RANDOMIZED CONTROLLED TRIAL

Dentoskeletal comparison of
miniscrew-anchored maxillary
protraction with hybrid and conventional
hyrax expanders: A randomized clinical
trial
Felicia Miranda,a Jose
Carlos da Cunha Bastos,b Alexandre Magno dos Santos,c Guilherme Janson,a
Jose
Roberto Pereira Lauris,d and Daniela Garibe
Bauru, S~ao Paulo, and Belo Horizonte, Minas Gerais, Brazil

Introduction: This randomized clinical trial aimed to compare the skeletal and dental effects of miniscrew-anchored
maxillary protraction (MAMP) using hybrid hyrax (HH) and conventional hyrax (CH) expanders in growing patients
with Class III malocclusion. Methods: This was a randomized, parallel, controlled trial. Forty growing patients with
Class III malocclusion and maxillary deficiency (Wits appraisal of less than 1 mm) were randomized into 2 groups.
Patients were recruited at the Orthodontic Clinic of Bauru Dental School, University of Sa ~o Paulo, Brazil. The HH
group was composed of patients with Class III malocclusions in the late mixed or early permanent dentition treated
with a HH expander with 2 miniscrews in the maxilla and 2 miniscrews in the anterior region of the mandible. Class
III elastics were used from the maxillary first molars to the mandibular miniscrews placed between permanent ca-
nines and first premolars. The CH group was composed of patients treated with a similar protocol except for the use
of a CH expander in the maxilla. The primary outcomes included the frequency of overjet correction and sagittal
skeletal effects produced with treatment. Allocation was performed with a simple randomization process. Blinding
was performed only during assessments. Data were analyzed blindly on an intention-to-treat basis. Intergroup
comparison was performed using analysis of covariance. Mean differences (MD) and 95% confidence interval
(CI) were obtained for all variables. Results: The final sample for the HH group was 20 subjects (8 female, 12
male; initial age of 10.7 years), whereas the final sample for the CH group was 15 subjects (6 female, 9 male; initial
age of 11.5 years). The frequency of overjet correction observed in the HH and CH groups was 94.4% and 71.4%
(risk ratio, 1.32; 95% CI, 0.93-1.88), respectively. Both groups presented similar skeletal sagittal and vertical out-
comes after maxillary protraction. The maxillary length (CoA) showed a similar increase in both groups (MD,
1.12 mm; 95% CI, 0.03 to 2.27). The CH group demonstrated a greater mesial displacement of maxillary first mo-
lars after treatment than the HH group (MD, 1.22 mm; 95% CI, 0.33-2.11). HH and CH groups produced 2.88 and
1.97 overjet corrections (MD, 0.53 mm; 95% CI, 0.52 to 1.59), respectively. Conclusions: MAMP using HH and
CH expanders produced a frequency of overjet correction of 94.4% and 71.4%, respectively. Similar skeletal ef-
fects were observed between MAMP using HH and CH expanders. Greater control of the mesial displacement
of maxillary first molar during maxillary protraction using hybrid expanders was observed. Registration: The trial
was registered at http://ClinicalTrials.gov, under the identifier NCT03712007. Protocol: This trial protocol was not
published. Funding: This study was financed in part by the Coordenaça ~o de Aperfeiçoamento de Pessoal de N
ıvel
Superior, Brasil (CAPES) - Finance Code 001, and by the Sa ~o Paulo Research Foundation (FAPESP) - Grants
nos. 2017/04141-9, 2017/24115-2, and 2019/03175-2. (Am J Orthod Dentofacial Orthop 2021;-:---)

a
Department of Orthodontics, Bauru Dental School, University of S~ao Paulo, This study was financed in part by the Coordenaç~ao de Aperfeiçoamento de Pes-
Bauru, S~ao Paulo, Brazil. soal de N
ıvel Superior, Brasil (CAPES) - Finance Code 001, and by the S~ao Paulo
b
Hospital for Rehabilitation of Craniofacial Anomalies, University of S~ao Paulo, Research Foundation (FAPESP) - Grants nos. 2017/04141-9, 2017/24115-2, and
Bauru, S~ao Paulo, Brazil. 2019/03175-2.
c
Private practice, Belo Horizonte, Minas Gerais, Brazil. Address correspondence to: Felicia Miranda, Department of Orthodontics, Bauru
d
Discipline of Statistics, Department of Public Health, Bauru Dental School, Uni- Dental School, University of S~ao Paulo, Alameda Oct
avio Pinheiro Brisolla 9-75,
versity of S~ao Paulo, Bauru, S~ao Paulo, Brazil. Bauru, S~ao Paulo 17012-901, Brazil; e-mail, felicia-miranda@hotmail.com.
e
Department of Orthodontics, Bauru Dental School, and Hospital for Rehabilita- Submitted, March 2020; revised and accepted, February 2021.
tion of Craniofacial Anomalies, University of S~ao Paulo, Bauru, S~ao Paulo, Brazil. 0889-5406/$36.00
All authors have completed and submitted the ICMJE Form for Disclosure of Ó 2021 by the American Association of Orthodontists. All rights reserved.
Potential Conflicts of Interest, and none were reported. https://doi.org/10.1016/j.ajodo.2021.02.017
This article is based on research submitted by Dr Felicia Miranda in partial fulfill-
ment of the requirements for the degree of PhD in Orthodontics at Bauru Dental
School, University of S~ao Paulo.

