RANDOMIZED CONTROLLED TRIAL

Comparative assessment of alignment

efficiency and space closure of active
and passive self-ligating vs
conventional appliances in adolescents:
A single-center randomized controlled
trial
Goldie Songra,a Matthew Clover,b Nikki E. Atack,c Paul Ewings,d Martyn Sherriff,e Jonathan R. Sandy,f
and Anthony J. Irelandf
Bristol, Salisbury, and Exeter, United Kingdom

Introduction: The aim of this study was to compare the time to initial alignment and extraction space closure
using conventional brackets and active and passive self-ligating brackets. Methods: One hundred adolescent
patients 11 to 18 years of age undergoing maxillary and mandibular fixed appliance therapy after the extraction of
4 premolars were randomized with stratification of 2 age ranges (11-14 and 15-18 years) and 3 maxillomandib-
ular plane angles (high, medium, and low) with an allocation ratio of 1:2:2. Restrictions were applied using a block
size of 10. Allocation was to 1 of 3 treatment groups: conventional brackets, active self-ligating, or passive self-
ligating brackets. All subjects were treated with the same archwire sequence and space-closing mechanics in a
district general hospital setting. The trial was a 3-arm parallel design. Labial-segment alignment and space
closure were measured on study models taken every 12 weeks throughout treatment. All measurements
were made by 1 operator who was blinded to bracket type. The patients and other operators were not blinded
to bracket type during treatment. Results: Ninety-eight patients were followed to completion of treatment (con-
ventional, n 5 20; active self-ligating brackets, n 5 37; passive self-ligating brackets, n 5 41). The data were
analyzed using linear mixed models and demonstrated a significant effect of bracket type on the time to initial
alignment (P 5 0.001), which was shorter with the conventional brackets than either of the self-ligating
brackets. Sidak's adjustment showed no significant difference in effect size (the difference in average
response in millimeters) between the active and passive self-ligating brackets (the results are presented as
effect size, 95% confidence intervals, probabilities, and intraclass correlation coefficients) ( 0.42 [ 1.32,
0.48], 0.600, 0.15), but the conventional bracket was significantly different from both of these ( 1.98 [ 3.19,
0.76], 0.001, 0.15; and 1.56 [ 2.79, 0.32], 0.001, 0.15). There was no statistically significant difference
between any of the 3 bracket types with respect to space closure. Space-closure times were shorter in the
mandible, except for the Damon 3MX bracket (Ormco, Orange, Calif), where active and total space-closure
times were shorter in the maxilla. No adverse events were recorded in the trial. Conclusions: Time to initial
alignment was significantly shorter for the conventional bracket than for either the active or passive self-
ligating brackets. There was no statistically significant difference in passive, active, or total space-closure
times among the 3 brackets under investigation. (Am J Orthod Dentofacial Orthop 2014;145:569-78)

a
Senior specialist registrar, School of Oral and Dental Sciences, University of All authors have completed and submitted the ICMJE Form for Disclosure of
Bristol, Bristol, United Kingdom. Potential Conflicts of Interest, and none were reported.
b
Private practice, Salisbury, United Kingdom. Address correspondence to: Anthony J. Ireland, School of Oral and Dental
c
Consultant orthodontist, School of Oral and Dental Sciences, University of Sciences, University of Bristol, Lower Maudlin Street, Bristol BS1 2LY, United
Bristol, Bristol, United Kingdom. Kingdom; e-mail, tony.ireland@bristol.ac.uk.
d
Visiting professor, Medical School, University of Exeter, Exeter, United Submitted, July 2013; revised and accepted, December 2013.
Kingdom. 0889-5406/$36.00
e
Visiting professor, School of Oral and Dental Sciences, University of Bristol, Copyright Ó 2014 by the American Association of Orthodontists.
Bristol, United Kingdom. http://dx.doi.org/10.1016/j.ajodo.2013.12.024
f
Professor, School of Oral and Dental Sciences, University of Bristol, Bristol,
United Kingdom.

