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REVIEW ARTICLE

G. Cordasco Efficacy of orthopedic treatment


G. Matarese
L. Rustico with protraction facemask on
S. Fastuca skeletal Class III malocclusion: a
A. Caprioglio
S. J. Lindauer
systematic review and meta-analysis
R. Nucera

Authors' afliations: Cordasco G., Matarese G., Rustico L., Fastuca S., Caprioglio A.,
G. Cordasco, G. Matarese, L. Rustico, S. Lindauer S. J., Nucera R. Efficacy of orthopedic treatment with
Fastuca, R. Nucera, Department of
Scienze Sperimentali Medico Chirurgiche
protraction facemask on skeletal Class III malocclusion: a systematic
ed Odontostomatologiche, Section of review and meta-analysis
Orthodontics, School of Dentistry, Orthod Craniofac Res 2014; 17: 133143. 2014 John Wiley & Sons A/S.
University of Messina, Messina, Italy
Published by John Wiley & Sons Ltd
A. Caprioglio, Department of Orthodon-
tics, School of Dentistry, University of
Insubria, Varese, Italy Abstract
S. J. Lindauer, Department of The objective of this systematic review was to estimate the efficacy of protrac-
Orthodontics, School of Dentistry, Virginia
tion facemask on the correction of Class III malocclusion in the short term. A
Commonwealth University, Richmond,
VA, USA systematic review of articles was performed using different electronic data-
bases (PubMed, Ovid, Cochrane Central Register of Controlled Trials, Web of
Correspondence to: Science, LILACS, and Google Scholar). Search terms comprised orthopedic
R. Nucera
Department of Scienze Sperimentali Med-
treatment and Class III malocclusion. The selection criteria were set in order
ico Chirurgiche ed Odontostomatologiche to include in this review only randomized clinical trials (RCTs) performed treat-
Section of Orthodontics ing with facemask Class III growing patients. Studies selection, data extrac-
School of Dentistry
tion, and risk of biass assessment were executed independently by two
University of Messina
AOU Policlinico G. Martino authors using pre-defined data forms. All pooled analyses of data were based
UOC di Odontoiatria e Odontostomatologia on random effects models. A pre-specified subgroup analysis was planned
Via Consolare Valeria to evaluate the effect of preliminary rapid palatal expansion on facemask effi-
1 98100 Messina
cacy. Three RCTs met our inclusion criteria. In total, data from 155 patients
Italy
E-mail: riccardo.nucera@gmail.com (92 treated and 63 controls) were collected. The treated group showed the
following significant changes: ANB +3.66 [95%CI (2.58, 4.74)]; SNA +2.10
[95%CI (1.14, 3.06)]; SNB 1.54 [95%CI ( 2.13, 0.95)]; SN-palatal plane
0.82 [95%CI ( 1.62, 0.02)]; and SN-mandibular plane +1.51 [95%CI
(0.61, 2.41)]. Heterogeneity varied from low to moderate (mean I2 value:
41.4  20.8). Facemask is effective correcting Class III malocclusion in the
short term. The skeletal modifications induced by facemask are forward dis-
Date:
placement of maxilla, backward displacement of mandible, clockwise rotation
Accepted 15 March 2014 of the mandibular plane, and counterclockwise rotation of the maxillary plane.
DOI: 10.1111/ocr.12040

2014 John Wiley & Sons A/S.


Key words: human study; malocclusion; meta-analysis; protraction face-
Published by John Wiley & Sons Ltd mask; review article
Cordasco et al. Efficacy of protraction facemask

