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Original Article

Predicted overbite and overjet changes with the Invisalign appliance:


a validation study

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Maurice J. Meadea; Haylea Blundellb; Tony Weirc

ABSTRACT
Objectives: To investigate whether the predicted changes in overbite (OB) and overjet (OJ) in Align
Technology’s (Santa Jose, Calif) digital treatment plan for the prescribed course of treatment with the
Invisalign appliance were consistent with those same changes in OB and OJ measured with the
Geomagic Control X (Geomagic US, Research, Triangle Park, NC) metrology software system.
Materials and Methods: Geomagic Control X software was used to determine OB and OJ differ-
ences between the pretreatment and predicted outcome. STL files for patients satisfying inclusion
criteria and undergoing nonextraction orthodontic treatment with the Invisalign appliance. The dif-
ferences were compared, using the Bland-Altman analysis, to the corresponding data provided
by Align Technology’s digital treatment-planning interface, ClinCheck.
Results: Data regarding 76 adult patients who satisfied strict inclusion criteria were assessed.
The Shapiro-Wilks test indicated normality (P . .05). The Bland-Altman analysis showed high
levels of agreement between the two measurements, with a bias range of 0.131 to 0.111 for
OB and 0.393 to 0.03 for OJ recorded.
Conclusions: Clinicians and researchers can be confident that measurement data provided by
Invisalign’s ClinCheck digital treatment-planning facility concerning OB and OJ changes from the
initial to the predicted treatment outcome are valid. (Angle Orthod. 0000;00:000–000.)
KEY WORDS: Clear aligner therapy; Invisalign; Metrology; Overbite; Overjet; Validation

INTRODUCTION Align Technology uses an online facility called Clin-


Check that enables the orthodontist to modify tooth
Clear aligner therapy (CAT) is commonly used to
position and plan treatment procedures virtually, such
address malocclusion, with the Invisalign (Align Tech-
as interproximal reduction, until an acceptable digital
nology, San Jose, Calif) appliance being among the
treatment plan (DTP) is finalized.5 An additional fea-
most frequently prescribed CAT appliances globally.1–4
ture is the ability to view the predicted outcome from
One of the proposed advantages of CAT is the use of
the finalized DTP. Also, Align Technology provides
three-dimensional (3D) technology for treatment plan-
supplementary treatment information, including the ini-
ning and the manufacture of aligners.5
tial and predicted overbite (OB) and overjet (OJ) mea-
surement values, via the facility.
3D metrology is a commonly used tool to assess treat-
a
Associate Professor, PR Begg Chair in Orthodontics, Adelaide ment changes associated with orthodontic therapy.6
Dental School, University of Adelaide, Adelaide, Australia. Among the most commonly used metrology software sys-
b
Associate Professor, La Trobe Rural Health School, La tems is Geomagic Control X software (Geomagic US,
Trobe University, Bendigo, Victoria, Australia. Research, Triangle Park, NC). It has been used in several
c
Honorary Clinical Senior Lecturer, Orthodontic Unit, Adelaide
Dental School, The University of Adelaide, Adelaide, Australia. investigations to compare changes in malocclusion traits
Corresponding author: Dr Maurice J. Meade, Associate between the initial pretreatment occlusal state, the pre-
Professor and PR Begg Chair in Orthodontics Orthodontic Unit, dicted occlusal outcome, and the actual treatment out-
Adelaide Dental School, Level 10, Adelaide Health and Medical comes with the Invisalign appliance.7–12 In addition, it has
Sciences Building Corner of North Terrace and, George St,
Adelaide SA 5000, Australia been shown to be accurate in the measurement of linear
(e-mail: maurice.meade@adelaide.edu.au) tooth movements on digital scans and changes in some
tooth movements associated with digital superimpositions
Accepted: July 2023. Submitted: April 2023.
Published online: September 1, 2023 and is considered to be a “gold standard” in metrology-
Ó 0000 by The EH Angle Education and Research Foundation, Inc. associated research.13,14

DOI: 10.2319/041323-269.1 1 Angle Orthodontist, Vol 00, No 00, 0000


2 MEADE, BLUNDELL, WEIR

Information regarding the accuracy of numerical treat-


ment information provided by CAT provider DTP interface
facilities is limited in the literature. Recent studies, how-
ever, have indicated that some values provided by Align
Technology may be incorrect.15,16 A recent investigation,
for example, established that Align’s mesiodistal tooth size
measurements, and the Bolton analysis derived from it,
was subject to systematic error and did not match two

