European Journal of Orthodontics, 2023, XX, 1–11

https://doi.org/10.1093/ejo/cjad018
Original Article

The effect of tooth borne versus skeletally anchored

Alt-RAMEC protocol in early treatment of Class III
malocclusion: a single-centre randomized clinical trial

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Emad Eddin Alzoubi1, , Simon Camilleri1, , Mohammed Al Muzian2, and Nikolai Attard3
1
Department of Child Dental Health and Orthodontics, University of Malta, Msida, Malta
2
Department of Orthodontics, Faculty of Dentistry, University of Edinburgh, Edinburgh, UK
3
Department of Restorative Dentistry, University of Malta, Msida, Malta
Correspondence to: Emad Eddin Alzoubi, BDS (Hons)., M.Sc. (Orth), PhD (Melit), Faculty of Dental Surgery, Department of Child Dental Health and
Orthodontics, University of Malta, Dun Karm street, Msida, MSD 2080, Malta. E-mail: [email protected]

Summary
Trial design: This was a randomized, controlled trial designed to compare outcomes between the use of dental and skeletal anchorage, using
the Face mask/Alternate Rapid Maxillary Expansion and Contraction (FM/Alt-RAMEC) protocol.
Methods and participants: The study was carried out at Mater Dei Hospital, Malta and included prepubertal skeletal Class III malocclusion
patients where the aetiology was primarily maxillary hypoplasia.
Interventions: Two groups were assigned. Group I was treated with FM/Alt-RAMEC and group II was treated with skeletally anchored FM/
Alt-RAMEC. Wear-time (WT) of the FM was monitored using TheraMon microsensors. Patients were instructed to wear the FM for 12–14 hours/
day for 9 months. Changes were evaluated with lateral cephalograms and analysed with Wilcoxon and Mann–Whitney U tests. ANOVA was
used to analyse the effect of gender on compliance parameters. Spearman’s correlation coefficient was used to assess the correlation between
compliance and skeletal changes.
Objective: To compare the skeletal and dentoalveolar changes in patients treated with these two protocols.
Outcomes: The primary outcome was to assess skeletal and dentoalveolar outcomes in patients treated with skeletally anchored FM/RME
and tooth-borne FM/RME; utilizing Alt-RAMEC protocol. The secondary outcome was compliance rate and adherence to FM wear among
patients.
Randomization: Randomizer software and the sealed envelope technique were used to randomly allocate patients 1:1 into either group I
(tooth-borne FM/Alt-RAMEC) or group II (skeletally anchored FM/Alt-RAMEC).
Blinding: It was not possible to blind to treatment allocation, but blinding was used when assessing the outcomes.
Results: Numbers randomized and analysed. Thirty-five patients were allocated. Group I consisted of 18 subjects and group II consisted of 17
subjects. One patient in group I dropped out due to illness, so 17 subjects in each group completed the study.
Outcomes: Post-treatment changes in group I showed significant increases in SNA (2.10°), ANB (3.90°), Wits (4.70 mm), and overjet (5.40 mm).
Group II showed significant increases in ANB (3.10°), Wits (3.20 mm), and overjet (4.50 mm). Wearing time for group I patients was 7.87 ± 2.88
hours/day and for group II was 6.98 ± 2.68 hours/day, with no significant difference between the groups.
Limitations: Lack of long-term follow-up post-treatment, making the conclusion applicable only in the short term.
Harms: No harm was observed in both groups
Conclusion: Despite the large difference between the measured and the patient-reported daily WT, both tooth-borne and skeletally anchored
FM/Alt-RAMEC showed positive, similar, skeletal and dental effects.
Clinical trial registration: ISRCTN12197405.

Introduction connection between the two (1). The skeletal base relation
Class III malocclusion is considered to be among the most deteriorates during puberty, with peak mandibular growth
challenging orthodontic problems in orthodontics. These pa- occurring during cervical vertebra maturation (CVM) stages
tients display unique dentofacial growth discrepancies that 3 and 4, and lasting, on average, 6 months longer than
appear as early as the age of 4 years and are characterized by in non-Class III individuals, until young adulthood. The
a retrusive maxilla with reduced effective length, increased average increase in mandibular length is double the mag-
mandibular effective length, increased vertical measure- nitude in girls and three-fold greater in boys, compared to
ments, and dentoalveolar compensation. A short anterior individuals with normal occlusion (2). The inability of the
cranial base is often correlated with altered mandibular maxilla to keep up with mandibular growth contributes to
morphology and an increase in size, indicating a biological the worsening Class III maxillomandibular relationship (3).

© The Author(s) 2023. Published by Oxford University Press on behalf of the European Orthodontic Society. All rights reserved. For permissions, please
email: [email protected]
2 European Journal of Orthodontics, 2023

Various combinations of sagittal and vertical developmental role in their treatment. Age, gender, maturity, motivation,
discrepancies have been described. A significant proportion and personality traits as well as the type of device they are
of Class III individuals (25%) exhibit either pure maxillary asked to wear, are all factors which have been investigated
retrognathia or a combination of maxillary retrognathism (15).
and mandibular prognathism (22.2%), meaning that almost Several RCTs and systematic reviews have been pub-
half of these individuals have midface underdevelopment lished on patients’ subjective reports of wearing time as
(1). It follows that maxilla retrognathia is one of the aetio- this factor determines proportionately the treatment re-
logical factors and modifying its forward growth would be sults. Thus, an accurate tool, independent of patients’ sub-
a sound idea. jective reports, is required to assess compliance (16). Schafer
et al. used Theramon microchips (TheraMon Microsensor,
Handelsagentur Gschladt, Hargelsberg, Austria) in order to
Background and objectives