Introduction (14). To date, a meta-analysis evaluating the


orthopedic effects of facemask including only
Treatment of skeletal Class III malocclusion is RCTs has not been performed.
one of the most challenging orthodontic correc- The aim of this meta-analysis was to evaluate
tions (1). The potentially unfavorable growth the short-term skeletal effects of facemask treat-
pattern of the patients affected by this skeletal ment on growing Class III patients using pub-
discrepancy (2), usually requires effective and lished RCTs in order to achieve the highest
early intervention. Facemask orthopedic therapy quality of evidence on this particular topic
has been proved to be effective treating success- (13, 14).
fully growing Class III patients (3). This treat-
ment alternative seems to affect all the skeletal
components that can contribute to causing a Material and methods
Class III malocclusion (3,4).
Haas suggested the use of facemask in combi- This meta-analysis was performed according the
nation with palatal expansion when a posterior guidelines provided by the PRISMA statement
crossbite is present (5, 6). He reported that rapid (15) and the Cochrane Handbook for Systematic
maxillary expansion (RME) can produce a Reviews of Interventions version 5.1.0 (16).
slightly forward movement of the maxilla (5, 6) A survey of articles published up to November
and supposed that RME could weaken the cir- 2012 about the effects of protraction facemask
cum-maxillary sutural forces, thereby facilitating for treatment of Class III malocclusion was per-
the orthopedic effect of the facemask (5, 6). In formed using several electronic databases: Pub-
1966, Starnbach demonstrated that RME is able Med, Ovid (Ovid Medline and Embase),
to promote the activity of surrounding maxillary Cochrane Central Register of Controlled Trials,
sutures in non-human primates (7). The ortho- Web of Science, LILACS, and Google Scholar. All
dontic literature is not unanimous, however, in electronic searches were performed on Novem-
supporting the use of RME to enhance the face- ber 22, 2012. The search strategy for PubMed
masks orthopedic effects. In 1995, Baik et al. (8) was conducted according to Cochrane Collabo-
found that the use of RME improves, in growing ration guidelines (16) and reported in Table 1. In
subjects, facemask efficacy. More recently, some the other databases, the key words used to iden-
clinical trials found that palatal expansion did tify the eligible studies were orthopedic treat-
not affect the orthopedic facemask correction ment and Class III malocclusion. A more
(9, 10). restrictive search was performed for Google
Randomized controlled trials (RCTs) are origi- Scholar with the following terms: orthopedic
nal investigations providing the highest level of treatment, Class III malocclusion, and ran-
evidence and thus are considered the gold stan- domized controlled trial. Keywords and elec-
dard for evaluating the efficacy of various ortho- tronic search results used for every database are
dontic treatment therapies. given in Table 2. No language restriction was
The skeletal effects of facemask therapy used applied during the research. The review protocol
in combination with and without RME has been of this meta-analysis was not previously
shown by different clinical studies (1, 3, 4, 810), published.
systematic review (11), and meta-analysis (12).
According to the GRADE Working Group (13), Selection of studies
different levels of quality of a body of evidence
exist for meta-analysis according to the level of To be included in our study, each article had to
evidence of the included studies. Only meta- fulfill the following requirements: related human
analysis performed including well-designed clinical trials; had a comparable untreated con-
RCTs can reach the highest level of evidence trol group; had subjects allocated randomly into

134 | Orthod Craniofac Res 2014;17:133143


Cordasco et al. Efficacy of protraction facemask

Table 1. PubMed search history the groups compared; had results evaluated by
cephalometric analysis performed before and
Keywords Results
immediately after treatment; were studies con-
(1) Randomized controlled trial 417 185 ducted on growing patients without any cranio-
(2) Randomized controlled trias 423 383 facial deformity; had treatment conducted
(3) Random allocation 77 152 without orthognathic surgery; had treatment
(4) Double blind 142 901 conducted using protraction facemask; and had
(5) Double blind method 118 144 analyzed treatment effects which were not con-
(6) Single blind 36 215 founded by additional and concomitant proce-
(7) Single blind method 29 595 dures (extractions, fixed appliances, etc.)
(8) #1 OR #2 OR #3 OR #4 OR #5 OR #6 OR #7 53 052 Duplicate reports were excluded. Articles were
(9) Class III malocclusion 2806 not selected if they did not meet the inclusion
(10) Malocclusion, angle class III/therapy 1742 criteria, if they did not relate to this topic, or if
(11) Orthopedic treatment class III 351 they were related but had a different aim.
(12) #9 OR #10 OR #11 2934 Abstracts, laboratory studies, descriptive studies,
(13) #8 AND #12 52 individual case reports, series of cases, reviews,
(14) #8 AND #12, limit: humans 49 studies of adult patients, controlled clinical tri-
als, retrospective longitudinal studies, and meta-

Table 2. Keywords and search results from various electronic databases

Articles not related


to the topic or related
with different aim;
Retrieved different design
Database Keywords articles Duplicates than RCT Selected

