RANDOMIZED CONTROLLED TRIAL

Efficacy of clear aligners vs rapid palatal

expanders on palatal volume and surface
area in mixed dentition patients: A
randomized controlled trial
Alessandro Bruni,a,b Martina Ferrillo,c Vittorio Gallo,a Simone Parrini,a Francesco Garino,d
Tommaso Castroflorio,d and Andrea Deregibusa
Modena, Turin, and Catanzaro, Italy

Introduction: This study aimed to evaluate the efficacy of Invisalign First Phase I treatment compared with tooth-
borne rapid maxillary expansion (RME) in mixed dentition patients by examining changes in palatal volume,
palatal surface area, and maxillary interdental transverse measurements. Methods: In this open-label, 2-arm,
parallel, randomized controlled trial, patients with a posterior transverse discrepancy #6 mm were allocated
into the clear aligner therapy (CAT) group (Invisalign First Phase I treatment) and RME group (tooth-borne
RME) according to a computer-generated randomization list immediately before the start of treatment. Digital
models were obtained before the beginning of the treatment (T0) and at the end of the retention period/
treatment (T1) using an intraoral scanner. Palatal volume was measured as the primary outcome, and palatal
surface area and intermolar and intercanine transverse widths at the cusps and gingival level were measured
as secondary outcomes. Patients and interventionists were not blinded because of the nature of the
intervention. Results: Out of 50 patients, 41 (19 males and 22 females; mean age, 8.12 6 1.53 years) were
enrolled and divided into 2 groups: 20 in the CAT group and 21 in the RME group. Two participants did not receive
the allocated intervention for different reasons (1 patient discontinued the intervention in the CAT group, and
another patient was lost to follow-up in the RME group). Thus, 19 patients (5 males and 14 females; mean
age, 8.48 6 1.42 years) were analyzed from the CAT group, and 20 patients (12 males and 8 females; mean
age, 7.83 6 1.19 years) from the RME group. Regarding intragroup comparisons, all outcome measures
significantly increased from T0 to T1 in both groups. In terms of intergroup comparisons, there were no
significant differences in the variation (D) of outcome measures between the 2 groups from T0 to T1, except
for the intermolar width at the gingival level (P \0.005). The change in palatal volume was 532.01 6540.52
mm3 for the RME group and 243.95 6 473.24 mm3 for the CAT group (P 5 0.084), with a moderate effect
size (d 5 0.57). Conclusions: RME showed trends favoring better outcomes compared with Invisalign First
Phase I treatment across all assessed measures. The only parameter that showed statistically significant
differences between the 2 groups was variation in intermolar width at the gingival level, suggesting the occur-
rence of buccal tipping in patients undergoing Invisalign First Phase I treatment. Trial Registration: The trial
was registered at ClinicalTrial.gov (no. NCT04760535). (Am J Orthod Dentofacial Orthop 2024;166:203-14)

M
axillary transverse deficiency is one of the most all spatial planes, not limited to the transverse. The
pervasive problems in the craniofacial region, most easily recognizable clinical signs are posterior
with several clinical features occurring across crossbite and dental crowding.1,2 Other features include
a
Department of Surgical Sciences, CIR Dental School, Universit
a degli Studi di Address correspondence to: Alessandro Bruni, Surgical, Medical and Dental
Torino, Turin, Italy. Department, University of Modena and Reggio Emilia, Via Universit
a, 4, Modena
b
Surgical, Medical and Dental Department, University of Modena and Reggio 41121, Italy; e-mail, [email protected].
Emilia, Modena, Italy. Submitted, August 2023; revised and accepted, April 2024.
c
Dentistry Unit, Department of Health Sciences, Universit
a degli Studi di Cata- 0889-5406
nzaro “Magna Graecia”, Catanzaro, Italy. Ó 2024 by the American Association of Orthodontists. This is an open access
d
Private Practice, Turin, Italy. article under the CC BY-NC-ND license (http://creativecommons.org/licenses/
All authors have completed and submitted the ICMJE Form for Disclosure of Po- by-nc-nd/4.0/).
tential Conflicts of Interest, and none were reported. https://doi.org/10.1016/j.ajodo.2024.04.006
The study protocol was approved by the Institutional Ethics Committee (Citt
a
della Salute e della Scienza di Torino, approval no. 0006323), and informed con-
sent was obtained from each subject before entering the study.

