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Original Article
Color fading of the blue compliance indicator encapsulated in removable
clear Invisalign TeenHaligners
Timm Cornelius Schott
a
; Gernot Go¨ z
b
ABSTRACT
Objective: To evaluate the color fading in aqueous solutions of the blue dot wear-compliance
indicators of the Invisalign TeenHSystem outside the oral cavity.
Materials and Methods: The compliance indicators in the Invisalign Teen aligners were tested for
color resistance in various aqueous models with no saliva involved.
Results: Color fading was observed as a function of time, pH, and temperature while compliance
indicators were stored in drinking water or sour soft drinks and in conjunction with the use of cleaning
tablets and a dishwasher. The findings of color fading were consistent with the color changes
observed when the aligners were being worn by patients. Color fading, notably as observed in
connection with acidic soft drinks and cleaning techniques, introduces uncertainty into the
assessment of actual patient compliance, as reflected by the fading colors of compliance indicators.
Conclusion: Compliance indicators are not immune to simple intentional or unintentional
manipulations. Therefore, they can best show an estimate of wear time but cannot be
recommended as objective wear-time indicators. (Angle Orthod. 2011;81:185–191.)
KEY WORDS: Removable aligners; InvisalignHTeen; Compliance indicator; Encapsulated dye
INTRODUCTION
Compliance is a mandatory for effective treatment
with a removable orthodontic appliance.
1,2
Studies of
self-reported wear times as compared to the results of
clinical assessment have shown that reliable informa-
tion was obtained in only 43% of patients.
3
A total of
140 patients with a mean age of 12.7 years were
surveyed by questionnaire.
4
The majority expressed a
desire to wear their appliances only at night, and they
did not wish to have wear times prescribed. When
patients were informed that their headgear wear times
were being recorded, they did tend to wear the
headgear more regularly but still fell short of the actual
instructions given.
1
Align Technology recently started distributing a
compliance indicator that was designed for use on
young patients treated with the InvisalignHTeen sys-
tem.
5
According to the manufacturer, the compliance
indicator uses the food dye Erioglaucine disodium salt,
which is encapsulated in the clear Invisalign Teen
aligner and is released from the polymer in the pre-
sence of oral fluid.
6
The amount of dye loss will
correspond with the amount of time the aligner was
worn in the oral cavity. Two different blue dot wear
indicators (fast and slow fading) are used to ensure
that individual patients’ different saliva compositions
are appropriately accounted for. The different color
fading is based on the different amount of the diffused
dye determined by the pore sizes of the polymer. The
blue dots are embedded in the vestibular part of the
molar segments of the aligners (Figure 1). Wear time
is determined by assessing the way in which the
compliance indicators change color as the aligner is
worn. The clinician is required to evaluate five potential
color changes (ranging from dark blue/dark blue to
clear/clear) to obtain a graphic representation of the
wear time.
In a study of 14 patients who were prescribed
Invisalign TeenHwith clear aligners and embedded
color indicators, it was concluded that the service times
determined from the compliance indicators showed
good agreement with the number of service hours
reported by the patients. The positive assessment of
compliance based on compliance indicators, however,
a
Resident, Department of Orthodontics, Eberhard Karl Uni-
versity, Tu¨bingen, Germany.
b
Professor and Department Chair, Department of Orthodon-
tics, Eberhard Karl University, Tu¨ bingen, Germany.
Corresponding author: Dr Timm Cornelius Schott, Depart-
ment of Orthodontics, Eberhard Karl University, Osianderstr. 2-
8, 72076 Tu¨bingen, Germany
(e-mail: timm_schott@gmx.de; timm.schott@med.uni-tuebingen.
de)
Accepted: August 2010. Submitted: May 2010.
G2011 by The EH Angle Education and Research Foundation,
Inc.
DOI: 10.2319/052610-288.1 185 Angle Orthodontist, Vol 81, No 2, 2011
rested on very different color changes observed in
individual patients against a background of similar
wearing patterns. Following the initial wear time of
2 weeks, the compliance indicators revealed that, of the
nine patient examples listed, four patients showed a
clear/clear pattern, four patients showed a clear/blue
pattern, and one patient showed a blue/blue pattern,
although all patients were expected to have worn the
aligners for 20 to 22 hours in a 24-hour period. The
theoretical possibility that patients included in the study
may have attempted to manipulate the compliance
indicator system was consciously ruled out.
5
Given the widely diverging color changes, it remains
unclear whether the variance in the values obtained
may have been caused by different wear times as a
result of lack of patient compliance or whether any
unknown factors may have exerted an influence on the
fading of the embedded dye. These considerations
prompted us to investigate factors that might have
contributed to the color changes.
