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2017 Laleman - Guided Implant Surgery in The Edentulous Maxilla - A Systematic Review

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Guided Implant Surgery in the Edentulous Maxilla:

A Systematic Review
Isabelle Laleman, DDS, MSc1/Lauren Bernard, DDS, MSc1/
Marjolein Vercruyssen, DDS, MSc, PhD1/Reinhilde Jacobs, MSc, PhD, Dr hc2/
Michael M. Bornstein, Prof Dr Med Dent2,3/Marc Quirynen, DDS, MSc, PhD1

Purpose: This systematic review verified the usefulness/limitations of static surgical guides during implant
surgery in the edentulous maxilla. The PICO question was: “Does the use of digitally generated surgical guides
vs conventional techniques affect the following outcomes: surgical complications, implant complications,
prosthesis complications, implant survival, prosthesis survival, economics, patient satisfaction, and
maintenance intervention?” Materials and Methods: The electronic searches retrieved 2,588 unique
articles from which eventually 36 full-text articles were read for eligibility. Because no randomized controlled
clinical trials could be found, the PICO question had to be reformulated, now only looking to the outcome
of digitally generated surgical guides without comparison with conventional techniques. Results: Although
long-term data are lacking, the outcome of implants placed with a static guide and of the prosthetic
reconstruction seems similar to that expected from conventional techniques. The number of surgical
complications with guided surgery is negligible. Guided flapless implant surgery offers slightly more comfort
for the patient; however, the economic benefits are unclear. Conclusion: Implant therapy via static surgical
guides in the maxilla is predictable, with slightly more comfort for the patient but with only minor economic
advantages. Int J Oral Maxillofac Implants 2016;31(suppl):s103–s117. doi: 10.11607/jomi.16suppl.g3

Keywords: edentulous maxilla, guided surgery, computer planning, dental implant

T he rehabilitation of partially and fully edentulous


patients by means of implant-supported prostheses
is considered highly predictable and very successful.1,2
Different methods are currently available to transfer
the “planned” information to the “clinical” situation. To
transfer the preoperative plan to the patient’s mouth,
In recent years, because of improved three-dimensional static surgical guides are currently most often applied,
(3D)–imaging techniques, new treatment planning more than dynamic methods.
software, and advances in computer-aided design/ Significant variations exist in the selection of static
computer-assisted manufacture techniques, comput- surgical guides. Most surgeons choose a flapless (mucosa-
er-guided surgery has become possible. 3 Therefore supported) approach with a small crestal incision or a
implant positions can be virtually planned with the aid punch before placement of the guide. The osteotomy
of cone-beam computed tomography (CBCT) images. preparation is then performed with minimal exposure
of the bone. In case of a bone-supported guide, a full-
thickness flap is reflected to position the guide directly
onto the jawbone. Some guiding systems use different
1Department
guides for one patient with sleeves with increasing di-
of Oral Health Sciences, Katholieke Universiteit
Leuven, University Hospitals & Dentistry Leuven, ameter, whereas others apply one single guide but with
Periodontology, Belgium. different sleeve inserts. Some systems offer special drills
2Department of Oral Imaging, Katholieke Universiteit Leuven,
or drill stops to allow depth control, whereas others only
University Hospitals & Dentistry Leuven, Belgium. have depth indication on the drills. Some guides have to
3Section of Dental Radiology and Stomatology, Department
be removed at the moment of implant insertion, whereas
of Oral Surgery and Stomatology, School of Dental Medicine,
University of Bern, Bern, Switzerland. others support guided placement of the implant (fully
guided implant placement).
Correspondence to: Dr Marc Quirynen, UZ St Raphael, The introduction of guided surgery in implant dentistry
Department of Periodontology, Kapucijnenvoer 33, B-3000 facilitated an optimal 3D implant planning/placement
Leuven, Belgium. Email: Marc.quirynen@med.kuleuven.be.
with respect to both anatomic and prosthetic param-
©2016 by Quintessence Publishing Co Inc. eters. Taking critical anatomic structures (such as nerves,

The International Journal of Oral & Maxillofacial Implants s103

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Group 3

arteries, sinuses) into account, implants also can be placed The search strategy and terms were adapted according
in an optimal prosthetic-driven position sometimes to the searched database.
avoiding bone augmentation or sinus lift procedures.
The final implant placement can be so accurate that it Eligibility Criteria
is possible to schedule an immediate loading protocol The following criteria were used for inclusion: studies in
with a “prefabricated prosthesis.” English and conducted in humans, trials with at least 10
A recent systematic review showed an acceptable participants with guided implant placement, the use of a
level of accuracy of implants placed with static computer- digitally generated static surgical guide, and availability
assisted implant surgery. Mean overall global inaccuracies of at least one of the following parameters:
of 1.1 mm at the entry point and 1.4 mm at the apex
were measured when the outcome of more than 1,400 • implant survival
implants was considered.4 The average angular devia- • prosthesis survival
tion was 3.9 degrees. It was also shown that implants • surgical complications
placed with a guide had a good survival rate.3–6 However, • implant complications
information on surgical peri-operative complications, • prosthesis complications
subsequent implant and prosthetic complications, eco- • economics
nomics, and patient satisfaction is scarce. Moreover, none • patient satisfaction
of the available systematic reviews made a distinction • maintenance intervention
between dentate and edentulous patients, nor between
the lower and upper jaws. For implant and prosthesis survival data, follow-up
Therefore, the aim of this review was to systematically of at least 12 months after implant placement had to be
review the current literature regarding the periopera- presented. A specific follow-up period was not defined
tive complications and the implant- and patient-related for the other parameters. The review was specifically
outcomes of digitally generated static surgical guides directed to the maxilla. Studies in which it was impos-
for implant placement in the edentulous upper jaw. sible to separate data between maxillae and mandibles
were handled separately. Studies with a mix of partially
and fully edentulous maxillae were excluded.
MATERIALS AND METHODS
Exclusion Criteria
This systematic review was conducted in accordance with Studies that did not describe one of the stated outcome
the guidelines of Transparent Reporting of Systematic variables were excluded. In addition articles report-
Reviews and Meta-Analyses (PRISMA).7 ing on zygoma/pterygoid implants, mini-implants for
orthodontic anchorage, and those restricted to radio-
PICO Question graphic evaluation of accuracy of implant positioning
The PICO (population, intervention, comparison, out- were excluded.
come) was: “For patients with an ‘edentulous maxilla’
who desire implant-supported prostheses, does the use Data Extraction
of digitally generated surgical guides vs conventional Two reviewers (L.B., I.L.) independently screened the
techniques affect the following outcomes: surgical com- titles, and subsequently, the abstracts of all articles
plications, implant complications, prosthesis complica- found. When there was disagreement or when an abstract
tions, implant survival, prosthesis survival, economics, contained insufficient information, the full text of the
patient satisfaction, and maintenance intervention?” article was reviewed. The final inclusion of studies was
made by discussion. Thereafter, both reviewers extracted
Search Strategy the data separately from the selected articles. The data
A computerized literature search of PubMed Medline, were collected for the studies reporting only guided
Embase, and the Cochrane databases was conducted to implant placement in the upper jaw as well as for those
identify studies concerning guided implant placement in treating both the upper and lower jaw and when it was
the maxilla regardless of their publication status. These not clear which jaw was treated. This information was
searches were restricted till January 2014. Additional hand transferred to a data extraction sheet. The following
searches were performed and included: (1) bibliographies characteristics were abstracted from each study: study
of previous reviews on the subject,3–6 and (2) bibliog- design, follow-up period, number of patients with guided
raphies of all publications cited in the selected full-text surgery, sex, mean age, number of smokers, case type,
articles. The search terms used were: (guided surgery the implant software and guide system used, implant
OR computer-aided surgery) AND (dental implant* OR system, number of implants, bone- or mucosa-supported
oral implant* OR tooth implantation OR implantology). guide, flapless or open flap approach, and immediate