569
570
A
lthough the first self-ligating bracket, the Rus-
sell lock attachment, was introduced in 1935,
it is only more recently that there has been a re-
newed interest in the use of self-ligating brackets.1
Currently, 2 main types of self-ligating brackets are
available, active and passive, both of which have a num-
ber of purported advantages over conventional brackets
and over each other. These include fewer treatment
visits, reduced overall treatment time, improved es-
thetics, reduced friction, improved oral hygiene, and
full and secure ligation.2-4
Previous retrospective research has shown that the
use of self-ligating brackets can reduce treatment times
by 4 to 6 months and by 4 to 7 visits when compared
with conventional brackets.5,6 In addition, laboratory
studies have suggested that friction is reduced,7-9
particularly with passive self-ligating brackets.10,11
Although improved treatment efficiency is highly
desirable, it has not been a universal finding,
particularly for initial alignment and space closure.
Some studies have found no difference in the rate of
initial alignment with either conventional or self-
ligating brackets and have usually compared passive
self-ligating brackets with conventional brackets.12-17
The only study to date that directly compared active
with passive self-ligating brackets showed no difference
in the time required to complete alignment, although
there was no conventional bracket control group.18
Most previous researchers have also looked only at
mandibular labial-segment alignment,12-16 with
relatively few investigating maxillary labial-segment
alignment.17,18
Studies investigating the rate of space closure have
also reported no difference between self-ligating and
conventional brackets.19,20 However, they have only
compared passive self-ligating brackets with conven-
tional brackets and either have used a split-mouth
design19,20 or have measured space closure for only a
limited time.17 This has been confirmed by recent sys-
tematic reviews highlighting the variability and differ-
ences between the studies and recommending that
further randomized clinical controlled trials are
needed.21,22
With these limitations in mind, the aim of this study
was to investigate the time to initial alignment of both
the maxillary and the mandibular labial-segment teeth
along with the time to achieve space closure in the
buccal segments when using 1 of 3 types of bracket:
Damon 3MX passive self-ligating bracket (Ormco, Glen-
dora, Calif), In-Ovation R active self-ligating bracket
(DENTSPLY GAC International, Islandia, NY), and Omni
conventional bracket (DENTSPLY GAC International).
The null hypotheses were that there are no differences
May 2014  Vol 145  Issue 5 American Journal of Orthodontics and Dentofacial Orthopedics
Songra et al
among the 3 bracket types during initial alignment or
during space closure, or between the maxillary and
mandibular arches (jaws).
MATERIAL AND METHODS
Ethical approval for the trial was granted by the ethics
research committee (06/02202/6) of Taunton and Som-
erset Hospital, Musgrove Park, Taunton, United
Kingdom. At the initial planning of this investigation,
there were no studies reporting on the time to initial
alignment comparing self-ligating and conventional
brackets to determine a power calculation. We decided
to recruit 90 subjects for the trial: 36 subjects to each
self-ligating group and 18 to the conventional bracket
group. However, to allow for a 10% dropout rate, 100
subjects were recruited with the following inclusion
criteria: less than 18 years of age, ready to commence
maxillary and mandibular fixed appliance treatment,
intact labial segments, and premolar extractions required
in all 4 quadrants. The principal exclusion criteria were
the following: subjects who could not understand En-
glish, had learning difficulties, and had incomplete labial
segments. The flow of the subjects in the trial is shown in
the CONSORT diagram (Fig 1), which clearly demon-
strates the 3-arm parallel design with its 2:2:1 allocation
ratio. In total, 100 patients were recruited into the trial,
and 98 were followed to completion of treatment, with
2 dropouts. There were no outcome changes during the
trial, and no interim analyses were planned or performed.