1
2 Miranda et al
I
nnovations in Class III malocclusion orthopedic in-
terventions were remarkable in the last decade. Face-
mask therapy constitutes the standard protocol to
treat growing Class III malocclusion with maxillary defi-
ciency.1 Maxillary protraction with facemask therapy
produces a combination of skeletal and dental effects.2
A forward and downward movement of the maxilla,
extrusion of the posterior maxillary teeth, and a counter-
clockwise rotation of the palatal plane can be observed
after facemask therapy.2 As a consequence, the mandible
rotates down and backward, increasing the lower ante-
rior facial height.2 Baccetti et al3 compared the out-
comes of facemask therapy in 2 age groups of growing
Class III malocclusion. The early treatment group
(mean age, 6.9 years) showed the significant forward
movement of the maxillary structures when compared
with an untreated Class III malocclusion sample.3
Conversely, the late treatment group (mean age,
10.3 years) did not produce significant changes in maxil-
lary position after treatment compared to the untreated
sample.3 These findings are in concordance with previ-
ous studies that reported more favorable effects of face-
mask therapy in younger age groups.2,4,5
A new protocol for treating growing Class III maloc-
clusion using skeletal anchorage was described by De
Clerck et al.6 Bone-anchored maxillary protraction
(BAMP) uses Class III elastics attached to titanium mini-
plates on the infrazygomatic maxillary crests and be-
tween the mandibular canines and lateral incisors,
bilaterally.6 BAMP produced favorable skeletal effects
in late treatment groups (mean age, 11.10 years).6-8 A
mean maxillary advancement of 3.5 mm with minimal
undesirable dentoalveolar effects were found using
BAMP therapy.6,8
BAMP-derived therapies were later described for pa-
tients with Class III malocclusion in the late mixed or
early permanent dentition. Wilmes et al9 used a hybrid
hyrax (HH) expander as anchorage in the maxilla and
modified miniplates in the mandible to anchor Class III
elastics in young patients (mean age, 10.6 years).9
Recently, Miranda et al10 described a miniscrew-
anchored maxillary protraction (MAMP) protocol using
a HH expander in the maxilla and 2 miniscrews in the
mandible. MAMP produced maxillary protraction with
an adequate overjet correction.10
Specific objectives and hypotheses
This study aimed to compare the dentoskeletal ef-
fects of MAMP using HH and conventional hyrax (CH)
expanders. The null hypothesis was that maxillary pro-
traction with HH and CH expanders present similar or-
thopedic and orthodontic changes.
- 2021  Vol -  Issue - American Journal of Orthodontics and Dentofacial Orthopedics
METHODS
Trial design and any changes after trial
commencement
This study is a single-center randomized clinical trial
with 2 parallel arms and a 1:1 allocation ratio. Changes
in participant numbers were performed after trial
commencement and were described in the flow chart
(Fig 1). This clinical trial was registered under the num-
ber NCT03712007 at Clinicaltrials.gov.
The study followed the Consolidated Standards of
Reporting Trials guidelines.11 The study was approved
by the Ethics in Research Committee of Bauru Dental
School, University of S~ao Paulo, Brazil (protocol number
67610717.7.0000.5417). All participants and parents
signed the written informed consent before treatment.
Participants, eligibility criteria, and settings
The patients were recruited in the Orthodontic Clinic,
Bauru Dental School, University of S~ao Paulo, Brazil,
from July of 2017 to March of 2018. The sample con-
sisted of 40 patients with Class III malocclusion aged
from 9 to 13 years. The eligibility criteria included: (1)
both sexes; (2) late mixed or early permanent dentition;
(3) skeletal Class III malocclusion with maxillary defi-
ciency (Wits appraisal of less than 1 mm); (4) anterior
crossbite or incisor edge-to-edge relationship. Exclusion
criteria included patients with a history of previous or-
thodontic treatment, nonerupted mandibular perma-
nent canines, special needs, or syndromic patients.
Interventions
The HH group was composed of growing patients
with Class III malocclusion treated with MAMP anchored
in a hybrid expander (Fig 2). The therapy consisted of a
HH in the maxilla and 2 mandibular miniscrews posi-
tioned distally to the permanent canines, bilaterally
(Fig 2). A premanufactured hybrid expander (PecLab
Ltda., Belo Horizonte, MG, Brazil) was supported by
bands in the maxillary first permanent molars and 2 min-
iscrew placed in the anterior region of the palate in a par-
asutural position (Fig 2, A). The miniscrews with 1.8 mm
diameter, 7 mm length, and 4 mm transmucosal length
were installed in the screw slots after placement of the
expander (Fig 2, A). In the mandible, 2 miniscrews
with 1.6 mm diameter, 6 mm length, and 1 mm trans-
mucosal length were placed on the buccal aspect be-
tween the permanent canines and first premolars at
the level of the mucogingival junction (Fig 2, B).
The CH group was composed of growing patients
with Class III malocclusion treated with a similar proto-
col to the HH group except for the use of CH expander as
anchorage for Class III elastics in the maxilla (Fig 3).
Miranda et al 3

