Original Article

Patient compliance with Hawley retainers fitted with the SMARTH sensor:
A prospective clinical pilot study
Paul Hyuna; Charles Brian Prestonb; Thikriat S. Al-Jewairc; Eunhae Park-Hyund; Sawsan Tabbaae

ABSTRACT
Objective: To evaluate the compliance of patients while wearing maxillary Hawley retainers
embedded with SMART microsensors.
Methods: The sample population consisted of 22 patients who were divided into an experimental
(group A) and a control group (group B). Group A was informed that they would be monitored
through the use of SMART microsensors, while group B was not informed that they would be
monitored. After the delivery of the retainers (T0), the patients were evaluated at T1 and T2,
represented by 6- and 12-week follow-up visits, respectively. At T1, group B was informed of our
ability to monitor their compliance. Both groups continued wearing their retainers during T1 to T2.
Results: During T0–T1, Group A wore their retainers for an average of 16.3 hours (SD 4.39), while
group B wore their appliances for an average of 10.6 hours (SD 5.36, t 5 2.426, P 5 .027).
Although group B increased their retainer wear by 0.5 hours/day from T1 to T2, this increase was
not statistically significant.
Conclusions: Despite significant differences being noted between the two groups at T1, group B
did not show significant mean changes in their wear time before and after becoming aware of the
use of the SMART microsensor. (Angle Orthod. 2015;85:263–269.)
KEY WORDS: Hawley retainer; Wearing times; Compliance; Microsensors

INTRODUCTION cooperation. Patient compliance while wearing ortho-

dontic retention appliances is of particular importance
With the advent of modern orthodontics, noteworthy
since the oral soft tissues can take considerable time
improvements have been made in the design of
to adapt to the orthodontically attained positions of the
orthodontic appliances and in their application. Despite
teeth.1 It appears that conscientious retainer wear is
the positive evolution made in orthodontic appliance
particularly important during the first year following
design, it remains true that success during ortho-
active orthodontic treatment.2
dontic treatment relies to a large extent on patient
Protocols of postorthodontic treatment retention and
a
Postgraduate Orthodontic Resident, State University of New more specifically the duration of the retention phase
York at Buffalo, Buffalo, NY. have been debated extensively in the orthodontic
b
Professor and Chairman, Department of Orthodontics,
literature.3–7 Some practices require that patients wear
School of Dental Medicine, State University of New York at
Buffalo, Buffalo, NY. their removable retainers ‘‘full-time’’ for the first
c
Adjunct Research Associate, Department of Orthodontics, 6 months after debonding, followed by a period during
State University of New York at Buffalo, Buffalo, NY, and which the appliance wear is restricted to nighttime
Assistant Professor, Department of Preventive Dental Sciences, only.8 It has also been recommended that retainers
University of Dammam, Dammam, Saudi Arabia.
d
Private practice, Buffalo, NY.
be worn ‘‘part-time’’ for as long as a patient has the
e
Assistant Professor, Department of Orthodontics, State potential for growth.7 The ultimate success of any
University of New York at Buffalo, Buffalo, NY. retention protocol relies greatly on patient coopera-
Corresponding author: Dr Thikriat Al-Jewair, State University tion, which at its best is somewhat suspect.9 Patient
of New York at Buffalo, Department of Orthodontics, 140 Squire feedback regarding compliance with retainer wear
Hall, 3435 Main Street, Buffalo, NY 14214 USA
(e-mail: taljewair@gmail.com) tends to be subjective and difficult to translate into
objective raw data. With the development of micro-
Accepted: April 2014. Submitted: March 2014.
Published Online: May 28, 2014
sensors that make it possible to record the duration of
G 2015 by The EH Angle Education and Research Foundation, retainer wear, it may become possible to monitor this
Inc. aspect of patient compliance.