s104 Volume 31, Supplement, 2016

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Laleman et al

Pubmed: Embase: Cocrane database:


2,509 articles 337 articles 0 articles

2,588 records after


removing duplicates

74 abstracts assessed for


eligibility

36 full-text articles
assessed for eligibility Removed:
3 studies did not describe
parameters of interest
3 studies just described the
technique or one case
2 studies dealt with dynamic
guided implant placement
9 studies included also
partially edentulous patients

from 12 studies describing


mixed results from edentulous
jaws information was noted for
comparison

7 studies included for descriptive analysis

Fig 1   Flow chart of the search process.

or delayed loading. When early complications (defined an edentulous maxilla who desire implant-supported
as < 2 weeks after implant surgery) were reported, the prostheses, what are the surgical complications, implant
number of surgical and prosthetic events and the reasons complications, prosthesis complications, implant survival,
were noted in a table. The studies reporting implant and prosthesis survival, economics, patient satisfaction, and
prosthesis survival (with a follow-up ≥ 12 months) were maintenance interventions when a digitally generated
summarized in a table, together with the data on mean surgical guide is used during implant placement?”
bone loss. Finally, for studies reporting patient-centered From the full-text articles read, three studies described
outcomes, the methods and outcome were noted. only the technique or only one case.8–10 Two studies
dealt with dynamic guided implant placement.11,12 Three
studies did not describe the parameters of interest.13–15
RESULTS Nine studies included partially edentulous patients.16–24
This resulted in the final inclusion of seven publications
Search and Selection that met all criteria,25–31 and another 12 studies that de-
The electronic searches through the Medline, Cochrane, scribed results for both the upper and lower jaw without
and ISI Web of Knowledge databases retrieved 2,588 specifying where the implants were placed32–43; from
unique articles (Fig 1). Of these, 2,514 were deleted after these studies, information was gathered to compare
a first selection, and 74 abstracts were screened. Full with the seven articles included.
texts of 36 articles were read for eligibility. Using hand
searches, no additional articles were found. Study Demographics
No randomized controlled trials (RCTs) could be Table 1 summarizes the study, patient, guide, and im-
found that met the inclusion criteria and answered plant characteristics, as well as the techniques used.
the PICO question; therefore, the authors reformulated Of the seven studies included, only one was an RCT
their focused question as follows: “For patients with comparing flapless and flapped guided implant surgery.

The International Journal of Oral & Maxillofacial Implants s105

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Group 3

Table 1  Demographics of Selected Studies*


Study
Characteristics Patient Characteristics
No. of Patients No. of Treated
Study Follow-up With Guided Lower/Upper Mean age No. of
Study Design Period (mo) Surgery Jaws Sex (F/M) (range) (y) Smokers
Gillot et al PO 12-51 33 0/33 21/12 61 (46–80) 0
(2010)*25
Johansson et al PO 12 52 0/52 21/31 72 (37–85) 7
(2009)*26
Lindeboom and RCT 1 8 0/8 6/2 55 0
van Wijk (2010)*27
8 0/8 7/1 59 0
Meloni et al RO 18 15 0/15 10/5 52 (40–70) 5
(2010)*28
Merli et al PO NR 13 0/13 9/4 62 (44–80) 6
(2008)*29
Sanna et al PO 60 30 0/30 12/18 56 (38–74) 13
(2007)*30
van Steenberghe PO 12 27 0/27 NR 63 (34–89) 5
et al (2005)*31
Total/range – 1–60 186 0/186 – 34–89 36
Arisan et al PC 2–4 21 24/30 27/25 49 (28–63) NR
(2010)‡32
16

15

Balshi et al PO 3–36 23 NR NR NR NR
(2008)‡33
Di Giacomo et al PO 30 12 NR 8/4 60 (41–71) 0
(2012)‡34
Komiyama et al PO 44 29 10/21 9/20 72 5
(2008)‡36
Komiyama et al PO 19 34 13/21 NR 72 (44–92) 3
(2012)‡35
Lal et al (2013)‡37 RO 24–48 36 23/19 26/10 53 (35–71) 6

Malo et al PO 12 23 5/18 NR NR NR
(2007)‡38
Marra et al PO 36 30 30/30 18/12 NR NR
(2013)‡39

Meloni et al PO 24 12 1/11 8/4 57 (40–68) NR


(2013)‡40
Pomares et al RO 12 30 17/25 24/6 53 (35–84) 3
(2010)‡41
Pozzi et al RO 36-60 22 14/12 11/11 68 (50–83) NR
(2013)‡42
Tahmaseb et al PO 12-36 35 15/25 18/17 NR NR
(2012)‡43
Total/range – 2-60 338 152/212 – 35–92 17
*Studies were restricted to full edentulous maxillae.
‡These studies include both maxillae and mandibles (without clear data per jaw) or with unknown jaw allocation.

