Clin Oral Invest
DOI 10.1007/s00784-016-1943-8
ORIGINAL ARTICLE
Slow versus rapid maxillary expansion in bilateral cleft lip
and palate: a CBCT randomized clinical trial
Araci Malagodi de Almeida 1 & Terumi Okada Ozawa 1 &
Arthur César de Medeiros Alves 2 & Guilherme Janson 2 & José Roberto Pereira Lauris 3 &
Marilia Sayako Yatabe Ioshida 2 & Daniela Gamba Garib 2
Received: 23 February 2016 / Accepted: 15 August 2016
# Springer-Verlag Berlin Heidelberg 2016
Abstract
Objectives The purpose of this Btwo-arm parallel^ trial was to
compare the orthopedic, dental, and alveolar bone plate
changes of slow (SME) and rapid (RME) maxillary expan-
sions in patients with complete bilateral cleft lip and palate
(BCLP).
Material and methods Forty-six patients with BCLP and
maxillary arch constriction in the late mixed dentition were
randomly and equally allocated into two groups. Computer-
generated randomization was used. Allocation was concealed
with sequentially, numbered, sealed, opaque envelopes. The
SME and RME groups comprised patients treated with quad-
helix and Haas/Hyrax-type expanders, respectively. Cone-
beam computed tomography (CBCT) exams were performed
before expansion and 4 to 6 months post-expansion. Nasal
cavity width, maxillary width, alveolar crest width, arch
width, palatal cleft width, inclination of posterior teeth, alve-
olar crest level, and buccal and lingual bone plate thickness
were assessed. Blinding was applicable for outcome
* Arthur César de Medeiros Alves
arthurcesar_88@hotmail.com
1
Hospital for Rehabilitation of Craniofacial Anomalies, University of
São Paulo, Rua Sílvio Marchione, 3-20, Vila Nova Cidade
Universitária, São Paulo, Bauru ZIP CODE 17012-900, Brazil
2
Department of Orthodontics, Bauru Dental School, University of São
Paulo, Alameda Doutor Octávio Pinheiro Brisolla, 9-75, Vila Nova
Cidade Universitária, São Paulo, Bauru ZIP CODE 17012-901,
Brazil
3
Department of Pediatric Dentistry, Orthodontics and Community
Health, Bauru Dental School, University of São Paulo, Alameda
Doutor Octávio Pinheiro Brisolla, 9-75, Vila Nova Cidade
Universitária, São Paulo, Bauru ZIP CODE 17012-901, Brazil
assessment only. Interphase and intergroup comparisons were
performed using paired t tests and t tests, respectively
(p < 0.05).
Results SME and RME similarly promoted significant in-
crease in all the maxillary transverse dimensions at molar
and premolar regions with a decreasing expanding effect from
the dental arch to the nasal cavity. Palatal cleft width had a
significant increase in both groups. Significant buccal inclina-
tion of posterior teeth was only observed for RME.
Additionally, both expansion procedures promoted a slight
reduction of the alveolar crest level and the buccal bone plate
thickness.
Conclusions No difference was found between the orthope-
dic, dental, and alveolar bone plate changes of SME and RME
in children with BCLP. Both appliances produced significant
skeletal transverse gains with negligible periodontal bone
changes. Treatment time for SME, however, was longer than
the observed for RME.
Clinical relevance SME and RME can be similarly indicated
to correct maxillary arch constriction in patients with BCLP in
the mixed dentition.
Keywords Palatal expansion technique . Cone-beam
computed tomography . Cleft lip . Cleft palate
Introduction
Rehabilitation of patients with complete bilateral cleft lip and
palate (BCLP) is a long and complex process that involves
interdisciplinary management [1]. In general, treatment begins
in the early childhood with lip and palate repair [1]. These
surgical procedures rehabilitate the esthetics and function;
however, they cause continuous restrictive effects on the
anteroposterior and transverse maxillary growth [2–6].

