ArticlePDF Available

Color fading of the blue compliance indicator encapsulated in removable clear Invisalign Teen (R) aligners

Authors:

Abstract and Figures

To evaluate the color fading in aqueous solutions of the blue dot wear-compliance indicators of the Invisalign Teen® System outside the oral cavity. The compliance indicators in the Invisalign Teen aligners were tested for color resistance in various aqueous models with no saliva involved. 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. 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.
Content may be subject to copyright.
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).
REFERENCES
1. Brandao M, Pinho HS, Urias D. Clinical and quantitative
assessment of headgear compliance: a pilot study.
Am J Orthod Dentofacial Orthop. 2006;129:239–244.
2. Lee SJ, Ahn SJ, Kim TW. Patient compliance and locus of
control in orthodontic treatment: a prospective study.
Am J Orthod Dentofacial Orthop. 2008;133:354–358.
3. Sahm G, Bartsch A, Witt E. [Orthodontic treatment from the
patients’ and parents’ viewpoint–the results of a practical
and clinical questionnaire study (II)]. Fortschr Kieferorthop.
1990;51:336–344.
4. Schott TC, Go¨z G. Young patients’ attitudes toward
removable appliance wear times, wear-time instructions
and electronic wear-time measurements–results of a ques-
tionnaire study. J Orofac Orthop. 2010;71:108–116.
5. Tuncay OC, Bowman SJ, Nicozisis JL, Amy BD. Effective-
ness of a compliance indicator for clear aligners. J Clin
Orthod. 2009;43:263–268.
6. Abolfathi A, Chen J, Li C, Tricca R, Wu B. inventors; Align
Technology, Inc, assignee, System and methods for dental
appliance compliance indication. US patent 7,553,157 B2.
June 30, 2009.
7. Ovsenik M, Farcnik F, Kosorok T, Zupancic S, Volk J. Mouth
temperature during removable orthodontic appliance wear.
Eur J Orthod. 2006;28:e245.
8. Moore RJ, Watts JT, Hood JA, Burritt DJ. Intra-oral
temperature variation over 24 hours. Eur J Orthod. 1999;
21:249–261.
9. Serbesis-Tsarudis C, Ruf S. Reinigung herausnehmbarer
kieferorthopa¨discher Apparaturen - Eine deutschlandweite
Umfrage. J Orofac Orthop. 2009;70:447.
10. Lussi A, Jaeggi T, Zero D. The role of diet in the aetiology of
dental erosion. Caries Res. 2004;38(suppl 1):34–44.
190 SCHOTT, GO
¨Z
Angle Orthodontist, Vol 81, No 2, 2011
11. Barbour ME, Finke M, Parker DM, Hughes JA, Allen GC,
Addy M. The relationship between enamel softening and
erosion caused by soft drinks at a range of temperatures.
J Dent. 2006;34:207–213.
12. Kravitz ND, Kusnoto B, Agran B, Viana G. Influence of
attachments and interproximal reduction on the accuracy of
canine rotation with Invisalign. A prospective clinical study.
Angle Orthod. 2008;78:682–687.
13. Kravitz ND, Kusnoto B, BeGole E, Obrez A, Agran B.
How well does Invisalign work? A prospective clinical
study evaluating the efficacy of tooth movement with
Invisalign. Am J Orthod Dentofacial Orthop. 2009;135:
27–35.
14. Vicens J, Russo A. Comparative use of Invisalign by
orthodontists and general practitioners. Angle Orthod.
2010;80:425–434.
COLOR FADING OF INVISALIGN TEENHALIGNERS 191
Angle Orthodontist, Vol 81, No 2, 2011
... A very good compliance is necessary to obtain successful results with clear aligner therapy [36,41], as the appliances should be worn 22 h per day and changed sequentially every 7, 10, 14 days [51]. An insufficient compliance may increase the treatment time and therefore may compromise the treatment outcome [35]. ...
... Yet, the evidence reported that wear-time monitoring by clinicians and caregivers does not necessarily boost compliance or increase the general amount of time spent wearing removable appliances [12]: if patients are informed that their wear-time is recorded, they tend to be more compliant but still wear the appliances for a shorter period than that prescribed by the given instructions [14,36]. ...