Fig 1. Consolidated Standards of Reporting Trials flow chart.

Fig 2. MAMP using the HH expander. A, Hybrid expander placed in the maxillla with two miniscrews.
B, Class III elastics were used from the maxillary first molar hooks to the mandibular miniscrews.

The screw activation protocol and Class III elastics
were similar for both groups. The expander screw was
activated 1/4 turn twice a day for 14 days, achieving
5.6 mm expansion. In the maxillary molar bands, distal
hooks of 1 mm-round–stainless steel wire were soldered
to accommodate the Class III elastics and provide a more
horizontal force. The Class III elastics were used from the
maxillary molar distal hooks to the mandibular minis-
crews (Figs 2 and 3). Traction started with a load of
150 g of force per side in the first month and 250 g of
force per side in the following period. Patients were in-
structed to wear the elastics full time, changing them
every morning and night.6 Composite build-ups on the
occlusal aspect of the mandibular permanent first molars
were used to open the bite during maxillary protraction.
Treatment was performed by the same operator in both
groups (F.M).
Patients and parents were oriented to maintain an
adequate level of oral hygiene during treatment. Peri-
implant chlorhexidine gel (2%) was prescribed twice a
day after oral hygiene during active treatment. Patients
were followed monthly. In every appointment, oral hy-
giene procedures and the importance of compliance
with Class III elastics were reinforced for both groups.
Maxillary protraction was maintained for a mean of
11.3 and 11.0 months for the HH and CH groups,

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4 Miranda et al
Fig 3. MAMP using the CH expander. A, Conventional hyrax expander placed in the maxillla. B, Class
III elastics were used from the maxillary first molars hook to the mandibular miniscrews.
Table I. Baseline characteristics of the groups and
treatment time
Variable HH CH
Sex, n
Male 12 9
Female 8 6
Total, n 20 15
Mean initial age (SD), y 10.7 (0.9) 11.5 (1.2)
Treatment time (SD), m 11.3 (3.9) 11.0 (3.7)
SD, standard deviation.
respectively (Table I). After appliance removal, a chincup
was recommended for nighttime wear as active reten-
tion. Comprehensive orthodontic treatment was started
only after the end of this study when necessary.
Cone-beam computed tomography (CBCT) was
obtained before (T1) and after therapy (T2) with the
i-CAT 3D system (Imaging Sciences International,
Hatfield, Pa). The protocol of 120 kVp, 5 mA, 0.25-
mm voxel size, scan time of 40 s, and field of view of
13 cm in height 3 16 cm in depth was used. All CBCT
data were exported in Digital Imaging and Communica-
tions in Medicine format to Dolphin 3D Imaging soft-
ware (version 11.5; Dolphin Imaging and Management
Solutions, Chatsworth, Calif). The head orientation was
standardized in the right sagittal view positioning the
Frankfurt plane parallel to the horizontal plane; in the
frontal view, the orbital plane was positioned parallel
to the horizontal plane; and in the axial view, and the
midsagittal plane passed through the anterior and pos-
terior nasal spines.
Outcomes (primary and secondary) and any
changes after trial commencement
The primary outcomes were the overjet correction
and the CoA changes. The secondary outcomes included
changes in the mandibular plane, incisor inclination, and
- 2021  Vol -  Issue - American Journal of Orthodontics and Dentofacial Orthopedics
molar relationship. Reformatted lateral cephalometric
images were obtained using Dolphin 3D Imaging soft-
ware. A cephalometric analysis with 20 linear and
angular variables was assessed with Dolphin 3D Imaging
software.
Sample size calculation
The sample size was calculated to provide a power of
80%, an alpha error of 5%, and a minimum intergroup
difference of 2 mm for maxillary length (CoA) changes,
with a standard deviation of 1.4 mm,7 a sample of 9 pa-
tients was required for each group.
Interim analyses and stopping guidelines
Not applicable.
Randomization (random number generation,
allocation concealment, and implementation)
The randomization process was performed on the
Randomization.com Web site (http://www.randomi
zation.com). Allocation concealment corresponded to
opaque, sealed, and sequenced numbered envelopes.
Each envelope contained the group name according to
the randomization sequence.12 A different operator
was responsible for randomization sequence generation,
allocation concealment, and processing.
The allocation process started after recruitment
for the patients who met the inclusion criteria and
signed the informed consent. Before opening the enve-
lope, the patient's name and allocation date were
irreversibly identified on the external surface. Inside
each envelope, a card containing the group name was
found. During treatment, undesirable dental effects in
the maxillary arch were observed in the CH group. For
ethical reasons, treatment in the CH group was interrup-
ted after 11 months of trial commencement and before
appliance installation in the last 5 volunteers.
Miranda et al 5