PO = prospective observational, RCT = randomized controlled trial, RO = retrospective observational, MS = mucosa-supported,


BS = bone-supported, FL = flapless, OF = open flap, I = immediate loading, I† = immediate final prosthesis, D = delayed loading, NR = not reported,
– = not applicable.

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Laleman et al

Patient Characteristics
Continued Guide and Implant Characteristics Techniques
Bone-/ Immediate/
No. of mucosa- Flapless/ Delayed
Implant Software Guide System Implant System Implants Supported Open Flap Loading
Procera NobelGuide Nobel Speedy, Nobel 211 MS FL I†
MkIII, Nobel MkIV
Nobel Guide NobelGuide Bränemark System, 312 MS FL I†
MKIII TiUnite
Procera NobelGuide Nobel Replace 48 MS FL D

48 BS OF D
Procera NobelGuide Nobel Replace Tapered 90 MS FL I
Groovy
Procera NR Nobel Speedy Groovy 89 MS FL I

Procera NR Bränemark System 212 MS FL I†


MKIII TiUnite
NR Oralim, Bränemark System 184 MS FL I
Medicum MKIII TiUnite
– – – 1,194 – – –
– – SPI-Element, Xive 141 – – D

3D StendCad Aytasarim- 101 BS OF D


classic system
Simplant Planner Simplant-SAFE 99 MS FL D
System
NR NobelGuide Bränemark System 168 MS FL I

Implantviewer 1.9 & SLS-Guide E-Fix 62 MS FL I†


Rhino 4.0
Procera NobelGuide Bränemark System 176 MS FL I†
MKIII TiUnite
Procera NobelGuide Bränemark System 191 MS FL I†
MKIII TiUnite
Procera NobelGuide Bränemark System 273 MS FL I/D
MKIII TiUnite
Procera NobelGuide NobelSpeedy 92 MS FL I

Procera NobelGuide Nobel Speedy, 312 MS FL I


Bränemark Standard
MKIII
Procera NobelGuide Nobel Replace Tapered 72 MS FL I
Groovy
Procera NobelGuide NobelSpeedy, 195 MS FL I
Bränemark MKIII
Procera NobelGuide Nobel Speedy, Nobel 170 MS FL I
Active, Nobel Replace
Exeplan NR Straumann standard 240 MS FL I†

– – – 2,292 – – –

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Group 3

Table 2  Early (<2 weeks) Complications During Surgery, of the Implant and/or with Prosthesis

Study Patient Groups No. of Events Reasons


Gillot et al (2010)25 33 MS, FL, I 3 Guide difficult to insert (1) and absence of primary
stability of the implant in type IV bone (2)

Johansson et al (2009)26 52 MS, FL, I 9 Misfit of surgical silicone index (3), misfit surgical guide
(2), and problems with installing implants (4)

Meloni et al (2010)28 15 MS, FL, I 1 Fracture of guide during surgery

Merli et al (2008)29 13 MS, FL, I 3 2 flaps had to be elevated to allow GBR; fracture of
surgical guide (1)
van Steenberghe et al 27 MS, FL, I 1 1 marginal fistula
(2005)31
Total 140 17 –
Arisan et al (2010)‡32 21 - - D 2 Hematoma (2)
16 BS, OF, D 3 Guides fractured during surgery (2); hematoma (1)
15 MS, FL, D NR NR
Balshi et al (2008)‡33 23 MS, FL, I NR NR

Di Giacomo et al (2012)‡34 12 MS, FL, I 11 Pulling of soft tissue (4), insertion of wider implant
than planned to improve implant stability (4), implant
instability in the tuber area (2), prolonged pain because
of proximity to nasopalatine nerve (1)
Komiyama et al (2008)‡36 29 MS, FL, I 6 Surgical templates fractured (3), bone defects led to a
suspected infection (3): in two patients around anchoring
pins in the maxilla and in 1 patient around fixtures in the
mandible
Pomares et al (2010)‡41 30 MS, FL, I 7 Surgical template fractured (3), a small flap had to be
elevated in case of insufficient keratinized mucosa (4)
Tahmaseb et al (2012)‡43 35 MS, FL, I 1 A flap had to be elevated to correct an extensive knife-
edge ridge
Total 181 30 –
‡These studies include both maxillae and mandibles (without clear data per jaw) or with unknown jaw allocation.
MS = mucosa-supported; BS = bone-supported; FL = flapless; OF = open flap; I = immediate loading; D = delayed loading;
GBR = guided bone regeneration; NR = not reported; – = not applicable.

The remaining six were either prospective (n = 5) or applying a delayed loading protocol. In the remaining
retrospective observational (n = 1) studies. studies, an immediate loading protocol was followed.
A total of 186 patients with fully edentulous jaws Three studies even directly placed an immediate “final”
could be included, representing a total of 1,194 implants. prosthesis in 101 cases (of 115 patients).25,26,30 Five
Patients ranged in age from 34 to 89 years. In five studies, studies explicitly mentioned that the patients could eat
smoking was not an exclusion criterion, so 36 smokers only soft foods after the surgery.26–30 The recommended
were included. period ranged from 1 week (in the study with the delayed
Most studies applied the NobelGuide system. All loading protocol) to 2 months.
implants were from the Nobel Biocare Company (Nobel Of the 12 studies that evaluated both the upper and
Speedy, Nobel Bränemark MKIII, Nobel Bränemark MKIV, the lower jaws without clear separation, or when it was
and Nobel Replace). All studies, except one, used a flap- unclear which jaws were treated, all but one were of ob-
less technique and a mucosa-supported guide. One RCT servational nature. Arisan et al32 compared the surgical
compared the flapless and open flap techniques; in the and postoperative outcomes of a standard technique, a
latter cases, a bone-supported guide was used.27 This bone- and a mucosa-supported guide.
study by Lindeboom and van Wijk27 was the only one

