Original Article

A comparative assessment of orthodontic treatment outcomes of mild

skeletal Class III malocclusion between facemask and facemask in
combination with a miniscrew for anchorage in growing patients:
A single-center, prospective randomized controlled trial

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Masahiro Seiryua; Hiroto Idab; Atsushi Mayamab; Satoshi Sasakib; Shutaro Sasakic; Toru Deguchid;
Teruko Takano-Yamamotoe

ABSTRACT
Objectives: To investigate the hypothesis that there is difference in the treatment outcomes of
milder skeletal Class III malocclusion between facemask and facemask in combination with a
miniscrew in growing patients.
Materials and Methods: Patients were randomly divided into two groups. In one group, the
patients were treated with facemask therapy (FM group: 12 males, eight females, average age: 10
years, 5 months 6 1 year, 8 months). In the other group, patients were treated with facemask
therapy along with a miniscrew (FMþMS group: 12 males, seven females, average age: 11 years, 1
month 6 1 year, 3 months). A lingual arch with hooks was fixed to the maxillary arch in both groups
and a protractive force of 500 g was applied from the facemask to the hooks. The patients were
instructed to use the facemask for 12 hours per day. In the FMþMS group, a miniscrew was inserted
into the palate and fixed to the lingual arch.
Results: Mobility and loosening of the miniscrew were not observed during treatment. Lateral
cephalometric analysis showed that SNA, SN-ANS, and ANB values were significantly increased in
the FMþMS group compared with those for the FM group (SNA, 1.18 SN-ANS, 1.38 ANB, 0.88).
Increase in proclination of maxillary incisors was significantly greater in the FM group than in the
FMþMS group (U1-SN, 5.08).
Conclusions: During treatment of milder skeletal Class III malocclusion, facemask therapy along
with a miniscrew exhibits fewer negative side effects and delivers orthopedic forces more efficiently
to the maxillary complex than facemask therapy alone. (Angle Orthod. 2020;90:3–12.)
KEY WORDS: Class III malocclusion; Maxillary protraction; Facemask therapy; Miniscrew;
Absolute anchorage

a
Assistant Professor, Division of Orthodontics and Dentofacial Orthopedics, Graduate School of Dentistry, Tohoku University, Sendai,
Japan.
b
Clinical Fellow, Division of Orthodontics and Dentofacial Orthopedics, Graduate School of Dentistry, Tohoku University, Sendai,
Japan.
c
Adjunct Instructor, Division of Orthodontics and Dentofacial Orthopedics, Graduate School of Dentistry, Tohoku University, Sendai,
Japan.
d
Associate Professor and Program Director, Division of Orthodontics, College of Dentistry, The Ohio State University, Columbus, OH,
USA.
e
Professor Emeritus, Division of Orthodontics and Dentofacial Orthopedics, Graduate School of Dentistry, Tohoku University, Sendai,
Japan; and Visiting Professor, Department of Biomaterials and Bioengineering, Faculty of Dental Medicine, Hokkaido University,
Sapporo, Japan.
Corresponding author: Dr Teruko Takano-Yamamoto, Division of Orthodontics and Dentofacial Orthopedics, Tohoku University
Graduate School of Dentistry, 4-1 Seiryo-machi, Aoba-ku, Sendai 980-8575, Japan
(e-mail: t-yamamo@m.tohoku.ac.jp)
Accepted: May 2019. Submitted: October 2018.
Published Online: August 12, 2019
Ó 2020 by The EH Angle Education and Research Foundation, Inc.

DOI: 10.2319/101718-750.1 3 Angle Orthodontist, Vol 90, No 1, 2020

4 SEIRYU, IDA, MAYAMA, SASAKI, SASAKI, DEGUCHI, TAKANO-YAMAMOTO

INTRODUCTION
Young patients with skeletal Class III malocclusions
are treated primarily with facemask therapy to promote
maxillary forward growth or to restrain mandibular
growth.1,2 A major feature of this treatment is that
orthopedic force is applied to the maxillary teeth as the
anchorage through which the force is delivered to the
maxillary complex. This results in stimulation of
maxillary forward growth, restraint of mandibular
growth, and posterior changes in the direction of

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mandibular growth and mandibular position.1,2 Howev-
er, negative side effects, such as proclination of the
maxillary incisors and mesial movement of the maxil-
lary molars, often become problematic.3
Miniscrews have been reported as being effective
anchorage in orthodontic treatment and they have
been used as a practical application for improving
Figure 1. CONSORT flowchart.
various types of malocclusions that are difficult to cure
with conventional orthodontic treatment.4–8 Because
miniscrews are reportedly highly stable in the young 1. Skeletal Class III (ANB  2.58), measured by
jawbone,9 the application of orthopedic force directly to inspection of initial lateral cephalograms.
the jaw by using miniscrews to control its growth and 2. Overjet 0, measured during initial cast analysis.
development is expected to be successful. 3. Undergoing circumpubertal phase of skeletal devel-
Nienkemper et al.10,11 evaluated the effect of the opment (CVMS II–IV).
Hybrid Hyrax bone-anchored rapid palatal expansion 4. No congenital or systemic disease.
(RPE) appliance as a part of facemask treatment. Their 5. No skeletal asymmetry.
report was useful for understanding the effect of this 6. No missing teeth.
appliance; however, the effect of the miniscrew itself 7. No temporomandibular joint disorder.
was not apparent. Ngan et al.12 reported that the Hybrid The cervical vertebral maturation stage (CVMS) was
Hyrax RPE appliance significantly minimized the side used for patient selection. CVMS II, III, and IV stages,
effects encountered by tooth-borne RPE appliances which correspond with the circumpubertal growth
during treatment with a facemask. However, the period, were defined by lateral cephalometric radio-
amount of maxillary protraction of the Hybrid Hyrax graphs.13 In this study, 28 patients were at CVMS II; 8
bone-anchored RPE appliance was almost the same at CVMS III; and 3 at CVMS IV. The minimum age was
as that observed with the tooth-borne RPE appliance. 7 years, 5 months and the maximum, 13 years, 8
The purpose of the present study was to compare months. The patients and guardians provided informed
the effect of treatment with facemask therapy and a consent for participation in this study. The CONSORT
miniscrew with that of facemask therapy alone in a flowchart is shown in Figure 1. The final number of
randomized controlled study. subjects was 39 (two refused to participate). No
patients terminated participation in this study during
MATERIALS AND METHODS treatment.
Trial Design
Sample Size Calculation
This study was a single-center, prospective random-
Calculation of sample size was based on the
ized clinical trial. No changes occurred during the trial.
evaluation of protocols for maxillary protraction previ-
ously performed by Cevidanes et al.14 They compared
Participants, Eligibility Criteria, and Settings
the treatment effects for maxillary protraction induced
This study protocol was reviewed and approved by by bone-anchored maxillary protraction (BAMP) and
the institutional board of Tohoku University (approval facemask in association with rapid maxillary expansion
number: 20-2). Forty-one young patients who visited (RME/FM). The BAMP protocol produced significantly
the Tohoku University Hospital orthodontic clinic were greater (1.8 times greater) maxillary protraction than
recruited from April 2008 to March 2013 and satisfied the RME/ FM therapy (BAMP; 5.2 6 1.9 mm, RME/
the following criteria: FM; 2.9 6 1.3 mm). In the current study, a 1.5 times