Blinding
Table II. Starting forms
No blinding was accomplished considering both
operator and patient were aware of the type of treatment Variable HH CH
Sagittal skeletal
performed. CBCT scans were unidentified before assess-
SNA ( ) 84.75 (4.87) 82.06 (3.24)
ment. The statistician was also blinded during the anal- SNB ( ) 83.87 (4.29) 81.99 (3.29)
ysis (J.R.P.L). ANB ( ) 0.73 (2.05) 0.14 (1.61)
Wits appraisal (mm) 5.26 (1.91) 5.76 (2.85)
Mx/Md diff (mm) 27.22 (3.65) 28.27 (4.04)
Statistical analysis Co-A (mm) 78.59 (4.52) 76.63 (5.47)
Co-Gn (mm) 110.76 (6.01) 110.45 (9.79)
After 1 month, 30% of the sample were randomly Co-Go (mm) 48.64 (3.79) 50.73 (4.93)
selected for remeasurement by the same examiner. The Na-AP ( ) 177.21 (6.05) 178.61 (3.47)
reliability of repeated measures was assessed by the in- Vertical skeletal
Occ plane to FH ( ) 6.80 (3.60) 6.96 (3.85)
traclass correlation coefficient and Bland-Altman limit
Palatal plane to FH ( ) 1.02 (3.08) 2.62 (3.53)
of agreement. FMA (MP-FH) ( ) 26.33 (4.95) 25.76 (4.24)
The statistical analyses were carried out on an Co-Go-Me ( ) 125.34 (5.27) 125.41 (5.30)
intention-to-treat basis, using multiple imputations to ANS-Me (mm) 59.71 (5.71) 61.43 (6.17)
deal with the missing data of the dropouts. Multiple im- Dental
U1.palatal plane ( ) 119.11 (7.10) 118.94 (6.88)
putations were performed in the SPSS software (version
IMPA ( ) 89.70 (5.93) 91.19 (7.43)
21.0; IBM, Armonk, NY). Five datasets were generated U6-A pt 23.56 (1.88) 22.98 (1.50)
during the imputation for the missing data; then, the Overjet (mm) 1.00 (1.84) 0.52 (2.08)
analysis was performed considering the pooled results Overbite (mm) 1.26 (2.33) 0.25 (2.10)
of the 5 datasets using Rubin's rule.13 A complete pa- Molar relation (mm) 3.45 (2.47) 2.64 (2.35)
tient analysis considering only the completed treated pa- Note. Values are mean (standard deviation).
tients was also provided.
Intergroup comparisons were performed using anal-
ysis of covariance, considering T1 data as a covariate. Table III. Clinical overjet correction frequencies (chi-
Intergroup comparison of the overjet correction fre- square test)
quency rate was performed using chi-square tests. Sta-
95%
tistical analyses were performed using SPSS software. Overjet confidence
A significance level of 5% was regarded. correction HH (%) CH (%) Risk ratio interval P value*
Yes 17 (94.4) 10 (71.4) 1.32 0.93-1.88 0.08
No 1 (5.6) 4 (28.6)
RESULTS
*Based on chi-square test statistically significant at P \0.05.
Participant flow
Twenty patients were allocated to the HH group. The Baseline data
final sample of the HH group comprised 20 patients (8
female and 12 male) with a mean initial age of 10.7 years. Table I demonstrates the baseline characteristics of
Two patients had missing data for T2. One patient inter- the sample. Table II describes the starting forms of all
rupted treatment, and the other demonstrated a palatal variables for both groups. The frequency of anterior
miniscrew instability during the active expansion period functional shift before treatment was 30% in the HH
(Fig 1). The mean treatment time for the HH group was group and 26.6% in the CH group.
11.3 months.
Twenty patients were allocated to the CH group (Fig 1). Number analyzed for each outcome, estimation and
However, the last 5 participants were not treated because precision, and subgroup analyses
of collateral effects during therapy in 2 out of 15 patients Good reproducibility of repeated measurements was
in treatment. These side effects consisted of extreme found for all variables (intraclass correlation coefficient
mesial movement of the posterior teeth and maxillary varying from 0.806 to 0.989). The variable with the
canine labial displacement. The final sample of group greatest limits of agreement was the IMPA ( 9.96 and
CH comprised 15 patients (6 female and 9 male) with a 13.87), and the variable with the smallest was the over-
mean initial age of 11.5 years. The mean treatment time bite ( 1.62 and 1.27).
was 11 months. One patient had missing data for T2 In the HH group, the overjet was corrected in 17 out
because of treatment interruption (Fig 1). of 18 patients. The CH group demonstrated an overjet