DOI: 10.2319/030814-163.1 263 Angle Orthodontist, Vol 85, No 2, 2015

264
The idea of measuring compliance in appliance
wear originated approximately 40 years ago.10 Due to
their bulkiness as well as their complexity, the original
recorders aimed at measuring the time of appliance
wear did not survive for long.10–13 Accuracy and
practicality presented the chief barriers that prevented
recording sensors from being utilized during routine
orthodontic treatment. Presently, the literature indi-
cates that two new sensors, the SMART14 and
the TheraMon15 microsensors, may be able to record
aspects of compliance in orthodontic patients. The
manufacturers of both microsensors state that their
recorders monitor the oral environment through tem-
perature, store the data in an encrypted form, and then
allow a provider to upload the information wirelessly
into a computer for further analysis.
Only one clinical study focused on the SMART
microsensor,9 while three studies reported on findings
obtained with the TheraMon sensor.16–18 Ackerman
and Thornton9 used the SMART microsensor in a
short-term randomized clinical trial that compared a
group that was aware of the microsensor with one that
was blinded to it. They concluded that the aware group
wore the retainer on average 2.3 hours per day more
than the unaware group. This finding was statistically
significant. Additional studies are required to deter-
mine if the SMART microsensor increases patient
compliance with the wear of removable retainers.
The first aim of this study was to measure patient
compliance with the wear of a maxillary Hawley
retainer fitted with the SMART microsensor. One
group of subjects was made aware of the presence
of the sensors while, for the first part of the study, the
second group was blinded to the fact. The null
hypothesis stated that there would be no differences
between the two groups in the time of appliance wear.
The second aim was to explore the change in retainer
wear time in the control group by repeating the
monitoring phase after they were informed of the
presence of the SMART microsensor. The null
hypothesis for this part of the study predicted that
there would be no difference in retainer usage
before and after being informed of the presence of
the sensor.
MATERIALS AND METHODS
After receiving approval from the University at
Buffalo Institutional Review Board, patients from the
University at Buffalo, School of Dental Medicine,
Orthodontic Clinic were recruited for this pilot study
between February 2012 and February 2013, based on
specific inclusion and exclusion criteria as shown in
Table 1. Following the completion of their fixed
orthodontic treatment, the patients who satisfied the
Angle Orthodontist, Vol 85, No 2, 2015
HYUN, PRESTON, AL-JEWAIR, PARK-HYUN, TABBAA
inclusion criteria were invited to participate in the study
and they were recruited continuously.
Twenty-two subjects fulfilled the inclusion criteria for
this study. By using a random number system, the
recruited sample was split into two equal groups (A
and B): group A (treatment group) was informed that
they would be monitored through the usage of the
SMART microsensor; group B (control group) was not
informed that they had the microsensor present in their
retainers. All of the maxillary Hawley retainers fitted in
the two groups contained the SMART microproces-
sors, and they were manufactured by the same
company and to the same standards (Great Lakes
Orthodontics, Buffalo, NY). The retainers were deliv-
ered to the patients at the T0 time point. Patients
were then evaluated at T1 and T2, 6 and 12 weeks,
respectively, following the delivery of the retainers. At
T0, one investigator gave both groups verbal instruc-
tions on what constituted an ideal retention protocol
then delivered a written form with the appropriate
retention instructions to each patient. The retention
protocol required the patients to wear the maxillary
Hawley retainers ‘‘full time’’ for the first 3 months after
debonding. ‘‘Full time’’ compliance was defined as
wearing the retainer at all times, and only removing it
while eating, tooth brushing, or while taking part in
contact sports. It was estimated that this constituted
about 19 hours a day of appliance wear. Patient-to-
patient interaction was avoided to prevent communi-
cation with one another regarding the presence of the
SMART microsensor.
The SMART microsensor has a built-in clock circuit
that resonates at a frequency of 32,768 Hz over
temperatures ranging from 240uF to 185uF. It records
the time of the day and corrects for 28-, 29-, 30-, and
31-day months.14 According to the manufacturer, their
product has a lifespan estimated to be approximately
18 months. The software program that accompanies
the microprocessor was designed to allow both the
provider and the patient to visualize the usage of the
retainer.15
At T1, the SMART system reader was used to scan
the SMART microsensors located in the retainers
of both groups A and B. The data were uploaded into
the proprietary computer software provided by
SMART. The data obtained at T1 was used by a
single investigator to ascertain how diligently the
subjects in groups A and B had worn the orthodontic
retainer appliances. The subjects of both groups were