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Figure 2. Intra- and extraoral appliances of the FM group. (A) Facemask; (B) Lingual arch with soldered hooks (front view); (C) Lingual arch with
soldered hooks (occlusal surface view); (D) lateral view (arrow shows direction of maxillary traction); (E) occlusal surface view. FM indicates
facemask.

increase was assumed in maxillary forward growth due In the FMþMS group, a miniscrew (Absoanchor
to treatment with facemask therapy with a miniscrew, a Dentos Inc., Taegu, Korea; diameter 1.4 mm, length 8
test power of 80%, a significance level of 5%, and an to 10 mm) was inserted in the anterior region of the
effect size of 0.98. The calculation was carried out palate (Figure 3). Multi-slice computed tomography
using the software G*power (Universität Düsseldorf, scans were performed with a Somatom Definition
Germany). The recommended sample size was 18 (Siemens, Forchheim, Germany) with a 0.8-mm slice
patients for each group. increment, 1.0-mm slice thickness, and a 512 3 512-
mm matrix before miniscrew implantation.15 Miniscrews
Randomization were inserted under local anesthesia into the anterior
region of the palate, avoiding the roots of anterior teeth,
Simple randomization was computer generated by incisive canal, and median palatine suture. A screw
use of a software program (R version 3.0.3, R hole was made in the bone with a 1.0-mm round bur
Foundation for Statistical Computing, Vienna, Austria) and a drill (ø 1.1 mm) operated at 500 rpm, and the
in a 1:1 ratio by someone not involved in the study. The miniscrew was placed via the self-tapping method.
patients were randomly allocated into two groups using Cone-beam computed tomography scans (3D Accui-
sequentially numbered, opaque, and sealed enve- tomo; J. Morita Co., Kyoto, Japan) were performed
lopes. (80–90 mVp, 3.5–5 mA, scanning time 17.5 s, field of
The FM group (10 years, 5 months 6 1 year, 8 view 60 3 60 mm, and voxel size 0.125 mm) after
months) consisted of 12 males and eight females and miniscrew implantation (Figure 5).16 At 3–4 weeks after
were treated with facemask therapy alone. The miniscrew implantation, mobility of the miniscrew was
FMþMS group (11 years, 1 month 6 1 year, 3 months) checked and the lingual arch was set. The lingual arch
included 12 males and seven females and were given was attached to the miniscrew by tying with a ligature
facemask therapy with a miniscrew. wire and fixing with resin. The treatment period was set
at more than a half year. As a result, the treatment
Interventions interval between initial observation (T1) and after
A lingual arch with soldered hooks was fixed to the facemask therapy (T2) was 1 year, 9 months 6 9.9
maxillary arch in both groups, and a protractive force of months in the FMþMS group and 1 year, 9 months 6
10.2 months in the FM group.
500 g (250 g per side) was applied from the facemask
to the hooks by the use of elastics. Patients were
Outcomes
instructed to use their facemask for 12 hours per day
(Figures 2 and 3). The direction of the traction force The main outcome of the study was determination of
was ,38 from the occlusal plane (Figure 4). the effect of treatment in terms of skeletal and

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6 SEIRYU, IDA, MAYAMA, SASAKI, SASAKI, DEGUCHI, TAKANO-YAMAMOTO

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Figure 3. Intra- and extraoral appliances of the FMþMS group. (A) facemask; (B) lingual arch with soldered hooks (front view); (C) lingual arch
with soldered hooks (occlusal surface view; arrow shows a miniscrew); (D) lateral view (arrow shows direction of maxillary traction); (E) occlusal
surface view (arrow shows a miniscrew).

dentoalveolar change. A secondary outcome was that differences in age and the treatment period were
of the success rate for use of the miniscrew. tested by performing Welch’s t tests since the
respective data sets showed normal distributions.
Cephalometric Analysis In the statistical analysis of the cephalometric
variables, the data sets that showed a normal
All cephalograms at the time of T1 and T2 were
traced by a single examiner. Cephalometric measures
evaluated the vertical and anteroposterior position of
the maxilla and mandible, pogonion, upper first molars,
and incisors (Figure 6). All cephalograms were traced
and measured two times within 1 week by the same
examiner. Accidental errors in duplicate measure-
ments were calculated from the equation: Sx ¼ =RD2/
2N, where Sx is the error of the measurement, D is the
difference between duplicated measurements, and N is
the number of double measurements.17 The error of
linear measurement was 0.45 mm and that of angular
measurement was 0.488.