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Laleman et al

the 2-week follow-up, a marginal fistula was detected


in one patient.31
No. of For the mixed study group, 28 complications were
Prosthetic Events Reasons
described for 181 interventions. During surgery, frac-
2 Major occlusal adjustment needed (1).
Distal implant could not be connected to
ture of the guide was the most common complication,
the prosthesis (1). followed by problems when installing the implants
13 Not possibly to get prosthesis completely
(impossible to obtain primary stability). Furthermore,
in place (10) and major occlusal in five cases, a flap had to be raised, and four patients
adjustment necessary (3). experienced pulling of the soft tissues. Various prob-
3 Prosthesis did not fit due to fracture of the lems were described during the 2-week postoperative
template during surgery (2) and full acrylic period. One patient experienced hematoma, three
resin complete denture fractured (1). patients had infections, and one complained of pro-
4 4 provisional prostheses did not fit. longed pain. The reason for this was that an implant
was placed in the proximity of the nasopalatine nerve.
NR NR Several studies evaluated the pain sensation after
surgery. Meloni et al28 reported that of 15 patients,
22 – five experienced mild pain and eight experienced
NR NR mild swelling. Johansson and coworkers26 reported
that more than 90% of the patients had no pain
NR NR
during the 2-week postoperative interval, and that
NR NR
in general, only minor surgical-related complaints
2 All-acrylic bridges did not fit passively to (swelling and minimal bleeding) occurred. In the
all abutments (2)
study of van Steenberghe and coworkers,31 4 of 27
1 Midline deviation of prosthesis (1)
patients reported moderate pain. Gillot et al25 con-
cluded that the pain after the guided implant surgery
was minimal, though one patient presented with a
8 Misfit of the abutment-bridge (5), jugal hematoma and a slight genial tumefaction for
extensive adjustment occlusion (3) 3 days.
With regard to the immediate connection of the
prosthesis (n = 113), 22 unexpected events in 4 stud-
3 Bad fit of prosthesis (3) ies25,26,28,29 are described; in almost all cases (n = 17),
it was not possible to get the immediate prosthesis in
1 Occlusal failure position. Other possible problems were the fracturing
of the full acrylic resin complete denture (n = 1) and
15 – the need for major occlusal adjustments (n = 4).
In the mixed study group, 15 complications (129
cases) of the immediate prosthesis placement were
mentioned. In 10 cases, it was not possible to get the
prosthesis into place. Other problems were midline
deviation of the prosthesis (n = 1) and occlusal prob-
Early Complications and Failures lems (n = 4).
Table 2 describes the early surgical and prosthetic
failures. These were defined as events that occurred Implant and Prosthesis Survival
during surgery or during the subsequent 2-week pe- The implant and prosthesis survival data are sum-
riod. Two studies did not report early complications marized in Table 3. Only studies with a follow-up of
or failures.27,30 The total number of surgical com- 12 months or longer were included in this evaluation.
plications at implant placement was 16 (out of 140 Of the seven studies included, four reported implant
interventions). Most were related to problems with survival after 1 year,26,28,30,31 of which three survived
the guide and the surgical index: fracture of the guide for an even longer period (1.5–3 years). Implant sur-
during surgery (n = 2), guide difficult to insert (n = 3), vival was defined as having the implant still in place.
and misfit of the silicone index (n = 3). In six patients, Implant survival 1 year after placement ranged
there were problems when installing the implants from 97.8% to 100%. Mean bone loss around these
(such as absence of primary stability of an implant implants ranged from 0.8 to 1.7 mm. The studies with
in type IV bone), and in two patients, flaps had to be a longer follow-up reported implant survival of 97.8%
elevated to allow guided bone regeneration. During after 18 months28 or 98.1% and 91.5% (98.9% for

The International Journal of Oral & Maxillofacial Implants s109

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Group 3

Table 3  Implant and Prosthesis Survival (Studies Reporting Outcomes ≥ 12 Months)


1-Year Evaluation
Number of Implant Evaluated/
Implants at (cumulative) Mean (SD) Bone Prosthesis Included Patients
Baseline survival rate (%) Loss in mm Survival (%) or Implants
Gillot et al Mx: 211 Mx: 99.1* Mx: NR Mx: NR Mx: 33/33
(2010)25
Johansson et al Mx: 312 Mx: 99.4*† Mx: 1.3 (1.3) Mx: 96.2* Mx: 48/52
(2009)26
Meloni et al Mx: 90 Mx: 97.8† Mx: 1.4 (0.2) Mx: NR Mx: 15/15
(2010)28
Sanna et al Mx: 212 Mx: 100*† Mx: S: 1.1 (1.4) Mx: NR Mx: 28/30
(2007)30 Mx: NS: 0.8 (1.1)
van Steenberghe Mx: 184 Mx: 100† Mx: M: 1.2 (1.1) Mx: NR Mx: 24/27
et al (2005)31 Mx: D: 1.1 (1.0)
Total/range Mx: 1,009 Mx: 97.8–100 Mx: 0.8–1.4 Mx: 96.2 Mx: 148/15–48
Balshi et al 168 97.6* NR 100 I: 68/168
(2008)‡33
Di Giacomo et al 62 NR NR NR NR
(2012)‡34
Komiyama et al 176 91.5† NR NR I: 168/176
(2008) ‡36 Mx: 92.7†
Komiyama et al 191 NR NR NR NR
(2012)‡35
Lal et al (2013)‡37 273 NR NR NR NR
Malo et al (2007) 92 97.8† 1.5 (1.5) NR I: 55/92
‡38 Mx: 97.2† Mx: 2.0 (1.6)
Marra et al 312 NR 1.2 (0.7) NR 30/30
(2013)‡39
Meloni et al 72 NR 1.2 (0.3) NR 12/12
(2013)‡40
Pomares et al 195 98* NR 100*† 30/30
(2010) ‡41 Mx: 98.5*
Pozzi et al 170 NR NR NR NR
(2013)‡42
Tahmaseb et al 240 95.4† NR NR 35/35
(2012) ‡43 Mx: 93.6†
Total/range 1,951 91.5–98 1.2–1.5 100 107/12–35

*Cumulative survival rate.