MATERIALS AND METHODS
Seven Invisalign TeenHaligners (A) were obtained
directly from the manufacturer (Align Technology Inc,
Santa Clara, Calif). Fourteen Invisalign TeenHaligners
(B) were provided by an orthodontic office that
routinely uses the InvisalignHsystem.
The light-dependent color stability of the food dye
Erioglaucine disodium salt (also known as Alphazur-
Figure 1. (a) Removable Invisalign TeenHAligner equipped with two dark blue compliance indicators. (b) Site of aligners with enclosed ‘‘fast’’
compliance indicators. The color intensity of the blue compliance indicator is shown in 1b before treatment (dark blue), in 2b during treatment
(light blue), and in 3b after treatment (clear) of the aligner in the aqueous environment (see Table 1).
186 SCHOTT, GO
¨Z
Angle Orthodontist, Vol 81, No 2, 2011
ine FG, FD&C Blue 1, Brilliant Blue FCF, or Acid
Blue 9), which was obtained from Sigma-Aldrich
Chemie (Munich, Germany), was proven by irradia-
tion with an ultraviolet lamp (254 nm) for 2 weeks.
The color stability of the dissolved dye was tested by
dissolving a spatula tip of solid Erioglaucine in
250 mL of drinking water, resulting in a dark blue
solution. The pH-, time-, and temperature-dependent
color stability of this blue solution was proven in a
range of pH 2–9 by adding 1 N HCl or 1 N NaOH
and keeping it in these solutions for 2 weeks at 20uC
or 35uC.
The oxidation-dependent color fading of the blue dye
solution was tested by adding Kukident cleaning
tablets (Reckitt Benckiser, Mannheim, Germany) to
the solution and storing it at 20uC or 35uC. Among
other chemicals, these tablets contain an oxidant com-
pound in the form of sodium carbonate peroxide.
The color fading of the compliance indicator was
investigated by storing the Invisalign TeenHaligners
in 250 mL drinking water at 20uC, 35uC, and 50uC
as well as in different aqueous solutions at 20uC
and 35uC. The first solution studied was created by
adding a Kukident cleaning tablet to 250 mL drinking
water. Commercially available soft drinks and a fruit
juice were used for the remaining solutions: Coca-
Cola (Berlin, Germany), Schweppes Original Bitter
Lemon (Schweppes, Kreuztal, Germany), and lemon
juice (Hitchcock Sportfit Fruchtsaft, Rheinberg,
Germany). Aligners were stored in 250 mL of each
aqueous medium.
RESULTS
Color Stability of Food Dye Erioglaucine
Disodium Salt
The Erioglaucine disodium salt that was used as the
compliance indicator was light resistant in its solid and
nonembedded form. The pH-dependent color stability
of the food dye can be postulated, because a deep
blue aqueous solution of the dye in the range of pH 2–
9 retained its color throughout the 2 weeks. This
finding was also obtained when lemon concentrate
(20% by vol) was added, regardless of whether the
solution was kept at 20uC or 35uC over the 2-week
period. In contrast, the blue aqueous solution lost its
color entirely within 24 hours of adding a Kukident
cleaning tablet and maintaining the solution at 35uC,
while storage at 20uC delayed the process of complete
color loss by a few days (Table 1). The loss of color of
the dye was presumably a result of oxidative degra-
dation in the wake of peroxide formation triggered by
the Kukident tablet dissolving in water.
Color Fading of the Compliance Indicator in
Different Aqueous Solutions
The pH-, time-, and temperature-dependent fading
patterns of the embedded compliance indicator were
determined. To this end, the aligners were stored in
drinking water and only in various common highly
acidic soft drinks (but not including saliva), as the
aligners under study embedded the dye in the form
of a stable sodium salt. Acidic soft drinks were
therefore more likely to destabilize the dye; in neutral
or slightly alkaline beverages, the sodium salt form of
the dye was more likely to be preserved. Alcoholic
beverages were not included. Testing was carried
out for a maximum of 2 weeks, as the aligners
included in the Invisalign TeenHsystem were rou-
tinely replaced within 2 or 3 weeks over the course of
treatment. The aligners were stored in various liquids
at both room temperature (,20uC) and/or at 35uC.
The latter temperature was used to simulate thermal
conditions present in the oral cavity: ranges of
33.10uC–37.80uC
7
and 35uC–36uC
8
have been re-
ported. Temperature-dependent color fading was
additionally evaluated by storing the aligners in
drinking water at 50uC, since temperatures may
reach peaks of 58.8uC in the anterior segment and
54uC in the premolar area (notably when drinking hot
beverages).
8
A wide variety of cleaning procedures
have been used on removable appliances (eg,
Kukident cleaning tablets, mechanical cleaning, or
application of vinegar).