Blinding
Blinding of both patient and operator to the inter-
vention was impossible. However, the investigator who
analyzed the cephalograms was blinded regarding the
origin of the films and the group to which the individual
subjects belonged. All data were labeled with numbers
and sent to the statistician, who was also blinded to the
patients’ groups.

Statistical Analysis
All values were tested for normal distribution by
use of the Shapiro-Wilk test. The significance of Figure 4. Direction of elastic force application.

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Figure 5. Cone-beam computed tomography scans after miniscrew implantation. (A) coronal view; (B) Sagittal view; (C) Axial view. (For all panels,
arrows show miniscrews.)

distribution were examined by using Welch’s t tests statistics were performed by using SPSS version 21
whereas those not showing normality were exam- (IBM, Armonk, NY, USA).
ined by performing Mann-Whitney U-tests. Statistical
significance was defined as *P , .05, **P , .01. All RESULTS
There was no statistically significant difference
between the FMþMS group and FM group in age
(FMþMS group: 11 years, 1 month 6 1 year, 3 months;
FM group: 10 years, 5 months 6 1 year, 8 months) or
treatment period (FMþMS group: 1 year, 9 months 6
9.9 months; FM group: 1 year, 9 months 6 10.2
months). There were no statistically significant differ-
ences between the FMþMS group and FM group at T1
or between males and females for the cephalometric
parameters analyzed (Table 1).
Cephalometric values of the patients at T2 are
shown in Table 2. There were significant increases
during T1 to T2 in SNA, ANB, SN-ANS, N-Me, PTM-
U6/NF, U6/NF, and L6/MP values in both groups (P ,
.01); however, no changes were found for SNB, MP-
SN, Facial A, Y axis in either group. Therefore, both FM
and FMþMS patients showed a significant increase in
maxillary forward growth without mandibular forward
growth. In addition, there were significant differences
(P , .01) in U1 to SN in the FM group, but not in the
FMþMS group.
Changes between T1 and T2 revealed significant
differences between the two groups with respect to the
effects of active treatment (Table 3). In particular, SNA
change was significantly greater in the FMþMS group
than in the FM group (FMþMS group: 2.28 6 1.38; FM
group: 1.18 6 1.08; P , .01; Table 3). SN-ANS change
was significantly greater in the FMþMS group than in
Figure 6. Landmarks and planes used in cephalometric analyses in the FM group (FMþMS group: 2.58 6 1.78; FM group:
this study. 1.28 6 1.38; P , .05; Table 3). ANB change was

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8 SEIRYU, IDA, MAYAMA, SASAKI, SASAKI, DEGUCHI, TAKANO-YAMAMOTO

Table 1. Cephalometric Values of the Patients at T1a

Case No Sex Age SNA SNB ANB SN-ANS MP-SN U1-SN N-Me PTM-U6/NF U6/NF L6/MP Facial A Y Axis
FM group (T1)
1 M 9Y4M 78.6 78.9 0.3 81.5 35.6 112.6 120.6 14.6 19.8 28.9 88.5 60.6
2 M 11Y5M 83.2 84.4 1.2 88.5 31.2 114.0 121.5 14.6 18.7 31.6 88.4 63.8
3 M 10Y7M 82.9 81.7 1.2 85.0 34.8 115.5 109.8 17.2 17.4 27.3 90.0 56.7
4 M 13Y8M 79.6 78.2 1.4 85.5 46.9 102.6 147.1 16.9 28.6 32.7 86.6 67.6
5 M 13Y0M 79.0 78.5 0.5 84.5 37.7 109.4 133.5 20.0 24.4 35.6 87.3 62.7
6 M 7Y5M 82.7 81.3 1.4 83.5 38.2 98.6 117.1 11.7 17.5 29.9 84.4 64.5
7 M 8Y11M 75.8 73.5 2.3 80.0 49.0 108.0 124.6 15.5 21.3 27.8 85.5 64.5
8 M 10Y0M 82.2 81.1 1.1 85.5 32.7 119.2 110.4 16.9 17.2 30.3 85.7 61.5
9 M 9Y1M 73.2 73.6 0.4 78.0 40.8 95.1 118.7 13.8 19.6 29.2 88.4 59.1