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assess compliance and found that the average wearing time
Rapid maxillary expansion (RME) either with banded or of a removable appliance was 8 hours per day, well below the
bonded expanders, combined with a face mask (FM), results recommended wearing time of 15 hours per day (15). Schott
in maxillary protraction. The skeletal response to 6–9 months found Theramon devices to accurately report wear time and
of FM/RME treatment in growing patients results in signifi- temperature deviations both in vivo and in vitro (17).
cant improvements in angular and linear measurements, with Therefore, the present prospective, randomized, controlled
improvement of maxillary length and reduction of the nega- single-centre study aimed to test the null hypothesis that there
tive Wits appraisal. The corresponding soft tissue changes would be no difference in skeletal and dentoalveolar changes
follow those of the hard tissues, being equal to 50–79 per induced by FM in combination with skeletally anchored Alt-
cent of the maxillary protraction and 71–81 per cent of the RAMEC or tooth-borne Alt-RAMEC protocols. No difference
mandibular downward and backward movement, improving in patients’ FM-wearing time was seen between skeletally an-
the outcome of Class III treatment (4). chored Alt-RAMEC or tooth-borne Alt-RAMEC groups.
FM/RME treatment is more effective when patients are
in the early mixed dentition rather than in later dental de- Methods
velopment stages, especially with regard to the magnitude
of maxillary advancement and the favourable post-pubertal Trial design
modifications in both maxillary and mandibular structures This study was designed, following Consort guidelines, to see
(5). Treatment of 4- to 7-year-old and 7- to 10-year-old Class whether the addition of skeletal anchorage to the conven-
III patients has shown to result in greater forward and vertical tional FM/Alt-RAMEC protocol conferred any dental or skel-
maxillary movement when compared to identical treatment etal advantages. The protocol was approved by the Faculty
on 10–14 year olds (6). of Dental Surgery Research Ethics Committee, University
A variation of RME, Alternate Rapid Maxillary Expansion of Malta, Research Ethics Committee and the Research
and Constriction (Alt-RAMEC) was proposed with the ra- Ethics Committee at the Ministry for Health and Research
tionale that the expansion-constriction cycles will further (HEC04/19).
disarticulate the circum-maxillary sutures and subsequently
enhance forward maxillary translation. Alt-RAMEC was pro- Eligibility criteria for participants
posed by Liou et al. The rationale of the expansion-constriction The sample was composed of children who had been re-
cycles is to further disarticulate the circum-maxillary sutures, ferred to the Department of Orthodontics, Mater Dei
aiding forward maxillary translation (7,8). The effectiveness Hospital Hospital, Malta, for treatment of their Class III mal-
of FM/Alt-RAMEC versus FM/RME was evaluated by Isci occlusion. The inclusion criteria were set to:
et al. They concluded that A point moved 4.13 mm forwards
in the Alt-RAMEC group in comparison to 2.33 mm move- 1. Prepubertal children, aged between 8 and 10.99 years.
ment in the RME group (9). A 4-week Alt-RAMEC protocol 2. Cervical Vertebral Maturation (CVM) Stage; CS 1 or 2
was successfully used on tooth-borne acrylic FM/RME for (18) Mixed dentition.
early treatment of Class III patients (10). FM/Alt-RAMEC 3. No previous history of orthodontic treatment.
had more favourable short-term outcomes compared to FM/ 4. Negative overjet of at least −2 mm and true skeletal Class
RME therapy, generating greater maxillary advancement and III malocclusion, ANB at least −1 degree.
intermaxillary improvement as an early Class III treatment 5. Caucasian ethnicity.
modality (11).
As these appliances are tooth-borne, dental side-effects, The exclusion criteria were:
namely incisor proclination and anchorage loss due to me-
sial movement of the dentition are unavoidable (12). A re- 1. Craniofacial growth anomalies including cleft lip and/or
cent meta-analysis reported that the Alt-RAMEC protocol in palate.
combination with bone-anchored appliances results in greater 2. History of previous orthodontic treatment.
sagittal skeletal effects, with less vertical and dentoalveolar 3. Positive overjet.
changes (13). The effects of skeletally anchored FM/RME and 4. Class I or II occlusion.
tooth-borne FM/RME have been investigated and the conclu-
sions emphasized the need for higher-quality evidence (14). The primary method of determining the onset of puberty
The effectiveness of treatment with protraction headgear was clinical and based on physical appearance (lack of sec-
depends on patients’ compliance and willingness to wear ondary sexual characteristics), height records and age. The
the appliance for long hours. Many factors may affect the CVM method (18) was used to supplement the clinical
willingness of children and adolescents to play an active impression.
E. E. Alzoubi et al. 3

Interventions for each group the screw by 0.25 mm). At the end of the seventh week, FM
Clinical procedures and treatment traction was initiated and the use of FM was initiated in both
Skeletal and dentoalveolar effects groups, once the ALT-RAMEC protocol was completed.
In both groups, a Petit FM was used. Elastics with a pro-
One orthodontist (EA) treated all patients. Group I (tooth-
traction force of 450–500 g per side and an anteroinferior
borne FM-Alt-RAMEC) had a conventional HYRAX ex-
force vector of approximately 30 degrees to the occlusal
pander cemented on UR6, UL6, ULD, and URD (Figure 1).
plane were connected from the FM to the hooks on the
Group II (Skeletally anchored FM-Alt-RAMEC) had a similar
intraoral appliance. The force delivered was measured
expander cemented on UR6 and UL6, in addition to being at-
with a strain gauge (Morelli, Brazil). The patients were in-
tached to two 9 × 2 mm paramedian implants (Figure 2). The
structed to change the extraoral elastics daily and to wear
appliances in both groups had a buccal traction hook arm
the FM between 12 and 14 hours per day until a 2 mm posi-
which was extended anteriorly to the canine region, in order