These collateral effects commonly result in constriction of the
maxillary dental arch and in a skeletal Class III facial pattern
[7]. Considering the high prevalence of maxillary constriction,
the use of slow or rapid maxillary expanders is a routine in
Orthodontic rehabilitation of patients with BCLP [1]. Ideally,
maxillary expansion is performed before secondary alveolar
bone grafting in order to correct the maxillary dental arch
constriction and posterior crossbite, widening the alveolar
cleft and making room for the bone graft [1].
In growing patients without oral clefts, rapid maxillary ex-
pansion (RME) corrects maxillary constriction and posterior
crossbites by opening the midpalatal suture [8]. RME effect
results in transverse bone gains increasing the maxillary dental
arch perimeter and the buccal inclination of the maxillary first
permanent molars and producing slight buccal bone changes
[9–11]. On the other hand, it has been suggested in the litera-
ture that slow maxillary expansion (SME) shows essentially
dentoalveolar effects, with smaller orthopedic repercussions
in the maxillary base, more bodily displacement of maxillary
first permanent molars compared to RME, and greater buccal
bone loss compared to rapid maxillary expansion [11, 12].
However, these aforementioned dentoskeletal effects of slow
and rapid maxillary expansion might be different in patients
with BCLP, as these individuals do not have midpalatal suture
and commonly undergo maxillary expansions before the sec-
ondary alveolar bone grafting.
Review of the orthodontic literature showed a deficiency of
cone-beam computed tomography (CBCT) studies comparing
SME and RME in patients with BCLP. Recently, a clinical
study including patients with complete unilateral and bilateral
cleft lip and palate showed no significant differences between
the dentoalveolar effects of quad-helix and Hyrax expanders,
using conventional dental model analyses [13]. An assessment
of the orthopedic, dental, and alveolar bone plate changes of
SME and RME by means of CBCT is necessary to a better
understanding of the orthopedic outcomes of these expansion
procedures in patients with BCLP.
The purpose of this study was to compare the orthopedic,
dental, and alveolar bone plate changes of slow and rapid
maxillary expansion in patients with complete bilateral cleft
lip and palate by means of cone-beam computed tomography.
The null hypothesis was that SME and RME are not different
regarding the orthopedic, dental, and alveolar bone plate
changes in patients with BCLP.
Materials and methods
Trial design
This randomized controlled trial was developed according to
the CONSORT statement and involved two parallel groups
Clin Oral Invest
randomized with a 1:1 allocation ratio [14]. No changes of
methods were necessary after trial commencement.
Participants, eligibility criteria, and settings
Ethical approval was obtained from the Research Institutional
Board of the Hospital for Rehabilitation of Craniofacial
Anomalies, University of São Paulo (protocol number 377/
2010).
Consecutive patients were recruited at the Institution, dur-
ing the period from September 2011 to September 2013.
Considering that patients were minors, written consent was
obtained from the participants’ parents or legal guardians be-
fore their recruitment.
Eligibility criteria for the participants were the following:
complete bilateral cleft lip and palate; both sexes; age ranging
from 8 to 10 years; mixed dentition period, lip repair and one-
step palate repair performed from 3 to 24 months of age;
maxillary constriction, presence of either unilateral or bilateral
posterior crossbite; and need of maxillary expansion prior to
secondary alveolar bone grafting. Exclusion criteria were the
presence of associated syndromes, enamel hypoplasia, carious
lesions, early loss of both first and second maxillary deciduous
molars on the same side, periodontal disease and history of
previous maxillary expansions, maxillary protractions, or sec-
ondary alveolar bone grafting.
Interventions
Interventions were performed by two orthodontic residents su-
pervised by two experienced orthodontists of the Institution,
during the period from October 2011 to February 2014.
At the initial orthodontic exam, the participants and their
parents or legal guardians were informed about the need of
maxillary arch expansion prior to secondary alveolar bone
grafting and they received the invitation to participate in the
study. Once informed consents were signed by parents, pa-
tients were randomly allocated into two study groups. After
at least a month of the initial orthodontic exam, the patients
returned for appliance installation.
The SME group was treated with slow maxillary expansion
using quad-helix appliances (Fig. 1a). Orthodontic bands were
adapted preferentially on maxillary first permanent molars.
When these teeth were partially erupted, second deciduous