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10 M 9Y3M 78.9 80.3 1.4 85.0 34.7 100.6 116.7 13.0 17.7 28.7 90.9 58.0
11 M 11Y11M 80.7 82.9 2.2 86.0 34.6 122.5 119.5 11.7 19.3 24.9 89.7 61.2
12 M 9Y6M 84.7 82.9 1.8 91.0 30.4 115.2 110.3 15.8 17.5 29.8 84.9 64.0
13 F 10Y1M 84.0 83.3 0.7 87.0 35.1 112.9 105.6 19.7 17.2 26.7 89.7 57.6
14 F 13Y5M 83.5 83.1 0.4 87.0 47.1 110.1 112.0 21.8 19.3 26.7 88.3 59.7
15 F 11Y7M 83.5 82.1 1.4 86.5 27.6 117.2 121.1 19.5 22.6 32.8 89.2 60.2
16 F 10Y9M 81.5 84.5 3.0 87.0 28.8 106.9 117.6 20.1 22.7 27.9 91.0 57.7
17 F 8Y4M 81.7 82.4 0.7 84.0 35.7 111.6 108.1 11.1 9.1 27.0 86.9 62.4
18 F 9Y5M 79.0 79.6 0.6 84.0 35.9 114.0 116.9 12.4 17.1 30.7 88.8 61.6
19 F 11Y3M 80.7 80.1 0.6 84.0 41.6 112.0 127.8 17.2 20.6 28.6 88.8 60.4
20 F 9Y10M 78.2 81.1 2.9 83.5 36.4 106.8 106.7 9.6 10.5 26.7 83.0 65.7
Average (total) 10Y5M 80.7 80.7 0.0 84.9 36.7 110.2 118.3 15.7 18.9 29.2 87.8 61.5
SD (Total) 1Y8M 2.9 3.0 1.5 2.9 5.9 7.0 9.9 3.5 4.3 2.6 2.2 2.9
95% CI 9Y6M 79.3 79.3 0.7 83.5 34.0 107.0 113.6 14.0 16.9 28.0 86.8 60.1
11Y2M 82.0 82.1 0.7 86.2 39.5 113.5 122.9 17.3 20.9 30.4 88.8 62.9
Average (M) 10Y4M 80.1 79.8 0.4 84.5 37.2 109.4 120.8 15.1 19.9 29.7 87.5 62.0
SD (M) 1Y10M 3.3 3.5 1.4 3.5 5.8 8.6 10.6 2.4 3.4 2.7 2.1 3.1
95% CI 8Y11M 78.0 77.6 0.6 82.3 33.5 104.0 114.0 13.6 17.7 28.0 86.2 60.0
11Y5M 82.2 82.0 1.3 86.7 40.9 114.9 128.0 16.7 22.1 31.5 88.9 64.1
Average (F) 10Y7M 81.5 82.0 0.5 85.4 36.0 111.4 114.5 16.4 17.4 28.4 88.2 60.7
SD (F) 1Y7M 2.1 1.7 1.7 1.6 6.3 3.5 7.8 4.7 5.1 2.3 2.4 2.6
95% CI 9Y3M 79.7 80.6 1.9 84.0 30.8 108.5 108.0 12.5 13.1 26.5 86.2 58.5
11Y10M 83.3 83.4 0.9 86.7 41.3 114.4 121.0 20.4 21.7 30.3 90.2 62.9
FMþMS group (T1)
21 M 12Y11M 83.9 84.9 1.0 88.0 35.4 114.6 131.0 16.5 22.9 33.6 88.3 67.7
22 M 12Y0M 75.4 75.1 0.3 77.0 41.1 108.2 121.3 19.6 18.6 30.5 88.4 59.2
23 M 12Y6M 82.2 81.6 0.6 85.0 42.4 118.3 112.3 11.1 16.3 21.8 91.1 58.2
24 M 13Y0M 84.9 84.1 0.8 89.0 32.0 118.6 112.5 22.3 19.7 28.5 91.6 56.1
25 M 10Y1M 80.0 79.8 0.2 84.0 39.0 112.1 125.2 16.9 21.7 32.2 87.0 64.0
26 M 10Y10M 80.1 80.9 0.8 85.5 34.5 112.1 115.0 17.3 18.7 30.9 87.3 60.4
27 M 10Y4M 81.5 80.7 0.8 86.0 33.9 116.0 117.2 17.7 19.5 31.1 89.0 59.6
28 M 11Y8M 81.4 79.6 1.8 84.5 33.5 114.6 128.0 16.8 22.2 33.2 84.3 65.0
29 M 10Y0M 74.7 74.1 0.6 77.5 36.4 102.3 117.9 15.3 18.7 31.1 84.9 62.0
30 M 10Y2M 80.0 79.0 1.0 85.0 38.9 111.9 121.0 11.9 20.0 29.9 87.8 61.2
31 M 10Y4M 81.9 81.8 0.1 90.0 33.8 111.7 121.3 14.7 20.0 30.4 90.3 59.9
32 M 11Y8M 87.7 87.3 0.4 90.5 31.3 121.7 112.6 21.2 16.7 30.2 90.2 61.1
33 F 10Y11M 83.2 85.7 2.5 85.0 31.2 116.6 114.0 18.4 18.7 27.8 91.8 58.1
34 F 8Y10M 75.5 73.6 1.9 80.5 39.5 110.6 113.1 13.6 18.6 26.5 87.3 58.6
35 F 12Y1M 83.7 87.8 4.1 86.5 30.2 118.7 113.5 22.7 23.4 28.8 90.5 56.5
36 F 9Y1M 86.0 84.1 1.9 89.0 34.3 113.6 115.6 13.9 20.3 26.5 91.6 59.3
37 F 10Y5M 81.9 84.0 2.1 87.0 35.3 109.8 115.5 16.3 19.8 26.5 90.6 59.9
38 F 12Y1M 84.5 84.9 0.4 88.0 32.6 115.0 117.0 16.2 22.5 28.4 90.7 58.9
39 F 11Y1M 81.9 84.3 2.4 84.5 33.4 116.4 129.5 15.8 26.6 30.8 89.8 62.1
Average (Total) 11Y1M 81.6 81.8 0.2 85.4 35.2 113.8 118.6 16.7 20.3 29.4 89.1 60.4
SD (Total) 1Y3M 3.5 4.2 1.6 3.7 3.5 4.4 6.0 3.2 2.5 2.8 2.2 2.9
95% CI 10Y5M 79.9 79.7 0.9 83.6 33.5 111.7 115.7 15.2 19.1 28.1 88.0 59.0
11Y7M 83.3 83.8 0.6 87.2 36.9 116.0 121.5 18.3 21.5 30.8 90.1 61.8
Average (M) 11Y3M 81.1 80.7 0.4 85.2 36.0 113.5 119.6 16.8 19.6 30.3 88.4 61.2
SD (M) 1Y2M 3.6 3.7 0.8 4.3 3.6 5.1 6.2 3.3 2.0 3.0 2.3 3.1
95% CI 10Y6M 78.8 78.4 0.1 82.4 33.7 110.3 115.7 14.7 18.3 28.4 86.9 59.2
12Y0M 83.4 83.1 0.9 87.9 38.3 116.8 123.5 18.9 20.9 32.2 89.8 63.2
Average (F) 10Y9M 82.4 83.5 1.1 85.8 33.8 114.4 116.9 16.7 21.4 27.9 90.3 59.1
SD (F) 1Y6M 3.4 4.6 2.3 2.8 3.1 3.3 5.7 3.1 2.9 1.6 1.5 1.7
95% CI 9Y5M 79.3 79.3 3.2 83.2 31.0 111.4 111.6 13.8 18.7 26.4 88.9 57.5
11Y10M 85.5 87.7 1.0 88.4 36.6 117.4 122.2 19.6 24.1 29.4 91.7 60.6
a
Upper section: FM group; Lower section: FMþMS group.