Article
Full-text available
This review aims to analyze the multiple factors affecting patients’ level of compliance (how much they wear removable devices/clear aligners) during orthodontic treatments and to investigate the available methods and devices to monitor the appliance wearing time and to improve it. A literature search was conducted on electronic databases (Pubmed, Scopus, and Google Scholar). The results of the present study suggest that compliance indicators may misestimate the intraoral wearing time. Compliance is affected by patient-related factors (age, personality traits, the importance of personal appearance, self-perception of malocclusion), appliance-related factors (visibility, pain/discomfort), and clinician-related factors (trust, clear and complete communication, motivation). The motivation of pre-pubertal patients is mostly external, while adolescents/young adults have intrinsic motivation for orthodontic treatment. Patients’ self-reports tend to overestimate the appliance wearing time. Even if there is a lack of evidence, teledentistry might improve patients’ awareness of being monitored, thus increasing the time for which orthodontic devices are worn. Compliance is a key factor for clear aligner treatments, but high-quality studies focusing on this aspect are missing. Further studies should focus on how to handle the lack of cooperation and how to increase compliance in order to maximize the treatment’s results.
... Compared with minimal-invasive detection using microneedles, non-invasive continuous detection Miniaturized sensor technologies for long-term monitoring of orthodontics. a Monitoring the compliance of wearing dental braces based on the degree of pigment diffusion from polymer pores and force required for orthodontics 33,36 . b Wearable devices to monitor pH and temperature of saliva 38 . ...
... d Wearable patch attached onto teeth to detect oral microbiomes 37 . Figure used with permission from Schott, T. C. et al. 33 Copyright © Allen Press Inc, has greater application potential. Chen et al. integrated a skin-like electrochemical biosensor with twin channels, forming an ultrathin (~3 μm) nanostructured biosensor, to accurately monitor glucose in skin surface through transporting intravascular blood glucose to the skin surface in a noninvasive way with high sensitivity (130.4 μA mM −1 ) 51 . ...
Article
Full-text available
Physiological monitoring can provide detailed information about health conditions, and therefore presents great potentials for personalized healthcare. Flexible miniaturized sensors (FMS) for physiological monitoring have garnered significant attention because of their wide applications in collecting health-related information, evaluating and managing the state of human wellness in long term. In this review, we focus on the time scale of human physiological monitoring, the needs and advances in miniaturized technologies for long-term monitoring in typical applications. We also discuss the rational sample sources of FMS to select proper strategies for specific monitoring cases. Further, existing challenges and promising prospects are also presented.
... 16 It is a versatile device due to its small dimensions and ability to distinguish attempts to deceive the microsensor. 17 Using microsensors, many factors influencing compliance can be identified, such as age, gender, and psychological parameters related to the patient. Age seems to be an important factor, with younger patients being more compliant, while the influence of gender has had conflicting results. ...
... Age seems to be an important factor, with younger patients being more compliant, while the influence of gender has had conflicting results. [14][15][16][17][18] There are also treatment-related factors, such as appliance type, 11,[18][19][20][21] prescribed wear time, 10 doctor-patient relationship, 22 and monitoring awareness. 19 Clinicians have more control over treatment-related factors as they can be modified. ...
Article
Objectives To assess the objective compliance levels in skeletal Class II patients with mandibular retrognathia wearing monoblock and twin-block appliances. Materials and Methods A prospective clinical study was conducted with 30 patients between 10 and 15 years old who were equally divided into two study groups. Group 1 was treated with monoblock, and group 2 was treated with twin-block appliances. The patients were instructed to wear their appliance for 15 hours per day. Wear times were monitored by a microsensor. (TheraMon; MCTechnology, Hargelsberg, Austria) for an average of six appointments. Patients were also instructed to record their wear times on a chart, and this record was admitted as subjective wear time. Statistical analysis was performed with the data derived from both the patients' charts and the monitoring records. Results The mean wear time by the patients was 10.67 ± 3.93 hours, which was less than the 15 hours prescribed by the orthodontist, with no difference between the two appliances (P > .05). The regular use rate, which included the days with a wear time of 8 hours or more per day, was 75%. Compliance levels decreased by 35% throughout the six control appointments. Patients declared that their wear time was more than their objective wear time by an average of 3.76 hours. Conclusions Despite their different designs, there was no significant difference between the monoblock and twin-block appliances in terms of compliance.