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tive overjet was achieved. FM wear of 10 hours and above
to minimize maxillary rotation.
was considered to be a good compliance rate. All patients
Mini implants of 9 mm were used (PSM, Germany). Cone
were followed up from the pre-treatment phase (T0) and till
beam computed tomography views to verify bicortical an-
the end of treatment at 9 months (T1) to assess the skel-
chorage were not obtained, due to objections by the Ethics
etal, dentoalveolar, and soft tissue changes. The success of
Research Committee. The mini implant was inserted using the
the clinical intervention was defined by achieving a Class I
NSK is900 electrical screwdriver. A pilot hole was made, fol-
incisor relationship and eliminating any transverse discrep-
lowed by the insertion of the mini implant, with the screw-
ancies by the end of the treatment.
driver torque set to 35N. Following the fitting of the appliance,
patients were asked to perform alternate cycles of expan-
Compliance rate and adherence
sion and constriction with the first week being a twice-daily
opening cycle and the second week a twice-daily closing cycle, A compliance sensor (TheraMon Microsensor, Handelsagentur
etc. The patients activated the appliance twice daily (one turn Gschladt, Hargelsberg, Austria) was placed just underneath
in the morning and one in the evening; with each turn widened the surface of the forehead pad, with the patient and parents
made aware of its presence. However, they were deceived as
to its true function, being told that its role was to monitor
fluctuations in FM pressure.

Cephalometric analysis
Pre- and post-treatment lateral cephalograms were digitized
and calibrated using the Dolphin Imaging software (Dolphin
Imaging, Chatsworth, CA, USA). The radiographs were
pseudonymised and coded by a member of staff blinded as to
the group of origin. Tracing was carried out by the principal
investigator, using Dolphin Imaging (Chatsworth, CA, USA).
Cephalometric radiographs were taken by an experienced
radiographer at the beginning (T0) and the end of the FM
treatment (T1), using the same cephalostat (Siemens Nanodor
2, Siemens AG, Munich, Germany). Lateral cephalograms
were analysed using a composite analysis of the McNamara
and Mills analysis (19,20) (Figure 3). Cephalometric ana-
lysis was used to assess the skeletal, dental, and soft tissue
Figure 1 RME banded cemented on UR6, UL6, ULD, and URD with changes at T0 and T1. The comparison was made at two
traction hooks extended to the maxillary canine region. levels; inter-group and intra-group, in order to estimate the
effect of change. All appliances and mini-implants were re-
moved prior to taking the second (T1) cephalometric view,
to ensure clinical blinding during tracing.

Outcomes
Primary outcome
Assessing skeletal and dentoalveolar outcomes in patients
treated with skeletally anchored FM/RME and tooth-borne
FM/RME; utilizing Alt-RAMEC protocol.

Secondary outcome
The compliance rate and adherence to FM wear among patients.

Sample size
The sample size was calculated based on a significance level
Figure 2 RME banded on UR6 UL6, with paramedian PSM 9 mm mini-
of α = 0.05 and a power of 80 per cent to detect a statistic-
implants. Traction hooks have been extended to the maxillary canine ally and clinically meaningful difference of 1 degree (±0.97)
region. change in SNA between the two groups for 12 hours of wear
4 European Journal of Orthodontics, 2023

statistician analysing the results was unaware of the nature

of the groups.

Statistical analysis
Data analysis
Statistical analyses were performed using SPSS software (SPSS
Inc., Chicago, IL, USA, version 25.0 for Windows). The sig-
nificance level was set at 5 per cent (α = 0.05). Differences
between the groups for age and gender were determined by
T-tests and Mann–Whitney U tests, respectively.
The majority of cephalometric variables did not follow a

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normal distribution at one or both time points, as determined
by the Shapiro–Wilk test. Thus, the Wilcoxon signed-rank test
was used to detect changes in cephalometric parameters, pre-
treatment (T0) and post-treatment (T1) (intra-group).
The Mann-Whitney U test was used to compare the dif-
ferences in cephalometric parameters between groups
(inter-group).
The difference in compliance rate was evaluated with a
two-tailed t-test. Two-way ANOVA was used to analyse the
effect of gender on the compliance parameters. Spearman’s
correlation coefficient was estimated to assess the association
between daily mean times of wear and skeletal changes.

Method error
The intra-examiner error for tracing, superimposition, meas-
urement of the changes of the landmarks and estimating the
CVM stage was calculated on the cephalograms of 10 ran-
Figure 3 Cephalometric reference points and planes.
domly selected subjects. Another blinded clinician traced and
measured the same lateral cephalograms to estimate inter-
examiner error. All measurements were recorded independ-
of the FM (21,22). The power analysis showed that 17 indi- ently, on two separate occasions, at a 2-week interval. For all
viduals were required in each arm. the cephalometric variables, the difference between the inde-
pendent repeated measurements of each individual before and
after treatment was recorded. The intra-class correlation co-
Randomization: sequence generation efficient of reliability (R) was used to determine the reliability
The selection was consecutive. An intermediary provided of cephalometric measurements.
verbal and written information about the trial and invited all
eligible patients and their parents to participate. After con- Results
sent, randomization was undertaken by staff not involved in
the trial. A randomization tool (Randomizer software) was Participant flow
used for assignation. The software generated codes for each Thirty-five pre-pubertal Class III patients were recruited. Group
patient, to pseudonymise the study and randomly allocate I consisted of 18 patients: 13 males and 5 females. Group II
the patients 1:1 into one of two groups: group I (tooth-borne consisted of 17 patients: 11 males and 6 females (Figure 4).
FM/Alt-RAMEC) and group II (skeletally anchored FM/
Alt-RAMEC). Losses and exclusions
One patient in group I developed leukaemia early in treat-
Allocation concealment mechanism ment and was unable to continue.
The sealed envelope technique was used to ensure random-
ization. The allocation sequence codes were contained within Baseline data
opaque envelopes that were handed to the patient via the inter- Sample description and demographics
mediary and opened sequentially at the time of participant Patient recruitment ran from October 2017 till December
enrolment, thereby excluding the clinician entirely from the 2018. The patients were followed up till September 2019.
process. The patients’ mean age in group I was 8.2 ± 0.6 years old
and in group II 8.8 ± 0.8 years old. Group I had 12 males
Blinding (70.6%) and 5 females (29.4%) while group II had 11 males
Because of the character of the trial, the operator and chil- (64.7%) and 6 females (35.3%). There was no statistically
dren could not be blinded to treatment allocation. However, significant difference between the groups as regards age or
blinding was used when assessing the outcomes. This was gender. All patients were primary school students (Table 1)
achieved by pseudonymising all data related to patients be- and were prepubertal. All subjects were in CVM stage 2 at the
fore and after treatment and by removal of the intraoral start of treatment, which correlated well with their physical
appliance just before the final cephalogram was taken. The appearance.
E. E. Alzoubi et al. 5