203
204 Bruni et al

protrusion, buccally flared posterior maxillary teeth, expansion has been observed in the deciduous canine
accentuated curve of Wilson, and dark spaces at the and first molar regions,16,17,23 with an overall mean pre-
corner of the mouth when maxillary constriction is dictability of nearly 80%.17 However, clear aligners have
camouflaged by the dentition.3 demonstrated better control of molar inclination than
Maxillary transverse deficiency usually requires palate slow palatal expanders.24 Because they control each
expansion, which is achievable through several treatment tooth simultaneously, clear aligners can act on the ante-
modalities that practitioners select on the basis of scientific rior teeth during expansion. Thus, they can induce more
evidence together with their personal beliefs and experi- significant morphologic modifications of the maxillary
ences.4 Palatal expansion may be performed using 2 arch shape than rapid/slow palatal expanders.19
different mechanisms, depending on the frequency of acti- Interdental linear measurements have been widely
vation, magnitude of the force applied, patient’s sutural used in the literature on clear aligner therapy (CAT) to
maturation, and treatment duration: rapid maxillary assess maxillary arch changes after expansion treat-
expansion (RME) or slow maxillary expansion (SME).3 ments. However, this measurement ignores the complex
If expansion is performed at a rate of approximately 0.5 3-dimensional (3D) characteristics of the palate and
mm/d, it is called rapid palatal/maxillary expansion. In this could be biased because of tooth inclination and angu-
instance, the expander jackscrew appliance, anchored to lation. The palatal surface area and volume, which have
teeth or tissues (eg, Hyrax or Haas), acts by transferring me- been identified as reliable indicators of maxillary arch
chanical load across the midpalatal suture, promoting expansion,25 were evaluated in only 1 recent study on
disjunction of the upper jawbones when interdigitation growing patients undergoing CAT.24 It reported a palatal
and bony bridging are still incomplete, modulating bone volume increase smaller than that achieved by RME and
remodeling and formation. The exogenous forces pro- similar to untreated controls.24
duced by these appliances result in a sutural bone strain To the best of our knowledge, no randomized
that promotes cellular growth in response to changes in controlled trials have evaluated the efficacy of clear
their mechanical environment.3,5 The orthopedic effect of aligners compared with RME regarding palatal volume
palatal expanders decreases with increasing skeletal matu- changes in early mixed dentition. Thus, this study eval-
ration as maxillary and circummaxillary suture closures. uated the efficacy of Invisalign First Phase I treatment
In contrast, expansion of the upper jaw is termed compared with tooth-borne RME, investigating changes
slow when expansion occurs at a rate of 0.5 mm/wk, in the transverse dimensions of the maxillary interdental
promoting dentoalveolar expansion rather than ortho- arch, palatal surface area, and palatal volume.
pedic disjunction obtained through lighter and contin- The study’s primary endpoint is to test the null hy-
uous forces applied over a more extended period.5. pothesis (H0), which is that there are no significant dif-
Many authors have supported appliances that promote ferences in palatal volume measurement after
slow expansion for less undesired effects and greater Invisalign First Phase I treatment and tooth-borne RME.
long-term postexpansion stability.6
Because of its viscoelastic nature, the periodontium MATERIAL AND METHODS
perceives the light continuous forces released by the Trial design and study registration
most commonly used slow palatal expanders as inter-
mittent.7 Clear aligners are increasingly being used in or- This is an open-label, 2-arm, parallel randomized
thodontic treatment,8 including the treatment of mixed controlled trial. The protocol followed guidance from the
dentition patients.9 Clear aligners similarly elicit forces Consolidated Standards of Reporting Trials guidelines.26
perceived as intermittent by the periodontium. Recent The study protocol was approved by the Institutional
studies have shown that clear aligners can achieve satis- Ethics Committee (Citt
a della Salute e della Scienza di Tor-
factory maxillary arch development in both adults10-15 ino, approval no. 0006323) of the coordinating center. It
and growing patients.16-19 In adult patients, the use of was performed according to the Declaration of Helsinki,
clear aligners results mainly in buccal crown tipping with pertinent national and international regulatory re-
over bodily movement with an overall mean quirements. The trial was registered at the ClinicalTrial.
predictability of nearly 70% with a decreasing gradient gov Web site (ClinicalTrials.gov registration no.
moving anteroposteriorly,11-14,20-22 showing the NCT04760535). The Protocol Registration System was
tendency of virtual treatment planning software to used to upload and update data on the controlled trial.
overestimate the expansion.15
The expansion of the maxillary arch with aligners in Participants and study setting
growing subjects mainly results in the buccal tipping In this study, patients referred to the Department of
of permanent molars. In contrast, the most significant Orthodontics of the University of Turin, Turin, Italy

September 2024  Vol 166  Issue 3 American Journal of Orthodontics and Dentofacial Orthopedics
Bruni et al 205

