European Journal of Orthodontics, 2020, 174–179

doi:10.1093/ejo/cjaa003
Advance Access publication 23 January 2020

Original article

Improving headgear wear: why force level and

direction of traction matter
Larissa Olivia Stocker, Raphael Patcas and Marc Andreas Schätzle

Downloaded from https://academic.oup.com/ejo/article/42/2/174/5714885 by guest on 24 September 2023

Clinic of Orthodontics and Pediatric Dentistry, Center of Dental Medicine, University of Zurich, Switzerland

Correspondence to: Raphael Patcas, Clinic of Orthodontics and Pediatric Dentistry, Center of Dental Medicine,
University of Zurich, Plattenstrasse 11, 8032 Zurich, Switzerland. E-mail: raphael.patcas@zzm.uzh.ch

Summary
Background: Empiric data on headgear wear are scarce. The aim was to examine a possible
discrepancy between the duration of wearing and force application, and whether such a difference
is influenced by force level or direction of traction.
Materials and methods: In this retrospective analysis, 122 consecutive patients were included. All
were treated with headgear (three subgroups: high-pull headgear [n = 60], cervical-pull headgear
[n = 32], and high-pull headgear in combination with an activator [n = 30]) and were monitored
for three successive months using an electronic module. The device recorded chronographically
the measured force magnitude and temperature, allowing to differentiate between the duration of
headgear wear (recorded body temperature) and actual force application (recorded force).
Results: For all subgroups, the average recorded force application was lower than wear time (mean
inactivity during wear: 15.9 ± 22.8 minutes/night). The direction of traction significantly influenced
the extent and length of wear time without force application (P < 0.001): patients with cervical-pull
headgear were more prone to inactive wear time (27.7 minutes/night) than patients with high-
pull headgear (13.7 minutes/night) or with headgear–activator (7.8 minutes/night). The observed
inter-individual variability of inactive wear time was considerable (0–134 minutes/night). The mean
applied force was highly significantly associated with inactive wear time (correlation coefficient:
−0.575; P < 0.001), and force levels below 250 g seem particularly related to episodes of inactivity.
Conclusions: There is a clear incongruity between the duration of headgear wear and the
duration of force application. Inactive wear time is influenced by the direction of traction and force
level applied. Clinicians should be aware of the likelihood of periods of inactive wear time and
researchers should search for options to reduce or even eliminate these periods.

Introduction (13, 14). Most commonly, either a neckband (cervical-pull head-

gear [CPHG]) or a head cap (high-pull headgear [HPHG]) is used as
Class II malocclusion is one of the most common dentoskeletal dis-
extra-oral anchorage. Depending on the direction of traction, treat-
crepancies, making its successful treatment essential in orthodontics
ment with a CPHG will result in the extrusion of maxillary molars,
(1, 2). Different components contribute to a Class II relationship,
thereby rotating the mandible in a clockwise direction and increas-
including skeletal and dentoalveolar maxillary prognathism and
ing anterior face height (15–17), whereas the use of an HPHG will
mandibular retrognathism (3–5).
cause an intrusive force on maxillary molars (7, 18, 19).
A widely accepted approach to correct a Class II relationship
Another well-established approach of Class II correction is to
during growth is the use of extra-oral traction with a headgear (6),
modulate, particularly during the pubertal spurt (20–22), condylar
which has been proved to be effective in both distalizing molars (7–
growth by forcing the mandible in a more anterior position using
9) and constraining skeletal maxillary sagittal displacement (10–12)
removable functional appliances (23–25). While some investigators
while at the same time allowing the mandible to grow unrestrictedly