When this trial began, there was less insistence on trial
registration; thus, the trial and its protocol were not
registered on a publicly accessible registry. No external
funding was received for this trial.
All subjects were treated in the orthodontic depart-
ment at Musgrove Park Hospital, Taunton, United
Kingdom, by 1 of 3 consultants or 5 specialist registrars.
Eligible participants and their guardians were given an
information sheet before inclusion in the trial and an
ample opportunity to ask any relevant questions. Block
randomization was used to ensure that each participant
was randomly allocated to 1 of the 3 bracket groups: the
control group with conventional Omni brackets, or a
self-ligation group: Damon 3MX or In-Ovation R. The
randomization was carried out by the local research
and development office, which was contacted by tele-
phone before the bond-up of each participant. This pro-
cess allowed allocation concealment from the
researchers and prevented the possibility of prediction
of the next randomization in each block. The randomi-
zation was also stratified to take into account patient
age and the Frankfort mandibular plane angle. The par-
ticipants were divided according to age at the start of the
Songra et al
Fig 1. Consort diagram of the flow of participants through the trial.
trial, either 11 to 14 years or 15 to 18 years. There were 3
groups for the Frankfort mandibular plane angle: low,
less than 22 ; average, 22 to 32 ; and high, greater
than 32 . This was assessed using a pretreatment lateral
skull radiograph and cephalometric analysis. The block
size was 10 (2 for the conventional brackets, 4 in each
of the other 2 arms), and blocks were used in each of
the 6 strata formed by the 2 age categories and the 3
mandibular plane angle categories.
The 3 treatment bracket groups were (1) 0.022-in slot
Damon 3MX passive self-ligating brackets, (2) 0.022-in
slot In-Ovation R active self-ligating brackets, and (3)
0.022-in slot Omni conventional brackets.
All brackets had a Roth prescription and were bonded
using the same protocol. Molar bands (DENTSPLY GAC
International) were placed on the permanent first
American Journal of Orthodontics and Dentofacial Orthopedics
571
molars; although the second molars were not routinely
included in the initial bond-up, if it was required as
part of the specific treatment plan, then the maxillary
or mandibular second molars were bonded with second
molar tubes (American Orthodontics, Sheboygan, Wis),
following the same bonding protocol as used at the
initial bond-up appointment.
For each subject, the same archwire sequence was
used: initial archwire, 0.014-in copper nickel titanium
(Ormco); second archwire, 0.018-in copper nickel tita-
nium (Ormco); third archwire, 0.016 3 0.022-in stain-
less steel (DENTSPLY GAC International); and final
archwire, 0.019 3 0.025-in stainless steel (DENTSPLY
GAC International).
In the case of the conventional brackets, the archwires
were ligated using elastomeric ligatures (OrthoCare,
May 2014  Vol 145  Issue 5
572
Bradford, United Kingdom). With the self-ligating
brackets, care was taken to ensure that the clip was fully
closed before progressing to the next wire size. Subjects
with the Omni conventional brackets were scheduled to
be seen routinely every 6 weeks, and subjects with the
self-ligating brackets were scheduled to be recalled every
12 weeks as per normal practice. Initial pretreatment
maxillary and mandibular alginate impressions were
taken for every participant before bond-up and then
were obtained every 12 weeks until completion of treat-
ment. In each case, they were cast in dental stone within
the hour. Beading wax was used to block out the brackets
and archwires before the impression. This was done to
facilitate easy removal of the impression and to ensure
that the bracket type would remain concealed on the
study models during subsequent measurements. There-
fore, only the model assessor (G.S.) was blinded during
the study. The patients and the operators carrying out
the treatment (N.E.A., G.S., and others) could not be
blinded.
Initial alignment of the maxillary and mandibular
labial segments was assessed to be complete when
the final 0.019 3 0.025-in stainless steel archwire