molars were banded. The quad-helix appliance was extraorally
activated 6 mm (3 mm per side) in the molar and canine regions
before delivery. Subsequent similar reactivations were per-
formed at a 2-month interval until achieving a slight
overcorrection at the molar and canine regions. At the molar
region, the palatal cusp tip of the maxillary posterior teeth
should contact the buccal cusp tip of the mandibular posterior
teeth, while, at the anterior region, a slight overcorrection of
2 mm should be achieved in the intercanine distance. The
Clin Oral Invest
Fig. 1 Slow and rapid maxillary
expanders. Quad-helix
appliance (a) and Hyrax
expander (b)
expansion active phase ranged from 4 to 21 months, and the
amount of expansion was determined on an individual basis,
depending on the severity of maxillary arch constriction. After
this phase, the expander was maintained in the oral cavity as a
retainer from 4 to 6 months and, then, removed. Cone-beam
computed tomography exams were performed immediately
pre-expansion (T1) and at the end of the retention phase when
the expander was removed (T2).
The RME group was treated with rapid maxillary expan-
sion using the Haas-type or Hyrax expanders (Fig. 1b). Haas-
type expanders were preferentially installed. When patients
showed flat palate, Hyrax expanders were installed.
Similarly to the SME group, orthodontic bands were adapted
preferentially on maxillary first permanent molars and circum-
ferential clasps were bonded on the deciduous canines. When
the second deciduous molars were banded, a lingual extension
wire was placed in the partially erupted maxillary first perma-
nent molars. An 11-mm screw (Dentaurum, Ispringen,
Germany) was activated with a complete turn a day (approx-
imately 0.8 mm) until achieving overcorrection at the molar
region with the palatal cusp tip of the maxillary posterior teeth
contacting the buccal cusp tip of the mandibular posterior
teeth. The active expansion phase ranged from 7 to 11 days,
and the amount of expansion was determined on an individual
basis, depending on the severity of maxillary arch constric-
tion. After this phase, the expander was maintained as a re-
tainer for 4 to 6 months and, then, removed. Similarly to the
SME group, cone-beam computed tomography exams were
all taken before (T1) and at the end of the retention phase,
when the expander was removed (T2).
Cone-beam computed tomography was performed using
iCAT New Generation System© (Imaging Sciences
International, LLC, Hartfield, PA). The technical parameters
for image acquisition were 120kVp, 8 mA, 26.9 s, FOV of
13 cm, and voxel size of 0.25 mm. CBCT exams replaced
conventional radiographs for orthodontic treatment planning,
at T1, and for alveolar bone graft planning, at T2.
CBCT images were measured using the Nemoscan©
Software (Nemotec, Madrid, Spain). Before measuring, the
head image position was standardized with the Frankfurt
plane and the infraorbital line parallel to the horizontal plane
in the lateral and frontal views, respectively. In the axial plane,
the ethmoidal septum was positioned parallel to the vertical
plane.
The primary variables were measured in two coronal im-
ages perpendicular to the midsagittal plane, one passing
through the center of the palatal root of the right maxillary
permanent first molar (molar region) and the other displaced
15 mm anteriorly (premolar region).
Outcomes
The primary outcomes were changes in the nasal cavity width
(NCW), maxillary width (MxW), and palatal cleft width (CW)
both at the molar and premolar regions; and the alveolar crest
width (ACW), arch width (AW), tooth inclination (I), alveolar
crest level (ACL), and buccal (BBPT) and lingual (LBPT)
bone plate thickness only at the molar region. Figures 2, 3,
4, and 5 illustrate the linear and angular variables obtained in
the coronal, axial, and cross-section images both before and
after expansion. No secondary outcome was considered.
There were no outcome changes after trial commencement.
Sample size calculation
Calculation of sample size was based on the ability to detect
an intergroup difference in the maxillary width (MxW) of
1.0 mm at the molar region, with a standard deviation of 1.1,
an alpha error of 5 %, and a test power of 80 % [15]. Twenty
participants were required in each group.
Randomization
A simple computer-generated randomization was accom-
plished with a 1:1 ratio using the Stata© software
(StataCorp, College Station, TX) to ensure equal distribution
of participants in the groups. Allocation concealment was
achieved with numbered, sequentially, opaque, sealed enve-
lopes containing the expansion modality allocation cards,
which were prepared before trial. One operator was responsi-
ble for opening the next envelope in sequence and
implementing the randomization process.
Blinding
Blinding of patients and operator regarding the modality of
expansion was not possible; however, the outcome assessment

