28.4 4 35.1
Mand canine 29.9 15 33.0 59.3 13 37.4 39.5 32 30.2 30.4 3 36.2
Total 40.5 109 35.6 47.1 120 35.9 41.3 189 29.5 29.6 64 32.5
Max central, Maxillary central incisor; Max lateral, maxillary lateral incisor; Max, maxillary; Mand central, mandibular central incisor; Mand
lateral, mandibular lateral incisor; Mand, mandibular; MD, mesiodistal; LL, labiolingual.
*P ⬍0.05.
Tooth (I) Tooth (II) Mean difference (I-II) Significnce Lower Upper
Max central, Maxillary central incisor; Max lateral, maxillary lateral incisor; Max, maxillary; Mand central, mandibular central incisor; Mand
lateral, mandibular lateral incisor; Mand, mandibular.
*P ⬍0.05.
Max central, Maxillary central incisor; Max lateral, maxillary lateral incisor; Max, maxillary; Mand central, mandibular central incisor; Mand
lateral, mandibular lateral incisor; Mand, mandibular.
*P ⬍0.05.
of mesiodistal tip was 40.5%. Only 21 of 180 teeth had incisors (38.6%) had the lowest accuracy. These data
attempted mesiodistal movement greater than 1.0 mm suggest that teeth with larger roots might have greater
(range, 1.0-3.8 mm), and only 8 teeth had attempted difficulty achieving mesiodistal movement.
movement greater than 2 mm. The highest accuracy Lingual crown tip (53.1%) was significantly more
was achieved by the maxillary (43.1%) and mandibular accurate than labial crown tip (37.6%), particularly for
(48.6%) lateral incisors. The maxillary (35.5%) and the maxillary incisors. It was nearly twice as accurate to
mandibular (26.9%) canines and the maxillary central retrocline the maxillary central incisors as to procline
34 Kravitz et al American Journal of Orthodontics and Dentofacial Orthopedics
January 2009
patients were of mild difficulty, and few translational 6. There was no statistical difference in accuracy be-
movements exceeded 2 mm. (2) Clinicians were in- tween maxillary and mandibular teeth of the same
structed not to use auxiliaries. Clearly, successful Invis- type for any tooth movement studied.
align treatment is not limited to aligners alone. Although
These results indicate that we still have much to learn
this research protocol might have handicapped the treat-
regarding the biomechanics and efficacy of the Invisalign
ment, it provides a baseline value to what can be achieved
system. Clinicians who prescribe Invisalign treatment
with aligners alone. (3) Overcorrections were not ac-
should fully recognize its limitations and commit them-
counted for. Many clinicians in the study requested
selves to providing the gold standard of care for their
overcorrection, but the final predicted tooth position was
patients. Providing quality care, regardless of the treat-
the measurement used. Therefore, even movements with
ment modality, is only way to truly be a premiere
low accuracy might have achieved their desired tooth
provider.
position. (4) Tooth movement could have been influenced
by the patient’s age, periodontal support, root length, and We thank Rohini Vajaria for her research assistance,
bone density. Because of limitations in the university’s and Eric Kuo and Suemi Gonzalez at Align Technology
institutional review board approval, periapical radiographs for providing technical assistance and support.
were not permitted. (5) Patient satisfaction was not mea-
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