... Traditionally, it was recommended that patients wear aligner sets for fourteen days before they changed to the next set in the series. However, in an attempt to accelerate tooth movement of clear aligners, and with the development of advanced materials (such as Align technology's SmartTrack® material) used in fabricating clear aligners by many companies , many patients were able to change their aligners every seven days [2]. The reduced number of days per set of aligners was contingent upon the patient wearing the aligners for minimum of 22 hours per day [1]. ...
... The reduced number of days per set of aligners was contingent upon the patient wearing the aligners for minimum of 22 hours per day [1]. This poses another challenge since many patients are not that compliant to the level of wearing their aligners 22 hours per day [2][3]. For this reason, the proposed seven-day aligner change by Align technology was not always easy to implement in daily practice due to also the increased complexity of cases these days that are being treated by Invisalign SmartTrack® clear aligners [4][5][6][7]. ...
Preprint
This study presents a novel technique utilizing high frequency vibration to shorten treatment time and preserve alveolar bone in challenging orthodontic cases treated with Invisalign® clear aligners. Four non-growing orthodontic patients (age range 14-47 years old) with Class II skeletal patterns (convex profiles with retrognathic mandibles) who sought correction of their crowded teeth and non-surgical correction of their convex profiles were included in this study. These patients were treated using Invisalign clear aligners together with high frequency vibration (HFV) devices (120 Hz) (VPro5™) that were used by all patients for five minutes per day during active orthodontic treatment. Vertical control and forward rotation of the mandible for each patient was achieved through pre-programming the Invisalign to produce posterior teeth intrusion. Successful forward rotation of the mandibles achieved in all patients led to improvement of their facial convex profiles (ANB improved 2.1 + 0.5 degrees; FMA improved 1.2 +1.1 degrees). Dental decompensation was achieved by lingual tipping of the lower incisors and palatal root torque of upper incisors. The use of HFV together with Invisalign facilitated achieving these results within a 12+6 month period. In addition, more bone labial to the lower incisors after their lingual movement was noted. In conclusion, the use of HFV concurrent with SmartTrack Invisalign aligners allowed complex tooth movement and forward projection without surgery in non-growing patients with skeletal Class II relationships. The clinical impact and implications of this case series is that the use of HFV facilitates complex orthodontic tooth movement including posterior teeth intrusion and incisor decompensation in addition to increased bone formation labial to lower incisors that may minimize future gum recession due to their labial inclination.
... Although not an objective monitoring method, clear aligners embedded with a food-grade dye (erioglaucine disodium salt) that dissolves when exposed to saliva are an available option for compliance monitoring. A subjective evaluation of color change (five shades from dark blue to clear) is used to obtain a visual representation of wear time [71,72]. However, not much is known about whether these colorimetric compliance indicators are affected by intraoral pH and temperature. ...
Article
Full-text available
Wearable technology to augment traditional approaches are increasingly being added to the arsenals of treatment providers. Wearable technology generally refers to electronic systems, devices, or sensors that are usually worn on or are in close proximity to the human body. Wearables may be stand-alone or integrated into materials that are worn on the body. What sets medical wearables apart from other systems is their ability to collect, store, and relay information regarding an individual’s current body status to other devices operating on compatible networks in naturalistic settings. The last decade has witnessed a steady increase in the use of wearables specific to the orofacial region. Applications range from supplementing diagnosis, tracking treatment progress, monitoring patient compliance, and better understanding the jaw’s functional and parafunctional activities. Orofacial wearable devices may be unimodal or incorporate multiple sensing modalities. The objective data collected continuously, in real time, in naturalistic settings using these orofacial wearables provide opportunities to formulate accurate and personalized treatment strategies. In the not-too-distant future, it is anticipated that information about an individual’s current oral health status may provide patient-centric personalized care to prevent, diagnose, and treat oral diseases, with wearables playing a key role. In this review, we examine the progress achieved, summarize applications of orthodontic relevance and examine the future potential of orofacial wearables.