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6 Miranda et al

Table IV. Intergroup comparisons of treatment changes

Variable HH, mean (SD) CH, mean (SD) Difference in means 95% confidence interval P value
Sagittal skeletal
SNA ( ) 1.37 (1.37) 0.82 (1.26) 0.75 0.21 to 1.71 0.122
SNB ( ) 0.29 (1.42) 0.31 (1.22) 0.15 0.80 to 1.10 0.748
ANB ( ) 1.74 (1.44) 1.19 (1.41) 0.86 0.05 to 1.78 0.064
Wits appraisal (mm) 1.82 (2.12) 1.54 (1.95) 0.35 1.07 to 1.79 0.614
Mx/Md diff (mm) 0.96 (2.21) 0.08 (1.45) 0.90 2.27 to 0.47 0.190
Co-A (mm) 1.89 (1.57) 0.76 (1.64) 1.12 0.03 to 2.27 0.057
Co-Gn (mm) 1.73 (2.45) 0.60 (2.47) 1.14 0.56 to 2.85 0.182
Co-Go (mm) 0.45 (2.43) 1.39 (3.36) 1.12 0.65 to 2.90 0.206
Na-AP ( ) 3.37 (3.31) 2.23 (2.80) 1.56 3.48 to 0.35 0.106
Vertical skeletal
Occ plane to FH ( ) 0.74 (1.70) 0.53 (1.45) 0.58 0.46 to 1.63 0.267
Palatal plane to FH ( ) 0.44 (1.96) 0.42 (1.47) 0.35 0.80 to 1.51 0.534
FMA (MP-FH) ( ) 0.84 (1.51) 1.10 (1.85) 0.21 1.34 to 0.92 0.706
Co-Go-Me ( ) 0.14 (2.42) 1.39 (2.05) 1.53 0.00 to 3.06 0.051
ANS-Me (mm) 1.02 (1.38) 0.98 (1.33) 0.22 0.94 to 0.99 0.963
Dental
U1-palatal plane ( ) 2.90 (5.14) 1.41 (3.84) 1.56 0.92 to 4.05 0.210
IMPA ( ) 0.89 (3.16) 1.43 (2.48) 1.29 0.75 to 3.34 0.208
U6-A pt (mm) 1.96 (1.21) 2.97 (1.61) 1.22 0.33-2.11 0.008*
Overjet (mm) 2.88 (1.92) 1.97 (2.37) 0.53 0.52 to 1.59 0.311
Overbite (mm) 1.06 (1.70) 0.65 (1.25) 0.07 0.70 to 0.86 0.838
Molar relation (mm) 2.31 (1.89) 2.46 (2.62) 0.46 1.91 to 0.98 0.516

SD, standard deviation.