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THE EFFECT OF THE FACEMARK THERAPY WITH MINISCREW 9

Table 2. Cephalometric Values of the Patients at T2a

Case No Sex Age SNA SNB ANB SN-ANS MP-SN U1-SN N-Me PTM-U6/NF U6/NF L6/MP Facial A Y Axis
FM group (T2)
1 M 12Y1M 79.9 80.4 0.5 82.5 34.7 121.6 124.4 18.1 21.3 29.3 90.0 59.3
2 M 13Y4M 85.5 84.4 1.1 90.5 29.0 116.6 127.2 17.7 21.5 34.3 89.8 63.6
3 M 11Y10M 83.1 81.7 1.4 85.0 32.9 120.7 110.8 20.7 19.0 27.9 90.0 56.3
4 M 15Y9M 79.2 77.1 2.1 85.5 47.8 104.3 152.4 21.2 29.6 36.9 86.7 68.0
5 M 15Y10M 80.8 79.9 0.9 86.5 37.0 114.9 141.0 21.4 27.4 38.6 87.2 63.3
6 M 9Y6M 84.9 81.4 3.5 86.5 39.9 113.2 122.8 15.7 19.7 31.6 81.9 67.4
7 M 9Y8M 75.2 72.8 2.4 78.5 49.5 113.3 128.5 16.9 21.8 30.1 84.6 65.0
8 M 11Y1M 83.3 82.0 1.3 87.5 32.6 126.2 112.1 17.6 17.8 30.6 86.2 61.1
9 M 9Y10M 74.7 74.0 0.7 80.0 40.8 104.0 123.0 16.6 20.7 31.4 89.3 58.9