... In more recent concepts these changes are suggested to be required after one to two weeks. Regularly changing aligners requires a high level of patient compliance [13,14]. Such compliance is further needed as they need to be worn near-permanently (minimum 22 h per day) [15]. ...
Article
Full-text available
Compliance is highly relevant during clear aligner therapy (CAT). In this retrospective cohort study, we assessed compliance and associated covariates in a large cohort of CAT patients. A comprehensive sample of 2644 patients (75.0% females, 25.0% males, age range 18–64 years, median 27 years), all receiving CAT with PlusDental (Berlin, Germany) finished in 2019, was analyzed. Covariates included demographic ones (age, gender) as well as self-reported questionnaire-obtained ones (satisfaction with ones’ smile prior treatment, the experience of previous orthodontic therapy). The primary outcome was compliance: Based on patients’ consistent use of the mobile application for self-report and aligner wear time of ≥22 h, patients were classified as fully compliant, fairly compliant, or poorly compliant. Chi-square test was used to compare compliance in different subgroups. A total of 953/2644 (36.0%) of patients showed full compliance, 1012/2644 (38.3%) fair compliance, and 679/2644 (25.7%) poor compliance. Males were significantly more compliant than females (p = 0.000014), as were patients without previous orthodontic treatment (p = 0.023). Age and self-perceived satisfaction with ones’ smile prior to treatment were not sufficiently associated with compliance (p > 0.05). Our findings could be used to guide practitioners towards limitedly compliant individuals, allowing early intervention.
... But though the visibility of the appliance is one of the principal concerns, this seems to be not the only one factor decisive to gain the correct use because, especially in the adolescents, the basic personality traits seem to play a more important role in this aspect (6). Bringing the action to the insertion of compliance control devices into the aligners seems not to change significantly in this aspect (7). ...
Article
Full-text available
The introduction, in the late years of the last century, of clear aligners therapy (CAT) has drastically changed the approach' perspective to orthodontic treatment. Both patients and clinicians' expectations appear to be addressed with clear aligner therapy achieving an aesthetic appearance and fewer side effects, mainly due to the difficult maintenance of proper oral hygiene in the conventional fixed approach. Research has partially confirmed these key points of CAT but similarly revealed several limitations to the overall benefit of this treatment. Both the aforementioned key points of the CAT are currently under discussion: the aesthetic appearance is not uniform, due to the presence in some cases of extensive need for attachments, and the better periodontal conditions are certainly present in the CAT but mainly limited to the short term. This critical review of the state of the art clarifies the gray areas, such as to inform the researcher with the aim of elaborating an adequate study design in order to evaluate the advantages and limitations of this orthodontic approach.
... The reduced number of days per set of aligners was contingent upon the patient wearing the aligners for minimum of 22 h per day [1]. This presents another challenge since many patients are not compliant to the level of wearing their aligners 22 h per day [4,5]. For this reason, the proposed seven-day aligner change by Align technology was not always easy to implement in daily practice, particularly with regard to the cases of increased complexity that are now being treated by Invisalign SmartTrack ® clear aligners [6][7][8]. ...
Article
Full-text available
This study presents a novel technique utilizing high-frequency vibration to shorten treatment time and preserve alveolar bone in challenging orthodontic cases that have been treated with Invisalign® clear aligners. Four non-growing orthodontic patients (age range 14-47 years old) with Class II skeletal patterns (convex profiles with retrognathic mandibles) who sought correction of their crowded teeth and non-surgical correction of their convex profiles were included in this study. These patients were treated using Invisalign clear aligners together with high-frequency vibration (HFV) devices (120 Hz) (VPro5™) that were used by all patients for five minutes per day during active orthodontic treatment. Vertical control and forward rotation of the mandible for each patient was achieved through pre-programming the Invisalign to produce posterior teeth intrusion. Successful forward rotation of the mandibles achieved in all patients led to improvement of their facial convex profiles (apical base relationship (ANB) improved 2.1 ± 0.5 degrees; FMA (Frankfurt mandibular plane angle) improved 1.2 + 1.1 degrees). Dental decompensation was achieved by lingual tipping of the lower incisors and palatal root torque of upper incisors. The use of HFV together with Invisalign facilitated achieving these results within a 12 ± 6 months period. In addition, more bone labial to the lower incisors after their lingual movement was noted. In conclusion, the use of HFV concurrent with SmartTrack Invisalign aligners allowed complex tooth movement and forward mandibular projection without surgery in non-growing patients with skeletal Class II relationships. The clinical impact and implications of this case series are: (1) the use of HFV facilitates complex orthodontic tooth movement including posterior teeth intrusion and incisor decompensation; (2) forward mandibular projection of the mandible and increased bone formation labial to lower incisors can be achieved in non-growing patients that may minimize the need for surgical intervention in similar cases or gum recession due to lower incisors labial inclination.