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other gold standards.15 In addition, Smith et al.16 noted
that the angular measurements supplied in the ClinCheck
Tooth Movement Table were not consistently supported
by independent metrological analysis. Relevant data, how-
ever, regarding OB and OJ measurements are lacking.
Knowledge in this regard can aid orthodontists in
determining the accuracy of information provided by
ClinCheck. It can also enable researchers to determine
Figure 1. Horizontal reference plane showing the palatal interproxi-
whether data provided by Align Technology regarding mal papilla between the upper first and second molars and the mid-
OB and OJ changes can be used in future relevant stud- point of the superior margin of the incisive papilla.
ies. If the pertinent information provided by Align Tech-
nology has been validated against accepted metrology • Nonextraction orthodontic treatment with the Invisalign
software-derived values, researchers may be able to appliance only
reduce the time-consuming and expensive metrological • Completion of an initial phase of dual-arch Invisalign
processes for some studies, and clinicians may feel therapy consisting of at least 14 aligners
more confident in basing treatment planning and case • Apparent open bite associated with one or more
analysis upon this readily available data source. central incisors in the maxilla according to clinical
The aim of the investigation, therefore, was to deter- images
mine whether the predicted changes in OB and OJ in • Prescribed anterior open bite reduction in the
Align’s DTP for the prescribed course of treatment with ClinCheck DTP
the Invisalign appliance were consistent with those same • Began treatment using SmartTrack aligner material
changes in OB and OJ measured with the Geomagic no earlier than January 2014
metrology software system. • Availability of the initial, predicted, and end of initial
sequence of aligner digital models
MATERIALS AND METHODS
Ethical approval was granted by the University of Ade- Exclusion Criteria
laide for this retrospective study using de-identified data of • Uncaptured teeth in the intraoral scanning process
orthodontic patients treated with the Invisalign appliance • Combined CAT/orthognathic surgery patients
between 2014 and 2022. The digital models were from a • Patients requiring restorative intervention during
database curated by a single practitioner (Dr. Weir) and treatment
comprise of a total of 12,000 patients treated with the Invis- • Medical conditions altering tooth movement or bone
align appliance by 14 experienced specialist orthodontists. metabolism
All patients signed informed consent forms to indicate their
consent to orthodontic treatment and for their data to be Data regarding patient gender and age were recorded
used for research purposes before treatment commenced. in a Microsoft (Redmond, Wash) Excel spreadsheet. Ini-
The de-identified digital models of 76 patients to be tial and predicted OB and OJ measurement values pro-
used for evaluation of changes between the initial and vided by the DTP in ClinCheck information tables were
predicted OB and OJ in the current study corre- also documented. The corresponding Geomagic mea-
sponded to the sample evaluated in a recent study surements were obtained by the creation of a horizontal
investigating the predictability of anterior open bite reference plane via the palatal interproximal papilla
treatment with Invisalign.17 Strict inclusion/exclusion between the upper first and second molars and the mid-
criteria were applied for patient inclusion in the study.
point of the superior margin of the incisive papilla.7,17 This
was used to align the .STL files of each patient at the ini-
Inclusion Criteria
tial and predicted time points (Figure 1). The initial and
• Aged 18 years or older before commencing ortho- predicted digital models were aligned to this reference
dontic treatment plane. Figure 2a shows the midpoint of the incisal edge

Angle Orthodontist, Vol 00, No 00, 0000


OVERBITE AND OVERJET CHANGES WITH INVISALIGN 3

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Figure 2. (a) Midpoint of the upper left central incisor incisal edge as measurement point for overjet and overbite. (b) Lower arch point defined
as the midpoint between the midpoints of the lower left central incisor and the lower left lateral incisor incisal edges for overjet and overbite
measurements.