Fig. 2 CBCT transversal dimensions at the first molar region (a) and
maxillary permanent first molars inclination (b). The meaning of each
abbreviation is described below: NCW—nasal cavity width—width of the
nasal cavity measured at the level of the intersection between nasal cavity
and maxillary sinus floor. When the right and left intersection was not
leveled, only the right side was used as reference for a measurement
parallel to the horizontal plane. MxW—maxillary width—maxillary
was blinded because cone-beam computed tomography
exams were unidentified during analysis.
Error study
One operator (A.M.A.) performed all the measurements on
CBCT images. A second measurement was performed in
50 % of the sample at least 1 month later by the same exam-
iner. Reproducibility was assessed using the Intraclass
Correlation Coefficient (ICC) [16].
Statistical analyses
Normal distribution of variables was verified using
Kolmogorov-Smirnov tests, which showed that the variables
had normal distribution. Thus, parametric statistical tests were
used. Intergroup comparisons for baseline data were
Fig. 3 CBCT transverse dimensions at the first premolar region. The
meaning of each abbreviation is described below: NCW—nasal cavity
width—width of the nasal cavity measured at the level of the
intersection between nasal cavity and maxillary sinus floor. When the
right and left intersection was not leveled, only the right side was used
as reference for a measurement parallel to the horizontal plane. MxW—
maxillary width—maxillary width at the level of the hard palate. CW—
palatal cleft width—measured from the right cleft border to the left cleft
border parallel to the horizontal plane
Clin Oral Invest
width at the level of the hard palate. CW—palatal cleft width—was
measured from the right cleft border to the left cleft border, parallel to
the horizontal plane. ACW—alveolar crest width—maxillary width at the
level of the interpalatal alveolar crests. AW—arch width—dental arch
width measured at the level of the palatal cusp tips. I—tooth
inclination—considered the angle between lines passing through the
buccal and lingual cusp tips of the first molars
performed with t tests. Chi-square test was used for intergroup
comparison regarding sex ratio.
Interphase change analysis for both groups was performed
using paired t tests. Intergroup comparisons of primary out-
comes were performed using t tests.
A statistical significance level of 5 % (P < 0.05) was
regarded for all tests, and associated 95 % confidence intervals
(CI) were calculated. All analyses were conducted with the
Statistica©, version 11 (StatSoft Inc., Tulsa, OK).
Results
Participant flow
One hundred participants were recruited from September
2011 to September 2013; 40 (40 %) patients were excluded
because they did not meet the eligibility criteria. Sixty patients
were randomized in a 1:1 ratio to the study groups (SME
group, 30; RME group, 30). The trial ended when the sample
size allowed a dropout rate of approximately 30 %. Figure 5
shows a flowchart with reasons of losses and exclusions be-
fore and after randomization.
Baseline data
Baseline characteristics showed that the patients’ initial mean
ages were similar in both groups (Table 1). Treatment time
was significantly longer for the SME group (11 months) com-
pared to the RME group (7.2 months) (p = 0.002). No inter-
group differences were found regarding sex distribution, and
most of the patients of both groups were male (Table 1).
Numbers analyzed for each outcome
Six out of 30 (20 %) and 5 out of 30 (16.66 %) patients from
the SME and RME groups, respectively, were lost during
Clin Oral Invest
Fig. 4 Alveolar bone measurements performed on axial (a, b) and cross
(c) sections. BBPT—buccal bone plate thickness—buccal bone plate
thickness measured from the external limit of the buccal alveolar bone
plate to the most buccal point of the mesiobuccal and distobuccal roots of
the first permanent molars. LBPT—lingual bone plate thickness—lingual
bone plate thickness measured from the external limit of the lingual
enrolment (Fig. 5). Expanders were installed in 24 patients of
the SME group and in 25 patients of the RME group. One
patient from the SME group was excluded from the sample
because the quad-helix appliance was misadjusted, while two
participants from the RME group were excluded because one
was under active expansion at the end of the study and the
other patient dropped out of treatment. Twenty-three patients
Fig. 5 CONSORT diagram
showing patient flow during the
trial
alveolar bone plate to the most palatal midpoint of the palatal root of
the first permanent molars. ACL—alveolar crest level—the buccal
alveolar bone crest level was measured as the distance between the
mesiobuccal cusp tip of the first permanent molar and the buccal
alveolar bone crest
of each group were properly analyzed in their original
assigned groups. The primary analysis was carried out on an
intention-to-treat basis involving all patients randomized after
consideration of missing data.
Intraexaminer reliability was considered excellent as
intraclass correlation coefficient for CBCT measurements
ranged from 0.978 to 0.999 (Table 2) [16].
 Clin Oral Invest