... To promote greater patient acceptance and to track compliance, CAT can be modified with indicators that change color with increased wear. 27 An advantage of the removable appliances is the greater ease of oral hygiene maintenance compared to traditional orthodontic brackets. Patients undergoing orthodontic treatment with CAT demonstrate lower plaque indices and have better periodontal health than patients undergoing treatment with fixed appliances. ...
Article
In recent years, the demand for esthetic orthodontic treatment options for adult patients has increased dramatically. Clear aligner therapy (CAT) has become a popular method of orthodontic therapy that now allows for comprehensive treatment with more complex dental movements. Moreover, the increasing role of technology in dental treatments has made CAT more appealing to providers and patients. The aim of this article is to highlight the clinical scope and limitations of CAT and to outline the differences among various clear aligner products.
Article
Routine alignment with fixed appliances and aligners is indeterminate mechanics because equilibrium equations are only applicable to two abutments: teeth, segments, or arches. Orthodontists must depend on compliance and resilience of materials (archwires and aligners) for initial alignment. However, stabilized segments and arches are "large multirooted teeth" that can be moved with determinate mechanics using temporary skeletal anchorage devices. Temporary skeletal anchorage devices have advanced from retromolar implants and inter-radicular miniscrews to extra-alveolar bone screws placed in the basilar bone buccal to the first molars: mandibular buccal shelf and infrazygomatic crest. Extra-alveolar anchorage is determinate mechanics to move teeth, segments, and arches. Retraction and rotation of the lower arch reverses the etiology of Class III open bite malocclusion to correct severe skeletal dysplasia with no extractions or orthognathic surgery.
Article
Full-text available
This study aimed to investigate temperature variation at archwire sites adjacent to the maxillary right central incisor and first premolar, its correlation with ambient temperature, and the influence of inter-racial variation. Twenty young adult male subjects were randomly selected (13 Asian, seven Caucasian). Thermocouples were attached to the labial archwire component of custom-made orthodontic retainers at the two intra-oral sites. A third thermocouple measured ambient temperature. A data-logger recorded temperatures at 5-second intervals over a 24-hour period. Temperatures ranged from 5.6 to 58.5 degrees C at the incisor and from 7.9 to 54 degrees C at the premolar, with medians of 34.9 degrees C and 35.6 degrees C, respectively. Ambient temperature correlated poorly with the intra-oral temperatures. The Asian and Caucasian groups had significantly different temperature distributions. On average during the 24-hour period, temperatures at the incisor site were in the range of 33-37 degrees C for 79 per cent of the time, below it for 20 per cent, and above it for only 1 per cent of the time. Corresponding figures for the premolar site were 92, 6, and 2 per cent. At both archwire sites the most frequent temperatures were in the range of 35-36 degrees C. The data presented demonstrate that the temperature at sites on an archwire in situ varies considerably over a 24-hour period and that racial differences may exist. This information should be considered during the manufacture and use of temperature-sensitive orthodontic materials, in particular nickel-titanium archwires and springs.