Baseline demographic and clinical characteristics (group I vs Numbers analysed

group II) Thirty-five Class III malocclusion patients fulfilled all inclu-
The data showed a well-balanced group except for sion criteria, 1 (3%) of these patients discontinued treatment
Mandibular length (Co-Gn) at T0 was significantly higher in after randomization, having developed leukaemia. Thus, 34
group II (100.7 mm) than in group I (80.9 mm), (P = 0.022). patients, that is 17 in group I and 17 in group II, completed
On the other hand, group I maxillary length (CO-A point) the study.
was significantly shorter at 75.5 mm in comparison to group
II at 90.7 mm (P = 0.021) (Table 2). Outcomes and estimation
Inter-rater and intra-rater reliability
The correlations of all the cephalometric variables ranged
from 0.88 to 0.96. The method of cephalometric analysis

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used in this study was deemed reliable and repeatable. The
CVM inter-rater reliability coefficient (ICC) was 0.79 and
the intra-rater reliability was 0.70, which reflects a very good
agreement (Table 3).

Skeletal and dentoalveolar effects

The cephalometric differences were calculated by taking the
mean of the medians of each group. The significance does not
depend on the median of change. For example, a high median
in a group does not imply that the P-value is smaller, or that
significance was reached. When dealing with non-parametric
tests, this is dependent on how many individuals show an in-
crease, versus those that show a decrease in the value of the
parameter under investigation.

Cephalometric analysis
Even though between the two groups several cephalometric
variables changed within each group, no significant differ-
ences were noted in either skeletal or dentoalveolar param-
eters. Group I SNA showed a significant mean difference
(T1−T0) of 2.10 degrees (0.90 5.20) (P = 0.007), but group II
did not. Group I ANB showed a significant mean difference
(T1−T0) of 3.90 degrees (2.40 4.90) (P = 0.001) and group II
showed a significant mean difference (T1−T0) of 3.10 degrees
(0.70 −4.20) (P = 0.007) (Table 4). Group I Wits appraisal
showed a significant mean difference (T1−T0) of 4.70 mm
(2.10 5.10) (P = 0.001). Group II showed a similar signifi-
cant mean difference (T1−T0) of 3.20 mm (0.30 −4.40) (P =
Figure 4 Flowchart of patients’ allocations in the trial. 0.002) (Table 4).

Table 1. Demographic data group I (tooth-borne FM/Alt-RAMEC) and group II (FM/Alt-RAMEC)

Variable Number Clinical data %

Duration Group I 9 months 2 mm

Group II 9 months 2 mm
Gender Group I Male 12 70.6
Female 5 29.4
Group II Male 11 64.7
Female 6 35.3
Age group (years) Group 1 8.2 ± 0.6
Group II 8.8 ± 0.8
Educational level Group I (primary school 17 100
students)
Group II (primary school 17 100
students)
Cervical maturational stage (CVM) Group I Male 12 CS2
Group II Female 5 CS2
Male 11 CS2
Female 6 CS2
6 European Journal of Orthodontics, 2023

Table 2. Cephalometric parameters inter-group at T0 (baseline)

Group T0 P value

Maxilla skeletal (Co-A point) mm Group I 75.5 (80.0 90.5) 0.021*

Group II 90.7 (80.5 105.2)
Mand. skeletal (Pg-Na Perp) Group I 1.80 (−5.00 5.00) 0.231
Group II 3.50 (−1.40 6.40)
Max. skeletal (A-N Perp) Group I −0.30 (−3.90 2.00) 0.760
Group II 0.00 (−3.80 2.30)
Mand. length (Co-Gn) Group I 80.9 (75.0 99.5) 0.022*

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Group II 100.7 (86.5 115.2)
SNA Group I 78.8 (77.0 81.6) 0.812
Group II 78.6 (78.0 80.2)
SNB Group I 79.6 (78.5 81.5) 0.274
Group II 80.6 (79.0 82.6)
ANB Group I −0.50 (−2.80 0.10) 0.339
Group II −1.40 (−3.30 −0.60)
SN-maxillary plane Group I 7.30 (5.70 10.0) 0.131
Group II 8.40 (7.90 8.60)
Palatal-mand. angle Group I 25.5 (24.9 28.1) 0.433
Group II 24.6 (21.3 26.9)
Lafh/Tafh Group I 55.0 (53.1 55.7) 0.259
Group II 55.9 (54.3 56.2)
Wits Group I −5.50 (−7.60 −3.20) 0.610
Group II −6.30 (−7.90 −3.90)
Overjet Group I −2.00 (−2.40 −0.40) 0.150
Group II −1.30 (−1.80 −0.30)
Overbite Group I −0.90 (−1.30 1.40) 0.586
Group II −0.40 (−1.10 1.40)
U1-maxillary plane Group I 114.1 (112.4 122.5) 0.683
Group II 119.5 (108.5 122.8)
IMPA Group I 95.6 (89.5 99.7) 0.555
Group II 88.9 (85.3 97.1)
Interincisal angle Group I 122.5 (121.2 125.2) 0.322
Group II 129.9 (119.1 137.4)
Nasolabial angle Group I 120.2 (113.9 132.9) 0.099
Group II 109.6 (94.0 124.3)

Mann–Whitney test for comparisons between groups, *P < 0.05; **P < 0.01; ***P < 0.001. Group I: tooth-borne FM/Alt-RAMEC.
Group II: skeletally anchored FM/Alt-RAMEC.

