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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
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
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.
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
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
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