†Survival rate.
‡These studies include both maxillae and mandibles (without clear data per jaw) or with unknown jaw allocation.

Mx = maxilla only; NR = not reported; NS = nonsmokers; S = smokers; M = mesial, D = distal


I = implants (when only reported on implant level and not on patient level; SD = standard deviation; – = not applicable.

nonsmokers, 81.2% for smokers after 48 months25,30). reported a 96.2% survival rate after 1 year, and
Meloni et al28 reported a marginal bone loss of 1.6 Gillot and coworkers25 100% after 36 months. For
mm after 18 months, and Sanna and coworkers30 the mixed study group, if reported, 100% survival
found a bone loss of 1.2 mm in nonsmokers and 2.6 rates were observed after a follow-up of 1 year or
mm in smokers after 48 months. more.
The mixed studies reported an implant survival
ranging from 91.5% to 98% after 1 year, and 83.5% Economics
to 97.9% after 3 years of follow-up. Bone loss ranged Unfortunately, no study could be found reporting
from 1.2 to 1.5 mm after 1 year and 1.2 to 1.9 mm the exact cost or the cost-benefit ratio for the
after 3 years. patient. Meloni and coworkers28 and Merli and
Only two of the seven studies included reported coworkers29 mentioned that the treatment was
on prosthesis survival. Johansson and coworkers26 worth the costs.

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Laleman et al

> 1-Year Evaluation

Mean (SD) Bone Loss Prosthesis Survival Evaluated/Included


Time Point (mo) Implant Survival (%) (mm) (%) Patients or Implants
36 Mx: 98.1* Mx: NR Mx: 100*† Mx: 22/33

NR Mx: NR Mx: NR Mx: NR Mx: NR

18 Mx: 97.8† Mx: 1.6 Mx: NR Mx: 15/15

48 Mx: S: 81.2* Mx: S: 2.6 (1.6) Mx: NR Mx: 6/30


Mx: NS: 98.9 Mx: NS: 1.3 (1.0)
NR Mx: NR Mx: NR Mx: NR Mx: NR

18–48 Mx: 81.2–98.9 Mx: 1.3–2.6 Mx: 100 Mx: 43/6–22


36 97.6* NR NR I: 8/168

30 98.3* NR 91.7* 12/12

36 88.4† NR 83* I: 63/176


Mx: 91.6†
19 98.2† 1,2 (1,4) 100† I: 165/191
Mx: 1,2 (1,2)
36 83.5* NR 100*† 34/36
NR NR NR NR NR

36 97.9† 1.9 (1.3) 100*† 30/30


Mx: 96.6†
24 100*† 1.4 (0.3) 100*† 12/12

NR NR NR NR NR

36 100*† NR 100*† 22/22

NR NR NR NR NR

19–36 83.5–100 1.2–1.9 83–100 110/12–34

Studies Reporting on Patient-Centered with regard to pain (dental), anxiety, treatment


Outcomes invasiveness, treatment time, or differences in surgi-
Table 4 summarizes the studies that explicitly inves- cal difficulty between flapless and flap procedures.
tigated patient-centered outcomes and the way in However, after dichotomizing pain during treatment,
which they were evaluated. Different research meth- it was shown that the number of patients without any
ods were used, and the timing of the evaluation varied pain was higher in the flap group compared with the
largely (ranging from 1 month after implant place- flapless group.
ment27 to 18 months after implant placement28). The Four studies reported that the patients were
RCT by Lindeboom and van Wijk27 evaluated emotional really satisfied with the prosthesis.25,28,29,31 Good
impact, dental anxiety, the oral health-related quality scores for speech were also noted31 and Meloni et al28
of life (OHIP-14), and pain and anxiety (with a custom reported that no patients experienced any phonetic
questionnaire). No differences could be observed problems during the provisional phase. When the

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Group 3

Table 4  Studies with Patient-Reported Outcomes


Patient
Study Groups Methods Outcome
Lindeboom and van 8 MS, FL IES-R, s-DAI, OHIP-14, No differences could be shown between conditions on
Wijk (2010)27 Questionnaire dental anxiety, emotional impact, and anxiety. However,
8 BS, FL (anxiety, pain) the flapless group did score consistently higher. The flap
procedure group reported less impact on quality of life and
included more patients who reported feeling no pain at all
during placement.
Meloni et al (2010)28 15 MS, FL Questionnaire All patients but two reported that their quality of life and
lifestyle improved with the implant-supported maxillary
prosthesis. All patients answered that they would undergo
the same therapy again and that the treatment was
worthwhile.
Merli et al (2008)29 13 MS, FL Questionnaire Eleven patients (of 12) reported that their quality of life
and lifestyle improved with the implant-supported maxillary
prosthesis. All patients answered that the rehabilitation
was worth the cost and that they would undergo the same
therapy again.
van Steenberghe et al 27 MS, FL VAS Most patients reported good scores for speech, oral
(2005)31 function, esthetics, and tactile sensation. Less satisfaction
with speech was reported by half of the patients at 3
months. Good satisfaction with other parameters.
Arisan et al (2010)‡32 21, D VAS Flapless group reported a lower pain score than the bone-
16 BS, OF, D supported group and control group.
15 MS, FL, D
Marra et al (2013)‡39 30 MS, FL, I OHIP-EDENT Patient’s grade of satisfaction with this rehabilitation is
very high, because it grants better stability and support,
together with lower postoperative discomfort. Significant
differences between base and 6-mo measurements:
physical pain, self-consciousness, physiologic discomfort,
psychological disability (embarrassment), and social
disability.
Pozzi et al (2013)‡42 22 MS, FL, I VAS All participants were functionally and esthetically satisfied
with their prosthesis.
‡These studies include both maxillae and mandibles (without clear data per jaw) or with unknown jaw allocation.
MS = mucosa-supported, BS = bone-supported, FL = flapless, OF = open flap, I = immediate loading, D = delayed loading, NR = not reported,
IES-R = Impact of Event Scale-Revised, s-DAI = Short version of the Dental Anxiety Inventory, OHIP-14 = Oral Health Impact Profile (short form),
VAS = visual analogue scale, OHIP-EDENT = Oral Health Impact Profile in Edentulous Adults; – = not applicable.