Dentoalveolar changes ANB angle: Spearman’s correlation coefficient showed no

Group I overjet showed a significant mean difference at (T1− correlation between the change in ANB angle and the compli-
T0) of 5.40 mm (4.10 5.70) (P ≤ 0.001). Similarly, group II ance hours (Table 5). Group I and II (r = −0.09 and r =0 .15),
showed a significant mean difference of 4.50 mm (2.80 5.70) respectively.
(P = 0.001). The lower incisor to the mandibular plane (IMPA)
showed a significant mean difference (T1−T0) of −4.00 de- Compliance
grees (−11.4 0.00) (P = 0.023) in group I and group II showed All patients reported full-time FM wear and excellent cooper-
a significant mean difference (T1−T0) of −6.10 degrees (−9.00 ation. However, according to the Theramon sensor record-
−0.50) (P = 0.005). The nasolabial angle for group I showed a ings, group I patients wore the FM 7.87 ± 2.88 hours per day
significant mean difference increase (T0−T1) of 13.0 degrees and group II wore the FM 6.98 ± 2.68 hours per day (Figure
(−20.4 3.1) (P ≤ 0.028) but the change in group II was not 5).
significant 1.00 (−12.9 12.0) (P = 0.717) (Table 4). The compliance rate of group I was 9.57 ± 1.88 and 7.16
± 2.98 hours per day for females and males, respectively. This
Effect of compliance on skeletal changes difference was especially large within group I when compared
SNA angle: Spearman’s correlation coefficient showed no cor- to group II 7.19 ± 4.02 and 6.86 ± 1.83 hours per day for
relation between the change in SNA angle and the compliance females and males, respectively. However, insignificant dif-
hours in group I (r = −0.10) and group II (r = −0.07) (Table 5). ferences were found between genders, both intra-group (P
E. E. Alzoubi et al. 7

= 0.186) and inter-group (P = 0.309). The compliance regu- age was consistent with their chronological age and physio-
larity between males and females in both groups was insignifi- logical features.
cant (P = 0.563) (Table 6).
Limitations
Harms The power analysis indicated 17 subjects in each arm. A
No harms or adverse events were reported throughout the larger sample size was originally envisaged, but the Covid-
study. 19 pandemic severely restricted patient recruitment. The
small sample size might be a limiting factor in this trial, lon-
gitudinal trials should consider recruiting larger numbers
Discussion of patients. The study investigated the short-term effects of

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Baseline characteristics tooth-borne and skeletally anchored FM/Alt-RAMEC. A
This was a randomized, controlled clinical trial that inves- long-term follow-up study is required to assess the stability
tigated the treatment outcomes for patients treated with of the results.
tooth-borne FM/RME compared to skeletally anchored FM/
RME; utilizing the Alt-RAMEC protocol. Allocation con- Generalisability
cealment was used to ensure randomization. This is a crit- The results of the present study apply to the ethnicity and age
ical concept that aims to minimise selection bias. It involves range under investigation, that is Caucasians aged 8–10.99
concealing the treatment allocation sequence from those who years.
are responsible for enrolling participants, thereby ensuring
that the allocation process is randomized and unbiased. Interpretation
In this study, the sealed envelope technique was used. The
According to Baccetti et al. (24)., significant forward displace-
mean age for group I was 8.2 ± 0.6 years and group II 8.8
ment of maxillary structures can be achieved when tooth-
± 0.8 years. All patients were in CVM stage 2 at the start
borne maxillary expansion and FM therapy are performed
of treatment, which correlated well with their physical ap-
at an early age. Two different multicentre randomized con-
pearance. Thus, the two groups were of similar age, gender
trolled trials, with 3- and 6-year follow-ups, confirmed the
and growth status. CONSORT guidelines do not recommend
favourable effects of early Class III protraction FM treatment
baseline comparison; however, this shows that randomiza-
undertaken in patients under 10 years of age. On the other
tion has worked well. CVM is a controversial method of as-
hand, the late treatment produces no significant skeletal im-
sessing skeletal maturation as variabilities between genders
provement in maxillary growth with respect to controls, the
or low reproducibility and reliability among patients have
only changes being dentoalveolar.
been reported in the literature (23–25). while McNamara
The mean age of patients in this investigation was similar
and Franchi also reported poor reproducibility for non-
to that of the Baccetti et al. early treatment group (25). The
expert users (18). Perinetti et al. reported that with proper
anterior movement of point A was reported as being 0.75
training, CVM reporting can reach a satisfactory level (23).
mm in group I and 1.00 mm in group II. This is less than
The CVM assessment was conducted by a trained, calibrated
the 2.33 mm produced by the traditional expansion and pro-
clinician and was used to verify that the patient’s skeletal
traction headgear treatment investigated by Isci et al. (9) and

Table 3. Inter-examiner and intra-examiner reproducibility of cephalometric parameters: Intra-class correlation coefficient (CCI)