© The Author(s) 2020. Published by Oxford University Press on behalf of the European Orthodontic Society.
174
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L. O. Stocker et al.
have challenged the orthopaedic effect of removable functional ap-
pliances and attributed the Class II correction mainly to dentoal-
veolar changes (26), a combined device of functional appliance and
headgear has been advocated to counteract the undesirable dental
effects (27–29).
Regardless of the type of headgear used and the exact underlying
biological changes, treatment results are only achieved if the appli-
ance is worn. As patient compliance is a key factor for treatment
success, several measuring devices have been introduced in the past,
in order to permit an objective quantification of wear time (30–33).
More recently, a novel module (Smartgear®, Swissorthodontics AG,
Cham, Switzerland) has successfully been approved for clinical use.
The unique feature of this module is its ability to not only record
time-related force magnitude but also temperature. While the re-
corded force reveals how long a force is acting on the system (active
time), the possibility to distinguish between room and body tem-
perature allows determining the hours the appliance is effectively
worn (wear time). According to anecdotal reports, the duration of
overall wear does not coincide with the actual hours of registered
force, implying that there are periods that no force is acting on the
respective module while the patient is actually wearing the appli-
ance. Up to date, this discrepancy between wear time and active time
has not been assessed and has not been addressed in literature so far.
Therefore, this investigation aims to evaluate the factors under-
lying this phenomenon. The hypothesis is that the headgear design
(high pull, cervical pull, and high pull in combination with the func-
tional appliance) and force level do not influence the duration of
active time.
Materials and methods
This is a retrospective study of 125 consecutive headgear patients
treated at the Clinic of Orthodontics and Pediatric Dentistry of the
local university. Ethical and judicial conformity of this study were at-
tested and approved by the governmental research ethics committee
(KEK-ZH 2014-0386).
To be eligible for inclusion, a patient had to meet the following
criteria:
•  PHG, CPHG, or HPHG in combination with an activator
H tinuous variables to determine possible deviations from a normal
(activator–HPHG) as part of the treatment plan.
• No other orthodontic appliances in use during the assessed
period.
• Informed consent for secondary use of patient data obtained
before onset of the study.
If these criteria were met, subjects were included regardless of
their severity of skeletal and dental Class II malocclusion, age, or
gender.
According to the clinic’s standardized protocol, all HG straps
were equipped with a clearly visible Smartgear measuring module
(Figure 1) on one side of the HG and patients were made aware
of the monitoring. The initial force magnitude was gauged to
Figure 1. Smartgear module. The built-in display allows the patient and the
orthodontist to access the data at all times.
175
approximately 350 g while patients were positioned horizontally.
This force level slightly exceeds the applied force in an upright pos-
ition, yet, as the majority of HG wear occurs during sleep, force cali-
bration was conducted while patients were lying down. To maximize
patient comfort, patients were allowed to tighten or loosen the HG
strap by one hole according to their preference. Each patient received
adequate instruction on HG wear and was required to wear the ap-
pliance for 10–12 hours during evening and night.
The data of the first month of HG use were disregarded, as it was
presumed not to be representative owing to initial adaption. Data of
the following 3 months, more specifically from day 30 to 119, were
retrieved and analysed. Subjects who did not wear the appliance for
at least 65 out of the 90 possible days were excluded (n = 3). Thus,
the sample assessed comprised 122 patients (HPHG: n = 60, CPHG:
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n = 32, and activator–HPHG: n = 30).
The Smartgear module records the measurable force (accuracy of
the device: ±10 g, range: 80–520 g) on the HG strap once every mi-
nute. After 15 minutes, the average force is calculated. Due to postural
changes, natural variability of the force magnitude is expected (34).
In a similar vein, a thermistor registers the temperature (accuracy of
the device: ±1°C). This information is saved on the module’s central
storage and can be extracted and transferred to an external computer
via an infrared interface. The data can then be visualized (Figure 2)
using a dedicated software (Smartgear Compliance Control System,
Swissorthodontics AG, Cham, Switzerland) that helps illustrate the
daily active time and wear time, which were defined as follows:
• Active time: time with a recorded force acting on the system.
• Wear time: time with recorded body temperature (i.e. active
time + wear time without activity).
• Inactive wear time: time with recorded body temperature but
no detectable force.
Statistical analysis
Data analysis was performed with SPSS (version 25; IBM Corp.,
Armonk, New York, USA). All variables were descriptively re-
viewed for the entire sample and subgroups separately. Sex distri-
bution across the subgroups was checked with a Fisher’s exact test.
Kolmogorov–Smirnov tests were conducted for all different con-
distribution, and accordingly either a one-way analysis of variance
or a Kruskal–Wallis test was performed to disclose differences be-
tween the subgroups. The association between the mean recorded
force and the extent of nightly wear time without activity was in-
vestigated with a Spearman’s Rho correlation test. A multiple linear
regression model was computed to account for possible confounder
when establishing the influence of several factors on the amount of
nightly wear time without activity. The significance level was set for
all tests at P < 0.05.
Figure 2. CCS Software extract: depiction of two nights of HG use. Blue curve:
registered force; red curve: registered temperature; vertical line: midnight.
Note the natural fluctuation of force magnitude and the three episodes of
inactivity during the first night.
176
Results
Data were retrospectively assessed from 122 patients (58 females;
47.5 per cent) who were on average 11.7 years of age (SD: ± 1.8 years;
min: 7.5 years; max: 15.9 years) at the beginning of orthodontic
treatment. The subgroups consisted of 60 HGHG patients, 32 CPHG
patients, and 30 activator–HPHG patients. No significant differences
were observed in sex distribution (P = 0.296) between the subgroups.
The number of nights that patients wore their appliance dur-
ing the observation period is shown in Figure 3 (median: 86 nights;
interquartile range [IQR]; 9 nights; min: 65 nights; max: 90 nights),
with no difference between the different subgroups (P = 0.214).
For the entire sample, the average wear time was 9.8 hours per
night (SD: ±1.2 hours), the average active time 9.5 hours per night
(SD: ±1.2 hours), and the average force during active time was 264 g
(SD: ±64 g). The results are summarized in Table 1 according to
subgroups.
On average, inactive wear time was 15.9 minutes per night (SD:
±22.8 minutes). Inactive wear time differed highly significantly be-
tween the subgroups, as illustrated in Figure 4 (P < 0.001). The acti-
vator–HPHG group was the least susceptible to ‘wear time without
activity’ (mean: 7.8 minutes/night; median: 1 minute/night; IQR: 9
minutes/night; range: 0–68 minutes/night), followed by the HPHG
group (mean: 13.7 minutes/night; median: 6.5 minutes/night; IQR:
17 minutes/night; range: 0–107 minutes/night) and the CPHG group
(mean: 27.7 minutes/night; median: 19.5 minutes/night; IQR; 37
minutes/night; range: 0–134 minutes/night).
Similarly, substantial differences could be observed regarding the
number of nights with prolonged inactive wear time. Episodes of 30,
60, or even 120 minutes without activity were commonplace, though
heavily dependent on the appliance (Table 2).
Figure 3. Histogram of patient distribution according to the number of nights
the appliance was worn during the observation period of 90 nights. Overall, a
high compliance rate could be seen across all subgroups and for both sexes.
Table 1. Recorded average times and force per night, according to subgroups.
HPHG (n = 60) CPHP (n = 32)
Mean (SD)
Average wear time per night (h) 9.9 (1.3) 9.7 (1.1)
Average active time per night (h) 9.7 (1.3) 9.2 (1.2)
Average force during active time (g) 246 (40) 268 (47)
HPHG, high-pull headgear; CPHP, cervical-pull headgear.
*P-value originating from one-way analysis of variance. All subgroups followed normal distribution for these variables (Kolmogorov–Smirnov tests ≥0.065).
European Journal of Orthodontics, 2020, Vol. 42, No. 2
The relationship between inactive wear time and the recorded
mean force is shown in Figure 5 (correlation coefficient: −0.575;
P < 0.001). The results indicate an evident negative correlation,
i.e. the greater the mean force, the shorter the inactive wear time.
In all subjects with a mean force of 250 g or more, inactive wear
time was 30 minutes or less. Hence, forces of 250 g (or more)
should be applied to eliminate the risk of extended inactive
wear time.
A multivariable linear regression model was calculated to deter-
mine the influence of sex, age at the beginning of therapy, type of HG
(i.e. subgroup), and mean force during active time on the amount of
nightly wear time without activity, while adjusting for potential con-
founders (Table 3). The model demonstrates that inactive wear time
is significantly influenced by the type of HG and the force applied
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but is apparently not related to sex or age.
Discussion
This headgear study is the first to demonstrate that significant time
discrepancies may occur between recorded body temperature and
recorded force, signifying an incongruity between wear time and
active time. This research reveals indisputably that active time
might be significantly shorter than overall wear time, implying
that even if the headgear is worn rigorously, it does not necessarily
mean that a continuous force is applied. As such, it becomes evi-
dent that treatment outcome does not depend solely on patient
compliance, but also is subject to influencing factors beyond the
patient’s control.
This study specifically addressed possible influencing factors
other than patient compliance. Compliance was controlled by dis-
regarding the patients with low compliance level (n = 3). The re-
maining subjects demonstrated an overall high compliance rate
(median wear: 86/90 nights; average nightly wear time: 9.8 hours).
Patients and parents were made aware of the monitoring device,
which was most likely the cause of the observed strict adherence to
instructions (35, 36).
While apparently neither sex nor age of the patients affected
headgear activity, the results conclusively establish both the direction
of traction and the level of applied headgear force to be two crucial
and independent factors influencing the active wear time. Thus, the
hypothesis has to be rejected.
The direction of traction has seemingly a major effect on the
registered active time. In fact, both the overall time without activity
and episodes of inactivity are seriously influenced by the direction
of the headgear traction. CPHG was most prone to inactive wear
time: with an average of more than 27 minutes per night, futile
wear time—which was nearly four times longer than for activator–
HPHG—was not only highly significantly amplified, but possibly
reached clinical relevance. In regard to treatment outcome, a recent
Activator–HPHG (n = 30) Difference between subgroups*
P
9.7 (0.8) 0.486
9.6 (1.0) 0.181
297 (66) <0.001
L. O. Stocker et al. 177