*Statistically significant at P \0.05. The difference in means is based on the analysis of covariance (intention-to-treat analysis).

correction in 10 out of 14 patients. The frequency of
overjet correction was 94.4% for the HH group and
71.4% for group CH without statistical differences be-
tween groups (risk ratio, 1.32; 95% confidence interval,
0.93-1.88; Table III).
Similar skeletal effects were observed between
groups (Table IV). No significant intergroup differences
were found for SNA angle and Wits appraisal
(Table IV). Both groups presented similar vertical skeletal
effects. The CH group demonstrated a greater mesial
displacement of maxillary first molars after treatment
than the HH group (Table IV). No intergroup differences
were observed for maxillary and mandibular incisor incli-
nation, overjet, overbite, and molar relation (Table IV).
Table V shows the intergroup comparisons on the com-
plete case analysis, demonstrating that the HH group
displayed a greater increase in the SNA and CoA than
the CH group.
The success rate for palatal miniscrews in the HH
group was 97.36% (37 out of 38). The instability/loss
rate of mandibular miniscrews in groups HH and CH
was 15.78% and 17.85%, respectively.
Harms
Patients’ compliance with Class III elastics was essen-
tial for successful results. Noncompliant patients
presented moderate to unsatisfactory results. Lack of
compliance with the use of Class III elastics was reported
for approximately 15% of the patients in each group.
Treatment was conducted until anterior crossbite
correction or for a maximum period of 12 months.
When mandibular miniscrews were unstable before
anterior crossbite correction, a replacement was per-
formed after 2 weeks in the same region with a 30 screw
inclination.
Negative overjet was still present after the interven-
tion in 5.6% and 28.6% of the HH and CH groups,
respectively. Compensatory orthodontic treatment or or-
thognathic surgery were considered alternative treat-
ment options for patients who did not achieve overjet
correction after maxillary protraction.
DISCUSSION
Main findings in the context of the existing evidence
and interpretation
This is the first randomized controlled trial
comparing the dentoskeletal effects of 2 protocols of
MAMP in growing patients with Class III malocclusion.
MAMP is a BAMP-derived therapy replacing miniplates
with miniscrews. The miniscrews are simpler to be placed
and removed than miniplates. In addition, the minis-
crews are orthodontic-friendly, not requiring the

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Miranda et al 7

Table V. Intergroup comparisons of treatment changes

Variable HH, mean (SD) CH, mean (SD) Difference in mean 95% confidence interval P
Sagittal skeletal
SNA ( ) 1.47 (1.41) 0.76 (1.29) 1.07 0.04-2.10 0.042*
SNB ( ) 0.15 (1.64) 0.36 (1.31) 0.56 0.66 to 1.78 0.355
ANB ( ) 1.83 (1.69) 1.15 (1.52) 0.90 0.25 to 2.06 0.122
Wits appraisal (mm) 1.92 (2.48) 1.45 (2.05) 0.54 1.26 to 2.34 0.542
Mx/Md diff (mm) 1.04 (2.64) 0.11 (1.56) 1.03 2.88 to 0.81 0.261
Co-A (mm) 2.38 (1.56) 0.64 (1.74) 1.69 0.34-3.05 0.016*
Co-Gn (mm) 1.32 (2.50) 0.54 (2.39) 0.74 1.22 to 2.70 0.444
Co-Go (mm) 0.78 (2.80) 1.65 (3.56) 1.32 1.01 to 3.66 0.255
Na-AP ( ) 3.46 (3.96) 2.08 (3.00) 1.73 4.21 to 0.75 0.163
Vertical skeletal
Occ plane to FH ( ) 0.21 (2.01) 0.54 (1.56) 0.77 0.51 to 2.05 0.228
Palatal plane to FH ( ) 0.40 (2.07) 0.46 (1.52) 0.44 0.82 to 1.71 0.477
FMA (MP-FH) ( ) 0.95 (1.81) 1.07 (1.99) 0.09 1.57 to 1.37 0.891
Co-Go-Me ( ) 0.44 (2.83) 1.37 (2.21) 1.74 0.23 to 3.73 0.082
ANS-Me (mm) 1.01 (1.64) 1.01 (1.42) 0.03 1.31 to 1.25 0.958
Dental
U1-palatal plane ( ) 3.03 (5.42) 1.30 (3.96) 2.33 0.19 to 4.87 0.069
IMPA ( ) 0.26 (3.74) 1.71 (2.56) 1.97 0.63 to 4.57 0.131
U6-A pt (mm) 1.91 (1.27) 3.00 (1.67) 1.35 0.39-2.31 0.007*
Overjet (mm) 2.99 (2.27) 2.03 (2.54) 0.37 0.94 to 1.70 0.562
Overbite (mm) 1.09 (2.01) 0.64 (1.35) 0.26 0.58 to 1.12 0.524
Molar relation (mm) 2.3 (1.99) 2.47 (2.72) 0.52 2.10 to 1.05 0.501

SD, standard deviation.