Figure 3. Linear measurement (in millimeters) of overjet (Y plane) and overbite (Z plane) between the midpoint of the upper left central incisor
incisal edge and the midpoint of the vector between the lower left central incisor and the lower left lateral incisor.

of the upper left central incisor. Figure 2b indicates the metrology software, direct comparisons at the initial (I)
vector determined by the midpoint of the incisal edges of and predicted (P) time points were not possible.
the lower left central incisor and the lower left lateral inci- Therefore, the difference (I P) for each method was
sor. The horizontal and vertical linear distance between compared. The Bland-Altman analysis was used to
the upper left central incisor midpoint and the vector mid- determine agreement between the differences of each
point were used to measure the OJ and the depth of OB method using the bland R package.18,19 The Shapiro-
(Figure 3) for the initial and predicted digital models. Wilks test was used to test for normality.
Intra- and interexaminer scores for the Geomagic mea-
surements were excellent.17 RESULTS
The data of 53 females and 23 males, with a mean
Statistical Analysis age of 35.17 years at the start of treatment, were
Statistical analyses were computed via R (version available for evaluation.
4.0; R Core Team, Vienna, Austria) and SPSS (ver- Table 1 outlines the summary statistics for the initial
sion 25; IBM Corp, Armonk, NY) and were presented and predicted OB and OJ measurements evaluated
in tabular, graphic, and text formats. As points of refer- via the Geomagic metrology software and the corre-
ence and centers of rotation used by ClinCheck were sponding measurements provided by ClinCheck. The
not defined in a manner allowing reproduction with mean (SD) predicted OB measurement provided by

Table 1. Initial and Predicted OB and OJ Measurementsa


Geo CC
Mean (SD) 95% CI Mean (SD) 95% CI
Initial OB 1.48 (1.09) 1.73, 1.23 1.48 (1.16) 1.75, 1.22
Predicted OB 1.66 (0.81) 1.42, 1.82 1.61 (0.92) 1.40, 1.82
Initial OJ 4.12 (1.87) 3.70, 4.55 3.5 (1.92) 3.06, 3.94
Predicted OJ 3.11 (0.87) 2.91, 3.31 2.3 (078) 2.12, 2.48
a
CI indicates confidence interval; CC, ClinCheck; Geo, Geomagic; OB, overbite; OJ, overjet; and SD, standard deviation.

Angle Orthodontist, Vol 00, No 00, 0000


4 MEADE, BLUNDELL, WEIR

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Figure 4. Bland-Altman plot comparing the difference between Geomagic and ClinCheck initial and predicted overbite differences. CC indi-
cates ClinCheck Geo, Geomagic; I, initial; LOA, level of agreement; OB, overbite; and P, predicted.

Geomagic was 1.66 (0.81) mm compared with the there was no proportional bias. The sample bias was
mean (SD) predicted OB measurement provided by 0.181. However, the confidence interval contained
ClinCheck of 1.61 (0.92) mm. zero; hence, no significant bias was present. Most of
The Bland-Altman plots of the changes in OB and OJ the points fell between the lower and upper limits of
are displayed in Figures 4 and 5, respectively. The agreement or within their respective confidence bands.
dashed lines represent the summary Bland-Altman statis-
tical data, namely, (1) bias, (2) upper limit of agreement, Checking Assumptions
and (3) lower limit of agreement. The dotted lines repre-
The validity of confidence intervals depended on the
sent confidence intervals for the summary statistics, and
normality of the measure involved. This assumption
the blue solid line represents a regression line measuring
was checked for the differences involved using normal
any proportional bias. If the regression slope is signifi-
quantile plots and a Shapiro-Wilks test (Figures 6 and
cantly different from zero, it may indicate proportional bias.
7). The OB plot and P value confirmed its normality,
For OB, there was no proportional bias, and the
and although the OJ data showed some deviation
sample bias was very close to zero, indicating the two
from normal, the P value was ..05, indicating no seri-
methods were similar on average. Most of the points
ous problem with normality.
fell between the lower and upper limits of agreement
or within their respective confidence bands.
DISCUSSION
For OJ, there may have been some proportional
bias. However, the 95% confidence interval for the The global popularity of the Invisalign appliance and
regression slope contained zero, indicating the slope the widespread use of Geomagic metrology software in
was not significantly different from zero; therefore, CAT studies highlighted the relevance of the present

Figure 5. Bland-Altman plot comparing the difference between Geomagic and ClinCheck initial and predicted overjet differences. CC indicates
ClinCheck Geo, Geomagic; I, initial; LOA, level of agreement; OB, overbite; and P, predicted.