Table 1 Intergroup comparisons

for age, treatment time, and sex Group SME (n = 23) Group RME (n = 23) p
ratio (T and Chi-square tests)
Mean SD Min. Max. Mean SD Min. Max.

Initial age (years) 8.50 0.83 8.00 10.90 8.58 1.00 8.20 9.30 0.853§
Treatment time 11.00 4.58 4 21 7.20 3.51 4 11 0.002§*
(months)
Sex Male 18 16 0.981¥
Female 5 7

*Statistically significant at p < 0.05

§
T tests
¥
Chi-square test

No significant differences were found between the SME Discussion

and RME groups at T1 regarding any of the investigated
values (Table 3).
SME and RME promoted significant increases of nasal
cavity width, maxillary width, alveolar crest width, arch
width, and palatal cleft width (Tables 4 and 5). A significant
buccal inclination of molars was observed only for the RME
group (Table 5). Slight decreases of alveolar crest level and of
buccal bone plate thickness were observed in both groups
(Tables 4 and 5). No differences were observed between
SME and RME changes (Table 6).
Harms
No serious harm was observed other than variable pressure
sensations around the teeth, under the eyes, and at the nasal
area, reported during treatment by participants treated with
rapid maxillary expansion. However, these symptoms rapidly
disappeared with no major discomfort.
Dentoskeletal effects of slow and rapid maxillary expansions
in growing patients without oral clefts are well documented in
the orthodontic literature [8–12, 17–23]. On the other hand,
there is a lack of clinical studies that compare the orthopedic
and orthodontic effects of these expansion procedures in pa-
tients with complete bilateral cleft lip and palate, especially by
means of CBCT.
The indiscriminate use of CBCT for research purposes in
the last years arose reservations regarding exposing patients to
great doses of ionizing radiation with the unnecessary risks
this implies [24]. On the other hand, the use of CBCT images
in Orthodontics is considered acceptable when there is a clin-
ical benefit and rational doses are used [24, 25]. In the present
study, pre and post-expansion CBCT exams were used for
performing the orthodontic treatment planning and for sec-
ondary alveolar bone graft planning, respectively.
Furthermore, both American and European guidelines for

Table 2 Error analysis of the

measurements performed on the Variables First measurement Second measurement ICC
cone-beam computed
tomography images (Intraclass Mean SD Mean SD
Correlation Coefficient)
Molar region
Nasal cavity width (mm) 27.27 3.13 27.33 3.08 0.991
Maxillary width (mm) 61.24 3.10 61.26 3.11 0.992
Alveolar crest width (mm) 32.32 3.41 32.33 3.38 0.996
Arch width (mm) 41.15 4.38 41.16 4.36 0.998
Palatal cleft width (mm) 7.32 3.16 7.29 3.18 0.997
Tooth inclination (°) 151.08 12.09 151.20 12.03 0.999
Alveolar crest level (mm) 8.50 0.67 8.52 0.65 0.999
Buccal bone plate thickenss (mm) 2.20 0.94 2.24 0.95 0.978
Lingual bone plate thickness (mm) 1.51 0.73 1.51 0.72 0.999
Premolar region
Nasal cavity width (mm) 26.84 3.24 26.83 3.13 0.993
Maxillary width (mm) 45.06 5.67 45.10 5.67 0.999
Palatal cleft width (mm) 7.01 3.35 7.09 3.33 0.984

ICC < 0.4: poor; 0.4 ≥ ICC < 0.75: satisfactory; ICC ≥ 0.75: excellent (Fleiss 1986)
Clin Oral Invest

Table 3 Intergroup
comparability at T1 (T tests) Variables Group SME (n = 23) Group RME (n = 23) p

Mean SD Mean SD

Molar region
Nasal cavity width (mm) 25.39 2.82 26.57 4.14 0.267
Maxillary width (mm) 60.12 3.00 59.85 4.02 0.807
Alveolar crest width (mm) 30.31 3.51 30.13 3.39 0.877
Arch width (mm) 37.38 5.15 38.90 3.86 0.312
Palatal cleft width (mm) 6.56 3.52 7.79 4.34 0.334
Tooth inclination (°) 153.82 11.58 149.69 11.64 0.294
Alveolar crest level (mm) 8.36 0.77 8.39 0.61 0.894
Buccal bone plate thickness (mm) 2.53 0.84 2.58 1.06 0.738
Lingual bone plate thickness (mm) 1.63 0.55 1.48 0.69 0.429
Premolar region
Nasal cavity width (mm) 25.53 2.37 26.81 3.62 0.191
Maxillary width (mm) 44.18 5.33 42.84 5.02 0.441
Palatal cleft width (mm) 8.15 3.90 7.95 2.83 0.866