then asked to complete a five-item questionnaire
(Table 2) regarding their overall experience and
comfort with their retainers.
During the T1 appointment, the subjects in the
control group (group B) were made aware of the fact
that their retainers were equipped with SMART
PATIENT COMPLIANCE WITH HAWLEY
Table 1. Sample Inclusion and Exclusion Criteria
Inclusion Criteria
(1) Subject age is between 14 and 17.6 years
(2) Retention treatment plan is maxillary Hawley retainer
(3) Acceptable alignment of maxillary anterior teeth with no teeth missing
(4) Language of the subject is English
(5) Written informed consent including a HIPAA authorization signed by
the patient’s parent/legal guardian prior to the start of the study
microsensors that made it possible to record for how
long they had worn their appliances. The patients of
both groups were once more instructed in the same
retention protocol that was provided at T0. It was now
possible to monitor the compliance of the subjects in
the original control group (group B) in response to the
knowledge that their retainers contained a micropro-
cessor. In essence, the control group of patients acted
as their own controls during this second part of the
study. Four of the 22 subjects were lost from the study
due to sensors that became faulty during the T0 to
T1 phase of the study, and only the data of the 18
remaining patients were analyzed.
At the T2 time points, the microprocessors in the
appliances of both groups were scanned again to gain
insight into the further compliance of the subjects
included in this study. It was of particular interest to
determine whether the Group B subjects modified their
appliance wear routine in response to being made
aware of the presence of the microprocessors.
Informed consent was obtained from the subjects in
the groups A and B and their parents/guardians at the
time of the removal of the fixed orthodontic appliances
(T0). Group B subjects were informed they were
enrolling in a study on compliance with retainer wear,
but no mention of the sensor was given. Due to the
blinding involved with this group, an additional
informed consent with full disclosure of the sensors
was required and obtained at T1.
Additional data were obtained from the patients’
treatment charts at T2. These data included the
Discrepancy Index (DI) of the American Board of
Orthodontics. The DI was used to determine whether a
statistical relationship existed between the severity of a
malocclusion and treatment time and difficulty and
the level of patient compliance in wearing retention
appliances.
Table 2. Questionnaire Delivered to Participants at T1
(1) Please rate the overall experience with the retainers. (Score from 22 to +2, ranging from very negative to very positive, with 0 representing
neutral.)
(2) Please rate the overall comfortability of the retainers. (Score from 22 to +2, ranging from very negative to very positive, with 0 representing
neutral.)
(3) How much do you think you wear the retainers? (Score from 0% to 100%, in 10% increments.)
(4) What was your self-perception of your teeth before the orthodontic treatment? (Score from 1 to 10, 10 being the best.)
(5) What was your self-perception of your teeth after the orthodontic treatment? (Score from 1 to 10, 10 being the best.)
265
Exclusion Criteria
(1) Craniofacial and/or dentofacial syndromes
(2) Early orthodontic treatment (Phase 1)
(3) Patients who turned 18 years old during the recording phase
of the study (T2)
Statistical Analysis
Data were analyzed using SPSS for Windows
version 20 (SPSS Inc, Chicago, Ill). Descriptive
statistics were calculated for each variable. Two
sample t-tests were used to compare groups A and
B at T1. The paired t-test was used to compare the
retainer wear times within the groups at T1–T2. Chi-
square test was used to analyze categorical variables.
Pearson correlation coefficient was used to assess the
relation between the retainer wear times and other
variables. Significance levels were set at .05.
RESULTS
Group A consisted of nine patients, of whom eight
had usable recording data. Group B consisted of 13
patients, of whom 10 had usable recording data,
(Table 3). The mean age of the subjects in group B
was slightly higher than that noted for group A (t-test,
P 5 .397). Although the sample size was not optimal
for a chi-square test, there was no evidence that the
test groups were unbalanced with respect to gender
(P 5 .914). The average treatment time for group B
(35.50 months, SD 13.575) was 9 months longer
than for group A (26.75 months, SD 5.497), but the
difference was not statistically significant (Table 4).
The standard deviation of the treatment time for group B
was nearly 2.5 times larger than that of group A. As a
result, the modified t-test that does not require homo-
geneity of variances was used to evaluate the difference
in duration of treatment time. The outcome was still a
nonsignificant difference (P 5 .087) for this entity.
Results of Phase I (Day 0 to Day 42)
During the first phase of the study (T0–T1), the
average daily hours of retainer wear for group A was
16.3 (SD 4.39), while for group B it was 10.6 (SD 5.36),
Angle Orthodontist, Vol 85, No 2, 2015
266 HYUN, PRESTON, AL-JEWAIR, PARK-HYUN, TABBAA