9
Kukident cleaning tablets
and cleaning in a dishwasher were included in the
present study of color changes in aligners. Aligners
obtained from two different sources (A 5obtained
directly from the manufacturer; B 5provided by an
orthodontic office) were used to determine whether
the dye was encapsulated with sufficient reproduc-
ibility during manufacturing to yield consistently
reproducible color changes in aligners. In addition,
parallel testing was conducted with aligners from the
same patients (B1/B2).
Color Fading After Storage in Water
The instructions for use provided by the manufac-
turer suggested that the embedded dye would fully
retain its blue color until exposed to moisture and
temperatures equal to or higher than body tempera-
ture. However, we observed that the compliance
indicators of two aligners belonging to different
sources would change their ‘‘fast’’ and ‘‘slow’’ color
formulation from dark to light blue when stored in
drinking water, even at approximately 20uC, which is
considerably below body temperature (see Table 1).
Corresponding fading of the compliance indicators was
found in patients taking part in the 12-week study after
COLOR FADING OF INVISALIGN TEENHALIGNERS 187
Angle Orthodontist, Vol 81, No 2, 2011
Table 1. Color Fading of the Blue Compliance Indicators After Soaking of Unused Aligners (A) in 250 mL of Different Aqueous Media at
Different Temperatures, pH, and Time in Comparison to the Color Change of the Compliance Indicators of 50 Aligners After Use by Patients for
17–22/24 Hours Over 14 Days (B)
188 SCHOTT, GO
¨Z
Angle Orthodontist, Vol 81, No 2, 2011
they had worn the aligners for 17.5 to 23 hours in a
24-hour period.
The initial dark blue of the ‘‘fast’’ formulation faded
completely when the aligner A was stored in water at
35uC over 13 days, while the dark blue color of the
‘‘slow’’ formulation changed to light blue under the
same conditions. The same pattern was observed on
graphical analysis of 22 of 50 compliance indicators in
patients who had each worn a total of six aligners for
2 weeks each. At 50uC, the dark blue color of both
compliance indicators of a used aligner faded to clear
after only 7 days.
Color Fading After Storage in Water with One
Kukident Tablet
Color fading was fast when a Kukident cleaning
tablet was added to the drinking water holding the
aligner. In this environment, both color formulations
(‘‘fast’’ and ‘‘slow’’) included in the compliance indica-
tors of aligner A changed from dark blue to clear within
13 days. Under the same conditions, the color of the
other aligner (B) changed from dark to light blue. When
the same experiment was conducted at 35uC, the
‘‘fast’’ color formulation in aligner A took 24 hours to
fade, and both formulations faded within 4 days. The
aligner B showed a clear/light blue pattern of fading
after 5 days, which faded to clear/clear after 9 days.
When the experiment was repeated with aligners B1
and B2, these changed to light blue/clear within 4.5
and 5.5 days, respectively. Complete fading was noted
after 7 days with aligner B1 and after 9 days with
aligner B2. Complete fading of both formulations was
also observed with the compliance indicators in 13 of
50 aligners of different patients worn for 2 weeks for
the prescribed wearing time, while the same pattern
was not observed in the remaining 37 aligners.
Color Alterations on Storage in Acidic Soft Drinks
Color changes were also observed when the
aligners were stored in Coca-Cola, a very popular
drink and one of the most acidic (pH 2.6)
10
soft drinks
available. At ,20uC, the dark blue color of the new
aligners (A) changed to clear (fast formulation) or light
blue (slow formulation) within 13 days, while the worn
aligners (B) acquired a light blue/light blue color during
the same period of time. Again, the fading pattern
obtained with Coca-Cola would have suggested good
patient compliance, even though the aligners had
never been worn. At 35uC, both formulations resulted
in a light blue/light blue pattern within 2 weeks.
Presumably, this weak change was caused by more
CO
2
escaping from the Coca-Cola solution at 35uC
than at 20uC, such that the initially low pH value would
rise toward a pH of 7 as the reaction proceeded.
Marked changes were also observed when the
compliance indicators were stored in Schweppes
Original Bitter Lemon (pH 2.5). When the aligners B
were stored at roughly 20uC, one of both formulations
of the indicator completely lost its color, while the other
formulation turned light blue. Strikingly, aligner B1 took
7 days to achieve this color change, while aligner B2
took 9 days. The fading was complete for both
compliance indicators by that time and did not
progress any further when the aligners were stored
in Schweppes for up to 2 weeks. Similar fading
patterns were observed at 35uC. Much as with Coca-
Cola as the medium, the fact that different tempera-
tures did not cause a difference in fading patterns was
presumably a result of CO
2
escaping at higher
temperatures, raising the pH and reducing the acidic
effect of the Schweppes medium. This assumption
was supported by the storage of the aligners in lemon
juice (pH ,2.3). At 20uC, the initially dark blue color of
both indicators changed to light blue within 2 weeks. At
35uC, by contrast, the compliance indicators complete-
ly lost their color in 9 days. This pronounced effect of
temperature was not observed with Coca-Cola and
Schweppes as media and was presumably a result of
the noncarbonated nature of the lemon juice. In other
words, the acidic pH of the lemon juice (,2.3)
remained unchanged at 35uC or even decreased
slightly, whereas the acid content of acidic soft drinks
increased slightly at higher temperatures.