study suggests that fewer hours of HG wear can be compensated for
by a higher force magnitude (37); however, if a prolonged duration
of inactivity is coupled with a lower force level, it is almost certainly
of clinical relevance. The number of nights with episodes of 30, 60,
or even 120 minutes of the absence of any recorded headgear force
was also significantly higher in the CPHG group. It is not within the
scope of this observational study to assign a conclusive cause for
this manifestation. Yet a possible reason for this difference could be
suspected in the dynamics of head posture, previously reported to
be altering during sleep (34), and thus affecting the tension of the
neckband.
Of clinical considerable interest is the observation of remark-
able inter-individual variance of wear time without activity, across
all three subgroups. On the one hand, all subgroups had individ-
Consequently, it can be stated that the force level should neither be
too low nor too high. Based on the presented empiric data, a clinical
recommendation not to set the force magnitude below 250 g can be
submitted. This force level appears to be a threshold, as all of the
subjects with force levels above 250 g had a maximal mean time of
inactivity of 30 minutes.
Limitations
This investigation suffers from its retrospective, monocentric set-
ting. Group size differed owing to the consecutive recruitment of
patient data, and selecting just four possible influencing factors
(headgear design, force, sex, and age) could inadvertently have
caused an information bias. A prospective study design certainly
would have provided a more homogeneous composition of sub-