quality of life and lifestyle was questioned, 89% (24 out preparing for and planning a case using the software was
of 27 patients) reported clear improvements. 145 minutes (range, 70–370 minutes).29 Unfortunately,
With regard to the mixed studies, it was also shown no comparison was made with nonguided surgery.
that the patients were satisfied with their rehabilita- Various maintenance and follow-up protocols were
tion. Arisan et al32 concluded that the use of mucosa- described. However, most of the articles do not clearly
supported guides for flapless implant placement may describe what happened during these follow-up visits.
reduce the surgery duration, pain intensity, related Despite their heterogeneity, they have one thing in
analgesic drug use, and most other complications typi- common: in each of these studies, the researchers con-
cal in the post–implant surgery period. tinued to follow-up the patients regularly. Three articles
on guided implant placement in the edentulous max-
Treatment Duration and Maintenance illa mention unexpected events during these follow-up
The reported duration of the surgery in the edentulous visits.28,29,31: two fractures of the provisional prosthesis;
maxillae varied from 30 to 72 minutes (mean, 57 min- fracturing of the porcelain material in three patients; and
utes27,29). Yet it is important to note the time spent by a loose retaining screw in two patients.
the clinician before surgery, for example, for manufac- In the mixed studies chip-off fractures were also
turing the scanning prosthesis and planning the guide. among the most commonly noted problems during
However, only one study included mentioned that the follow-up (n = 13 patients).34,39,42 In addition, peri-
average time spent by the dentist and laboratory for implant problems were detected in eight patients.38,40,41

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Laleman et al

Table 5  Specific Indications for the Use of Cone Beam Computed Tomography Imaging in the Upper
Jaw*
Timing Clinical Situation Specific Indication(s)
Preoperative All sites Clinical doubt of alveolar bone height, width and/or shape
Bone density evaluation

Anterior Nasal floor, nasopalatine canal, anterior superior alveolar canal


maxilla

Posterior maxilla Maxillary sinus and related structures, posterior superior alveolar canal,
maxillary tuberosity, pterygoid plates

Anterior esthetic zone Sinus augmentation


Block or particulate bone grafting
Ramus or symphysis grafting
Pathology/impacted teeth in field of interest
Prior traumatic injury

Computer-assisted treatment planning, treatment options, optimal implant position

Postoperative Integration Marginal peri-implant bone height


Bone-implant interface
Post augmentation assessment (eg, sinus, particulate/block)

Postoperative complications Altered sensation


Infection/postoperative integration failure
Implant mobility
Rhinosinusitis
*Adapted from Bornstein et al (2014).55

DISCUSSION Table 6  Effective Doses (ICRP2007) for


Specific CBCT, MSCT and Extraoral
Currently, a lot of research is available on guided implant
Two-Dimensional Images in Adults*
placement. However, because this review focused solely
on the upper jaw, few articles were found in which only Effective dose
Imaging Type (µSv)
those jaws were treated or where a distinction was
Panoramic imaging 10–50
made between the maxilla and mandible. Furthermore,
no articles could be identified which answered the Cephalometric imaging 4.5–10
authors’ original PICO question comparing surgical MSCT 199–1,410
guides with conventional techniques, because there CBCT
simply are no RCTs available on this topic. This led to Small FOV (< 40 cm2) 11–166
the rephrasing of the focused question: “For patients Medium FOV (40–100 cm2) 28–674
with an edentulous maxilla who desire implant-supported Craniofacial (> 100 cm2) 52–1,073
prostheses, what are the surgical complications, implant
*Adapted from Bornstein et al (2014).55
complications, prosthesis complications, implant survival, CBCT = cone beam computed tomography; MSCT = multislice
prosthesis survival, economics, patient satisfaction, and computed tomography; FOV = field of view.
ICRP = International Commission on Radiological Protection.
maintenance interventions when a digitally generated
surgical guide is used for implant placement?”
The current results point to the fact that, except for mention a survival of 91.5% and 98.1%. A longer follow-
one study, all available studies describe results from up period is of course necessary, but implants placed
mucosa-supported guides. In addition, it can be as- with a guide appear to have a comparable survival rate
sumed that only normal jaws, not severely atrophied as those without a guide in the edentulous maxilla.44
jaws were included, because only one study described However, this comparison must be made with caution
a priori sinus augmentation techniques. because there are no RCTs comparing both techniques
The present findings indicate that implants placed and there are almost no long-term follow-up data on
with a static guide have a good prognosis, with all studies guided placed implants.
reporting a survival rate of 97.8% or higher after 1 year. For future research, it is also important to distinguish
However, long-term follow-up data are not yet available. between smokers and nonsmokers, taking into account
The studies with the longest follow-up period, 48 months, the statistically significant lower implant survival rates

