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doi:10.1093/ejo/cjz054
Advance Access publication 1 August 2019
Correspondence to: Ola Sollenius, Department of Orthodontics, Halland County Council, S-30246 Halmstad, Sweden. E-mail:
ola.sollenius@regionhalland.se
Summary
Objectives: The objectives of this study were to assess the three-dimensional (3D) treatment
changes (palatal surface area and volume) of forced unilateral posterior crossbite correction using
either quad-helix or removable expansion plate appliances in the mixed dentition, and to compare
the treatment changes with the three-dimensional changes occurring in age-matched untreated
unilateral posterior crossbite patients as well as in subjects with normal occlusion and with no or
mild orthodontic treatment need.
Trial design: Six-arm parallel group multicentre randomized controlled trial.
Materials and methods: One-hundred and thirty-five patients with unilateral posterior crossbite
with functional shift were recruited. The patients were randomized by an independent person not
involved in the trial. The randomization used blocks of 25, and the patients were randomized into
the following five groups: quad-helix treatments in specialist orthodontic clinics (QHS), quad-
helix treatments in general dentistry (QHG), removable expansion plate treatments in specialist
orthodontic clinics (EPS), removable expansion plate treatments in general dentistry (EPG),
and untreated crossbite (UC). Twenty-five patients with normal occlusion who served as normal
controls were also included in the trial. Blinding of the outcome assessor and data analyst was
accomplished. Data on all children were evaluated on an intention-to-treat basis, regarding 3D
palatal surface area, palatal projection area, and palatal shell volume; two-dimensional linear
measurements were registered at the same time.
Results: After treatment, the surface and projection area and shell volume increased in the four
treatment groups (QHS, QHG, EPS, and EPG). QHS increased significantly more than EPG for the
surface and projection area. The QHS and EPS had significantly higher mean difference for shell
volume.
Limitations: The trial considers a short-term evaluation.
Conclusion: After treatment, there were no significant differences between the four treatment
groups and the normal group, which implies that the surface and projection area together with the
shell volume for the four treatment groups and the normal group were equivalent.
Trial registration: The trial was registered with https://www.researchweb.org/is/sverige, registration
number: 220751.
© The Author(s) 2019. Published by Oxford University Press on behalf of the European Orthodontic Society.
415
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416 European Journal of Orthodontics, 2020, Vol. 42, No. 4
Ethical approval relationship was achieved (maximum treatment time 1 year) and
The Regional Ethical Review Board in Lund, Sweden, approved the no overcorrection was produced. Steel- or elastic ligatures were
trial protocol and informed consent form (Dno: 2012/650). used to secure the QH to the bands. The treatment result was
retained for 3 months.
Randomization procedure
The randomization was prepared and carried out by an independent The removable expansion plate
person not involved in the study and the randomization used blocks The removable expansion plate (EP) consisted of acrylic with an
of 25 (5 + 5 + 5 + 5 + 5). Thus, the orthodontists carried boxes of al- expansion screw, lined up with the midpalate suture, and stainless-
ready prepared envelopes. Six opaque envelopes were prepared with steel clasps on the primary and permanent first molars. There was no
25 sealed notes in each (5 notes for each group), and for every new acrylic covering the occlusal surfaces. The EP was activated 0.2 mm
patient in the study, a note was extracted from the first envelope. once a week by the patient until a normal transverse relationship
When the envelope was empty, the second envelope was opened, and was achieved (maximum treatment time 1 year) and no overcorrec-
the 25 new notes were extracted as the patients were recruited to the tion was produced. The dentist thoroughly instructed the patient
trial. This procedure was then repeated five more times. to use the EP day and night except for meals and tooth brushing.
a b c
Figure 1. Illustrations of surface area (a), projection area (b), and surface volume (c) on three-dimensional scannings.