(coordinating center) and to the private practice of the au- the arch as anchorage. When they reached their final po-
thors were recruited from January 2020 to January 2021. sition, the deciduous molars and canines moved buccally
All authors are orthodontists who routinely conduct using permanent molars and incisors as anchorage units.
cephalometric radiographs before and after treatment. Because of the short clinical crowns of deciduous teeth,
They possess the capability to collect intraoral scans specific attachment shapes were designed to increase
and affirm that their practice can dedicate sufficient aligner retention and control the tipping movement (to
time to patient scheduling to allow focused recording obtain torque compensation and to avoid a deepening
of all data required for the study. Furthermore, they of the curve of Wilson).28,29 The expansion was planned
did not anticipate retiring, selling the practice, or relo- with a request for 0.15 mm of extrusion plus 2 of addi-
cating during the study period. Signed, written informed tional buccal root torque for each stage, performed until
consent was a prerequisite for inclusion in the trial. the palatal cusp tip of the posterior maxillary teeth con-
The inclusion criteria were as follows: (1) patients tacted the buccal cusp tip of the mandibular posterior
with a posterior transverse interarch discrepancy of a teeth. Patients wearing Invisalign First were also asked
maximum of 6 mm; (2) mixed dentition phase with to complete an aligner wear chart. The self-reported
CVMS \3; (3) fully erupted maxillary and mandibular compliance levels were categorized as follows: compliant
first molars; (4) maxillary second premolar cusps posi- (reported wear of aligners as advised), partially compliant
tioned apically to the half pulp chamber line of the ipsi- (aligners wear instructions not followed precisely), and
lateral maxillary first permanent molars on pretreatment noncompliant (not wearing aligners). Maxillary and
panoramic radiographs,27 indicating that the deciduous mandibular vacuum-formed retainers (Essix C1; Dents-
molars can serve as secure anchoring teeth for a mini- ply Sirona, Charlotte, NC) were produced using an Erko-
mum of 12 months; and (5) good general health, accord- form thermoforming machine (Erkodent,
ing to medical history and clinical judgment. Subjects Pfalzgrafenweiler, Germany). The retainers were trimmed
with craniofacial malformations (including cleft lip or to cover the palatal surface and all fully erupted teeth and
palate), a history of dental trauma, oral neoformations, extended halfway across the occlusal surface of the most
and other oral cavity pathologies, or previous or concur- distal molar. Participants were instructed to wear their re-
rent orthodontic treatment were excluded from the tainers exclusively during the night, adhering to a nightly
study. routine. After the delivery of the retainers, thorough oral
The posterior transverse discrepancy between the hygiene instructions were conveyed through written and
maxillary and mandibular arches was determined on verbal communication.
the basis of the difference between the maxillary inter- Subjects assigned to the RME group underwent RME
molar width (distance between the central fossae of using a tooth-borne Hyrax-type appliance. The Hyrax-
the maxillary first molars) and the mandibular intermolar type maxillary expander is a tooth-borne expansion
width (distance between the mesiobuccal cusps of the appliance that is fixed to the maxillary second deciduous
first mandibular molars).17 All participants provided molars using bands and includes a midline 12-mm self-
written informed consent and could withdraw from the locking screw (0.9 mm, complete turn; Forestadent,
study at any time. Pforzheim, Germany). The expansion screw was con-
nected to the conventional molar bands or printed
Intervention clasps, which were modeled surrounding the molars via
Subjects assigned to the CAT group underwent Invis- a 0.9-mm stainless steel wire framework. The framework
align First Phase I treatment (Align Technology, Inc, was soldered to the bands and extended on the palatal
Santa Clara, Calif). The Invisalign First aligners were side to the deciduous canines. A qualified laboratory
fabricated in a multilayer aromatic thermoplastic technician fabricated the expander. The Hyrax-type
polyurethane/co-polyester 0.75 mm (0.030-in)-thick maxillary expander was bonded to the teeth with an or-
with a fine 3D manufacturing process. Subjects in this thodontic band composite (Transbond Plus Light Cure
group were instructed to wear aligners 22-24 h/d for Band Adhesive; 3M Unitek, Monrovia, Calif) and light-
the entire duration of the therapy. They were asked to re- cured using a halogen lamp (Optilux, Kerr, Orange, Calif)
move their aligners only while eating, drinking (except for 20 seconds per tooth.
water), or cleaning. The expansion protocol was one quarter-turn twice a
The ClinCheck software (Align Technology, Inc) was day (0.45 mm activation per day) until overcorrection
used to plan orthodontic movements. Regarding staging, with the maxillary lingual cusps in contact with the
permanent molars moved buccally first, using the rest of mandibular buccal cusps.

American Journal of Orthodontics and Dentofacial Orthopedics September 2024  Vol 166  Issue 3
206 Bruni et al