Inter-examiner Intra-examiner

CCI Assessment CCI Assessment

Mand. skeletal (Pg-Na Perp) 0.920 Excellent reliability 0.950 Excellent reliability
Max. skeletal (A-N Perp) 0.990 Excellent reliability 0.910 Excellent reliability
Mand. length (Co-Gn) 0.90 Excellent reliability 0.940 Excellent reliability
SNA 0.910 Excellent reliability 0.90 Excellent reliability
SNB 0.910 Excellent reliability 0.950 Excellent reliability
ANB 0.920 Excellent reliability 0.97 Excellent reliability
SN-maxillary plane 0.994 Excellent reliability 0.910 Excellent reliability
Palatal-mand. angle 0.980 Excellent reliability 0.920 Excellent reliability
Lafh/Tafh 0.90 Excellent reliability 0.90 Excellent reliability
Wits 0.930 Excellent reliability 0.910 Excellent reliability
Overjet 0.90 Excellent reliability 0.70 Good
Overbite 0.880 Excellent reliability 0.930 Excellent reliability
U1-maxillary plane 0.997 Excellent reliability 0.890 Excellent reliability
IMPA 0.889 Excellent reliability 0.984 Excellent reliability
Interincisal angle 0.990 Excellent reliability 0.890 Excellent reliability
Nasolabial angle 0.890 Excellent reliability 0.950 Excellent reliability
8 European Journal of Orthodontics, 2023

Table 4. Cephalometric parameters intra-group at baseline (T0) and the end of treatment (T1)

Intra-group Inter-group

Parameters Group T0 T1 Diff. T1−T0 P-value P-value

Mand. skeletal (Pg-Na Perp) mm Group I 2.80 (−5.00 5.00) 0.80 (−3.90 1.00) −2.00 (−9.60 1.10) 0.906 1.00
Group II 3.50 (−1.40 6.40) 0.20 (−4.00 2.10) −3.10 (−6.30 0.00) 0.129
Max. skeletal (A-Na Perp) mm Group I −0.30 (−3.90 2.00) 0.20 (−2.30 2.20) 0,75 (−1.40 1.70) 0.449 0.683
Group II 0.00 (−3.80 2.30) 1.00 (−4.50 1.30) 1.00 (−1.30 1.25) 0.277
Mand. length (Co-Gn) mm Group I 80.9 (75.0 99.5) 94.8 (93.8 97.4) 3.70 (−9.30 21.1) 0.332 0.680
Group II 100.7 (86.5 115.2) 107.5 (101.8 112.1) 3.00 (−4.50 19.8) 0.121

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Maxilla skeletal (Co-A point) mm Group I 75.5 (80.0 90.5) 93.8 (90.8 97.4) 8.70 (−9.30 21.1) 0.552 0.030*
Group II 90.7 (80.5 105.2) 107.5 (100.8 110.1) 10.00 (−4.50 19.8) 0.481
SNA (degrees) Group I 78.8 (77.0 81.6) 80.9 (79.5 82.5) 2.10 (0.90 5.20) 0.007** 0.332
Group II 78.6 (78.0 80.2) 81.0 (79.0 82.0) 2.50 (0.00 3.80) 0.88
SNB (degrees) Group I 79.6 (78.5 81.5) 79.7 (77.8 80.2) −1.40 (−2.90 1.20) 0.201 0.946
Group II 80.6 (79.0 82.6) 81.3 (79.0 81.8) 0.00 (−2.00 1.20) 0.530
SN-maxillary plane Group I 9.30 (5.70 10.0) 11.30 (6.90 9.30) 1.5 (−1.10 2.70) 0.495 0.120
Group II 10.40 (7.90 8.60) 11.90 (2.90 7.30) 2.10 (−5.20 −0.40) 0.408
ANB (degrees) Group I −0.50 (−2.80 0.10) 2.50 (1.10 3.80) 3.90 (2.40 4.90) 0.001** 0.812
Group II −1.40 (−3.30 −0.60) 1.00 (-0.90 2.40) 3.10 (0.70 4.20) 0.001**
Palatal-mand. angle (degrees) Group I 25.5 (24.9 28.1) 26.8 (18.9 28.2) −0.20 (−4.40 1.90) 0.619 0.245
Group II 24.6 (21.3 26.9) 26.3 (24.8 27.2) 0.30 (−0.60 4.80) 0.140
Lafh/Tafh Group I 55.0 (53.1 55.7) 53.6 (52.7 55.7) −0.40 (−1.50 0.90) 0.148 0.160
Group II 55.9 (54.3 56.2) 55.6 (54.9 57.1) 0.30 (−0.40 1.00) 0.352
Wits (mm) Group I −5.50 (−7.60 −3.20) −3.30 (−3.90 0.40) 4.70 (2.10 5.10) 0.001** 0.919
Group II −6.30 (−7.90 −3.90) −2.80 (−4.50 −0.80) 3.20 (0.30 4.40) 0.002**
Overjet (mm) Group I −2.00 (−2.40 −0.40) 3.30 (2.10 3.90) 5.40 (4.10 5.70) <0.001*** 0.496
Group II −1.30 (−1.80 −0.30) 2.90 (2.50 3.90) 4.50 (2.80 5.70) <0.001***
Overbite (mm) Group I −0.90 (−1.30 1.40) 0.10 (−1.10 3.10) 1.90 (−1.30 3.30) 0.093 0.322
Group II −0.40 (−1.10 1.40) 0.80 (0.40 2.50) 1.00 (0.00 3.70) 0.062
U1-maxillary plane (degrees) Group I 114.1 (112.4 122.5) 119.6 (116.4 122.6) 1.90 (−2.90 7.40) 0.245 0.812
Group II 119.5 (108.5 122.8) 121.5 (110.0 127.1) 4.40 (−1.40 5.00) 0.162
IMPA (degrees) Group I 95.6 (89.5 99.7) 88.0 (85.6 96.7) −4.00 (−11.4 0.00) 0.023* 0.786
Group II 88.9 (85.3 97.1) 86.6 (81.8 91.0) −6.10 (−9.00 −0.50) 0.005**
Interincisal angle (degrees) Group I 122.5 (121.2 125.2) 124.9 (121.7 131.5) 2.40 (0.20 4.40) 0.124 0.973
Group II 129.9 (119.1 137.4) 129.6 (114.2 134.0) 0.60 (−4.10 4.00) 0.836
Nasolabial angle (degrees) Group I 120.2 (113.9 132.9) 124.0 (101.0 124.8) 13.0 (−20.4 3.1) 0.028* 0.540
Group II 109.6 (94.0 124.3) 110.3 (108.9 120.8) 1.00 (−12.9 12.0) 0.717