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10 M 10Y4M 81.9 81.8 0.1 89.0 33.8 111.7 121.3 14.7 20.0 30.4 90.3 59.9
11 M 12Y7M 82.6 84.1 1.5 87.0 33.5 121.9 119.8 18.2 21.3 26.0 89.6 61.7
12 M 10Y10M 85.4 83.1 2.3 92.5 29.9 114.3 113.3 17.9 20.0 29.8 85.2 64.0
13 F 11Y3M 84.6 80.2 4.4 88.0 34.8 118.2 108.5 19.9 17.6 28.9 89.4 57.1
14 F 15Y5M 83.6 81.8 1.8 87.5 45.8 108.6 117.5 23.6 19.9 29.5 89.0 61.1
15 F 13Y7M 83.3 82.5 0.8 88.0 27.5 122.7 124.7 25.8 23.5 33.0 90.2 59.3
16 F 11Y11M 82.5 83.6 1.1 87.0 31.6 114.9 121.0 22.8 23.7 27.9 89.5 59.7
17 F 10Y0M 83.6 80.5 3.1 87.0 36.4 112.3 112.7 11.8 14.7 30.3 84.2 64.7
18 F 11Y11M 81.0 79.8 1.2 84.0 35.7 111.6 120.5 17.7 20.5 32.2 89.4 60.2
19 F 12Y4M 81.2 80.7 0.5 85.0 42.0 115.5 130.2 17.2 22.4 28.6 89.2 60.1
20 F 13Y10M 79.5 80.9 1.4 84.0 37.1 109.5 119.9 15.7 19.4 30.6 86.9 64.8
Average (Total) 12Y2M 81.8 80.6 1.2 86.1 36.6 114.8 122.6 18.6 21.1 30.9 87.9 61.8
SD (Total) 2Y0M 3.0 3.0 1.6 3.3 6.1 5.9 10.3 3.3 3.3 3.0 2.4 3.2
95% CI 11Y2M 80.4 79.2 0.4 84.5 33.8 112.0 117.7 17.0 19.6 29.5 86.8 60.3
13Y0M 83.2 82.0 1.9 87.6 39.5 117.6 127.4 20.1 22.6 32.3 89.1 63.3
Average (M) 11Y11M 81.4 80.2 1.2 85.9 36.8 115.2 124.7 18.1 21.7 31.4 87.6 62.4
SD (M) 2Y2M 3.6 3.7 1.4 4.1 6.6 6.8 12.0 2.1 3.4 3.6 2.7 3.5
95% CI 10Y6M 79.1 77.9 0.3 83.3 32.6 110.9 117.1 16.7 19.5 29.1 85.8 60.1
13Y3M 83.7 82.6 2.0 88.5 41.0 119.5 132.3 19.4 23.8 33.7 89.3 64.6
Average (F) 12Y6M 82.4 81.3 1.2 86.3 36.4 114.2 119.4 19.3 20.2 30.1 88.5 60.9
SD (F) 1Y8M 1.7 1.3 2.0 1.7 5.7 4.7 6.7 4.6 3.1 1.8 2.0 2.7
95% CI 11Y1M 81.0 80.2 0.5 84.9 31.6 110.2 113.8 15.4 17.6 28.6 86.8 58.7
13Y11M 83.8 82.3 2.8 87.7 41.1 118.1 125.0 23.2 22.8 31.6 90.1 63.1
FMþMS group (T2)
21 M 13Y6M 85.4 85.0 0.4 90.5 35.7 116.8 131.4 18.0 23.7 33.7 86.3 67.7
22 M 14Y5M 77.6 73.1 4.5 79.0 42.0 110.1 131.2 20.0 22.1 32.0 86.9 61.0
23 M 14Y9M 87.5 82.8 4.7 89.8 41.7 114.9 119.9 13.7 19.2 24.6 91.8 58.8
24 M 15Y10M 86.0 84.8 1.2 90.0 30.1 115.9 121.4 27.1 21.4 34.4 92.0 56.1
25 M 13Y6M 83.9 80.6 3.3 90.5 38.5 115.9 135.5 22.8 25.2 35.3 87.9 64.3
26 M 14Y0M 83.9 82.2 1.7 90.0 34.1 110.8 123.7 21.2 22.0 32.7 89.2 60.2
27 M 11Y6M 84.8 81.2 3.6 87.0 32.3 116.4 118.3 18.3 19.6 31.1 88.9 59.2
28 M 13Y7M 82.2 79.6 2.6 85.0 34.4 109.1 132.8 20.8 21.8 38.4 85.2 64.7
29 M 10Y6M 75.1 73.7 1.4 78.5 35.8 101.4 118.8 14.6 18.2 32.6 82.5 62.4
30 M 11Y8M 82.3 79.5 2.8 88.0 38.6 115.7 127.5 15.2 22.2 30.3 88.6 60.7
31 M 11Y4M 83.7 81.9 1.8 91.5 32.9 122.4 129.3 16.6 19.8 33.6 90.4 59.9
32 M 13Y7M 90.2 88.4 1.8 93.0 29.5 119.9 122.1 24.5 18.8 32.8 89.2 60.0
33 F 13Y1M 84.5 81.9 2.6 88.0 34.8 108.8 122.0 20.8 19.3 31.5 88.1 61.6
34 F 10Y4M 78.1 73.7 4.4 82.5 39.8 114.8 115.4 15.0 19.5 27.2 87.5 59.0
35 F 14Y0M 86.5 89.0 2.5 89.0 29.9 115.0 117.6 23.2 23.2 30.5 93.2 56.2
36 F 10Y11M 86.9 83.3 3.6 89.5 35.7 112.0 121.6 16.6 21.2 28.5 91.1 59.8
37 F 11Y3M 83.2 84.7 1.5 88.5 35.1 107.9 118.7 17.5 20.3 27.9 92.2 59.0
38 F 13Y2M 85.6 84.1 1.5 89.5 32.8 115.3 118.3 18.0 22.4 28.7 91.0 58.8
39 F 12Y4M 84.0 85.9 1.9 90.0 32.4 112.1 140.8 23.8 27.9 36.3 92.5 60.7
Average (Total) 12Y10M 83.8 81.9 1.9 87.9 35.1 113.4 124.5 19.4 21.5 31.7 89.2 60.5
SD (Total) 1Y7M 3.6 4.5 2.1 4.0 3.7 4.8 7.1 3.8 2.4 3.4 2.8 2.8
95% CI 12Y0M 82.0 79.7 0.9 86.0 33.3 111.1 121.1 17.5 20.3 30.1 87.8 59.2
13Y7M 85.5 84.0 2.9 89.8 36.8 115.7 128.0 21.2 22.6 33.3 90.5 61.9
Average (M) 13Y2M 83.6 81.1 2.5 87.7 35.5 114.1 126.0 19.4 21.2 32.6 88.2 61.3
SD (M) 1Y6M 4.1 4.4 1.3 4.7 4.1 5.5 6.0 4.1 2.1 3.3 2.7 3.1
95% CI 12Y2M 81.0 78.3 1.6 84.8 32.9 110.6 122.2 16.8 19.8 30.5 86.5 59.3
14Y2M 86.1 83.8 3.3 90.7 38.1 117.6 129.8 22.0 22.5 34.7 90.0 63.2
Average (F) 12Y2M 84.1 83.2 0.9 88.1 34.4 112.3 122.1 19.3 22.0 30.1 90.8 59.3
SD (F) 1Y4M 3.0 4.8 2.8 2.6 3.1 3.0 8.6 3.4 3.0 3.1 2.2 1.7
95% CI 10Y10M 81.4 78.8 1.7 85.8 31.5 109.5 114.1 16.1 19.2 27.2 88.8 57.7
13Y5M 86.9 87.6 3.5 90.5 37.2 115.1 130.0 22.4 24.7 33.0 92.8 60.9
a
Upper section: FM group; Lower section: FMþMS group.

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10 SEIRYU, IDA, MAYAMA, SASAKI, SASAKI, DEGUCHI, TAKANO-YAMAMOTO

Table 3. Changes After Treatment With Active Protraction (T2-T1)

FM Group FMþMS Group
Mean SD 95% CI Mean SD 95% CI Difference P Value Significance
T2-T1 (total) a

SNA, 8 1.1 1.0 0.6 1.6 2.2 1.3 1.6 2.8 1.1 .006 **
SNB, 8 0.0 1.0 0.6 0.5 0.1 1.3 0.5 0.7 0.1 .531 NSd
ANB, 8 1.2 1.2 0.6 1.7 2.0 1.3 1.4 2.7 0.8 .034 *
SN-ANS, 8 1.2 1.3 0.6 1.8 2.5 1.7 1.7 3.3 1.3 .021 *d
MP-SN, 8 0.1 1.2 0.7 0.4 0.1 1.3 0.7 0.5 0.0 .976 NS
U1-SN, 8 4.6 4.5 2.5 6.6 0.4 4.2 2.4 1.6 5.0 .001 **
N-Me, mm 4.3 2.7 3.0 5.6 5.9 3.6 4.2 7.7 1.6 .113 NSd