Angle Orthodontist, Vol 00, No 00, 0000


OVERBITE AND OVERJET CHANGES WITH INVISALIGN 5

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Figure 6. Normal quantile plot of overbite measure difference.

study. The findings indicated that the differences in the measurements via ClinCheck and Geomagic were
initial and predicted OB and OJ values provided by accepted as validation of the numerical data provided
Invisalign’s ClinCheck software facility were consistent by Align Technology. Since recent studies have indi-
with the corresponding differences from the Geomagic cated problems with some measurements provided by
metrology software. Align regarding mesiodistal tooth size measurements
A sample of patients with reduced OB or anterior and mesiodistal tooth uprighting, it was encouraging
open bite was chosen for the study presented here, that the present study indicated acceptability of the
as one of the proposed strengths of CAT over fixed data regarding OB and OJ changes provided by
appliance therapy is its effectiveness in deepening a ClinCheck.15,16
reduced OB anteriorly.20 Exact agreement with the The findings suggested that the algorithms used by
specific numbers involved was not sought in the pre- Align Technology for their OJ- and, particularly, OB-
sent study, as it was uncertain how Align Technology related data were similar to that observed via the
measures OB and OJ. However, consistency in the methodology used with the Geomagic software in the
changes of both traits between initial and predicted present study. Further investigation and information

Figure 7. Normal quantile plot of overjet measure difference.

Angle Orthodontist, Vol 00, No 00, 0000


6 MEADE, BLUNDELL, WEIR

from Align Technology, however, are required to con- and Education and the University of Adelaide Kwok Paul
firm this. The data from this investigation, neverthe- Lee bequest. The funding bodies did not have any role in the
less, can provide orthodontists with reassurance study design, collection, analysis, interpretation, or writing of
regarding the accuracy of the numerical information the manuscript.
related to OB and OJ changes provided by Clin-
Check. It will also enable researchers to use these REFERENCES
data in future studies, thus facilitating the reduction
1. Meade MJ, Weir T. A survey of orthodontic clear aligner
of time-consuming and expensive metrological pro-

Downloaded from http://meridian.allenpress.com/angle-orthodontist/article-pdf/doi/10.2319/041323-269.1/3254393/10.2319_041323-269.1.pdf by Mexico user on 10 September 2023