418 European Journal of Orthodontics, 2020, Vol. 42, No. 4
Enrollment Aged-matched
Assessed for eligibility (n = 135) subjects with
normal occlusion
included as
Excluded (n = 0)
normal controls
Not meeting inclusion criteria
n = 25
(n = 0)
Declined to participate (n = 0)
Other reasons (n = 0)
Allocation
Follow-Up
Lost to follow-up (n = 0) Lost to follow-up Lost to follow-up Lost to follow-up Lost to follow-up (n Lost to follow-
Discontinued Discontinued intervention Discontinued Discontinued intervention = 0) up (n = 0)
intervention (n=4), 2 patients could not intervention (n= 3) (n=7) Discontinued Discontinued
(n = 0) 1 patient moved intervention intervention
tolerate the appliance, and 1 patient refused second
6 patients gave up (n = 0) (n = 0)
according to above, 1 impression after one treatment
patient unable to cement the broken appliance, 2
QH and 1 patient unable to patients gave up
take impressions. treatment
Analysis
Analysed (n =
Analysed (n = 28) Analysed (n = 27) Analysed (n = 27) Analysed (n = 28) Analysed (n = 25) 25)
Excluded from analysis Excluded from analysis (give Excluded from analysis Excluded from analysis Excluded from Excluded from
(give reasons) (n=0) reasons) (n=0) (give reasons) (n=0) (give reasons) (n=0) analysis (give analysis (give
reasons) (n=0) reasons) (n=0)
According to ITT, all 28 According to ITT, all 27 According to ITT, all 27 According to ITT, all 28 According to
were analysed were analysed were analysed were analysed According to ITT, ITT, all 25 were
all 25 were analysed analysed
Intention-to-treat Blinding
Data on all children were evaluated on an intention-to-treat (ITT) Children and trial personnel could not be blinded due to the char-
basis; consequently, if the crossbite was not corrected during the acter of treatment, but blinding was performed of the outcome
trial period of 1 year, the outcome was judged as unsuccessful, and evaluator and the person who analysed the data. Hence, the evalu-
the possible change in palatal area and volume as well as linear ator was unaware of the group to which the child had been allo-
expansion effect was quoted. Accordingly, all children, success- cated or whether the data were from baseline, follow-up, or after
ful or not, were incorporated in the final analysis. Moreover, any treatment.
withdrawals in the course of the trial were regarded as unsuccess-
ful and with no expansion or changes. If data were lacking at the
follow-up or after treatment, the last observation carried forward Statistical analysis
principle was used (21). This implies that the last measured val- The data were statistically analysed using SPSS software (version
ues or data were imputed at the follow-up. After treatment and 24, SPSS, Chicago, Illinois, USA). Numerical variables, arithmetic
3 months of retention, a second impression was taken 1 month means, and standard deviations (SDs) were calculated. Analysis of
after the removal of appliance. This was performed to enable variance with the Tukey post hoc test was used to compare the pal-
blinding. For UC and NC, the second evaluation was performed atal surfaces area, palatal projection area, and palatal shell volume
after 1 year of observation. changes as well as the linear maxillary and mandibular intercanine
O. Sollenius et al. 419
and intermolar distance changes within and between groups. The palatal shell volume (Table 3). Also, the surface areas were significantly
chi-square and Fisher’s exact test was used to calculate the success larger in the QHS and EPS groups compared to the untreated control
rate of crossbite correction. Differences with probabilities of less group whereas the projection area and shell volume were significantly
than 5% (P < 0.05) were considered statistically significant. larger in the EPS than in the untreated control group (Table 3).
After treatment, the four treatment groups reached the normal
group values considering the surface and projection area together
Method error analysis
with the shell volume (Table 2).
Twenty randomly selected scanned models were measured at two
No within-group changes were found for the untreated and
separate times. No significant mean differences between the records
normal groups during the 1-year follow-up.
were found using paired t-test, i.e. no systematic errors could be de-
In the mandible, small or negligible and insignificant changes
tected. The ICC and error of the measurements (in percentages) were
within and between the groups were noted considering surface and
calculated and were for palatal surface area less than 3.5 and 4.5
projection area as well as shell volume.
for palatal volume. For the linear measurements (in millimetres), the
error according to Dahlberg’s formula (22) was less than 0.17 mm
or between 0.1 and 0.2 mm. Linear measurements
Table 1. Baseline/pre-treatment demographic characteristics. QHS, quad-helix treatments in specialist orthodontist clinics; QHG, quad-
helix treatments in general dentist clinics; EPS, removable expansion plate treatments in specialist orthodontist clinics; EPG, removable
expansion plate treatments in general dental clinics; UC, untreated posterior crossbite control group; NC, normal control group with nor-
mal occlusion and no or mild orthodontic treatment need; SD, standard deviation
Baseline/pre-treatment
Table 2. Surface area, projection, area, and shell volume at baseline/pre-treatment and after treatment. QHS, quad-helix treatments in specialist orthodontist clinics; QHG, quad-helix treat-
ments in general dentist clinics; EPS, removable expansion plate treatments in specialist orthodontist clinics; EPG, removable expansion plate treatments in general dental clinics; UC, un-
treated posterior crossbite control group; NC, normal control group with normal occlusion and no or mild orthodontic treatment need. One-way analysis of variance with Tukey’s post hoc test.