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uals for whom no wear time without activity could be registered, i.e.
their wear time equalled the active time. On the other hand, certain
individuals were wearing their headgear on average 68 minutes per
night (activator–HPHG), 107 minutes per night (HPHG), or even
134 minutes per night (CPHG) without any activity. This diversity—
disclosed here for the first time—is perturbing, as both individuals
(i.e. one with 2 hours of inactive wear time every night, and one
without any episodes of inactivity) will report a high level of compli-
ance, and rightly so. As such, being aware of the difference between
wear time and active time as an orthodontist can positively influence
the patient–doctor relationship.
In addition to the direction of traction, the mean applied force
had a highly significant effect on inactive wear time. In literature,
a force of 350–450 g (38) is recommended to achieve an ortho-
paedic impact. Newer investigations indicate, however, that compli-
ance is subject to decrease when high forces are being applied (39).
groups and allowed to include further influencing factors not
usually recorded (e.g. sleeping posture). Nevertheless, this study
offers valuable insights into a hitherto unreported phenomenon.
The number of patients included exceeds the samples of compar-
able previous studies (40) and certainly is large enough to war-
rant statistical inferences in order to draw conclusive statements.
Empiric data on headgear wear are scarce, and there is a com-
pelling need for investigations aiming to establish a causal rela-
tionship between (duration and magnitude of) applied force and
biological response. While more recently such laudable attempts
have been initiated (37), this study reveals the vital element that
for any effort to establish causality between headgear wear and
dentoskeletal effects, the active time and not the wear time has
to be taken into consideration. Finally, concerns about possible
discrepancies between the administered force and the active force
or between asymmetrical active force (left/right) have already
been refuted: The initial force level intended to be delivered is, on
average, maintained, and the mean force remains equal on both
sides (41).