PubMed Search history as described 49 17 28 4


by Table 1
Cochrane Central (1) Orthopedic treatment; 14 12 1 1
Register of Controlled (2) Class III malocclusion;#1 AND #2
Trials
Ovid (1) Orthopedic treatment; 95 32 63 0
(2) Class III malocclusion; #1 AND #2
Web of Science (1) Orthopedic treatment; 172 6 165 1
(2) Class III malocclusion; #1 AND #2
Google Scholar (1) Orthopedic treatment; 535 14 520 1
(2) Class III malocclusion;
(3) Randomized Controlled
Trial; #1 AND #2 AND #3
LILACS (1) Orthopedic treatment; 23 1 22 0
(2) Class III malocclusion; #1 AND #2
Hand search Bibliographies of RCTs, RCTs 1 0 1 0
known to the authors before
this study, and RCTs
encountered during searches
for other projects
Total 889 82 800 7

Orthod Craniofac Res 2014;17:133143 | 135


Cordasco et al. Efficacy of protraction facemask

analyses were also excluded. Articles reporting risk of bias assessment was resolved after con-
interim outcomes or updates were considered sulting the third author (G.C.). The level of
only once. RCTs including patients who had agreement between the two investigators was
received previous or concomitant treatment for assessed with the Cohen kappa statistic. The fol-
their Class III malocclusion were excluded. Two lowing qualitative criteria of each article were
review authors (L.R. and S.F.) screened all titles examined: sequence generation; allocation con-
and abstracts achieved from the database cealment; blinding of participants, personnel,
searches. The same authors reviewed the full and outcome assessors; incomplete outcome
texts of the potentially relevant articles and data; selective outcome reporting; and other
abstracts. The eligibility of the trials was sources of bias. The risk of bias for each domain
assessed independently, and any disagreement was judged as low risk, high risk, or unclear risk.
was resolved after consulting a third author Each randomized controlled trial was assigned
(R.N.). The level of agreement between the two an overall risk of bias in terms of low risk (low
reviewers was assessed with the Cohen kappa for all evaluated domains), high risk (high for
statistic. one or more domains), and unclear risk (unclear
for one or more domains).
Data extraction and management
Quantitative data synthesis
Two authors (L.R. and S.F.) independently
extracted study characteristics (appliances fea- Data were analyzed by means of Review Man-
tures, sample size, age, sex, setting, time of treat- ager computer program (version 5.2). For all the
ment and observation, time of daily appliance evaluated cephalometric parameters, difference
wear, presence of follow-up) and outcomes from in means and standard deviations of the contin-
the selected studies using pre-defined data uous outcomes were used to summarize and
extraction forms. Any disagreements were combine data using the random effect model. A
resolved by discussion with a third author (R.N.). pre-specified subgroup analysis was planned
The Cohen kappa statistic was used to score the with the aim to evaluate the capabilities of RME
agreement between the two review authors. The promoting facemask effectiveness. It was per-
following angular cephalometric parameters formed for particular outcomes (SNA, SNB,
were collected as outcomes: SNA, SNB, ANB, ANB), comparing the data of two subgroups
SN-palatal plane, and SN-mandibular plane. treated with and without preliminary RME. A
sensitivity analysis that excluded the studies
Assessment of risk of bias with the higher risk of bias was performed in
order to examine the influence of the study
A qualitative evaluation for assessment of risk of quality assessment on the overall estimates of
bias of the selected articles was performed using effect.
the Cochrane Collaborations tool for assessing
risk of bias by means of the specific software Assessment of heterogeneity
Review Manager [computer program] (version
5.2, Copenhagen, Denmark: Nordic Cochrane Clinical heterogeneity among studies was evalu-
Centre, Cochrane Collaboration; 2012). A sum- ated by examining the types of participants and
mary assessment of the risk of bias within and the interventions for the outcome in each
across the evaluated RCTs was performed included study. For all the performed analysis,
according to Cochrane Collaboration guidelines heterogeneity was assessed by means of the I2
(16). The qualitative assessment of risk of bias index, which is an indicator of true heterogene-
was undertaken autonomously and in duplicate ity in percentages. A value of 0% indicates no
by using separate printed forms by two review- observed heterogeneity, and larger values show
ers (G.M. and A.C.). Any disagreement on the increasing heterogeneity with 25% indicating