was in situ and passive. At this point, the degree of pas-
sive space closure was also assessed. Active space
closure was also carried out on a 0.019 3 0.025-in
stainless steel archwire in both arches. Crimpable hooks
were attached to the archwire between the lateral
incisor and the canine brackets in each quadrant
when required, and active space closure was carried
out using a 150-g nickel-titanium coil spring and
sliding mechanics. A passive long ligature was placed
in a quadrant to prevent the space from reopening if
space closure in a quadrant was complete. The use of
intraoral elastics was permitted where clinically justi-
fied. This was usually once the subjects were in a stain-
less steel archwire. All measurements were carried out
by 1 operator (G.S.). Maxillary and mandibular labial-
segment alignment was measured on all participants'
study models taken at each of the nominal 12-week in-
tervals until the end of initial alignment and the end of
treatment. Little's index of irregularity23 was measured
in each subject using a digital Vernier caliper (Fred V.
Fowler, Newton, Mass). The time to achieve total space
closure was also measured using the subjects' study
models from the start of treatment and at each 12-
week interval until the end of treatment with the
same caliper. This was split into 2 measurements: pas-
sive space closure during the initial alignment phase
and active space closure once the active space-closure
mechanics were in situ. Space closure was measured
from the buccal groove of the first molar to the distal
contact point of the corresponding canine in each
May 2014  Vol 145  Issue 5 American Journal of Orthodontics and Dentofacial Orthopedics
Songra et al
quadrant. To ensure repeatability, all measurements
were made under similar conditions with a strict proto-
col to within 0.01 mm. Before the study, 1 researcher
(G.S.) had undertaken a reproducibility study in which
Little's index and extraction space on 10 randomly
selected maxillary and mandibular models were
measured twice 1 week apart using the Vernier caliper.
The trial was considered to be completed when all
spaces were closed.
Statistical analysis
The data were analyzed using Stata software (version
12.1; Stata, College Station, Tex) with a predetermined
significance level of a 5 0.05. The experimental design
was repeated measures with time recorded in days from
the start of treatment rather than the “nominal times” in
weeks when the patient was scheduled for an appoint-
ment, which was at 12-week intervals. This was therefore
an intention-to-treat analysis. Since there were 98 pa-
tients, individual plots of the dependent variable against
time were too cluttered to show any trends in the data.
For this reason, the data for each variable (eg, bracket
and arch) were smoothed using a restricted cubic spline,
which allowed for irregularly spaced data, and the result-
ing predicted smoothed values were plotted against
time. These plots were an exploratory analysis to show
trends and did not imply a formal relationship between
the variables.24 The splines have increased errors with
increasing time because of the reduction in the amount
of data still present.
Because the data were recorded at irregular time in-
tervals, the appropriate analysis involved mixed models
rather than standard repeated-measures analysis of vari-
ance (ANOVA), which would require each patient visit to
be at the same time.25-27 This would mean the use of the
incorrect nominal time. The mixed-models approach
also allowed for the fact that measurements on arch
(jaw) were clustered in each patient. Stata module
“xtmixed” was used with restricted maximum likelihood
estimation, and effects were compared using margins in
conjunction with Sidak's adjustment for multiple com-
parisons. Two participants dropped out of this trial.
However, their data until dropout were included in the
statistical analysis because of the use of the linear
mixed-model analysis instead of conventional ANOVA.
RESULTS
The demographic data on Frankfort mandibular
plane angle, sex, age, and initial Little's index23 value
for the bracket groups are shown in Table I. Summary
statistics for the time to initial alignment are shown in
Table II. The repeatability data for Little's index and
Songra et al 573