Table 3. Sample Characteristics experience with the retainers (62.5% for group A and
Mean 80% for group B). Most patients found the retainers to
Eligible* Group Female Male Total Age, y SD be comfortable (87.5% of group A and 90% of group
No A 0 1 1 15.00 – B). About 61% of the patients (Figure 3) overestimated
B 2 1 3 15.33 1.528 the time (x-axis) that they wore their retainers as
A and B 2 2 4 15.25 1.258 compared to the actual recorded time (y-axis). All of
Yes A 5 3 8 15.13 1.553
B 6 4 10 15.70 1.252
the patients rated their teeth as 6 or less on the
A and B 11 7 18 15.44 1.381 attractiveness scale before they started wearing
Total A 5 4 9 15.11 1.453 braces. The average for group A was 3.0 (SD 2.00)
B 8 5 13 15.62 1.261 and for Group B it was 3.8 (SD 1.81), (t 5 0.889, P 5
A and B 13 9 22 15.41 1.333
.387). All of the patients rated their teeth to be 9 or 10
* Data could be scanned from the SMART microsensor with no on the attractiveness scale at the completion of their
malfunctions.
orthodontic treatment. Group B was more positive
about the outcomes of their orthodontic treatment than
was group A. The correlation between the hours per
(86% compliance rate in group A vs 56% in group B). day of retainer wear and the appointment show rate
The difference in average wear of 5.7 hours per day was statistically significant (Table 5).
was statistically significant (t 5 2.426, P 5 .027). Only
one patient (12.5%) in group A averaged less than DISCUSSION
12 hours per day of retainer wear compared to seven
patients (70%) in group B. At T1 the compliance in retainer wear between
group A and group B was statistically significant (t 5
Results of Phase 2 (Day 43 to Day 84) 2.426, P 5 .027). This finding is consistent with that of
Ackerman and Thornton9 who showed that the aware
The average daily retainer wear for group A group wore their appliances for an average of
decreased by 0.7 hours to 15.6 hours (SD 4.77), 2.3 hours a day longer than the non-aware group.
while in Group B it increased by 0.5 hours to This finding is in accordance with the Hawthorne
11.1 hours (SD 6.08). The difference between the phenomenon according to which subjects perform
groups of 4.48 hours was not statistically significant better when they are aware that they are being
(t 5 1.703, P 5 .108). Figures 1 and 2 illustrate the monitored.19
retainer usage between T1 and T2 for each subject. In The present study was novel in that it compared the
group A (Figure 1), six of 8 patients maintained their compliance of subjects (group B) prior to, and after
appliance usage, while two decreased their wear being made aware of our ability to monitor them. While
times. In group B, four maintained their appliance these subjects increased their compliance by an
wear times, four increased these times, and two
average of 0.5 hour a day after T1, this increase was
decreased their wear times. The data for most
not statistically significant and therefore the null
patients (Figure 2) seem to be located close to the
hypothesis cannot be rejected. This finding may be
no difference line, indicating that there was not a
explained by the possibility that once this group
significant change in appliance wear between the two
achieved a habitual pattern of retainer wear (T0 to
phases studied. The Pearson correlation was 0.972
T1), it was difficult to change the habit even after being
for group A and 0.917 for group B.
told that they were being monitored. Further, the
relatively small sample size might have prevented a
Post Study Results
significant effect from emerging.
Results from the questionnaires showed that the The results indicate that patients who commence
majority of patients in each group had a positive overall treatment with a higher DI score are more compliant in