136 | Orthod Craniofac Res 2014;17:133143


Cordasco et al. Efficacy of protraction facemask

low, 50% moderate, and 75% high heterogeneity characteristics of the selected RCTs. Clinical sex
(17). heterogeneity was good for two RCTs (9, 18) and
poor for one RCT that evaluated only female
subjects (3). Weak heterogeneity was found in
Results time of daily appliance wear that was around
1014 h/day for all evaluated RCTs. Weak heter-
Electronic searches identified the following items: ogeneity was also found for treatment and
49 articles were retrieved from PubMed, 14 from observation time ranging from 12 to 15 months.
Cochrane Central Register of Controlled Trials, 95 No article reported long-term results.
from Ovid, 23 from LILACS, 172 from Web of Sci- Evaluating the selected RCTs relatively to the
ence, and 535 from Google Scholar. Duplicates performed subgroup analysis, it was found that
articles, studies that did not relate to our topic or Kilicoglu and Kirlic (3) evaluated a standalone
related with a different aim, and those that were facemask protocol, Mandall et al. (18) evaluated
not RCTs were excluded (Table 2). the RME + facemask protocol, and Vaughn et al.
Of the remaining potentially appropriate RCTs, (9) assessed and compared both of the protocols
seven were identified as eligible RCTs to be previously mentioned. Vaughn et al. (9) reported
included in this analysis (3, 9, 1822). Four of mean values for each of the groups included in
the seven selected RCTs were withdrawn accord- the RCT (i.e., facemask; RME+facemask, control).
ing to the exclusion criteria reported in Table 3. Because of these characteristics, the RCT of Vau-
Three articles met all eligibility criteria and were ghn et al. (9) was included in the meta-analysis
selected for the final analysis. Figure 1 illustrates as if it were two different substudies (RME+face-
the flow diagram of the selection of the studies mask and standalone facemask). Its control
process according to the PRISMA guidelines group was divided into two control subgroups
(16). (nine and eight subjects) presenting the same
mean outcome. The subgroup of nine patients
Study characteristics was associated with the RME + facemask treat-
ment substudy; the subgroup of eight patients
All of the selected RCTs evaluated orthopedic was associated with the facemask standalone
facemask treatment in growing children in the treatment substudy. Using this method, the con-
mixed dentition with Class III malocclusion. In trol subjects of the study of Vaughn et al. (9)
total, data from 155 patients (92 treated and 63 were not included two times in the meta-analy-
controls) were collected. The samples were het- sis. Moreover, Vaughn et al. (9) reported the
erogeneous for the numbers and the ages of par- mean standard error (SE) of its coupled sub-
ticipants. Table 4 describes the study group; consequently, the SE values for each

Table 3. Studies excluded from the data analysis and reasons of exclusion

Study Authors Reason of exclusion

Chin cup effects using two different force Abdelnaby & Nassar (19) Different appliance from the facemask
magnitudes in the management of Class III malocclusions
Maxillary rotation following early orthopedic Shargill (20) Identified like a multiple report from the
treatment of Class III malocclusion study of Mandall et al. (34)
nkels function regulator on the
The effects of the Fra Ulgen & Firatli (21) Different appliance from the facemask
Class III malocclusion.
Short-term soft- and hard-tissue changes following Saleh M et al. (22) Different appliance from the facemask
Class III treatment using a removable mandibular
retractor: a randomized controlled trial

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Cordasco et al. Efficacy of protraction facemask

a good homogeneity relative to the angular


parameters that were used to evaluate the sagittal
and vertical skeletal effects of facemask (ANB,
SNA, SNB, SN-palatal plane, and SN-mandibular
plane). To test how robust the results of this
meta-analysis were, a sensitivity analysis was per-
formed. A new meta-analysis was performed rela-
tive to the ANB parameter without the study
presenting the highest risk of bias (3), with a sub-
stantially similar outcome of 3.16 (Fig. 7).