is the effect of a covariate on the response adjusted for

Table I. Demographic data for sex, age (mean age and
the other covariates in the model.29 Probabilities have
standard deviation), Frankfort mandibular plane
been rounded to 3 decimal places, and all other values
angle, and Little's index (mean and minimum/
to 2. There was a significant effect of bracket type on
maximum)
the time for initial alignment, P 5 0.001. Sidak's adjust-
Damon 3MX In-Ovation R Omni ment showed no significant difference between In-
Male Ovation R and Damon 3MX ( 0.42 [ 1.32, 0.48],
n 17 12 8 0.600, 0.15), but Omni was significantly different from
Age (y) 14.3 (1.1) 14.1 (1.5) 14.3 (0.9)
both of these ( 1.98 [ 3.19, 0.76], 0.001, 0.15; and
Female
n 25 26 12 1.56 [ 2.79, 0.32], 0.001, 0.15). The effect size
Age (y) 14.2 (1.3) 13.8 (1.4) 13.2 (1.5) was the difference in average response in millimeters.
Frankfort mandibular Due to the nonlinear response to both initial alignment
plane angle and space closure, along with the variable time intervals
Low 4 4 11
involved, a figure for the rate of tooth movement in mil-
Average 27 25 9
High 11 9 5 limeters per month would not be particularly meaningful.
Little's index (mm) However, the overall differences are illustrated in the
Maxilla 11.42 12.17 10.59 spline plots for the main effects (Figs 2 and 3). Table II
(1.89-25.82) (2.66-23.52) (3.28-19.98) also illustrates the clinically significant differences in
Mandible 8.80 8.17 6.75
the mean time (days) to achieve alignment, which was
(4.01-19.75) (2.60-14.51) (2.15-15.55)
significantly less for the conventional brackets than for
either self-ligating bracket. For passive (P 5 0.982),
active (P 5 0.928), and total (P 5 0.509) space closure,
Table II. Univariate summary statistics for time in days there was no significant effect of bracket type.
to initial alignment When considering the effect of arch (jaw) on initial
alignment and space closure, there was a statistically sig-
Bracket n Mean time (d) SD (d) Max time (d)
nificant difference between the maxilla and the
Damon 3MX 41 422 124 749
In-Ovation R 37 399 107 664
mandible with respect to the times to initial (1.72
Omni 20 251 107 470 [1.32, 2.12], 0.001, 0.15) and final (1.58 [1.29, 0.86]
Total 98 379 131 749 0.001, 0.12) alignment, with shorter times to final align-
ment and space closure in the mandible. For passive
(0.13 [0.01, 0.26] 0.046, 0.44), active (0.40 [0.27,
space closure were analyzed using Lin's concordance 0.52] 0.001, 0.53), and total (0.25 [0.14, 0.35] 0.001,
correlation coefficient, rc , which is a product of the 0.42) space closure, there was a statistically significant
Pearson correlation coefficient, r, a measure of preci- difference between the arches, with shorter space-
sion; and the bias correction factor, Cb, a measure of ac- closure times in the mandible in each case, except for
curacy.28 For both measures, the accuracy over the 2 the Damon 3MX bracket, where active and total space-
time periods was Cb 5 1.00. For Little's index, rc 5 closure times were shorter for the maxilla.
0.996 [0.989, 0.992]; for extraction space measure- There was no significant arch-bracket interaction in
ments, rc 5 0.999 [0.998, 0.999]. Patient flow through any analyses.
the trial is illustrated in Figure 1. The recruitment span
was 2006 to 2010, with the last patient debonded
in 2011. DISCUSSION
The null hypothesis was that neither bracket nor arch A number of factors in addition to bracket type might
(jaw) has a significant effect on alignment or space be expected to influence the time to initial alignment of
closure. The results are presented in the form (es, [ci], the labial-segment teeth, including the degree of initial
p, icc), where es is the effect size as measured by the malalignment, arch (jaw), archwire engagement, arch-
contrast calculated from the predictive margins from wire sequence, and the presence or absence of extraction
the mixed modeling, [ci] is the associated 95% confi- spaces.
dence interval, p is the probability associated with the This study demonstrated a statistically and clinically
statistical test, and icc is the intraclass correlation coeffi- significant difference between the conventional and
cient. The effect size is the pair-wise difference for the the 2 self-ligating brackets in the time to achieve initial
response variable as measured by the contrast calculated alignment. Alignment was achieved more rapidly with
from the predictive margins from the mixed modeling. It the conventional Omni bracket, with no difference

American Journal of Orthodontics and Dentofacial Orthopedics May 2014  Vol 145  Issue 5
574 Songra et al

Fig 2. A, Restricted cubic spline plot showing the effect of bracket type on initial alignment; B, restricted
cubic spline plot showing the effect of arch (jaw) on initial alignment.

between the 2 self-ligating brackets. This contradicts the
study by Pandis et al14 on passive self-ligating vs con-
ventional brackets in nonextraction patients; they found
a statistically significant difference in the rate of initial
alignment between the 2 bracket types. They found
that in patients with moderate crowding, alignment
with the passive self-ligating brackets was 2.7 times
faster than in the conventional bracket group, although,
interestingly, in subjects with severe crowding it was
only 1.37 times faster and was not reported as statisti-
cally significant. However, the archwire sequence they
used was different between the 2 bracket types, unlike
in our study, where all 3 groups had the same archwire
sequence.
The concept that the degree of initial malalignment
can affect the time to achieve alignment is not new. It
was initially proposed by Shivapuja and Berger7and is
most probably related to the degree of archwire defor-
mation rather than to the bracket type. In our investiga-
tion, the pretreatment Little's index23 values were similar
in all 3 groups. Although it might be argued that using
the same archwire sequence for all 3 groups favored
the conventional and not the self-ligating brackets,
this was done because it was the sequence in common