*Statistically significant at P \0.05. The difference in means is based on the analysis of covariance (complete case analysis).

maxillofacial surgeon. In this study, reformatted lateral
cephalometric images were obtained from the CBCT ex-
aminations to perform a dentoskeletal appraisal of the
MAMP protocol. Three-dimensional (3D) CBCT images
were used for planning miniscrew installation at T1
and for planning comprehensive orthodontic treatment
at T2. In addition, airway changes were analyzed in a
previous study.
A frequency of overjet correction of 94.4% after
1 year of treatment was observed in the HH group.
Only 1 patient demonstrated a negative overjet after
treatment in the HH group. In the CH group, a negative
overjet remained in 28.6% of the patients after treat-
ment. The frequency of overjet correction in the HH
group can be explained by the use of skeletal anchorage
in the maxilla. However, the intergroup comparison was
not statistically significant (Table III).
Both HH and CH groups showed adequate sagittal
skeletal changes after maxillary protraction. Increases
of 1.82 mm and 1.54 mm in Wits appraisal were found
for HH and CH groups, respectively. Similar increases
in the maxillomandibular relationship and maxillary
length were observed in both groups (Table IV). Consid-
ering only the completed patients, the SNA angle and
CoA demonstrated a greater increase in the HH group
than the CH group (Table V). The use of an HH expander
in the palate probably produces a more effective skeletal
anchorage leading to greater maxillary advancement in
the HH group. Previous studies using miniplates as skel-
etal anchorage reported successful maxillary advance-
ment.7,8,14 Our results showed smaller skeletal changes
when compared with BAMP therapy, showed an
improvement of 5.9 mm in the Wits appraisal after treat-
ment.7,8 In BAMP therapy, the protraction forces are
applied directly to the maxillary bone and at the level
of the maxillary center of resistance.6 In contrast,
MAMP therapy uses an indirect anchorage on the HH
expander, and the protraction forces are applied below
the maxillary center of resistance (Fig 2, A). A previous
study reported a 3.8 mm increase in the Wits appraisal
and a 2.0 increase in the SNA angle after facemask
maxillary protraction anchored on the HH expander.14
Patients included in the study were younger (mean initial
age of 9.5 years)14 than patients treated with MAMP
therapy in HH and CH groups (10.7 years and 11.5 years,
respectively). In addition, the force applied with the face-
mask (400 g of force per side) was greater than the force
applied with Class III elastics (250 g of force per side).14
In addition, the alternating rapid maxillary expansion
and constriction followed by facemask therapy showed
adequate skeletal effects in growing patients with Class
III malocclusion.15 A 3.4 mm increase in the Wits

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8 Miranda et al

Fig 4. A, Superimposition of lateral tracing before (black) and after (red) maxillary protraction in the HH
group. B, Superimposition of lateral tracing before (black) and after (red) maxillary protraction in the CH
group.

appraisal and a 2.7 increase in the SNA angle were
observed.15 The HH expander implemented in the alter-
nating rapid maxillary expansion and constriction proto-
col combined with the facemask therapy also showed
effective skeletal outcomes in a previous series of pa-
tients.16
The mandible had similar changes in both groups
(Table IV). As expected, MAMP therapy with a HH or
CH expander led to minimal mandibular changes. A
slight restraining effect on mandibular growth was
observed after BAMP therapy.8 Similar vertical skeletal
effects were observed in both groups, with the mandib-
ular plane rotating back and downward (Table IV). These
results are similar to facemask therapy that produced
clockwise rotation of the mandibular plane.7 Conversely,
counterclockwise rotation (1 ) of the mandibular plane
was observed after BAMP therapy.
Dental changes were similar in HH and CH groups
(Table IV). Changes in maxillary incisor inclination
were negligible in both groups. This similarity between
groups was not expected because of the different types
of anchorage in the maxilla. The CH group clinically dis-
played mesial migration of the posterior teeth,
decreasing the arch perimeter and leading to maxillary
canine crowding. Maxillary incisor inclination was not
affected by the effects from the side above. Changes in
mandibular incisor inclination were variable and similar
between the groups. BAMP produced labial inclination
of the mandibular incisors because of overjet correc-
tion.8 In contrast, facemask therapy produced lingual