When an increase in the mandibular anterior arch The primary outcome was to evaluate changes in
perimeter or a curve of Wilson flattering was requested, palatal morphology, defined as variations in palatal vol-
a removable mandibular Schwarz appliance was used for ume. The palatal surface area and volume were calcu-
mandibular “dental decompensation”30 The Schwarz lated from digitized study models within the
appliance was an acrylic horseshoe-shaped appliance boundaries of the palate by creating mutually perpen-
that fitted along the lingual border of the mandibular dicular median sagittal, distal, and gingival planes25
dentition, extending distally to the permanent first mo- (Figs 1 and 2).
lars. It included a midline 9-mm self-locking screw (For- Then, intermolar and intercanine transverse widths at
estadent, Pforzheim, Germany; 0.9 mm, complete turn), the cusp and gingival level were measured: the maxillary
and the connection with the mandibular second decidu- intercanine width at the cusp level was defined as the
ous molars was ensured by ball clamps at their interprox- distance between the cusp tips of the maxillary right
imal undercut. A qualified laboratory technician and left canines; the maxillary intermolar width at the
fabricated it. The expansion protocol for mandibular ap- cusp level was defined as the distance between the me-
pliances was one quarter-turn a week with full-time siobuccal cusp tips of the maxillary right and left first
wear. The expander was left passively for retention for molars; the maxillary intercanine at the gingival level
a minimum of 6 months, and the Schwarz appliance was defined as the distance between the midpoints of
continued to be worn full-time as a passive retainer until the palatal dentogingival junction of the maxillary right
the maxillary expander was removed. At the time of and left canines; and the maxillary intermolar width at
appliance delivery, written and verbal oral hygiene in- the gingival level was defined as the distance between
structions, including cleaning methods, were provided. the midpoints of the palatal dentogingival junction of
In addition, written informed consent was obtained the maxillary right and left first molars25 (Fig 3). The 2
from each patient or the parents. observers (M.F. and V.G.) performed all measurements
In both intervention groups, the amount of expansion 3 times.
was determined individually, depending on the severity
of maxillary arch constriction. In case of breaking or Blinding
losing the appliances, the patients were asked to visit Patients and interventionists were not blinded
the Orthodontic Department or private practice of the because of the nature of the intervention. The trial
authors as soon as possible. adhered to established procedures to maintain separa-
For all patients, full mouth intraoral scans were ob- tion between staff taking outcome measurements and
tained using an intraoral scanner (iTero Element; Align delivering the intervention, ensuring that those who
Technology, Inc) before appliance placement (T0) and conducted and evaluated measurements differed from
at the end of the retention period/treatment (T1), the interventionists. Both interventionists and partici-
when the appliances were removed. pants and outcome assessors were blinded to the group
assignment. Interventionists and participants were
Randomization blinded to outcome measurements and trial results
Patients who fulfilled the eligibility criteria were throughout the study. Only outcome assessors were
enrolled and randomly allocated into the 2 groups using not blinded to outcome measurements and trial results.
the Microsoft Excel (Microsoft, Redmond, Wash) random
number generator. Sample size and statistical analysis
The CAT group comprised patients who underwent In- The sample size was calculated based on the primary
visalign First Phase I treatment (Align Technology, Inc), objective of comparing palatal volume changes between
and the RME group comprised patients who underwent the two groups. Using the software G* Power (version
RME treatment with a tooth-borne Hyrax-type appliance. 3.1; Heinrich-Heine-Universit€at D€
usseldorf, D€
usseldorf,
Germany), an a priori sample size calculation was con-
Outcomes ducted to ensure adequate power for detecting clinically
The stereolithographic (STL) files obtained from the meaningful differences between the groups, based on
scanner were imported into the reverse modeling soft- data from a previous study41 evaluating similar out-
ware package Geomagic Control X (3D Systems Inc, comes in comparable patient populations.
Rock Hill, SC) to perform all measurements by 2 opera- Considering an expected effect size of 1.0, a mini-
tors (M.F. and V.G.). Each study cast scan was manually mum of 17 subjects per group was necessary to achieve
preprocessed to remove unwanted data artifacts from a power of 0.80 with an alpha level set at 0.05. To ac-
the analysis. count for a potential dropout rate of approximately

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Bruni et al 207

Fig 1. Definition of palatal boundaries on digital models: A, Distal plane: passing through points A and
B; B, Sagittal plane: passing through points C and D; C, Gingival plane: passing through points A, B,
and C by connecting the midpoints of the dentogingival junction of all primary teeth. Point A, distal of the
permanent maxillary right first molar; Point B, distal of the permanent maxillary left first molar; Point C, at
the center of incisive papilla; Point D, in the middle between points A and B).

Fig 2. Schematic representation of: A, Palatal surface area; B, Palatal volume on digital models.

10%, the resulting sample size for each group was 20 groups and the indipendent samples t-test for the inter-
subjects. group differences among T0-T1 variation. All reported P
Univariate and bivariate descriptive statistics for cat- values were obtained from the 2-sided exact method at
egorical variables were described as relative/absolute the conventional 5% significance level.
frequencies, whereas continuous variables were The intraclass correlation coefficient (ICC) was calcu-
described as mean and standard deviation. Bivariate lated to assess intrarater and interrater reliability.
descriptive statistics for continuous variables were esti- For intrarater reliability, measurements for interca-
mated for the whole cohort or stratified by the group nine width, intermolar width, palatal surface, and palatal
(CAT and RME) and the T0 vs T1 measurements. The volume were conducted by 1 investigator (V.G.) using a
Shapiro-Wilk test and the skewness and kurtosis test specified approach detailed in the outcome subpara-
were performed to verify the distribution of continuous graph. The same investigator (V.G.) then repeated all
variables, considering P \0.05 for significance. A measurements after a 4-week interval to evaluate the
Fisher's exact test was performed to assess the compara- consistency of the assessments. For interrater reliability,
bility of gender distribution between the two interven- a different investigator (M.F.) applied the same stan-
tion groups. The paired t-test assessed the intragroup dardized procedure to assess intercanine width, intermo-
differences for all parameters from T0 to T1 in both lar width, palatal surface, and palatal volume.