CBCT use include the rehabilitation of cleft lip and palate as
one of the indications [24, 25]. Thus, in the context of CBCT
in orthodontics and CLP rehabilitation, the present study ad-
hered, as far as possible, to the radiation protection principles.
Homogeneity of a study sample is especially important for
comparison parameters in randomized clinical trials. Our
study sample was homogeneous regarding the type of oral
cleft, initial age, and sex (Table 1). Additionally, the absence
of statistical significance for intergroup comparison at T1 sug-
gests that both groups had no differences for the initial
dentoskeletal features (Table 3). The comparability of the
study groups not only confirms the sample homogeneity but
also ensures the effectiveness of the randomization and allo-
cation processes of patients.
Treatment time was significantly greater for the SME com-
pared to the RME group (Table 1). Intergroup difference for
treatment time may be associated to both the recurrence of
maladjustments of the appliances and the activation protocol
of each type of expander, as the retention time was the same
for both groups. The Quad-helix appliance showed a greater
number of maladjustments episodes compared to the Haas-
type or Hyrax expanders and was bimonthly activated during
a period that ranged from 4 to 21 months. On the other hand,
either the Haas or the Hyrax expanders were activated daily

Table 4 Interphase comparison

for the group SME (paired t tests) Variables T1 T2 Dif. p

Mean SD Mean SD

Molar region
Nasal cavity width (mm) 25.39 2.82 27.07 2.80 1.68 0.000*
Maxillary width (mm) 60.12 3.00 62.00 3.35 1.89 0.000*
Alveolar crest width (mm) 30.31 3.51 34.17 3.81 3.86 0.000*
Arch width (mm) 37.38 5.15 42.90 4.26 5.52 0.000*
Palatal cleft width (mm) 6.56 3.52 7.70 3.76 1.14 0.003*
Tooth inclination (°) 153.82 11.58 150.97 12.73 −2.85 0.244
Alveolar crest level (mm) 8.36 0.77 8.95 0.79 0.59 0.005*
Buccal bone plate thickness (mm) 2.53 0.84 1.84 0.85 −0.76 0.000*
Lingual bone plate thickness (mm) 1.63 0.55 2.07 1.44 0.44 0.154
Premolar region
Nasal cavity width (mm) 25.53 2.37 26.92 3.25 1.38 0.000*
Maxillary width (mm) 44.18 5.33 46.03 5.19 1.84 0.001*
Palatal cleft width (mm) 8.15 3.90 9.55 3.84 1.40 0.002*

*Statistically significant at p < 0.05

 Clin Oral Invest

Table 5 Interphase comparison

for the group RME (paired t tests) Variables T1 T2 Dif. p

Mean SD Mean SD

Molar region
Nasal cavity width (mm) 26.57 4.14 27.65 4.04 1.08 0.003*
Maxillary width (mm) 59.85 4.02 61.44 4.05 1.59 0.000*
Alveolar crest width (mm) 30.13 3.39 34.03 3.49 3.90 0.000*
Arch width (mm) 38.90 3.86 44.20 4.15 5.29 0.000*
Palatal cleft width (mm) 7.79 4.34 8.97 4.54 1.18 0.000*
Tooth inclination (°) 149.69 11.64 142.82 13.09 −6.87 0.002*
Alveolar crest level (mm) 8.39 0.61 8.89 0.79 0.50 0.005*
Buccal bone plate thickness (mm) 2.58 1.06 2.05 0.94 −0.60 0.000*
Lingual bone plate thickness (mm) 1.48 0.69 1.78 0.87 0.29 0.066
Premolar region
Nasal cavity width (mm) 26.81 3.62 27.95 3.67 1.13 0.000*
Maxillary width (mm) 42.84 5.02 44.38 5.03 1.55 0.001*
Palatal cleft width (mm) 7.95 2.83 9.21 3.47 1.27 0.001*