SD, standard deviation; CI, confidence interval
Group QHS Group QHG Group EPS Group EPG Group UC Group NC
Mean SD CI (%) Mean SD CI (%) Mean SD CI (%) Mean SD CI (%) Mean SD CI (%) Mean SD CI (%0 Difference
Baseline
Maxilla
Surface 1154 87.69 1120– 1205 122.60 1156– 1159 85.26 1126– 1154 68.73 1128– 1170 89.06 1133– 1292 123.19 1241– QHS, QHG, EPS,
area (mm2) 1188 1253 1193 1181 1207 1343 EPG, UC<NC
P < 0.02
Projection 810 67.22 784– 781 160.34 718– 836 69.85 809– 841 56.99 819– 835 64.17 808– 939 77.15 907– QHS, QHG, EPS,
area (mm2) 836 844 864 863 861 970 EPG, UC<NC
P< 0.002
Shell 4823 639.53 4575– 5079 845.92 4744– 4887 638.19 4635– 4843 486.59 4655– 4815 711.57 4521– 5676 1013.52 5258– QHS, QHG, EPS,
volume 5071 5414 5140 5032 5108 6095 EPG, UC<NC
(mm3) P< 0.05
Post-treatment
Maxilla
Surface 1261 95.51 1224– 1276 130.31 1224– 1275 95.14 1238– 1220 73.88 1191– 1184 91.07 1146– 1300 129.06 1247– QHG > UC
area (mm2) 1298 1328 1313 1248 1221 1354 P = 0.02
EPS > UC
P = 0.022
NC > UC
P = 0.002
Projection 922 74.52 894– 870 182.76 797– 933 90.52 897– 894 59.87 871– 843 63.13 817– 940 79.16 907– EPS > UC
area (mm2) 951 942 969 917 869 972 P = 0.02
NC > UC
P = 0.012
Shell volume 5423 649.70 5171– 5618 943.60 5245– 5758 785.97 5447– 5355 538.61 5146– 4976 833.90 4632– 5823 1119.68 5361– EPS > UC
(mm3) 5675 5992 6069 5563 5320 6286 P = 0.011
NC > UC
P = 0.005
European Journal of Orthodontics, 2020, Vol. 42, No. 4
Table 3. Mean differences in surface area, projection area, and shell volume within and between the groups. QHS, quad-helix treatments in specialist orthodontist clinics; QHG, quad-helix
treatments in general dentist clinics; EPS, removable expansion plate treatments in specialist orthodontist clinics; EPG, removable expansion plate treatments in general dental clinics; UC,
untreated posterior crossbite control group; NC, normal control group with normal occlusion and no or mild orthodontic treatment need. One-way analysis of variance with Tukey’s post hoc
P < 0.000
parents were satisfied.
Discussion
–19.2 to
–18.1 to
CI (%)
365.5
19.6
Main findings
The palatal surface and projection area increased the most in
66.19
45.65
Mean SD
327.5
21.5
finding was that, after treatment, all four treated groups reached
the same palatal surface area and volume as the normal group.
Group UC
CI (%) Mean SD
26.0–
62.8
the palatal surface area and volume after treatment in the treated
groups would not reach the dimensions of the normal group was
57.30
47.43
Group EPG
rejected.