American Journal of Orthodontics and Dentofacial Orthopedics September 2024  Vol 166  Issue 3
208 Bruni et al

The mean treatment duration in the CAT group was 8

6 3 months. The mean active treatment duration was 10
6 2 days, and the total treatment duration was 9 6 1
months in the RME group. The average number of ap-
pointments was 6 6 2 in the CAT group and 8 6 1 in
the RME group.
The Shapiro-Wilk test, alongside skewness and kur-
tosis tests, was employed to evaluate the distribution
of the variables, with results indicating no evidence of
nonnormality for any of the variables (P .0.005).
The ICC for assessing palatal volume (primary
outcome) showed excellent reliability, with a 0.989
(95% confidence interval [CI], 0.985-0.993). Intrarater
and interrater reliability were excellent, with an ICC of
0.98 (95% confidence interval [CI], 0.84-0.99) and
0.93 (95% CI, 0.79-0.98), respectively, for assessing
palatal volume (primary outcome).
Fig 3. Intercanine and intermolar maxillary arch widths To test for the existence of selection bias in the
assessed at the cusp level (blue) and gingival level cohort at T0, a indipendent samples t-test was
(red) on digital models. performed, which showed no significant difference
between the 2 intervention groups in terms of palatal
volume (primary outcome), palatal surface, and
Data were analyzed using Stata software (version 17; intercanine and intermolar widths at the gingival level
StataCorp LLC, College Station, Tex), which was also (P .0.05) (Table I). Significant differences were reported
used for chart making. for intercanine and intermolar widths at the cusp level
(P 5 0.047 and P5 0.019, respectively) (Table II).
RESULTS
We used the paired t-test for intragroup differences
Out of 50 patients screened for eligibility, 4 did not for all parameters from T0 to T1 in both groups (Table
meet the inclusion criteria, 3 subjects declined to partici- II). All outcome measures significantly improved from
pate, and 2 were no longer willing to participate. Forty- T0 to T1 in both groups (P \0.005).
one patients (19 males and 22 females; mean age, 8.12 We also investigated the differences between the
6 1.53 years) were enrolled and divided into 2 groups: groups regarding variation from T0 to T1, as described
20 in the CAT group and 21 in the RME group; however, in Table III. There was not a significant difference in
1 patient discontinued the intervention (only compliant terms of variation from T0 to T1 between the groups
patients were included) in the CAT group, and 1 patient for all the outcomes (P .0.005), except for the intermo-
was lost to follow-up in the RME group. Thus, 19 patients lar width at the gingival level (P\0.005). Concerning in-
(5 males and 14 females; mean age, 8.48 6 1.42 years) tercanine width, both at the cusp and gingival levels, the
were analyzed from the CAT group, and 20 subjects (12 RME group demonstrated slightly higher increases than
males and 8 females; mean age, 7.83 6 1.19 years) from the CAT group (4.22 6 1.50 mm vs 3.52 6 2.17 mm and
the RME group. The gender distribution between the 3.74 6 1.45 mm vs 3.00 6 1.81 mm, respectively). How-
two groups was marginally comparable (Fisher's exact ever, the differences did not reach statistical significance
test, p 5 0.054). Although this difference was not (P . 0.05).
statistically significant, it is close to the threshold for A similar trend was observed in the intermolar width.
significance, suggesting that gender distribution could Although the RME group exhibited a more significant
have a subtle influence on the outcomes. Refer to the increase than the CAT group at both cusp and gingival
Consolidated Standards of Reporting Trials Flow Diagram levels (4.10 6 1.70 mm vs 3.22 6 2.43 mm and 3.87
in Figure 4 for a detailed illustration of participant flow, 6 1.67 mm vs 1.58 6 1.53 mm, respectively), the differ-
including the screening process, enrollment, and reasons ence at the gingival level was statistically significant
for excluding some patients from the final analysis. No (P \0.001). In contrast, the difference at the cusp level
patient-reported bilateral crossbite. Unilateral crossbite did not reach statistical significance (P 5 0.196).
was observed in 9 patients and was distributed as follows: Analyzing the changes in the palatal surface, we
1 tooth in 2 patients, 2 teeth in 4 patients, and 3 teeth in noted that the RME group experienced a slightly higher
3 subjects. increase than the CAT group (81.34 6 71.05 mm2 vs

September 2024  Vol 166  Issue 3 American Journal of Orthodontics and Dentofacial Orthopedics
Bruni et al 209

    

 
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Fig 4. Flow chart according to the Consolidated Standards of Reporting Trials guidelines.26

Table I. Baseline characteristics of our study cohort (n539)

Outcome measure Group A Group B P value
Inter-canine width at cusp level (mm) 30.24 6 2.84 28.36 6 2.73 0.047*
Inter-canine width at gingival level (mm) 23.93 6 2.2 22.81 6 2.4 0.146
Inter-molar width at cusp level (mm) 48.46 6 2.69 46.41 6 2.52 0.019*
Inter-molar width at gingival level (mm) 32.57 6 1.82 32.06 6 2.22 0.442
Palatal surface (mm2) 1160 6 114.2 1130 6 138.2 0.451
Palatal volume (mm3) 4927 6 995.6 46126957.9 0.325
Continuous variables are expressed as means 6 standard deviations. P\0.05 was considered for significance.