11
Color Alterations After Cleaning in a Dishwasher
Color fading was also observed when the aligners
were subjected to dishwashing. After two program
cycles in the dishwasher (roughly 5 hours), including
the use of a commercially available detergent and
temperatures of up to 50uC, the compliance indicators
changed from dark blue to light blue.
DISCUSSION
This investigation adds to the existing series of reports
dealing with the InvisalignHsystem.
12–14
Interindividual
differences in color change patterns had, in the past,
been attributed to different compositions of saliva. Since
the dark blue color remained unchanged when the food
dye was stored in nonencapsulated form in aqueous
media within the same temperature (20uC/35uC) and pH
(2–9) ranges, the observed fading of the compliance
indicators was not caused by instability of the dye. The
reason for the different fading patterns among aligners
was presumably caused by the manufacturing of
different encapsulations of the dye, with each pair
consisting of a ‘‘fast’’ and a ‘‘slow’’ compliance indicator.
The encapsulations of the ‘‘fast’’ and ‘‘slow’’ formulations
were located on alternating sides of the aligners. It was
COLOR FADING OF INVISALIGN TEENHALIGNERS 189
Angle Orthodontist, Vol 81, No 2, 2011
not possible to determine the locations of the ‘‘fast’’ vs
‘‘slow’’ formulations on the aligners.
Once the aligner was exposed to aqueous medium,
the way in which the blue dye physically diffused from
the encapsulation in a time-, pH-, and temperature-
dependent fashion would result in a gradual change
from dark blue to clear. The addition of Kukident
cleaning tablets presumably induced not only diffusion
but also chemical reactions that gave rise to colorless
metabolites of the encapsulated dye.
Therefore, our experiments indicate that the wide
variation of color changes noted between aligners
despite similar wear times
5
are not caused solely by
individual differences in the composition of saliva (as
postulated by the manufacturer) but also by effects
demonstrated in the present study for the first time.
The finding that the compliance indicators of Invisalign
Teen taken from the same source and tested in
identical experimental setups (eg, drinking water plus
Kukident cleaning tablet at 35uC) failed to show
identical fading patterns would suffice to account for
the large variances in fading that can occur even in
patients who strictly adhered to the prescribed wear
times. Another possible source of error is in the very
technique of determining wear times based on the
fading patterns of compliance indicators, as it requires
the investigator to rate the color changes on a five-
point scale. Because of its inherent subjectivity, this
method does not yield objective wear times. Based on
experience and on the precision of fit presented by the
aligners, the orthodontist can judge their patients’
compliance even without the use of compliance
indicators.
It would appear that patients could easily manipu-
late the color indicators, either on purpose or
unintentionally. Clinicians should remember this
possibility whenever, for instance, an aligner does
not fit, even though the color indicators would seem
to suggest an adequate level of patient compliance.
One should also bear in mind that undesirable color
changes may be present because the patient forgot
to remove the aligner from the mouth during drinking.
Situations in which aligners no longer fit during
treatment, requiring extensive new treatment plan-
ning despite the fact that the indicators of the aligners
have completely or partially faded, will constitute a
dilemma. Clinicians will have to assume in this
situation that the aligners have been worn by the
patient as instructed, and this is also what the
patients themselves (or their parents) may think.
Based on current thinking, the finding of color
indicators having duly faded would effectively rule
out that patient compliance was lacking. Consequent-
ly, this factor would no longer be suspected in the
event of treatment failure, but the focus of suspicion
might well shift to the Invisalign Teen system or the
clinician’s skills.
CONCLUSIONS
NThe compliance indicator encapsulated in the clear
Invisalign Teen aligners was released in different
aqueous solutions in the absence of oral fluid outside
the oral cavity.
NColor changes deviating from the graphically deter-
mined baseline throughout the treatment period with
removable aligners could be caused by the following
reasons: the aligners were left in the mouth during
drinking, were kept in water, were cleaned with
tablets containing oxidizing agents, or were cleaned
in a dishwasher.
NThe fading pattern of the compliance indicators is not
suitable as an objective measure of wear time.
ACKNOWLEDGMENTS
We would like to thank Dr T. Drechsler (private practice,
Wiesbaden, Germany) and Align Technology Inc for kindly
providing the Invisalign Teen aligners used in these experi-
ments. The study was supported by the Fortu¨ ne Program
(project no. 1850-0-0).
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