Wilcoxon test for comparisons within groups and Mann–Whitney U-test intergroup comparisons, *P < 0.05; **P < 0.01; ***P < 0.001. Group I: tooth-
borne FM/Alt-RAMEC, group II: skeletally anchored FM/Alt-RAMEC.

the 4.3 mm reported by Miano et al. (4.33 mm) for their Wits appraisal. Our results also indicated that, as the skeletal
Alt-RAMEC protocol group (26). However, our sagittal sagittal improvement values in both group I and group II
cephalometric measurements were similar to the short-term were similar, the use of skeletal anchorage did not add sig-
results reported in the meta-analysis of Cordasco et al., as nificant benefit in terms of skeletal sagittal correction in com-
was treatment duration (19). Significant sagittal skeletal im- parison to tooth-borne FM/Alt-RAMEC. In contrast, Koh
provement was achieved after 9 months of reverse headgear and Chung (27) compared the treatment changes of skeletal
protraction. This was evidenced by the mean 2.10 degrees versus tooth-borne FM and found a greater skeletal improve-
change in SNA and mean 4.7 mm change in Wits appraisal ment in young Class III patients for the skeletal anchorage
for group I. Group II showed a mean improvement of 2.50 group.
degrees in SNA, which did not reach statistical significance; It may seem contradictory that, although the mean increase
however, the 3.20 mm mean improvement in Wits appraisal in SNA for group II was larger than that of group I, the result
was statistically significant. These results are in agreement of the smaller change was statistically significant, while that
with those reported by Nienkemper et al. (20). who used of the larger was not. As the data were not normally distrib-
conventional FM/RME and obtained a mean improvement uted, the difference between the two groups was determined
of 2.4 degrees in SNA and a 4.5 mm mean improvement in using the mean of the medians of the different categories of
E. E. Alzoubi et al. 9

Table 5. SNA and ANB in correlation to compliance wearing time reach statistical significance. In the present study, the lower in-
(Spearman’s correlation coefficient) cisors retroclined −4.00 degrees in group I and −6.10 degrees
in group II, which is in agreement with other studies (20,29).
Reference N Spearman’s correlation P No change was noted in the maxillomandibular plane angle
plane/angle coefficient (r) value in both treatment protocols indicating that the direction of
SNA Total 34 −0.10 0.609
the applied forces, as recommended also by Nienkemper et al.
(21)., maintained the vertical relationship.
Group 17 −0.10 0.693
I
The results indicate that tooth-borne and skeletally an-
chored FM/Alt-RAMEC had similar comparable skeletal and
Group 17 −0.07 0.786
II
dental effects on young prepubertal patients. A possible ex-
planation might be that, as the subjects were young and the
ANB Total 34 0.08 0.558

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circum-maxillary sutures were still patent, using skeletally an-
Group 17 −0.09 0.740
chored FM/Alt-RAMEC may not have any additional benefit
I
in correcting the sagittal relationship in comparison to tooth-
Group 17 0.15 0.558
borne FM/Alt-RAMEC.
II
In this trial, the mini-implants were also found to remain
stable. This stability might be related to the high bone quality
of the insertion site and the stable screw coupling to the appli-
ance. Both these factors might lead to an increased biomech-
anical load capacity (30,31). Compared to other anchorage
modalities such as mini plates, the hybrid HYRAX is less in-
vasive in both during insertion and removal. Mini-implants
provide additional skeletal anchorage during RME, minim-
izing transverse and sagittal side effects (32).
Compliance with FM wear is crucial to achieving sa-
gittal improvement in Class III patients; however, its meas-
urement is difficult. Previous attempts to assess compliance
with removable appliances, or to identify predictive factors
for compliance, were contradictory or inconclusive (33,34).
This inconsistency can be attributed to the fact that compli-
ance is a complex multifactorial process, combined with the
inability to objectively assess compliance accurately and re-
Figure 5 Daily compliance rate in conventional FM/Alt-RAMEC (group I)
and skeletally anchored FM/Alt-RAMEC (group II).
liably. Furthermore, previous studies suffered from methodo-
logical issues, such as sample size and gender or age matching.
Therefore, data were likely to be skewed or obscured, leading
Table 6. Compliance rate by gender: 2-way ANOVA model for to incorrect conclusions.
comparisons of the mean within subjects In this investigation, patients were instructed to wear the
FM 12–14 hours per day. The average FM-wearing time
Group I Group II P value was 7.87 ± 2.88 hours per day for group I and 6.98 ± 2.68
hours per day for group II. Only 23.5 per cent of the chil-
Wearing hours/day Males Females Males Females 0.30
dren in group I and 11.7 per cent in group II wore the FM
Mean 7.16 9.57 6.86 7.19
for more than 10 hours. Female to male compliance rates
SD 2.98 1.88 1.83 4.02
were similar in both groups, with insignificant differences in
SD hours Mean 3.71 3.12 3.77 3.75 0.56 wearing time. This is also in agreement with the literature,
SD 1.15 1.64 1.06 1.79 as compliance in younger patients is much better (35) and
the sex difference in compliance seen in adolescents is not
P < 0.05; **P < 0.01; ***P < 0.001.
* evident at this age (36).
All patients and parents reported wear times of over 12
hours per day, while the Theramon sensor did not confirm
change between T0 and T1. Taking the case of the parameter these numbers. This is consistent with the literature as Schott
SNA, it depends on how many patients showed an increase and Ludwig reported that children wore removable ap-
in SNA against how many showed a decrease. For example, pliances for 9 hours, while the prescribed time was 12–15
in group I, there were 16 patients who increased SNA against hours (36). In this study, both patients and parents were made
one who decreased, while in group II, there were 14 patients aware of the presence of the sensor, as it would have been dif-
who increased SNA, one who decreased and two showed no ficult to hide. However, they were given the impression that
change. Consequently, group I reached significance, while its function was to record fluctuations in pressure and not
group II did not. In both groups, dental changes were com- hours of wear.
parable to the tooth-borne FM/RME study by Westwood et Even though only a small percentage of the groups wore
al. (28). In Westwood’s study, the overjet improved by 4.8 their FMs for 10 hours or more, significant, positive sa-
mm, compared to our findings of 5.40 mm and 4.50 mm for gittal changes took place, leading to the correction of the
groups I and II, respectively. It is worth mentioning that upper Class III malocclusion (37). This is in agreement with other
incisor inclination in both groups increased; however, this re- studies (33,34) and suggests that even though patients did
sponse varied as depicted in the 95 per cent CIs and did not not wear the FM as instructed, the desired orthopaedic and
10 European Journal of Orthodontics, 2023