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Group 3

in smokers compared with nonsmokers.45,46 Sanna and the implant placement and early/short-term problems)
coworkers30 distinguished between these groups and and a sufficient length of time later (for evaluation of the
concluded that smoking may eventually compromise the function of the prosthesis/long-term).
outcome (implant survival and marginal bone loss) of Almost all implants included in this review were placed
guided implant placement in the edentulous maxilla.30 without flaps. Theoretically, this could have several ad-
When the survival of implants placed via digitally vantages: the procedure is less time consuming, bleeding
generated static guides is compared between maxilla is minimal, implant placement is expedited, and there
and mandible, an important heterogeneity was noticed. is no need to place and remove sutures.32,47–49 Thereby
Two studies report a better implant survival in the max- it was demonstrated that patients with flapless surgery
illa,35,41 with three studies reporting the opposite.38,39,43 reported less pain and for a shorter period compared
It is important to search for factors that could explain with patients who underwent a classic, nonguided
these differences. One of them could be the need for open flap approach with less postsurgical complications
sinus lifting or bone regeneration. Tahmaseb and co- (swelling, hematoma, hemorrhage, trismus).32,48,49 It was
workers,43 for example, showed a statistically significant also shown that flapless implant placement reduces the
lower survival rate for guided placed implants in the incidence of surgery-related bacteremia.14 However,
maxilla after sinus augmentation (90%) than when the only study included in this review comparing flap-
implants could be placed in the edentulous maxilla in less and open flap–guided implant placement in the
a straightforward fashion (96.7%).43 edentulous maxilla did not find significant differences. It
In addition to good implant survival, high prosthesis even exhibited a trend to the contrary: after dichotomiz-
survival was also demonstrated, ranging from 100% (36 ing pain felt during treatment, it was shown that more
months) to 96.2% (12 months).25,26 However, these results patients in the open flap group reported not feeling
are from studies in which an immediate “final” prosthesis any pain at all compared with patients in the flapless
was placed. In contrast to the good prosthesis survival, group. However, it should be noted that in the open
multiple early prosthesis complications were reported. A flap group, the mucosal flaps were repositioned before
prosthetic problem was described in 12% of the patients. positioning of the guide, leaving the bone unexposed
Although guided implant placement means ad- during implant placement.
ditional costs for the patient (manufacturing of the These results are in line with recent observations from
guide, anchoring screws) it is not clear how much this our own research group. Vercruyssen and coworkers50–52
treatment costs compared with conventional implant performed an RCT comparing accuracy and implant and
treatment. Only two authors mention that their patients patient-centered outcomes of guided implant surgery
thought the guided implant placement was worth the (bone or mucosa-supported) with conventional implant
costs,28,29 the remaining authors did not include this in placement. Sixty patients (72 jaws, both mandibles
their analyses. In addition to the costs for the supple- and maxillae) were randomly assigned to one of the
mentary material, one must also consider the additional treatment groups (Materialise Universal/mucosa (Ma-
time invested by the clinician and the laboratory. The terialise Dental), Materialise Universal/bone, Facilitate/
surgery time for a guided implant placement might be mucosa (Dentsply Implants), Facilitate/bone-supported,
less than half compared with a conventional implant mental navigation, pilot drill template). The Materialise
placement,32 but on average, 145 minutes were spent Universal system can be used to place oral implants of
on the preparation phase. It is therefore important that different manufacturers, but drilling is done without
future research focuses on the costs (and time)–benefit depth control and there is no guidance during implant
ratio of guided implant placement vs conventional im- placement. The Facilitate system is specially designed
plant placement. In this calculation, the laboratory costs to place Astra Tech implants and drilling, and implant
also should be included, because these costs might be placement is performed both in a guided manner and
less for guided cases, in which the implant placement with depth control (physical stops). In the mental navi-
is more prosthetically driven. gation group, no guide was used, only images from the
All patients appeared to be satisfied with the esthet- software planning as a reference were allowed. For the
ics and function of their prostheses on guided placed template group, a surgical stent was used to indicate
implants, and said that they would undergo the same the implant position with the pilot drill, the stent was
treatment again. However, given the differences in then removed and further drilling was performed in the
patient evaluation methods and time points chosen conventional way.
for evaluation, the studies are difficult to compare. It is In this study,50 the postoperative discomfort (Dutch
important that future research uses standardized methods version of the McGill Pain Questionnaire, the health-
to describe patient-centered outcomes. Furthermore, related quality of life instrument, visual analogue scales)
the evaluation should take place at two distinct time was generally very low, with little difference between
points, just after implant placement (for evaluation of the different treatment groups. However, this finding is

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Laleman et al

in conflict with a recent systematic review,6 but might than the lowest effective CBCT dose. In the vast majority
be explained by the very low overall scores. There was a of cases, CBCT is therefore preferred.
tendency for patients treated with conventional flapped The justified use of CBCT for guided implant placement
implant placement to experience pain longer than is not only related to the need for integrated 3D data,
those treated with the flapless guided approach. The but also because of the crucial role of CBCT in visualizing
mean marginal bone loss after the first year of loading critical anatomic structures. When implants are planned
was 0.04 mm (standard deviation [SD] = 0.34) for the in the upper jaw, attention has to be paid to the maxillary
guided surgery and 0.01 mm (SD = 0.38) for the control sinus, the canalis sinuosus, and the nasopalatine canal.
groups.52 No significant difference in bone loss was ob- Through the canalis sinuosus, a clearly defined bony canal,
served between individual treatment groups, bone- and palatal of the canine region, runs the anterior superior
mucosa-supported guidance, or type of guidance. For all alveolar nerve supplying the incisors and the canines, as
treatment groups, a significant improvement in quality well as the adjacent soft tissues.53,54 In a recent systematic
of life (OHIP) was observed at 1-year follow-up (P ≤ .01). review on the use of CBCT imaging in oral implantology,
For this study, the authors performed a reanalysis 24 articles were identified describing the critical anatomic
comparing the data of the edentulous maxillae treated structures on cross-sectional imaging in relation to im-
with guided surgery with the nonguided groups. A total plant placement, and 10 of these focused on the upper
of 208 implants were placed with a guide in 47 patients jaw.52 Of these, six describe the maxillary sinus and four
and 102 implants were placed in 24 patients with mental the nasopalatine canal.55 Currently there are no articles
navigation or a pilot drill template. The mean marginal describing the risks of canalis sinuosus involvement in
bone loss after the first year of loading in the maxilla relation to implant placement. Nevertheless, considering
was 0.06 mm for the guided surgery and –0.03 mm for that all these nutrient canals have a clear neurovascular
the control group; in the mandible it was 0.03 for the content, risks for neurovascular complications should
guided group and 0.03 for the nonguided group. No dif- always be taken into account.
ferences were found between the guided and nonguided Indeed, placement of dental implants is a relevant
surgery in the maxilla with regard to the duration of the cause of iatrogenic nerve injuries. When analyzing data
implant surgery, postoperative discomfort, and quality on neural injuries, the incidence of lingual nerve injury
of life measurements. (mostly related to wisdom tooth surgery) appears to
Guided implant placement requires 3D imaging. have remained stable over the last 30 years, while the
In dental medicine, the latter is currently most often incidence of inferior alveolar nerve injury (related to im-
obtained using CBCT, because it is performed using a plant placement) has steadily increased.56 To the best of
compact machine with a lower cost and lower radiation the authors’ knowledge, all articles up to date on neu-
dose compared with multislice computed tomography rosensory disturbances after implant placement relate
(MSCT). The increased needs for 3D imaging when con- to iatrogenic damage to the inferior alveolar nerve. For
sidering guided implant placement requires the proper the maxillary nerve, no reports have been published on
justification of mechanisms. Table 5 summarizes guide- iatrogenic damage after implant placement. Renton and
lines and indications for cross-sectional imaging in the coworkers57 described iatrogenic damage to the inferior
upper jaw, with CBCT being the preferred method for alveolar nerve in 30 patients, of whom only 10% under-
guided implant placement. If opting for CBCT on such went preoperative CBCT.57 All others had underwent 2D
occasions, it is obvious that the justification should meet intraoral and panoramic imaging alone.55,57 Interestingly,
the “as low as reasonably achievable” (ALARA) principle. in three quarters of those patients with neurosensory
Nowadays, CBCT may offer generally high-quality images disturbances caused by implant placement, nerve dam-
at low radiation doses. Yet a wide variation in effective age was of a permanent nature.58 Thus the proportion
doses has been reported for different CBCT machines. of permanent nerve damage after implant placement
Table 6 presents the published effective doses for pan- seems to be much higher than in all other surgical pro-
oramic and cephalometric imaging, MSCT, and CBCT, as cedures for iatrogenic injuries, with the majority being
measured in adults. Effective doses of CBCT may range of a transient nature.58 Only one article included in this
from 11 to 1,073 μSv, depending on the machine used, systematic review pointed out a neurovascular problem.
the selected field of view and the parameter settings. Di Giacomo and coworkers34 mentioned that a patient
This enormous dose range implies an equivalent dose complained of prolonged pain because of the proximity
of 1 to 107 panoramic radiographs. To obtain the lowest of the nasopalatine nerve. This implant was removed 1
possible radiation exposure, it is important to reduce the week after installation.
field of view to the region of interest and to adjust the Neurovascular complications of implant surgery
operating parameters (including exposure factors). At can also result in severe intraoral hemorrhage. These
the same time, it should be realized that clinical MSCT are predominantly described after anterior mandibu-
may easily yield radiation doses up to 20 times higher lar implant placement (19 case reports available), but