Discussion

To the best of our knowledge, this is the first


meta-analysis that investigated the current liter-
ature with best evidence (RCTs) about the effi-
cacy of protraction facemask treatment for Class
III malocclusion.
Evidence is lacking about this topic because of
Fig. 1. Flow chart of the selection of the studies (performed the difficulties related to conducting RCTs (23).
according to the PRISMA guidelines).
Despite an accurate and wide bibliographic
group were calculated with systems of equations search strategy, we found only three eligible tri-
and then converted to standard deviation values. als (3, 9, 18). The results obtained from this
The other two selected RCTs (3, 18) reported meta-analysis showed that protraction facemask
mean values and standard deviations of the is an effective orthopedic approach to correct
treatment and control groups, so it was possible Class III malocclusion in the short term.
to insert their data in the comprehensive data Relative to the vertical modifications induced
analysis without any conversion. by the facemask; results showed that palatal
The results of risk of bias evaluation of the plane angulation changes significantly during
selected studies are shown in Table 5. Of three treatment, averaging 0.82 (p = 0.04; Z = 2.01).
RCTs, two studies were assessed with a low risk Biomechanical studies on dry human skulls have
of bias (9, 18), and one study was assessed with demonstrated that the direction of the force is a
an uncertain risk of bias (3). Considering that critical factor in controlling rotation of the upper
most information of this meta-analysis raised jaw during facemask therapy (24, 25). A force
from studies at low risk of bias (9, 18), the sum- generated parallel to the maxilla produces coun-
mary assessments of risk of bias across the stud- terclockwise rotation of the palatal plane (24,
ies were considered as low. 25). Both of the RCTs used in this meta-analysis
The agreement between the reviewers for for the calculation of this finding (3, 9) applied
study selection, data extraction, and risk of bias the elastics with a downward inclination of 15
assessment was good, with kappa scores of 30, and it is possible that this characteristic of
0.875, 0.942, and 0.852, respectively. the orthopedic force partially counteracted the
rotation of the palatal plane reported in the liter-
Quantitative data synthesis ature (24, 25). The mandibular plane showed sig-
nificant clockwise rotation with a standard mean
The results of the meta-analysis including the difference of 1.51 (p < 0.01; Z = 3.28). The rota-
subgroup analysis are shown in the forest plots tion of the mandibular plane is assumedly
reported as Figs 26. The selected RCTs showed responsible for at least part of the SNB observed

138 | Orthod Craniofac Res 2014;17:133143


Table 4. Study characteristics of the selected RCTs

Treatment and Time of daily


Selected Appliances Sample Age observation appliance Methods of
References features size (years)  SD Sex Setting time wear measurement Follow-Up

Mandall Facemask + Treated = 33 8.7  0.9 Female = 38 Eight UK 15 months Minimum of SNA, SNB, ANB, No
et al. (18) RME Controls = 36 9.0  0.8 Male = 32 hospital 14 h/day SN/Maxillary
plane
Vaughn Facemask and Facemask = 22 8.1  1.9 Female = 29 Seattle, 12 months Full time at the SNA, SNB, ANB, No
et al. (9) Facemask + FM + RME = 21 7.3  1.9 Male = 31 Wash, beginning of SN/Palatal plane,
RME Controls = 17 6.6  1.9 Phoenix, treatment, SN/Go-Gn
Ariz, and then 14 h/day
Los Angeles,
Calif
Klc  lu &
og Facemask Treated = 16 8.6  1.4 Female = 26 Istanbul 12 months Minimum of SNA, SNB, ANB, No
Kirlic
(3) Controls = 10 9.2  1.4 Male = 0 University, 1012 h/day SN/Go-Me
Turkey

RME, rapid maxillary expansion; FM, facemask.

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| 139
Cordasco et al. Efficacy of protraction facemask

Table 5. Summary assessment of risk of bias performed according the guidelines provided by the Cochrane Handbook for
Systematic Reviews of Interventions (16)

Type of Bias

Blinding of Selective Other


Sequence Allocation outcome Incomplete outcome sources of Overall risk
Articles generation concealment assessors outcome data reporting bias of bias

Mandall et al. (33) Low risk Low risk Low risk Low risk Low risk Low risk Low risk
Vaughn et al. (26) Low risk Low risk Low risk Low risk Low risk Low risk Low risk
Klc  lu & Kirlic
og (14) Unclear Unclear Unclear Unclear Low risk Low risk Unclear

Fig. 2. Forest plot representing the effect of facemask on the ANB angle. A subgroup analysis was performed. Two subsamples
were created and compared according the used protocol: facemask standalone or facemask + patal expansion.