May 2014  Vol 145  Issue 5 American Journal of Orthodontics and Dentofacial Orthopedics
Songra et al 575

Fig 3. A, Restricted cubic spline plot showing the effect of bracket type on total space closure; B,
restricted cubic spline plot showing the effect of arch (jaw) on total space closure.

usage in the orthodontic department. In addition, previ-
ous studies with varying archwire sequences have
demonstrated no difference in the rate of initial align-
ment.12-17
The presence or absence of extractions might also be
expected to affect the time to achieve initial alignment.
A complicating factor in a number of studies is that
both extraction and nonextraction patients were included
in the samples, with the proportion of extraction subjects
ranging from 14% to 40%.5,12,13 Those trials investigating
either extraction15,17 or nonextraction14,16 treatments
again found no statistically significant difference in the
rate of initial alignment between conventional and self-
ligating brackets. Although in our study of extraction pa-
tients we found no significant difference between the 2
self-ligating brackets, agreeing with the findings of Pandis
et al,18 there was a significant difference between the self-
ligating and conventional brackets, with initial alignment
achieved in less time with the latter brackets. These results
are similar to those reported by Miles et al,13 who also
showed a significant difference in alignment between
conventional and passive self-ligating brackets in the

American Journal of Orthodontics and Dentofacial Orthopedics May 2014  Vol 145  Issue 5
576
mandibular arch. However, that trial was short, lasting
only 20 weeks; it was also a split-mouth design with
both bracket types used in the same arch, and in both
extraction and nonextraction subjects. The problem with
short studies of only 10 to 20 weeks is that full alignment
might not have been achieved.12,13,17 It can be argued
that initial alignment is not complete until a full-sized
0.019 3 0.025-in steel archwire is in place in a 0.022-in
bracket system, which was the chosen end point for initial
alignment in our trial. A trial ending before full-sized
working wire engagement might miss any true differences
between the bracket types.
In this investigation, we measured the changes in
alignment until the insertion of the final 0.019 3
0.025-in stainless steel archwire in both mandibular
and maxillary labial segments and found it to be signif-
icantly quicker in the maxilla than in the mandible.
Most previous research into initial alignment has only
looked at 1 arch, either the maxilla18 or, more usually,
the mandible.12-16 More recently, Ong et al17 compared
the rates of initial alignment between the 2 arches and
found no difference; this is contrary to the results of
our study. However, alignment was only measured until
week 20. The shorter time to alignment with the
conventional brackets, when compared with both
self-ligating brackets, could be due to archwire engage-
ment. By using an elastomeric module, even a 0.014-in
initial archwire would be firmly ligated into the base of
the conventional bracket slot, ensuring good rotational
control. This might not be the case with either a passive
or an active self-ligating bracket. It has also been
postulated that the differing widths of the brackets
could have an effect on alignment. Narrower brackets
generate higher moments that lead to higher forces at
the edge of the bracket slot when compared with wider
brackets.30 This, along with the greater critical contact
angle, can lead to notching and binding, which in turn
can affect the resistance to sliding and hence align-
ment.17 This might be 1 explanation for the observed
differences between the brackets under investigation
in this study.
The more frequent appointments—6 weeks for con-
ventional brackets vs 12 weeks for self-ligating
brackets—might also have had an effect. Allowing faster
progression up the recommended archwire sequence
with the conventional bracket could have advanta-
geously affected both initial alignment and active space
closure. Taloumis et al31 showed that elastomeric mod-
ules undergo rapid force loss within the first 24 hours
and that they can also be affected by the oral environ-
ment. This is a main reason that the conventional
bracket group participants were recalled every 6 weeks,
unlike the self-ligating bracket groups, which were
May 2014  Vol 145  Issue 5 American Journal of Orthodontics and Dentofacial Orthopedics
Songra et al
seen every 12 weeks in accordance with the manufac-
turer's instructions when the study began. Even if the
teeth had aligned fully in the self-ligating brackets and
the archwire was passive after 6 weeks, it would not
have been changed for another 6 weeks, thus delaying
the progression to the next archwire in the sequence.
Currently, many self-ligating bracket manufacturers
recommend intervals of 6 to 10 weeks.
An interesting finding of this investigation was that
most participants with both self-ligating and conven-