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PTM-U6/NF, mm 2.9 2.0 2.0 3.9 2.6 2.1 1.6 3.6 0.3 .652 NS
U6/NF, mm 2.2 2.0 1.2 3.1 1.2 1.4 0.5 1.9 1.0 .089 NSd
L6/MP, mm 1.7 1.3 1.1 2.3 2.3 1.8 1.4 3.2 0.6 .262 NS
Facial A, 8 0.1 1.4 0.5 0.8 0.0 1.6 0.7 0.9 0.1 .771 NS
Y axis, 8 0.3 1.2 0.3 0.9 0.1 1.1 0.4 0.6 0.2 .771 NSd
T2-T1 (M)b
SNA, 8 1.3 1.1 0.5 2.0 2.4 1.4 1.5 3.3 1.1 .038 *
SNB, 8 0.4 0.9 0.1 1.0 0.3 0.9 0.2 0.9 0.1 .795 NSd
ANB, 8 0.8 0.8 0.3 1.3 2.1 1.3 1.3 2.9 1.3 .007 **
SN-ANS, 8 1.4 1.5 0.5 2.3 2.6 1.8 1.4 3.7 1.2 .105 NS
MP-SN, 8 0.4 1.1 1.1 0.3 0.5 0.9 1.1 0.0 0.1 .784 NS
U1-SN, 8 5.8 4.7 2.8 8.8 0.6 4.3 2.1 3.3 5.2 .009 **
N-Me, mm 3.9 2.1 2.6 5.2 6.4 3.7 4.0 8.7 2.5 .043 *d
PTM-U6/NF, mm 2.9 1.6 1.9 3.9 2.6 1.9 1.4 3.9 0.3 .693 NS
U6/NF, mm 1.8 0.8 1.2 2.3 1.6 1.6 0.6 2.6 0.2 .736 NS
L6/MP, mm 1.7 1.3 0.9 2.5 2.3 1.9 1.2 3.5 0.6 .323 NS
Facial A, 8 0.0 1.1 0.6 0.7 0.1 1.3 1.0 0.7 0.1 .764 NS
Y axis, 8 0.4 1.1 0.3 1.1 0.0 0.7 0.4 0.5 0.4 .427 NS
T2-T1 (F)c
SNA, 8 0.9 0.8 0.2 1.6 1.7 0.8 1.0 2.4 0.8 .062 NS
SNB, 8 0.8 1.3 1.8 0.3 0.3 1.8 1.9 1.4 0.5 .530 NS
ANB, 8 1.7 1.6 0.4 3.0 2.0 1.5 0.6 3.4 0.3 .706 NS
SN-ANS, 8 0.9 1.0 0.1 1.8 2.3 1.7 0.9 3.8 1.4 .073 NS
MP-SN, 8 0.3 1.2 0.7 1.3 0.6 1.5 0.8 2.0 0.3 .744 NS
U1-SN, 8 2.7 3.6 0.3 5.7 2.1 3.8 5.6 1.4 4.8 .025 *
N-Me, mm 4.9 3.5 2.0 7.8 5.2 3.5 1.9 8.4 0.3 .999 NSd
PTM-U6/NF, mm 2.9 2.7 0.7 5.1 2.6 2.5 0.3 4.9 0.3 .999 NSd
U6/NF, mm 2.8 3.0 0.3 5.4 0.6 0.5 0.1 1.1 2.2 .054 NSd
L6/MP, mm 1.7 1.6 0.4 3.0 2.2 1.8 0.5 3.9 0.5 .616 NS
Facial A, 8 0.3 1.9 1.4 1.9 0.2 2.0 1.6 2.5 0.1 .919 NS
Y axis, 8 0.2 1.5 1.0 1.4 0.2 1.6 1.2 1.7 0.0 .970 NS
Upper section: total; Middle section: males; Lower section: females.
a
FM group (N ¼ 20), FMþMS group (N ¼ 19).
b
FM group (N ¼ 12), FMþMS group (N ¼ 12).
c
FM group (N ¼ 8), FMþMS group (N ¼ 7).
* P , .05; **P , .01;d Mann-Whitney U-test.

significantly greater in the FMþMS group compared (FMþMS group: 2.18 6 1.38; FM group: 0.88 6 0.88; P
with that for the FM group (FMþMS group: 2.08 6 1.38; , .01; Table 3). The increase in proclination of the
FM group: 1.28 6 1.28; P , .05; Table 3). Also, the maxillary incisors in the FM group was significantly
increase in proclination of the maxillary incisors was greater than that in the FMþMS group (FM group: 5.88
significantly greater in the FM group than in the
6 4.78; FMþMS group: 0.68 6 4.38; P , .01; Table 3).
FMþMS group (FM group: 4.68 6 4.58; FMþMS group: Additionally, the increase in anterior facial height (N-
0.48 6 4.28; P , .01; Table 3).
Me) was significantly greater in the FMþMS group than
In males (FM group: N ¼ 12; FMþMS group: N ¼ 12),
in the FM group (FMþMS group: 6.4 mm 6 3.7 mm; FM
increase in SNA was significantly greater in the
FMþMS group compared with that for the FM group group: 3.9 mm 6 2.1 mm; P , .05; Table 3).
(FMþMS group: 2.48 6 1.48; FM group: 1.38 6 1.18; P In females (FM group: N ¼ 8; FMþMS group: N ¼ 7),
, .05; Table 3). Increase in ANB was significantly the increase in proclination of the maxillary incisors
greater in the FMþMS group than in the FM group was significantly greater in the FM group than in the