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Miranda et al
tipping of the mandibular incisors because of the pres-
ence of the chincup.1,2,5,7 In the HH group, mandibular
incisors inclination remained stable during treatment.
The only dental outcome that differentiates HH and
CH groups was the mesial shift of the maxillary first mo-
lars. The CH group demonstrated a greater mesial move-
ment of the anchorage first molars. The HH group
probably had an important role in controlling the dental
side effects in the HH group (Table IV; Fig 4). In the CH
group, the dental anchorage in the maxilla led to an un-
predictable amount of dental side effects, especially in
patients with vertical growth patterns. These results
are not in accordance with the study by Ngan et al,17
in 2015, showing a similar mesial displacement of maxil-
lary first molars when the HH and CH expanders were
used during facemask therapy. The possible explanation
is that younger patients were treated in their study, and
therefore a smaller amount of orthodontic effects were
expected even in the CH expander group.
Similar increases in the overjet and molar relation
were found for both groups (Table IV). A 2.65 mm
change in overjet was observed after treatment in the
HH group, whereas the CH group showed a 2.26 mm
change (Table IV). However, the HH group showed a
greater frequency of overjet correction than the CH
group. BAMP therapy produced a 3.7 mm increase in
overjet and a significant improvement in the molar rela-
tionship after 1 year of treatment.8 A previous study
using facemask therapy also showed significant
improvement in the molar relationship after treatment.5
However, a smaller increase in the molar relationship was
observed after facemask therapy than BAMP therapy.7
As expected, palatal miniscrews showed a high suc-
cess rate (97.36%). High stability rates were previously
reported for miniscrews inserted in the palatal mu-
cosa.18,19 Our findings showed greater instability of
the mandibular miniscrews than palatal miniscrews, as
previously reported.20 The mandibular miniscrews were
placed between the permanent canines and first premo-
lars, bilaterally, using the mucogingival junction as
reference. Some patients presented a limited amount
of keratinized mucosa, which forced apical displacement
of the miniscrews. In addition, miniscrews delivered in
movable mucosa are less stable than those installed in
keratinized mucosa.21 To overcome these complications,
patients in both groups were instructed to maintain a
high level of oral hygiene, and peri-implant 2% chlor-
hexidine gel was prescribed during treatment. Mandib-
ular miniscrew failure and lack of compliance with the
use of Class III elastics are limitations of these therapies.
In BAMP therapy, miniplates presented high stability
rates during treatment and can be maintained for the
retention period.6 In MAMP therapy, the miniscrews
American Journal of Orthodontics and Dentofacial Orthopedics
9
need to be removed after treatment, and retention pro-
cedures may require a different approach as a chincup.
Although both groups presented similar skeletal
effects, MAMP therapy using the HH expander as
anchorage demonstrated a frequency of overjet correc-
tion of 94.4% and greater control of dental side effects
than the protocol using CH expanders. Therefore, the HH
expander should be the clinical choice. Future 3D anal-
ysis should compare midface protraction and condyle
and glenoid fossa changes between MAMP and BAMP.
Limitations
A limitation of the present study was the patient
assignment interruption in the CH group, which led to
a smaller sample size in this group and is a potential
bias. However, the ethical aspects were more relevant
when extreme dental side effects were observed in the
CH group. The absence of an untreated growing Class
III malocclusion sample as a control group was a limita-
tion for this study. In contrast, using CBCT records for a
population of growing Class III malocclusion without
treatment would have ethical issues. Future studies
should be conducted to demonstrate 3D maxillary
changes of MAMP therapy with HH expanders compared
with BAMP therapy.
Generalizability
The generalizability of these results is limited to
growing patients with Class III malocclusion. Future
studies should verify the association between maxillary
protraction achieved with MAMP and skeletal matura-
tion.
CONCLUSIONS
1. The null hypothesis was rejected.
2. The frequency of overjet correction observed in HH
and CH groups was 94.4% and 71.4%, respectively.
3. MAMP associated with HH expanders promoted
similar skeletal effects in growing patients with
Class III malocclusion compared to CH expanders.
4. The HH expander promoted a greater control of the
mesial displacement of maxillary first molar during
maxillary protraction than the CH expander.
ACKNOWLEDGMENTS
The authors thank PecLab (Belo Horizonte, Brazil)
and Morelli (Sorocaba, Brazil) for their support.
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10 Miranda et al

SUPPLEMENTARY DATA 10. Miranda F, Bastos JCDC, dos Santos AM, Vieira LS, Aliaga-Del
Castillo A, Janson G, et al. Miniscrew-anchored maxillary protrac-
Supplementary data associated with this article can tion in growing Class III patients. J Orthod 2020;47:170-80.
be found, in the online version, at https://doi.org/10. 11. Schulz KF, Altman DG, Moher D, CONSORT Group. CON-
1016/j.ajodo.2021.02.017. SORT 2010 statement: updated guidelines for reporting
parallel group randomised trials. PLoS Med 2010;7:
e1000251.
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