tional brackets did not fully achieve a score of zero on
Little's index of irregularity,23 even at the end of treat-
ment. This was despite the placement of the final
0.019 3 0.025-in stainless steel archwire. This might
be explained by the “slop” of the self-ligating clip or
the inability of the elastomeric modules to truly fully
engage the full-sized archwire on all teeth.32,33 This
then permits minute movements of the labial teeth in
the first order.34 Alternatively, it might mean that initial
bracket positioning was not always optimal on every
tooth, and this might have been improved by the use
of indirect bonding.
An obvious question from these results is: If there is a
difference in the speed of initial alignment between con-
ventional and self-ligating brackets, what is the effect
size? Although it would seem reasonable to want this re-
ported as millimeters per month, the nonlinear response
rates as illustrated in the spline plots (Figs 2 and 3) show
that this would be relatively meaningless, since it
changed with time; it was most rapid at the start of treat-
ment and slowed as treatment progressed. It is the over-
all effect and therefore the overall time (Table II) that is
important, rather than a rate at a particular moment in
time.
Unlike initial alignment, there was no statistically
significant difference between any brackets with respect
to passive, active, or total space closure. These results
are similar to those of other studies that showed no dif-
ference between conventional brackets and passive
self-ligating brackets.17,19,20 Both Miles19 and Mezomo
et al20 carried out split-mouth studies, and Mezomo
et al performed space closure with a round 0.018-in
stainless steel archwire. Other major differences be-
tween our trial and previous research are the number
of participants and the overall length of the study. Pre-
vious studies have used smaller samples and measured
the effects for only 12 weeks20 or 20 weeks,17 which
might not be long enough to show any significant dif-
ferences between the bracket types.16 Although this
investigation was longer than previously published
studies, it was not without some limitations. For
example, there might have been some performance
bias because it was not possible to blind the clinicians
Songra et al
treating the patients to the bracket allocation, although
the operator measuring the study models was blinded
to bracket allocation. Another possible limitation was
in the use of mechanics. Specific inclusion and exclu-
sion criteria were used, as was a predefined archwire
sequence. However, it is possible that some patients
had periods when intermaxillary elastics were used to-
ward the end of treatment; these might have affected
space closure. Despite these limitations, we believe
that our results are generalizable to other clinical set-
tings, with patients of a similar age treated by operators
with similar levels of experience.
There were no differences between the brackets in
terms of space closure, but there was a significant differ-
ence between the maxilla and the mandible for each of
the passive, active, and total space-closure phases. For
the conventional Omni bracket and the active self-
ligating In-Ovation bracket, space closure was less in
the mandible than in the maxilla. For the Damon MX
bracket, the active and total space-closure times were
shorter in the maxilla.
When the results of this study are considered with the
results of other studies investigating not only treatment
time, but also number of appointments, it would seem
that there is little to choose between conventional and
self-ligating brackets in terms of space-closing effi-
ciency.35,36 However, there was a statistically and
clinically significant difference in initial alignment,
with a shorter time for the conventional brackets. This
might, however, be a reflection of other factors such as
the difference in the length of time between
appointments rather than the method of bracket/
archwire ligation.
CONCLUSIONS
The following conclusions can be drawn from this
investigation.
1. There was no statistically significant difference in
the time to initial alignment between active and
passive self-ligating brackets. The time to alignment
was significantly shorter with conventional
brackets.
2. There was no significant difference in the time to
passive, active, or total space closure among all
bracket types.
3. There was a statistically significant difference in the
time to initial alignment between the mandible and
the maxilla, with a shorter time to alignment in the
maxilla.
4. There was a statistically significant difference in
space closure with time between the mandible and
the maxilla. The times for passive and active space
American Journal of Orthodontics and Dentofacial Orthopedics
577
closure were shorter in the mandible, except for
the Damon 3MX bracket, where active and total
space-closure times were shorter in the maxilla.
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