*Statistically significant at p < 0.05

during a smaller period ranging from 7 to 12 days. Our finding
is in accordance to a previous study that also found greater
treatment time for SME compared to RME in patients without
oral clefts [26].
In the SME group, there were significant increases of all
maxillary transverse dimensions at molar and premolar re-
gions, with a decreasing expanding effect from the nasal cav-
ity to the dental arch (Table 4). The mean increase in the lower
third of the nasal cavity (1.68 mm) and maxillary base
(1.89 mm) at the molar region corresponded to approximately
30 and 34 %, respectively, of the amount of the arch width
increase (5.52 mm). These skeletal transverse changes suggest
that SME seems to be effective in correcting maxillary con-
striction and posterior crossbites in patients with BCLP in the
mixed dentition. The orthopedic effect of SME can also be
confirmed by the statistical significant palatal cleft width in-
crease at the molar region (Table 4). No previous study
assessed the orthopedic, dental, and alveolar bone plate
changes of SME in patients with BCLP by means of CBCT.
In patients without oral clefts, a recent study observed through
CBCT analysis that the quad-helix appliance increased the
intermolar, alveolar, and palatal widths [12]. The authors sug-
gested that SME produced an orthopedic effect considering
the difference between the overall expansion and the dental

Table 6 Intergroup comparisons

of the expansion changes (T2-T1, Variables Group SME Group RME Dif. p
T tests)
Changes SD Changes SD

Molar region
Nasal cavity width (mm) 1.68 1.30 1.08 1.58 0.59 0.171
Maxillary width (mm) 1.89 1.57 1.59 1.23 0.29 0.496
Alveolar crest width (mm) 3.86 2.02 3.90 1.67 −0.04 0.950
Arch width (mm) 5.52 3.35 5.29 2.27 0.23 0.810
Palatal cleft width (mm) 1.14 1.46 1.18 1.12 −0.03 0.935
Tooth inclination (°) −2.85 9.72 −6.87 8.42 4.02 0.192
Alveolar crest level (mm) 0.59 0.86 0.50 0.76 0.09 0.710
Buccal bone plate thickness (mm) −0.83 0.90 −0.75 0.82 −0.07 0.563
Lingual bone plate thickness (mm) 0.44 1.39 0.29 0.71 0.14 0.669
Premolar region
Nasal cavity width (mm) 1.38 1.42 1.13 0.85 0.25 0.496
Maxillary width (mm) 1.84 1.98 1.55 1.64 0.30 0.624
Palatal cleft width (mm) 1.40 1.35 1.27 1.30 0.13 0.785
Clin Oral Invest
effects [12]. They reported that the orthopedic effect com-
bined with growth accounted for approximately 50 % of the
overall transverse expansion [12]. In our study, the orthopedic
effect in the SME group was 34.2 % considering the ratio
between maxillary width changes and arch width changes
(Table 4). This increase may be associated mainly with the
expander effect as maxillary transverse growth in patients with
BCLP is deficient [7]. Previous studies on finite elements
suggested that the absence of midpalatal suture in CLP could
reduce the resistance to maxillary lateral movements, resulting
in greater orthopedic movement [27, 28]. Our study did not
attest greater orthopedic effect in BCLP compared to previous
clinical studies in noncleft patients probably because the main
resistance to maxillary expansion are the circummaxillary su-
tures and neighboring craniofacial bones instead of the
midpalatal suture [19].
No buccal inclination of the maxillary permanent first mo-
lars was observed for SME (Table 4). This finding might be
associated to a buccal bodily movement of the first molars.
However, further analyses would be required in this study to
better evaluate this issue. Previous investigations found buccal
bodily movement of the first molars after SME consequent to
the balance between light and prolonged forces released by the
quad-helix appliance and the counteracting physiological
forces of the buccinators [11, 12].
A decrease of the alveolar crest level and of the buccal bone
plate thickness was observed after SME (Table 4). These
changes might have occurred in consequence to dental effects
of the quad-helix and are in accordance to previous CBCT
studies in patients without oral clefts [11, 12]. Although sta-
tistical significance was found, the buccal alveolar bone
change was less than 1 mm and not clinically significant
(Table 4). A recent study found greater decrease of buccal
bone thickness (1.5 mm) and significant increase of lingual
bone plate thickness (1.6 mm) after SME in noncleft patients
[12]. However, the authors of this aforementioned study stated
that buccal root torque activation was sometimes performed
before cementation, which may explain the differences in the
amount of alveolar bone changes.
Both Hyrax and Haas-type expanders were used and in-
cluded in the final analysis of the RME group because previ-
ous studies showed that these orthopedic expanders had sim-
ilar expansion effects in patients with and without oral clefts
[15, 29, 30]. The RME group showed significant increases of
all maxillary transverse dimensions and palatal cleft width at
the molar and premolar regions, with a decreasing expanding
effect from the nasal cavity to the dental arch (Table 5). The
mean increase in the lower third of the nasal cavity (1.08 mm)
and maxillary base (1.59 mm) at the molar region
corresponded to approximately 20 and 30 %, respectively, of
the amount of the arch width increase (5.29 mm). This pro-
portion of orthopedic effects is in accordance to a previous
RME study [13]. Although patients with BCLP do not have
the midpalatal suture, the pattern of orthopedic, dental, and
alveolar bone plate changes of RME seems very similar to
individuals without oral clefts [15]. The maxillary segments
laterally rotate during expansion due to the circummaxillary
suture resistance [27, 28].
The RME promoted a significant buccal inclination of the
maxillary permanent first molars with a mean increase of 6.87
degrees (Table 5). These results are in accordance to previous
studies in individuals with and without oral clefts [13, 15, 31].
The buccal inclination of posterior teeth is the result of the
lateral rotation of the maxillary segments associated with
greater lateral displacement of the anchorage tooth crown in
comparison to the movement of the tooth apex [13]. As a
consequence of the RME dental effect, significant decreases
of the alveolar crest level and buccal bone plate thickness were
observed after RME (Table 5). These bone losses were also
observed in other studies that assessed the periodontal chang-
es after RME in patients without oral clefts [11, 31]. A recent
CBCT study concluded that there is a positive correlation
between reduction of buccal bone level and thickness and
buccal inclination of molars and premolars [31]. The reducing
changes in the buccal alveolar bone, however, were less than
1 mm and not clinically relevant.
The intergroup comparisons showed no significant differ-
ences between the orthopedic, dental, and alveolar bone plate
changes of SME and RME (Table 6). No other study com-
pared the orthopedic effects of SME and RME in patients with
complete cleft lip and palate. Recent studies found no signif-
icant differences between the dentoalveolar effects of SME
and RME in patients with complete unilateral [32] and bilat-
eral [32, 33] CLP, stating that slow maxillary expansion can be
a reasonable alternative to rapid maxillary expansion in pa-
tients with oral clefts. In individuals without oral clefts, a
recent CBCT study concluded that RME is not more effective
than SME in correcting posterior crossbites [34]. On the other
hand, previous studies found that SME produces greater buc-
cal inclination of the posterior teeth and smaller orthopedic
effects compared to RME in noncleft patients [19, 26].
The variation in molar anchorage in both groups was a
limitation of this study and may have influenced the absence
of signficant differences between SME and RME for posterior
tooth inclination. In the SME group, 8 (35 %) patients had
maxillary second deciduous molars banded while 15 (65 %)
patients had the bands adapted on the maxillary first perma-
nent molars. In the RME group, these corresponded to 12
(52 %) and 11 (48 %) patients, respectively. However, this
variation could not be avoided because, during the mixed
dentition, the maxillary permanent first molar may still show
gingival covering on the distal.
No important harm was caused to the participants of this
study. The benefits and collateral effects of both types of ex-
panders were already known from previous literature in indi-
viduals without oral clefts.