64.51 6 64.25 mm2), with no statistically significant dif- palatal volume changes between the groups was moder-
ference observed (P 5 0.442). ate (Cohen's d 5 0.57), indicating a meaningful differ-
In terms of palatal volume, the change was more pro- ence even though it was not statistically significant.
nounced in the RME group (532.01 6 540.52 mm3) Thus, the null hypothesis (H0) that there were no sig-
than in the CAT group (243.95 6 473.24 mm3), nificant differences in palatal volume measurement be-
although the difference did not reach statistical signifi- tween Invisalign First Phase I treatment and tooth-borne
cance (P 5 0.084). The effect size for the difference in RME was retained.

American Journal of Orthodontics and Dentofacial Orthopedics September 2024  Vol 166  Issue 3
210 Bruni et al

Table II. Intragroup differences for all outcome measures from T0 to T1 in both groups.
Group Outcome measure T0 T1 P value
A Inter-canine width at cusp level (mm) 30.37 6 2.85 33.89 6 1.81 \0.0001*
Inter-canine width at gingival level (mm) 24.02 6 2.2 27.02 6 1.43 \0.0001*
Inter-molar width at cusp level (mm) 48.46 6 2.69 51.67 6 2.2 \0.0001*
Inter-molar width at gingival level (mm) 32.57 6 1.82 34.15 6 1.57 \0.0001*
Palatal surface (mm2) 1160 6 114.2 1225 6 114.6 0.0003*
Palatal volume (mm3) 4927 6 995.6 5171 6 1089 0.0326*
B Inter-canine width at cusp level (mm) 28.36 6 2.73 32.57 6 1.97 \0.0001*
Inter-canine width at gingival level (mm) 22.81 6 2.4 26.55 6 2.03 \0.0001*
Inter-molar width at cusp level (mm) 46.41 6 2.52 50.51 6 3.05 \0.0001*
Inter-molar width at gingival level (mm) 32.06 6 2.22 35.94 6 2.45 \0.0001*
Palatal surface (mm2) 1130 6 138.2 1211 6 143.7 \0.0001*
Palatal volume (mm3) 4612 6 975.9 5144 6 1036 0.0004*
Continuous variables are expressed as means 6 standard deviations. P\0.05 was considered for significance.

Table III. Between-groups differences in terms of variation (D) from T0 to T1 for all outcome measures.
Outcome measure Group A Group B P value
Inter-canine width at cusp level (mm) 3.52 6 2.17 4.22 6 1.5 0.275
Inter-canine width at gingival level (mm) 3 6 1.81 3.74 6 1.45 0.194
Inter-molar width at cusp level (mm) 3.22 6 2.43 4.1 6 1.7 0.196
Inter-molar width at gingival level (mm) 1.58 6 1.53 3.87 6 1.67 \0.001*
Palatal surface (mm2) 64.51 6 64.25 81.34 6 71.05 0.442
Palatal volume (mm3) 243.95 6 473.24 532.01 6 540.52 0.084
Continuous variables are expressed as means 6 standard deviations. P\0.05 was considered for significance.

DISCUSSION the axial inclination of the anchoring teeth and the alve-
This in vivo study demonstrated changes in palatal olar bridge.25
volume among growing patients treated with clear This study is one of the earliest attempts to assess the
aligners when their initial transversal interarch discrep- effects of clear aligners on palatal volume, surface area,
ancy was #6 mm. In addition, the study confirmed the and maxillary interarch distances in mixed dentition pa-
occurrence of buccal tipping in maxillary molars during tients. A further study has been published on the topic,
CAT. which was a pilot study comparing the achieved expan-
Regarding the characteristics of the study partici- sion using aligners in mixed dentition patients with
pants, our study focuses on growing patients with an in- those treated using a slow activation protocol with a
terarch discrepancy of #6 mm. This choice aligns with tooth-borne jackscrew expander and an untreated
some of the previous studies, which included patients control group.24
with a posterior transverse discrepancy between maxil- In this study, both treatments have been shown to
lary and mandibular arches of up to 6 mm.17,19 One study effectively modify palatal dimensions in mixed denti-
specified #5 mm of interarch discrepancy,31 whereas 3 tion, resulting in a significant increment in palatal vol-
did not mention the transverse discrepancy.16,18,24 ume from T0 to T1 (P \0.05) with better performance
Interdental linear measurements have been used in by RME (532.01 6 540.52 mm3 average increase) over
most previous publications on CAT for both aligners (243.95 6 473.24 average increase). However,
adults10-15,32 and growing patients,16-19,24 for assessing the difference between the 2 groups did not reach statis-
maxillary arch changes after expansion. However, they tical significance (P .0.05), considering the baseline
have the limitation of not capturing essential informa- characteristics of the sample. Other parameters signifi-
tion concerning the palate, such as palatal surface area cantly increased (P \0.05) after treatment in both
and volume, which are considered reliable indicators of groups. The increases in the interarch distance obtained
maxillary arch expansion.25 Another limitation of these in this study are consistent with those reported in previ-
measurements is that they could be biased because of ous articles.16-19,31 Indeed, the RME demonstrated