Mean SD
44.4
100.4
913.8
63.3–
52.6–
Interpretations
71.01
60.45
Group EPS
To our knowledge, this is the first RCT that has used and analysed
CI (%) Mean SD
76.5
592.3
61.67 45.3–
85.71 54.3–
crossbite control group and another control group with normal oc-
94.1
129.0
733.5
showed that the maxillary parameters reached the size of the param-
Mean
eters found in the normal group with normal occlusion. These post-
treatment results contrasted with the treatment outcomes presented
area (mm2)
(mm3)
Maxilla
Shell
Table 4. Intermolar and intercanine distances at baseline/pre-treatment and after treatment. QHS, quad-helix treatments in specialist orthodontist clinics; QHG, quad-helix treatments in gen-
eral dentist clinics; EPS, removable expansion plate treatments in specialist orthodontist clinics; EPG, removable expansion plate treatments in general dental clinics; UC, untreated posterior
crossbite control group; NC, normal control group with normal occlusion and no or mild orthodontic treatment need. One-way analysis of variance with Tukey’s post hoc test. SD, standard
deviation; CI, confidence interval
Group QHS Group QHG Group EPS Group EPG Group UC Group NC
Mean SD CI (%) Mean SD CI (%) Mean SD CI (%) Mean SD CI (%) Mean SD CI (%) Mean SD CI (%) Difference
Baseline
Maxilla
Intermolar distance, 47.0 1.96 46.2–47.8 47.6 3.16 46.3–48.9 48.2 2.53 47.2–49.2 48.0 2.54 46.9–49.1 47.3 2.57 46.3–48.4 50.6 2.47 49.5–51.6 QHS, QHG, EPS, EPG, UC <
mesiobuccal cusp tips NC P < 0.02
Intermolar distance, 30.2 1.54 29.6–30.8 30.9 2.33 30.0–31.9 30.8 2.21 30.0–31.7 30.7 1.93 29.9–31.6 30.5 2.34 29.6–31.5 33.2 2.36 32.2–34.1 QHS, QHG, EPS, EPG, UC <
gingival margin NC P <0.03
Intercanine distance, 29.0 2.05 28.2–29.9 29.8 2.53 28.7–30.9 30.0 2.41 29.0–31.0 29.8 2.03 28.9–30.6 29.7 2.4 28.7–30.7 31.0 1.26 30.2–31.8 NS
cusp tips
Intercanine distance, 22.5 1.57 21.9–23.1 23.1 1.98 22.2–23.9 23.0 1.96 22.2–23.8 22.9 1.75 22.1–23.6 22.7 1.98 21.8–23.5 25.0 1.42 24.1–25.8 QHS, QHG, EPS, EPG, UC <
gingival margin NC P < 0.04
Post-treatment
Maxilla
Intermolar distance, 52.2 2.8 51.2–53.3 52.3 2.58 51.2–53.5 52.0 2.70 50.9–53.1 51.5 2.65 50.2–52.8 47.9 2.49 46.8–49.0 50.8 2.23 49.8–51.7 UC < QHS, QHG, EPS, EPG,
mesiobuccal cusp tips NC P < 0.003
Intermolar distance, 35.1 2.07 34.3–35.9 35.2 2.19 34.2–36.1 34.2 2.01 33.4–35.1 33.7 1.93 32.8–34.7 31.0 2.40 29.9–32.0 33.4 2.12 32.5–34.2 UC < QHS, QHG, EPS, EPG,
gingival margin NC P < 0.002
NC < QHS, QHG P < 0.05
Intercanine distance, 33.5 1.97 32.7–34.4 33.2 2.46 31.9–34.5 33.4 2.50 32.4–34.5 32.5 2.03 31.4–33.7 29.9 2.35 28.9–31.0 31.7 1.13 31.0–32.4 UC < QHS, QHG, EPS, EPG
cusp tips P < 0.01
Intercanine distance, 25.8 1.79 25.1–26.6 25.5 2.03 24.5–26.6 25.6 2.07 24.8–26.5 24.9 1.72 23.9–25.9 23.1 1.95 22.2–24.0 25.6 1.39 24.7–26.4 UC < QHS, QHG, EPS, NC
gingival margin P < 0.005
European Journal of Orthodontics, 2020, Vol. 42, No. 4
Table 5. Mean differences in intermolar and intercanine distances within and between the groups. QHS, quad-helix treatments in specialist orthodontist clinics; QHG, quad-helix treatments
in general dentist clinics; EPS, removable expansion plate treatments in specialist orthodontist clinics; EPG, removable expansion plate treatments in general dental clinics; UC, untreated
posterior crossbite control group; NC, normal control group with normal occlusion and no or mild orthodontic treatment need. One-way analysis of variance with Tukey’s post hoc test. SD,
standard deviation; CI, confidence interval
Group QHS Group QHG Group EPS Group EPG Group UC Group NC
Maxilla Mean SD CI% Mean SD CI% Mean SD CI% Mean SD CI% Mean SD CI% Mean SD CI% Difference
Intermolar 5.2 1.61 4.62– 3.8 2.20 2.90– 3.3 1.63 2.67– 2.6 2.21 1.59– 0.5 0.36 0.34– 0.2 0.67 −0.07 to QHS > QHG P = 0.013, QHS > EPS, EPG,
distance, 5.86 4.65 3.96 3.50 0.65 0.49 UC and NC P = 0.000.