Figure 4. Box and whisker plot for nightly average time patients wore their
appliances without any recorded activity. The average wear time without
activity differed highly significantly between the subgroups (Kruskal–Wallis
test: P < 0.001). HPHP, high-pull headgear; CPHG, cervical-pull headgear.
Conclusions
The present findings demonstrate a substantial discrepancy between
the duration of HG wear and actual force application, implying that
even if the prescribed treatment plan is followed rigorously, the ac-
tivity cannot be taken for granted. Clinicians should be aware of this
incongruity in order to improve the patient–doctor relationship and
researchers should search for options to reduce these episodes of in-
activity. The results are suggestive of force levels below 250 g being
particularly prone to cause inactive wear time and a recommenda-
tion not to set the force magnitude below this threshold can be sub-
mitted. The amount and length of episodes of wear time without
activity observed in this study seem to be of clinical importance;
however, its relevance for treatment outcome is subject to further
investigations.

Table 2. The amount of episodes with substantial differences between wear time and active time, according to subgroups.

Difference between wear time and active time HPHG (n = 60) CPHG (n = 32) Activator–HPHG (n = 30) Difference between subgroups*

Number of nights** with more than: Mean (95% CI) P

30 min difference 10.4 (6.9, 13.9) 23.0 (15.3, 31.3) 6.3 (2.2, 10.4) <0.001
60 min difference 5.8 (3.3, 8.4) 14.3 (8.3, 20.3) 3.6 (0.7, 6.5) <0.001
120 min difference 2.5 (1.1, 3.8) 4.6 (1.2, 7.9) 1.3 (0.0, 2.7) <0.003

HPHG, high-pull headgear; CPHP, cervical-pull headgear.

*P-value originating from Kruskal–Wallis tests. All subgroups differed from normal distribution for these variables (Kolmogorov–Smirnov tests ≤0.005).
**Number of nights stratified to 90 nights.
178
Figure 5. Scatterplot depicting all patients according to subgroup, with the
mean force applied plotted against the recorded wear time without activity.
Linear regression line (green line; correlation coefficient: −0.575) with its 95%
confidence intervals (grey dotted lines). HPHP, high-pull headgear; CPHG,
cervical-pull headgear.
Table 3. Summary of multivariable regression predicting the
amount of nightly wear time without activity.
Variable Beta 95% CI P 16.
Sex 0.008 −6.924, 7.617 0.925
Age 0.092 −0.851, 3.091 0.263
Subgroup 0.199 0.689, 10.303 0.025
Mean force during active time −0.570 −0.317, −0170 <0.001
Funding
No funding was available for this study.
Conflict of interest
None to declare.
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