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Bruni et al 211

superior results compared with CAT, albeit without widening of the nasal cavity base.34 Indeed, expansion
reaching statistical significance, except for the intermo- has also been associated with improved respiratory pat-
lar width measured at the gingival level, suggesting the terns and reduced nasal airway resistance, particularly in
occurrence of buccal tipping in the molar area with the patients with maxillary constriction-related oral breath-
use of aligners. Tipping, which occurs when a single ing, snoring, and obstructive sleep apnea syndrome.34
force is applied to the crown of a tooth, is a byproduct However, the literature presents conflicting evidence
of the moment of force in which the line of the force regarding the impact of RME on the airway. Although
is away from the tooth’s center of resistance. Clear some studies suggest positive effects on airway dimen-
aligners exert forces on the target teeth by causing sions and oxygen saturation, others caution against
elastic deformation of the material through the prees- justifying expansion solely for airway improvement.34
tablished mismatch between the aligner shape and the For rapid maxillary expanders, in addition to skeletal ef-
dental crown geometry, thus sequentially moving the fects, several dentoalveolar effects have been reported,
teeth to the desired position.33 and studies have documented that dentoalveolar trans-
The activation of the aligners during maxillary expan- verse expansion is more significant than skeletal expan-
sion generates a force system that “pushes” at the level of sion with buccal tipping of both premolars and molars.35
the palatal surfaces of the teeth, distant from the center The dentoalveolar effect occurs essentially as tran-
of resistance, primarily inducing uncontrolled tipping.33 sient buccal tipping, extrusion of molars, and alveolar
In a recent study, the finite element method was em- bending.3 Dental compensation is predominant in the
ployed to analyze the biomechanics of maxillary arch molar region compared with the anterior region because
expansion, revealing that incorporating torque compen- of the progressive anteroposterior increase in skeletal
sation was effective for controlling the buccal tipping resistance.3 Our study used rapid palatal expanders
of the posterior teeth. However, it concurrently led to a anchored on second deciduous molars, and recent evi-
reduction in the efficiency of maxillary arch expansion.29 dence supports this choice.36,37 RME anchored on decid-
Moreover, the use of attachments, whether horizontally uous teeth reduces buccal inclination and increases
rectangular or occlusal beveled bonded to the buccal sur- distorotation of the first permanent molars, whereas
face of posterior teeth, should enhance third-order con- anchorage on permanent molars is associated with
trol by counteracting the undesired tipping moment increased buccal inclination, albeit with little clinical sig-
with forces acting at the occlusal surface and the gingival nificance.36 The spontaneous rotation of the maxillary
aspect of the attachment. In a recent unpublished finite molar is considered favorable, particularly in patients
element analysis study, it was also observed that placing with crowding, providing a gain in arch perimeter and
attachments on the palatal surface of the maxillary first improvement in molar relationships.36 In addition, de-
molars exerted better control over buccal tipping ciduous teeth could serve as an alternative to avoid
compared with the labial surface,28 offering noteworthy reduction in buccal bone thickness.37 These differences
insights for future investigations. underscore the importance of using deciduous teeth as
Our study observed a statistically significant differ- anchorage for RME, as this approach may offer signifi-
ence in the intermolar width measured at the gingival cant advantages over anchorage on permanent teeth.
level despite applying torque compensation and using According to the literature, the moderate magnitude
attachments to control the buccal tipping of posterior produced by aligners, in which the force magnitude is
teeth. This difference indicates a more significant occur- influenced by the degree of mismatch and the character-
rence of buccal tipping in the molar area when aligners istics of the aligner material, is highly unlikely to provide
are used. Although the virtual treatment plan provided skeletal expansion.38 Considering this limitation, the
an overcorrection with 2 of extra buccal root torque differing treatment outcomes could also be attributed
at each stage, the amount of expansion obtained using to the significantly greater magnitude of forces expressed
aligners was presumably because of dentoalveolar by RME than with aligners.38 This is particularly evident in
displacement (buccal tipping) rather than bodily move- the distal portions of aligners, which lack sufficient stiff-
ment, as reported by other authors.10,11,32 ness to support a predictable buccal movement.17
RME is the treatment modality of choice when a pre- Another factor that needs to be considered is the stress
dominantly skeletal effect is required. Indeed, the skel- relaxation and creep of orthodontic thermoplastic appli-
etal effects of RME are well-documented and ances (for example, due to intraoral temperature fluctua-
multifaceted.3 When the force applied to the teeth and tions and hygroscopic expansion), which can affect the
maxillary alveolar processes exceeds the limits needed aligners’ ability to consistently apply force over time.39
for orthodontic tooth movement, it can lead to the sep- A further explanation of the different ways of action
aration of the 2 maxillary bone halves and subsequent of the 2 appliances is represented by the force