mesiobuccal cusp QHG > UC and NC P = 0.000
tips EPS >UC and NC P = 0.000. EPG > UC
and NC P = 0.000
Intermolar 4.9 1.47 4.32– 3.3 1.90 2.59– 2.9 1.46 2.36– 2.1 1.80 1.35– 0.3 0.37 0.16– 0.2 0.57 −0.04 to QHS > QHG P = 0.01
distance, gingival 5.46 4.09 3.51 2.91 0.48 0.43 QHS > EPS, EPG, UC, NC P = 0.000
margin QHG > EPG P = 0.034 QHG > UC and NC
P = 0.000
EPS/UC and NC P = 0.000
EPG/UC and NG P = 0.000
Intercanine 4.4 1.38 3.87– 2.3 1.73 1.52– 3.3 1.46 2.71– 1.8 1.72 0.93– 0.3 0.77 -0.03 to 0.6 0.90 0.06 to QHS > QHG, EPG, UC and NC P = 0.000
distance, cusp tips 5.01 3.06 3.92 2.60 0.68 1.20 QHG > UC and QHG > NC P = 0.017
EPS > EPG P = 0.006 EPS > UC and NC
P = 0.000
EPG > UC P = 0.019
Intercanine 3.3 1.23 2.74– 1.7 1.21 1.16– 2.5 1.29 2.01– 1.3 1.42 0.65– 0.4 0.56 0.13– 0.5 0.81 −0.02 to QHS > QHG, EPG, UC, NC P = 0.000
distance, gingival 3.76 2.23 3.07 2.02 0.64 1.02 QHG > UC P = 0.004
margin EPS > EPG P = 0.011
EPS > UC and NC P = 0.000
423
instance, between 0.3 and 0.6 mm of the increased palatal width Conflict of interest
corresponded to natural growth in the untreated and normal control
None declared.
groups (Table 5)
References
Strengths
1. Thilander, B. and Myrberg, N. (1973) The prevalence of malocclusion in
One of the strengths of this trial was that there were few dropouts
Swedish schoolchildren. Scandinavian Journal of Dental Research, 81, 12–21.
and we used a multicenter RCT with an ITT approach. Thus, all 2. Heikinheimo, K. (1978) Need of orthodontic treatment in 7-year-old Finn-
children, successfully treated or not, were included, which minimized ish children. Community Dentistry and Oral Epidemiology, 6, 129–134.
the risk of false positive treatment results. Moreover, measurement 3. Andrade, A.D.A.S., Gameiro, G.H., Derossi, M. and Gavião, M.B. (2009)
errors were judged to be small and clinically irrelevant. Posterior crossbite and functional changes. A systematic review. The Angle
Blinding of the trial staff and the treated children could not be Orthodontist, 79, 380–386.
performed because of the character of the treatments but blinding of 4. Iodice, G., Danzi, G., Cimino, R., Paduano, S. and Michelotti, A. (2016)
the outcome evaluator was performed. Consequently, the evaluator Association between posterior crossbite, skeletal, and muscle asymmetry:
a systematic review. European Journal of Orthodontics, 38, 638–651.
did not know to which group the child belonged or whether the
18. Primožič, J., Perinetti, G., Contardo, L. and Ovsenik, M. (2013) Diagnostic tions of methodology and recommendations for the accurate use of ITT
performance of 3-dimensional evaluation of palatal vault changes in assess- analysis and handling dropouts. European Journal of Orthodontics, 40,
ing successful treatment of constricted maxilla in growing subjects. American 409–413.
Journal of Orthodontics and Dentofacial Orthopedics, 143, 42–49. 22. Dahlberg, G. (1940) Statistical Methods for Medical and Biological Stu-
19. Dunnett, C.W. and Tamhane, A.C. (1992) A step-up multiple test proce- dents. Allen and Unwin, London, UK, pp. 122–132.
dure. Journal of the American Statistical Association, 87, 162–170. 23. Primožic, J., Baccetti, T., Franchi, L., Richmond, S., Farčnik, F. and Ovs-
20. Generali, C., Primozic, J., Richmond, S., Bizzarro, M., Flores-Mir, C., Ovs- enik, M. (2013) Three-dimensional assessment of palatal change in a con-
enik, M. and Perillo, L. (2017) Three-dimensional evaluation of the maxil- trolled study of unilateral posterior crossbite correction in the primary
lary arch and palate in unilateral cleft lip and palate subjects using digital dentition. European Journal of Orthodontics, 35, 199–204.
dental casts. European Journal of Orthodontics, 39, 641–645. 24. Primozic, J., Ovsenik, M., Richmond, S., Kau, C.H. and Zhurov, A. (2009)
21. Bondemark, L. and Abdulraheem, S. (2018) Intention to treat (ITT)
Early crossbite correction: a three-dimensional evaluation. European Jour-
analysis as reported in orthodontic randomized controlled trials-evalua- nal of Orthodontics, 31, 352–356.