practices among orthodontists. Am J Orthod Dentofacial
cesses in some investigations.
Orthop. 2022;162:e302–e311.
A limitation of the present study was that the find- 2. Abu-Arqub S, Ahmida A, Da Cunha Godoy L, Kuo CL,
ings may not be applicable to patients with an initial Upadhyay M, Yadav S. Insight into clear aligner therapy pro-
presentation of very deep OB. Also, the study did not tocols and preferences among members of the American
validate additional numerical data provided in the Clin- Association of Orthodontists in the United States and Can-
Check facility. A strength of the investigation was the ada. Angle Orthod. 2023;93:417–426.
excellent intra- and interexaminer reliability in the 3. Meade MJ, Dreyer CW. A content analysis of orthodontic
Geomagic measurements. An additional strength was treatment information contained within the websites of
the use of the Bland-Altman analysis to compare the general dental practices. J Consum Health Internet. 2022;
26:396–409.
two methodologies for changes in OB and OJ mea-
4. Arun M, Usman Q, Johal A. Orthodontic treatment modali-
surements. The analysis provided a rigorous, visual,
ties: a qualitative assessment of Internet information. J
easy-to-interpret estimation of the agreement or reli- Orthod. 2017;44:82–89.
ability between two measurements of the same object 5. Meade MJ, Ng E, Weir T. Digital treatment planning and
and is superior to the use of correlation coefficients clear aligner therapy: a retrospective cohort study [published
and t tests in this regard.21,22 online ahead of print April 1, 2023]. J Orthod. doi:10.1177/
Further investigation, however, is necessary to 14653125231166015
determine why two points fell outside the lower and 6. Weir T. The application of 3D metrology software in the
upper limits of agreement for OB and three points fell quantitative and qualitative assessment of aligner treatment
outside the lower and upper limits of agreement for outcomes. Austral Orthod J. 2021;37:100–108.
7. Blundell HL, Weir T, Kerr B, Freer E. Predictability of over-
OJ. Future research is also required to determine the
bite control with the Invisalign appliance. Am J Orthod Den-
accuracy and validity of the additional numerical data
tofacial Orthop. 2021;160:725–731.
provided by Align Technology’s ClinCheck facility and 8. Bowman E, Bowman P, Weir T, Dreyer C, Meade MJ.
the numerical data by other companies’ DTP interface Occlusal contacts and treatment with the Invisalign® appli-
facilities. ance: a retrospective analysis of predicted versus achieved
outcomes. Angle Orthod. 2023;93:275–281.
CONCLUSIONS 9. Goh S, Dreyer C, Weir T. The predictability of the mandibu-
lar curve of Spee leveling with the Invisalign appliance. Am
• The predicted changes in OB and OJ during treat- J Orthod Dentofacial Orthop. 2022;162:193–200.
ment with the Invisalign appliance as reported by 10. Houle JP, Piedade L, Todescan R Jr, Pinheiro FH. The pre-
Align Technology are consistent with the changes in dictability of transverse changes with Invisalign. Angle
OB and OJ reported by direct measurement using Orthod. 2017;87:19–24.
the gold standard Geomagic metrology software 11. Maree A, Kerr B, Weir T, Freer E. Clinical expression of
system. programmed rotation and uprighting of bilateral winged
• Clinicians and researchers can be confident that mea- maxillary central incisors with the Invisalign appliance: a
surement data provided by Invisalign’s ClinCheck dig- retrospective study. Am J Orthod Dentofacial Orthop.
2022;161:74–83.
ital treatment-planning facility concerning OB and OJ
12. Bowman E, Bowman P, Weir T, Dreyer CW, Meade MJ.
changes from the initial to the predicted treatment out-
Evaluation of the predicted vs. achieved occlusal out-
come are valid. comes with the Invisalign® appliance: a retrospective
• Further research is required to determine the investigation of adult patients. Int Orthod. 2023;21:
validity of additional numerical data provided by 100746.
Invisalign’s ClinCheck facility and the numerical 13. Adel SM, Vaid NR, El-Harouni N, Kassem H, Zaher AR. Digital
data provided by other CAT providers’ DTP inter- model superimpositions: are different software algorithms
face facilities. equally accurate in quantifying linear tooth movements? BMC
Oral Health. 2022;22:1–2.
ACKNOWLEDGMENTS 14. Adel SM, Vaid NR, El-Harouni N, Kassem H, Zaher AR. Tip,
torque & rotations: how accurately do digital superimposition
The authors acknowledge the support provided by the software packages quantify tooth movement? Prog Orthod.
Australian Society of Orthodontists Foundation for Research 2022;23:8.

Angle Orthodontist, Vol 00, No 00, 0000


OVERBITE AND OVERJET CHANGES WITH INVISALIGN 7

15. Shailendran A, Weir T, Freer E, Kerr B. Accuracy and reliability 19. Datta D. blandr: a Bland-Altman Method Comparison pack-
of tooth widths and Bolton ratios measured by ClinCheck Pro. age for R. (Zenodo. https://doi.org/10.5281/zenodo.824514,
Am J Orthod Dentofacial Orthop. 2022;161:65–73. https://github.com/deepankardatta/blandr, 2017). Accessed
16. Smith JM, Weir T, Kaang A, Farella M. Predictability of lower April 2, 2023.
incisor tip using clear aligner therapy. Prog Orthod. 2022; 20. Harris K, Ojima K, Dan C, et al. Evaluation of open bite closure
23:37. using clear aligners: a retrospective study. Prog Orthod. 2020;
17. Blundell H, Weir T, Byrne G. Predictability of anterior 21:1–9.
open bite treatment with Invisalign®. Am J Orthod Dento- 21. Donatelli RE, Lee SJ. How to report reliability in orthodontic
facial Orthop, In press. https://doi.org/10.1016/j.ajodo. research: Part 1. Am J Orthod Dentofacial Orthop. 2013;144:

Downloaded from http://meridian.allenpress.com/angle-orthodontist/article-pdf/doi/10.2319/041323-269.1/3254393/10.2319_041323-269.1.pdf by Mexico user on 10 September 2023


2023.04.017 156–161.
18. Bland JM, Altman D. Statistical methods for assessing 22. Donatelli RE, Park JA, Alghamdi YM, Pandis N, Lee SJ.
agreement between two methods of clinical measurement. Assessment of reliability in orthodontic literature: a meta-
Lancet. 1986;327:307–310. epidemiological study. Angle Orthod. 2022;92:409–414.

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