The results showing similarity of SME and RME effects
might be limited to patients with BCLP treated in the
mixed dentition with the same expanders and activation
protocols used. Different results could be found in patients
with different types of oral cleft, in individuals with differ-
ent age range, when different types of expanders are used,
or when the same expanders are used with different activa-
tion protocols.
Relapse and stability of the transverse correction were not
analyzed in the present randomized clinical trial. Further stud-
ies must compare the long-term stability of slow and rapid
maxillary expansions in patients with complete bilateral cleft
lip and palate. In noncleft individuals, SME and RME show
quite similar long-term stability [35–37].
Conclusions
The null hypothesis was accepted because of the following:
& Slow and rapid maxillary expansions caused similar or-
thopedic, dental, and alveolar bone plate changes in pa-
tients with complete bilateral cleft lip and palate;
& Both appliances produced significant skeletal transverse
gains with negligible periodontal bone changes in the
mixed dentition, and;
& Treatment time for RME, however, was shorter than the
observed for SME.
Compliance with ethical standards
Conflict of interest The authors declare that they have no conflict of
interest.
Funding This study was not supported by fundings.
Ethical approval All procedures performed in the studies involving
human participants were in accordance with the ethical standards of the
institutional and/or national research committee and with the 1964
Helsinki Declaration and its later amendments or comparable ethical
standards.
Informed consent Informed consent was obtained from all individual
participants included in the study.
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