Article
Im Rahmen einer umfangreichen Fragebogenstudie an ber 300 funktionskieferorthopdisch behandelten Patienten und ihren Eltern wurden die Zufriedenheit mit Behandlungsmitteln sowie Arzt-Patient-Interaktion und die Einschtzung des eigenen Trageverhaltens untersucht. Bei der berwiegenden Mehrheit der Befragten lie sich eine positive oder indifferente Haltung zur Behandlung erkennen. Differenzierungs-und Kritikfhigkeit nehmen mit dem Lebensalter zu. Sprechbeeintrchtigungen stellen den meistgenannten Kritikpunkt dar; psychosoziale Nachteile durch das Tragen der Apparatur werden vor allem von den Eltern vermutet. Eine Minderheit der Patienten fhlt sich vom Kieferorthopden nicht entsprechend ihren sozial-emotionalen Bedrfnissen und Erwartungen behandelt. Abstriche vom verlangten Soll werden besonders beim vor- und nachmittglichen Tragen der Apparatur eingerumt. Die fr den Befolgungsgrad mitentscheidende elterliche Kontrolle erfolgt entweder mit Engagement und Anteilnahme oder in eher formal-ritualisierter Weise oder bleibt insgesamt unzureichend, und zwar in jeweils etwa einem Drittel der Flle.A questionnaire investigation enrolling more than 300 orthodontic patients and their parents was conducted into the subjective appraisal of treatment means and doctor-patient-interaction. The majority of the interviewees showed a positive respectively indifferent attitude toward their treatment. As patients grow older, their views become more differentiated and critical. Impaired speaking was mentioned most frequently; psychosocial disadvantages caused by appliance wear were suggested mostly by parents. In a minor part of patients, the orthodontist's behavior was not in line with their social-emotional needs and expectations. Slight failures of adherence with prescriptions were admitted for the daytime. Parental supervision appeared to be either energetic or formal yet superficial, or insufficient respectively in one third of our cases.
Article
To determine the attitude of young patients to removable appliance wear times, wear-time instructions and electronic wear-time measurement. 140 patients (mean age 11.97 years) undergoing orthodontic treatment with removable appliances expressed their wishes about wear times and wear-time instructions in a questionnaire. The questionnaires were analyzed by means of descriptive statistical analysis. Analysis of this questionnaire investigation according to gender revealed that the majority of the respondents preferred wearing their appliances overnight only, and that they did not want their practitioners determining the length of the appliance wear. We observed gender-specific differences in the acceptance of wear times as determined by the dental practitioner, which were accepted by 58% of the girls but only 28% of the boys. Willingness to wear a removable appliance increased markedly when the orthodontic objectives included offering patients the prospect of an improvement in their appearance from wearing a removable appliance. A recently-developed removable appliance with an integrated microsensor on the market that provides an objective measure of appliance wear times would only be worn without reservations by about 21% of boys and 32% of girls. 41-45% of the respondents only agreed to treatment using this kind of microsensor provided the treatment period would be thereby shortened. The extent to which the clinician can respond to the wishes and requirements of young patients in terms of removable appliance wear is crucial to the compliance necessary for success. Acceptance of a removable appliance with an integrated electronic wear-time recorder can be enhanced if the practitioner explains to the patient in a simple, straightforward manner the therapeutic advantage of this new generation of appliances. Society's growing openness towards electronic devices does not yet appear to be reflected in the desire of young patients for braces with an integrated microsensor.
Article
To test the hypothesis that there is no difference in the use of Invisalign between orthodontists and general practitioners. Materials and A questionnaire was mailed to all Invisalign providers within a 35-mile radius of Stony Brook University. The answers were statistically analyzed. The level of significance was set at P < .05. Orthodontists started more Invisalign cases (P < .0001). General practitioners started more Invisalign cases in the last 12 months (P = .0012). For both groups, the percentage of cases started in the last 12 months was inversely related to the number of years certified in Invisalign (P < .0001). Significant differences in opinion (P < .001) were noted between orthodontists and general practitioners regarding the level of experience necessary to treat a Class I malocclusion with a large diastema, and whether a Class II subdivision case should be treated with Invisalign. The hypothesis is rejected. The use of Invisalign by orthodontists and general practitioners was compared, and significant differences were found.
Article
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). 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. 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 degrees, 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. 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.