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212 Bruni et al

application duration, which differs between the 2 appli- significant, it suggests that gender distribution might
ances and could impact the clinical outcome. The have subtly impacted the results. Future studies should
aligners provide intermittent forces, and their effect consider balancing gender distribution more carefully to
strongly depends on patient compliance. Otherwise, avoid potential confounding effects. Despite the lack of
the rapid maxillary expander is a bonded appliance, statistical significance, the observed effect size (Cohen's
and the delivered interrupted forces strictly rely on the d 5 0.57) suggests that the primary outcome, palatal
clinician’s need for activation. volume changes, may have shown a clinically relevant
In young children aged up to 8-9 years (and some- difference between RME and CAT. However, this observed
times up to early adolescence), opening the midpalatal effect size was lower than the expected effect size of 1.0
suture can potentially be achieved using light continuous used in the sample size calculation, which may have
forces.35 Therefore, it can be inferred that intermittent resulted in the study being underpowered to detect this
forces released by aligners may be sufficient to influence more moderate difference. This highlights the need for
the transversal dimension of the maxilla in this age group. future studies with larger sample sizes or adjusted expec-
However, there is currently no evidence in the literature to tations regarding effect size to more accurately assess the
support this. Indeed, considering the mean age of the pa- impact of these treatments.
tients included in our study (mean age of 8.48 6 1.42 Despite the questionnaire, the compliance of the pa-
years for the CAT group and 7.83 6 1.19 years for the tients allocated to the CAT group was impossible to
RME group), a substantial portion of the subjects in the assess, with potential differences in outcome expected.
sample is expected to have an immature midpalatal su- The data for both groups were gathered considering
ture. However, despite the potential for a skeletal short-term treatment effects only: the stability of results
response, the primary effect of appliances promoting obtained through CAT could be limited, as the expansion
SME is predominantly dentoalveolar. This finding is sup- was achieved as the buccal inclination of crowns. How-
ported by previous studies reporting buccal molar tipping ever, it is essential to acknowledge that the effectiveness
associated with such treatment modalities, similar to of treatment with RME may not be immune to relapse, as
those reported for CAT.16 reported in the existing literature.40 Future studies
In the absence of posterior crossbite, the treatment of incorporating extended follow-up periods are crucial
maxillary transverse deficiency must consider the poten- to elucidate the durability and potential for relapse asso-
tial dentoalveolar effects on the maxillary first molar (the ciated with both treatment modalities, thereby
buccal flaring could result in periodontal problems and enhancing the robustness of our conclusions.
occlusal interferences affecting both curve of Wilson The intraoral scans at T1 were obtained at different
and occlusal plane),36,37 with the actual space gained time points depending on patients’ baseline characteris-
from this approach possibly being insufficient; ideally, tics; therefore, the potential different lengths of treat-
an expansion limited to the anterior region of the arch, ment duration between groups might have impacted
combined with a controlled movement of maxillary first skeletal maturation and, consequently, treatment
molars, would be desirable in noncrossbite patients. CAT outcome. Moreover, the patients included in the study
can provide simultaneous control of all the teeth of the were recruited for .6 months, and this should be
maxillary arch, combining adequate control of the counted as a possible risk of bias considering the physi-
maxillary molar in all the space planes with an expansion ological growth. Indeed, it has been demonstrated that
targeted to the anterior region when necessary. physiological maxillary growth between the age ranges
of 7-8 years and 28-32 years is associated with changes
in the intercanine width of 1.55-2.14 mm and changes
Limitations in the intermolar width of 0.38-3.01 mm.40
Acknowledging the study findings, it is essential to An additional consideration pertains to the
consider the associated limitations. anchorage of RME appliances in deciduous second mo-
The sample included subjects without some teeth, lars within the RME group. Recent literature suggests
such as deciduous canines, elements required for both that anchoring RME to deciduous teeth may lead to a
linear and volumetric measurement; therefore, some spontaneous reduction in buccal inclination and
measurements needed to be included. However, these increased distorotation of maxillary first permanent mo-
subjects were not excluded to avoid introducing bias. lars.36 Conversely, anchorage to first permanent molars
Only those variables that could not be measured is associated with increased buccal inclination, albeit
were excluded from the analysis. The gender distribution with little clinical significance.36 The choice of
between the groups was marginally comparable anchorage in our study, using deciduous second molars,
(p 5 0.054). Although this difference was not statistically may yield results different from those obtained with

September 2024  Vol 166  Issue 3 American Journal of Orthodontics and Dentofacial Orthopedics
Bruni et al 213

anchorage to first permanent molars, highlighting a po- draft preparation; Martina Ferrillo contributed to investi-
tential factor influencing the outcomes. gation, formal analysis, and original draft preparation;
Other linear measures, such as anterior segment Vittorio Gallo contributed to investigation and formal
length, posterior segment length, or posterior teeth analysis; Simone Parrini contributed to manscript review
inclination (buccal tipping), could be supplemented in and editing; Francesco Garino contributed to manscript
future investigations and other secondary outcomes, review and editing; Andrea Deregibus contributed to
such as appliance survival, patient satisfaction, and peri- manscript review and editing; and Tommaso Castroflorio
odontal health assessment. contributed to manscript review and editing.
While the use of 3D radiographic imaging would be
essential for assessing the type of tooth movement (cor- SUPPLEMENTARY DATA
onal tipping or bodily movement) achieved after expan- Supplementary data associated with this article can
sion following the two treatments, the high be found, in the online version, at https://doi.org/10.
susceptibility to ionizing radiation in children necessi- 1016/j.ajodo.2024.04.006.
tates keeping exposure as low as reasonably achievable.
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