orthodontic movements were still accomplished. The impli- parison of three age groups. American Journal of Orthodontics
cation is that treatment efficacy can be achieved with less and Dentofacial Orthopedics, 113, 204–212. doi:10.1016/s0889-
wear time, reducing the burden of compliance both to pa- 5406(98)70141-6.
tients and the supervising parents. The results of this study 7. Liou, E.J.W. and Tsai, W.C. (2005) A new protocol for maxillary
protraction in cleft patients: repetitive weekly protocol of alter-
indicate that FM wear can be reduced to 5–7 hours daily or
nate rapid maxillary expansions and constrictions. Cleft Palate-
limited during night-time while still achieving considerable Craniofacial Journal., 42, 121–127.
changes. 8. Liou, E.J.-W. (2005) Effective maxillary orthopaedic protraction
for growing Class III patients: a clinical application simulates dis-
Conclusions traction osteogenesis. Progress in Orthodontics, 6, 154–171.
9. Isci, D., Turk, T. and Elekdag-Turk, S. (2010) Activation-
• The hybrid HYRAX FM/Alt-RAMEC and tooth-borne deactivation rapid palatal expansion and reverse headgear in

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FM/Alt-RAMEC are equally effective orthopaedic treat- Class III cases. European Journal of Orthodontics, 32, 706–715.
ment modalities in growing Class III patients. doi:10.1093/ejo/cjq006.
• FM use of 5–10 hours daily or only during night-time 10. Masucci, C., Franchi, L., Franceschi, D., Pierleoni, F. and Giuntini,
V. (2021) Post-pubertal effects of the Alt-RAMEC/FM and RME/
can still achieve substantial and positive sagittal maxil-
FM protocols for the early treatment of Class III malocclusion: a
lary. retrospective controlled study. European Journal of Orthodontics,
44, 303–310. doi:10.1093/ejo/cjab057.
11. Masucci, C., Franchi, L., Giuntini, V. and Defraia, E. (2014) Short-
term effects of a modified Alt-RAMEC protocol for early treatment
Registration of Class III malocclusion: a controlled study. Orthodontics and
Craniofacial Research, 17, 259–269. doi:10.1111/ocr.12051.
The study was registered as a Randomized Clinical Trial
12. Papadopoulou, A.K., Koletsi, D., Masucci, C., Giuntini, V., Franchi,
(RCT), https://doi.org/10.1186/ISRCTN12197405). L. and Darendeliler, M.A. (2022) A retrospective long-term com-
parison of early RME-facemask versus late Hybrid-Hyrax, alt-
RAMEC and miniscrew-supported intraoral elastics in growing
Funding Class III patients. Int Orthod., 20, 100603. doi:10.1016/j.
This project is fully funded by University of Malta grant num- ortho.2021.100603.
ber: CDORP02. 13. Wu, Z., Zhang, X., Li, Z., Liu, Y., Jin, H., Chen, Q. and Guo, J.
(2020 Feb) A Bayesian network meta‐analysis of orthopaedic treat-
ment in Class III malocclusion: maxillary protraction with skeletal
Conflicts of interest anchorage or a rapid maxillary expander. Orthodontics & Cranio-
facial Research., 23, 1–15. doi:10.1111/ocr.12339.
The authors declare that there is no conflict of interest.
14. Almuzian, M., McConnell, E., Darendeliler, M.A., Alharbi, F. and
Mohammed, H. (2018) The effectiveness of alternating rapid max-
illary expansion and constriction combined with maxillary pro-
Data availability
traction in the treatment of patients with a class III malocclusion: a
The data underlying this article cannot be shared publicly systematic review and meta-analysis. Journal of Orthodontics, 45,
due to ethical approval restrictions that govern the privacy 250–259. doi:10.1080/14653125.2018.1518187.
of individuals’ data that participated in the study. The data 15. Schäfer, K., Ludwig, B., Meyer-Gutknecht, H. and Schott, T.C.
will be shared on reasonable request with the corresponding (2015) Quantifying patient adherence during active orthodontic
author. treatment with removable appliances using microelectronic wear-
time documentation. European Journal of Orthodontics, 37, 73–
80. doi:10.1093/ejo/cju012.
16. Yepes, E., Quintero, P., Rueda, Z.V. and Pedroza, A. (2014) Op-
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