Article
A questionnaire investigation enrolling more than 300 orthodontic patients and their parents was conducted into the subjective appraisal of treatment means and doctor-patient-interaction. The majority of the interviewees showed a positive respectively indifferent attitude toward their treatment. As patients grow older, their views become more differentiated and critical. Impaired speaking was mentioned most frequently; psychosocial disadvantages caused by appliance wear were suggested mostly by parents. In a minor part of patients, the orthodontist's behavior was not in line with their social-emotional needs and expectations. Slight failures of adherence with prescriptions were admitted for the daytime. Parental supervision appeared to be either energetic or formal yet superficial, or insufficient respectively in one third of our cases.
Article
Acids of intrinsic and extrinsic origin are thought to be the main etiologic factors for dental erosion. There is evidence that acidic foodstuffs and beverages play a role in the development of erosion. However, the pH of a dietary substance alone is not predictive of its potential to cause erosion as other factors modify the erosive process. These factors are chemical (pKa values, adhesion and chelating properties, calcium, phosphate and fluoride content), behavioural (eating and drinking habits, life style, excessive consumption of acids) and biological (flow rate, buffering capacity, composition of saliva, pellicle formation, tooth composition, dental and soft tissue anatomy). The interplay between erosion and abrasion (specially oral hygiene practices) may be the main driver leading to the clinical manifestation of this disorder. Recommendations for patients at risk for dental erosion such as reducing acid exposure by reducing the frequency and contact of acids will be discussed.
Article
Investigations of the erosive potential of soft drinks are usually performed at room or body temperature, but drinks are more frequently served chilled, with ice, or hot. Since the rate of chemical reactions usually increases with temperature, it is predicted that erosion is more severe at high temperatures and reduced at low temperatures. The aim of this study was to investigate the correlation between enamel softening, enamel erosion, and temperature. Atomic force microscopy nanoindentation and non-contact optical profilometry were used to assess changes in enamel nanomechanical properties after 5 min and erosive material loss after 30 min exposure to two different non-carbonated soft drinks at 4, 25, 50 and 75 degrees C. For one drink (Robinson's Original Juice Drink), there was a statistically significant difference between nanomechanical properties and erosion depth at all temperatures, with softening and erosion increasing with temperature. For another drink (Ribena ToothKind Juice Drink), there was a slight softening and virtually no material loss, and temperature had no statistically significant impact on erosion. There was a good linear correlation (R2 = 0.94) between nanomechanical properties and material loss. The difference between the drinks can be explained by their composition. For the erosive drink, material loss increased, and nanohardness decreased, approximately linearly with temperature. The correlation between softening and erosion demonstrated that nanomechanical properties after very short erosion times can be considered a good predictor of bulk material loss after considerably longer erosion times.
Article
This study was undertaken to evaluate the compliance of patients using headgear with a timing device and to determine the efficiency of the electronic module timer as a patient motivator. Twenty-one patients (average age, 14 years 10 months) were selected from the orthodontic clinic of Federal University of Paraná on the basis of headgear wear for anchorage. The patients were instructed to wear their headgear 14 hours a day for a given number of days. The headgears were equipped with recorders (Compliance Science System and Affirm smart headgear modules, Ortho Kinetics, Vista, Calif). The patients were not told about the recorders, but they were instructed to keep track of their wear times. At the end of the test period (T1), the patients' reported wear times were compared with readings from the electronic modules. The patients were assigned a second period of headgear wear (T2) and told that their use would be monitored electronically. Again, the wear times reported by the patients were compared with the values from the electronic modules. Total time, number of hours accumulated between sessions, and quality time (uninterrupted use of headgear) were assessed. Patients reported wearing their headgear an average of 13.6 hours per day; the electronic modules detected 5.6 hours per day in T1 and 6.7 hours per day in T2. Quality time was 1.8 hours per day in T1 and T2. The mean actual hours of daily wear relative to the provider's requirement was 56.7% in T1 and 62.7% in T2. Boys were more compliant than girls. After they learned of the electronic device, the girls' compliance improved. Younger patients were more compliant than older ones. The compliance rate of older patients improved slightly in T2. Patients tend to overreport their headgear wear times. The mean actual hours of daily wear relative to the providers' requirement was 56.7%. This increased to 62.7% when patients knew a recording device was being used. A monitoring system can provide feedback to the patient, facilitate parental involvement, and motivate patients to comply with headgear wear.