Angle Orthodontist, Vol 90, No 1, 2020

THE EFFECT OF THE FACEMARK THERAPY WITH MINISCREW 11

FMþMS group (FM group: 2.78 6 3.68; FMþMS group: zygomaticomaxillary sutures and that the maxillary
2.18 6 3.88; P , .05; Table 3). bone was positioned anteriorly. Additionally, maxillary
anterior teeth showed lingual inclination due to dental
Harms compensation. The current study findings showed that,
No serious harm to the patients was observed during compared with orthopedic force alone, that force
treatment. For three of the screws (three patients), the anchored by miniscrews had fewer negative side
insertion direction was changed immediately after effects on the maxillary dentition although a greater
CBCT imaging because root proximity of the miniscrew maxillary orthopedic effect was exerted.
to the root was confirmed in those individuals. There Recently, a new method consisting of the application
was no looseness or mobility of the miniscrews during of miniplates into the jaw, combined with the use of

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treatment in the FMþMS group. elastics to apply maxillary orthopedic force, has been
reported to improve skeletal mandibular prognathism
DISCUSSION during the growth period.14,19,20 In a previous animal
study, Ito et al.18 reported that posterior dislocation of
The present study clarified that facemask therapy
the mandibular condyle occurred during the application
with miniscrew anchorage exhibited fewer negative
of maxillary orthopedic force through the use of
side effects and more efficiently delivered orthopedic
miniplates. Similarly, De Clerck et al.20 also reported
forces to the maxillary complex. The amount of
backward displacement of the mandible and bone
maxillary protraction was approximately twofold greater
remodeling occurred in the anterior portion of the
in the FMþMS group than in the FM group. Nienkemper
et al.10,11 evaluated the effect of the Hybrid Hyrax RPE articular fossa, with bone resorption observed in the
appliance on treatment with a facemask. They reported posterior wall of the articular fossa. In the present
a significant improvement in skeletal sagittal values in study, SNB, facial angle, MP-SN, and Y-axis angle
the treatment group compared with the control group. remained virtually unchanged after treatment in both
Their report was useful for understanding the effect of the FM and FMþMS groups. Therefore, although
the Hybrid Hyrax bone-anchored RPE appliance. forward growth of the mandible was suppressed and
However, the effect of the miniscrew itself was not the mandibular growth was shifted forward and
apparent. Ngan et al.12 compared the effect of the downward, there was neither clockwise rotation of the
Hybrid Hyrax bone-anchored RPE appliance with that mandible nor posterior displacement of it. These
of the tooth-borne RPE appliance on treatment with a findings suggest that facemask therapy with a mini-
facemask. They reported that the bone-anchored RPE screw caused less posterior displacement of the
appliance significantly minimized side effects such as mandible compared with the use of miniplates and
forward movement of the maxillary molars, excessive elastics.
proclination of the maxillary incisors, and an increase in
lower face height encountered with the tooth-borne Limitations
RPE appliance.12 However, the amount of maxillary
One limitation of this study was the lack of untreated
protraction with the Hybrid Hyrax bone-anchored RPE
mild skeletal Class III patients as a control. However, it
appliance was almost the same as that obtained with
the tooth-borne RPE appliance.12 The reason for this would not be ethical for the control patients to go
similarity might have been the difference in the intraoral untreated, and to expose control subjects to radiation
appliance used (Ngan et al., RPE; this study, lingual despite their need for immediate intervention. In
arch), the treatment period (Ngan et al., 6 months; this addition, the absence of blinding for participants and
study, 1 year, 9 months), the age at the start of the operators were limitations of this study. However,
treatment (Ngan et al., 9.6 years; this study, 11.1 though this factor is an inherent issue in this kind of
years), and the ratio of males and females (Ngan et al., study, it is very unlikely that this source of bias would
eight males and 12 females; this study, 12 males and have influenced the results.
seven females).
In the present study, proclination of the maxillary Generalizability
anterior teeth at T1 in the FMþMS group, which was The results of this study could be applied to similar
due to dental compensation, was reduced by the
patients with mild skeletal Class III malocclusions.
improvement of the maxillomandibular relationship at
T2. In a previous report, Ito et al.18 inserted miniplates
CONCLUSIONS
into the maxilla and mandible of beagle dogs and
applied orthopedic force (2.0 N) by using coil springs.  In the treatment of mild skeletal Class III malocclu-
They reported that bone apposition occurred at the sion, facemask therapy with a miniscrew for anchor-

Angle Orthodontist, Vol 90, No 1, 2020

12 SEIRYU, IDA, MAYAMA, SASAKI, SASAKI, DEGUCHI, TAKANO-YAMAMOTO

age may promote more maxillary forward growth than asymmetry. Am J Orthod Dentofacial Orthop. 2007;132(2):
facemask therapy alone. 237–242.
 In addition, this new method resulted in fewer 9. Motoyoshi M, Matsuoka M, Shimizu N. Application of
orthodontic mini-implants in adolescents. Int J Oral Max-
negative side effects, such as proclination of the
illofac Surg. 2007;36(8):695–699.
maxillary incisors. 10. Nienkemper M, Wilmes B, Pauls A, Drescher D. Maxillary
 Miniscrews in the palate exhibited a high success protraction using a hybrid hyrax-facemask combination.
rate in growing patients. Prog Orthod. 2013;14:5.
11. Nienkemper M, Wilmes B, Franchi L, Drescher D. Effective-
ness of maxillary protraction using a hybrid hyrax-facemask
ACKNOWLEDGMENTS combination: a controlled clinical study. Angle Orthod. 2015;
85(5):764–770.

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This study did not receive any specific grants from funding
agencies in the public, commercial, or not-for-profit sectors. 12. Ngan P, Wilmes B, Drescher D, Martin C, Weaver B, Gunel
E. Comparison of two maxillary protraction protocols: tooth-
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Angle Orthodontist, Vol 90, No 1, 2020