Table 4. Descriptive Statistics of Variables Obtained From The Patients’ Treatment Charts at T2
Variable Group N Mean SD SE Mean t-test P Value*
Treatment duration, mo Group A 8 26.75 5.497 1.943 1.706 .107
Group B 10 35.50 13.575 4.293
Discrepancy Index Group A 8 14.38 6.948 2.456 1.818 .088
Group B 10 9.30 4.900 1.550
Appointment show rate, % Group A 8 80.88 7.882 2.787 0.067 .947
Group B 10 80.60 9.131 2.888
* Significance at .05.

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PATIENT COMPLIANCE WITH HAWLEY 267

Figure 1. Comparisons of mean wear times of the SMART retainer between T1 and T2.

terms of retainer wear than those who commence The average total treatment time in months for group
treatment with lower DI scores. Patients with more B was 9 months longer than that for group A. This
disfiguring malocclusions may be more conscious of finding could be due to poor compliance with treatment
the possibility of postorthodontic treatment relapse. instructions during the orthodontic treatment. Poor

Figure 2. Mean wear times of the SMART retainer during T1 and T2.

Angle Orthodontist, Vol 85, No 2, 2015

268 HYUN, PRESTON, AL-JEWAIR, PARK-HYUN, TABBAA

Figure 3. Comparisons of mean wear times of the SMART retainer between T1 and T2.

compliance during orthodontic treatment may well be
carried forward into the retention phase.
None of the attempted correlations within groups A
and B were statistically significant (Table 5). However,
when combining all of the subjects into one group, a
moderately statistically significant correlation was
evident between retainer wear and appointment show
rate (r 5 0.555, P 5 .017). Given that this significant
correlation was, in part, due to the larger sample size,
it would be essential to increase the sample size for
future studies to obtain more conclusive results.
Eighty-nine percent of all subjects reported overall
positive experience and comfort with the retainers.
This is similar to the findings of a previous study.20
Despite the overall positive experience with the
retainers, the dimensions of the SMART microsensor
need some discussion. The microsensor was mea-
sured to have a diameter of 15 mm and a width of
4.5 mm. When the microsensor is placed in the
Hawley retainer (average thickness of 2–3 mm), the
thickness of the acrylic on the palate is increased to
about 7–11 mm. The TheraMon microsensor has
similar dimensions of 13 mm 3 9 mm 3 4.5 mm.16
Schott and Göz15,21 in previous in vitro studies found
that the TheraMon had greater versatility and more
accurate recordings of wear time down to the minute
than the SMART microsensor. They did conclude,
however, that both microsensors could be used as
objective wear-time sensors in orthodontic applianc-
es.21 The reason that the SMART microsensor was
used in our study is that the product is manufactured
domestically and it is readily available in North
America.
Only 22 patients were recruited and four of them
were lost due to sensor malfunction (27 subjects would
produce 85% certainty at a significance of 5%). The
manufacturers advise that that the removal of a
microsensor from a retainer (grinding, vibration, etc.)
could cause them to malfunction. Ackerman and
Thornton9 reported that in their study of 23 subjects,

Table 5. Correlations Between the Retainer Wear Times Per Group and the Potential Indicators of Compliance With Retainers Wear at T2
Variable Group A (N 5 8) Group B (N 5 10) All groups (N 5 18)
Appointment show rate, % Pearson correlation 0.617 0.585 0.555
Sig. (2-tailed) .103 .075 .017
Discrepancy Index Pearson correlation 20.261 0.174 0.140
Sig. (2-tailed) .533 .630 .579
Pre and post self-perception Pearson correlation 20.123 0.085 0.816
(Questions 4 and 5) Sig. (2-tailed) .771 .816 .918
Treatment duration, mo Pearson correlation 0.687 0.159 0.062
Sig. (2-tailed) .060 .660 .807

Angle Orthodontist, Vol 85, No 2, 2015

PATIENT COMPLIANCE WITH HAWLEY
three of the subjects lost their retainers while one
SMART microsensor malfunctioned.
Several factors could impact the outcomes of this
study, Appliances that incorporate the SMART micro-
sensors tend to be thicker than usual, and this fact may
discourage patients from wearing the retainers with
them. Malfunctions with the microprocessors are likely
to become less of a problem as the science advances,
but at the present time, this factor may cause some
reluctance to use them in randomized clinical trials.
CONCLUSIONS
In this study:
N The aware group wore the retainer more than the
non-aware group, and the difference was statistically
significant.
N The non-aware group did not have any significant
change in wear time before and after becoming
aware of the use of the SMART microsensor.
Whether it is difficult to change the level of a patient’s
compliance between the periods or the results are
due to the small sample size, future studies are
warranted to provide conclusive results.
N Although SMART microsensors embedded into
removable appliances do allow orthodontists to
measure the time of appliance wear, the function-
ality and practicality of the sensor needs several
improvements.
ACKNOWLEDGMENTS
We thank Bob Dunford for his expert assistance with the
statistical analysis of this research project.
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