Fig. 3. Forest plot representing the effect of facemask on the SNA angle. A subgroup analysis was performed. Two subsamples
were created and compared according the used protocol: facemask standalone or facemask + patal expansion.

140 | Orthod Craniofac Res 2014;17:133143


Cordasco et al. Efficacy of protraction facemask

Fig. 4. Forest plot representing the effect of facemask on the SNB angle. A subgroup analysis was performed. Two subsamples
were created and compared according the used protocol: facemask standalone or facemask + patal expansion.

Fig. 5. Forest plot representing the effect of facemask on the SN-mandibular plane angle.

Fig. 6. Forest plot representing the effect of facemask on the SN-palatal plane angle.

variation. From this perspective, the 1.54 of SNB ular change could be partly due to mandibular
reduction could be the result of two different rotation, it appears that facemask treatment
phenomena: anterior mandibular growth inhibi- induces a prevalent orthopedic effect on the
tion and/or clockwise mandibular plane rotation. maxilla rather than on the mandible.
There is some evidence in the literature that The limitations of this review article are
when the mandibular plane rotates upward, in related to the small number of RCT (three) that
non-growing patients, an increase in the SNB was possible to include in the meta-analysis.
angle occurs (26). As this meta-analysis found The small number of included trails affects the
relatively larger effects of facemask treatment on I2 index, underestimating the extent of between-
the maxilla (SNA: +2.10) than the mandible study heterogeneity (17). It is important to con-
(SNB: 1.54), and considering that the mandib- sider this assumption to properly consider the

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Cordasco et al. Efficacy of protraction facemask

Fig. 7. Sensitivity analysis: forest plot representing the effect of protraction facemask on the ANB angle. The RCT presenting the
highest risk of bias (3) was excluded.

reported heterogeneity among studies. The I2 Conclusions


values described a total variation across the
studies varying from low to moderate (mean Facemask therapy in growing subjects with Class
value and standard deviation: 41.4  20.8). This III malocclusion is effective in the short term.
variation was presumably due to clinical hetero- The skeletal modifications induced by facemask
geneity rather than chance. Although the sub- are forward displacement of the maxilla, back-
jects included in the treatment and control ward displacement of the mandible, clockwise
samples of selected RCTs were of similar age rotation of the mandibular plane, and counter-
and had a similar observation period of time clockwise rotation of the maxillary plane. When
and a comparable amount of daily time appli- used with the intent to enhance anterior maxillary
ance wear (Table 4), they differed in some clini- movement during facemask therapy, preliminary
cal characteristics. More specifically, in the rapid palatal expansion does not seem to affect the
overall sample, more females than males were effectiveness of the orthopedic treatment. The
included; in particular, one study was performed results of this study refer only to the modifications
only on female subjects (3). It is known that induced by the facemask in the short term, and
female subjects undergo skeletal maturation ear- further studies are necessary to elucidate the
lier than males (27). Considering that there is effects of the facemask in the long term.
evidence to support that skeletal maturation
affects the response to facemask protraction
(28), the sex characteristics of the sample could Clinical relevance
have potentially affected clinical heterogeneity.
Of the 92 subjects included in the final treat- Protraction facemask therapy in growing Class
ment sample, 55 subjects underwent RME III patients is effective in the short term. The
before facemask therapy and 37 subjects did skeletal modifications induced by facemask are
not. The subgroup analysis revealed on average forward dislocation of the maxilla, backward
a stronger orthopedic effect in the subgroup movement of the mandible, clockwise rotation
that did not perform preliminary RME, of the mandibular plane, and counterclockwise
although no significant difference was found rotation of the maxillary plane. Taking account
between the two groups. This finding supports of the protraction facemasks effects, it should
the concept that RME is not required if per- ideally be used in Class III cases with counter-
formed primarily with the aim of improving clockwise rotation of mandibular plane. Preli-
protraction of the maxilla during facemask minary rapid palatal expansion does not seem to
therapy. improve the effectiveness of facemask.

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