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Group 3

significant bleeding may also be related to maxillary   7. Moher D, Liberati A, Tetzlaff J, Altman DG, PRISMA Group. Preferred
sinus augmentation (4 articles available).59 Because of reporting items for systematic reviews and meta-analyses: The
PRISMA statement. PLoS Med 2009;6(7):e1000097.
the location of different arterial structures in the lateral   8. Randelzhofer P, de la Barrera JM, Spielberg M, Kurtz C, Strub JR.
sinus wall, it is possible that bleeding complications oc- Three-dimensional navigation in oral implantology: A preliminary
cur during lateral window osteotomies. This concerns investigation. Int J Periodontics Restorative Dent 2001;21:617–626.
  9. Katsoulis J, Pazera P, Mericske-Stern R. Prosthetically driven,
the anastomosis between the posterior superior alveo- computer-guided implant planning for the edentulous maxilla:
lar artery and the infraorbital artery: the intraosseous A model study. Clin Implant Dent Relat Res 2009;11:238–245.
artery and the extraosseous anastomosis.60 Zijderveld 10. Nikzad S, Azari A. Computer-assisted implant surgery; a flapless
surgical/immediate loaded approach with 1 year follow-up. Int J
and coworkers61 revised 100 consecutive maxillary Med Robot Comput Assist Surg 2008;4:348–354.
sinus floor elevation procedures and found a strong 11. Wittwer G, Adeyemo WL, Wagner A, Enislidis G. Computer-guided
convexity of the lateral sinus wall in 6% of the patients. flapless placement and immediate loading of four conical screw-
type implants in the edentulous mandible. Clin Oral Implants Res
Hemorrhages were reported in 2% of cases, which 2007;18:534–539.
were shown to be related to this anatomic constraint 12. Wittwer G, Adeyemo WL, Schicho K, Figl M, Enislidis G. Navi-
and to compromised visualization of the trapdoor gated flapless transmucosal implant placement in the man-
dible: A pilot study in 20 patients. Int J Oral Maxillofac Implants
preparation.61 2007;22:801–807.
13. Ersoy AE, Turkyilmaz I, Ozan O, McGlumphy EA. Reliability of
implant placement with stereolithographic surgical guides gener-
ated from computed tomography: Clinical data from 94 implants.
CONCLUSIONS J Periodontol 2008;79:1339–1345.
14. Arısan V, Bölükbaşı N, Öksüz L. Computer-assisted flapless implant
Implants and prostheses placed in the edentulous max- placement reduces the incidence of surgery-related bacteremia.
Clin Oral Investig 2013;17:1985–1993.
illa with a static guide seem to have very good survival 15. Verhamme LM, Meijer GJ, Boumans T, de Haan AF, Bergé SJ, Maal
rates. Moreover, patients are satisfied with this treat- TJ. A clinically relevant accuracy study of computer-planned im-
ment option. Most complications were found to be plant placement in the edentulous maxilla using mucosa-support-
ed surgical templates. Clin Implant Dent Relat Res 2013;17:343–352.
related to the surgery itself and the immediate loading 16. Nickenig HJ, Eitner S. Reliability of implant placement after virtual
protocol. Future research has to focus on comparing planning of implant positions using cone beam CT data and surgi-
guided surgery with conventional nonguided open cal (guide) templates. J Craniomaxillofac Surg 2007;35:207–211.
17. Berdougo M, Fortin T, Blanchet E, Isidori M, Bosson JL. Flapless
flap surgery, standardized protocols, the influence of implant surgery using an image-guided system. A 1- to 4-year
smoking, and the cost-benefit ratio. retrospective multicenter comparative clinical study. Clin Implant
Dent Relat Res 2010;12:142–152.
18. Danza M, Zollino I, Carinci F. Comparison between implants
inserted with and without computer planning and custom model
ACKNOWLEDGMENTS coordination. J Craniofac Surg 2009;20:1086–1092.
19. Danza M, Carinci F. Flapless surgery and immediately loaded
implants: A retrospective comparison between implantation with
All authors declare that they have no conflict of interest.
and without computer-assisted planned surgical stent. Stoma-
tologija 2010;12(2):35–41.
20. Vasak C, Watzak G, Gahleitner A, Strbac G, Schemper M, Zech-
ner W. Computed tomography-based evaluation of template
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