Received: 20 August 2018

Revised: 21 October 2018

Accepted: 25 October 2018

DOI: 10.1111/cid.12704

ORIGINAL ARTICLE

Accuracy of newly developed sleeve-designed templates
for insertion of dental implants: A prospective multicentersclinical trial
Marco Tallarico DDS, MSc1

| Yong-Jin Kim DDS, MMSc2 | Fabio Cocchi ME3 |Matteo Martinolli DDS, PhD4 | Silvio Mario Meloni DDS, MSc, PhD5
1
Implantology and Prosthetic Aspects, Masterof Science in Dentistry Program, Aldent
University, Tirana, Italy

Abstract
Background: The insertion of dental implants by means of computer-assisted template-based2

Ilsan Apsun Dental Clinic, Ilsan, Korea

surgery is an established method.

3

Private Practice, Modena, Italy

Purpose: To investigate the accuracy of a newly developed sleeve-designed template and to evalu-

4

Private Practice, Porto Viro, Italyate differences between maxillary and mandibular implants as well as anterior versus posterior area.

Surgical, Micro-Surgical and Medical Science
Department, University of Sassari, and Private
Practice, Arzachena, Italy

Materials and Methods: Any partially edentulous patients requiring at least one implant to be

5

Correspondence
Silvio Mario Meloni, Surgical, Micro-Surgicaland Medical Science Department, Universityof Sassari, and Private Practice, Arzachena,
Italy.
Email: melonisilviomario@yahoo.it

planned on three-dimensional cone beam computed tomography scan, according to a computerassisted template-based protocol, were consecutively enrolled at two centers. Any potential
implant position was considered eligible for the present trial. Outcome measures were: implantfailure, complications, and accuracy.
Results: A total of 39 patients with 119 implants were evaluated. No patients dropped out during the study period (mean follow-up 12.4  7.1 months). Three implants failed at centre two,
whereas, one complication was experienced at centre one (limited access in posterior area). Differences were not statistically significant (P > .05). The mean deviations were 0.53  0.46 mm(range 0.05-3.38 mm; 95% CI 0.32-0.48 mm) in the horizontal plan (mesio-distal);
0.42  0.37 mm (range 0.0-1.53 mm; 95% CI 0.26-0.40 mm) in the vertical plan (apico-coronal);
and 1.43  1.98 (range 0.03-11.8 ; 95% CI 0.31-1.01 ) in angle. Differences between centerswere compared using the nonparametric Mann-Whitney U test (P > .05). More accurate results
were found for anterior implants in both horizontal plan and angle.
Conclusion: This study showed good precision in all the parameters measured. The results werethus in a range equal to or better than the mean precision found in numerous clinical trials
described in the literature. Posterior implants were less accurate because of the use of open
sleeves template.
KEYWORDS

accuracy, drill guide, guided surgery, implant planning, sleeve, sleeve-designed

1 | I N T RO D UC T I O Ndemand for dental implants to replace teeth has encouraged
advancement in digital technology to improve patients' acceptance

The insertion of dental implants by means of computer-assisted
template-based surgery is an established method.

1–3

and clinical outcomes.3 Recently, the evaluation of digital data from

One of theintraoral optical scanner (IOS) has been shown to be a viable option

most important stages for the development of guided implant

for the rehabilitation of partial edentulous patients whenplacement has been the diffusion of 3-dimensional imaging tech-computer-guided template-assisted implant placement is used.9,10

nique and modern implant planning softwares.3–8 The increased

Among the advantages of digital technologies, intraoral digital

Clin Implant Dent Relat Res. 2018;1–6.

wileyonlinelibrary.com/journal/cid© 2018 Wiley Periodicals, Inc.

1

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TALLARICO ET AL.

impression may reduce the number of appointments, resulting inshorter treatment time.

10

performed at two centers by two expert clinicians (MT and J-YK)
between July 2016 and May 2018.

Glossary of prosthodontic terms defines surgical template (or surgical

The study was performed before approval was received from theguide) as “a guide used to assist in proper surgical placement and angula-institutional review board of the Aldent University, Tirana, Albania

tion of dental implants”.11 Implant survival rate has been showed similar(2/2017). All participants were enrolled and treated in the study infor conventional and computer-guided template-assisted implant place-consecutive order after being informed about the nature of the study

ment procedures.1,12 Furthermore, the reduction of postoperative pain

and providing their written consent.

and surgical time, as well as lower marginal bone loss after 5 years of func1

Any partially edentulous patient with at least five remaining teeth
in two quadrants, aged 18 years or older, able to sign an informed

tion were founded placing implants with a template-based approach.

The main purpose of the surgical template is to guide the implant

consent, and in need of an implant-supported fixed restoration was

drilling system and provide accurate placement of the implant accord-considered eligible for this study and consecutively enrolled. Any

ing to the virtual treatment plan. At now, guided surgery is based on

potential implant position, based on individual patient requirements

metal sleeves integrated into the surgical guides, through which dedi-

was considered eligible for the present trial. Patients were not admit-

cate drill are used. Hence, surgical template represents the union ofted to the study if any of the following exclusion criteria was present:

guiding cylinders (sleeves) and contact surface. The contact surface

general medical contraindication to oral surgery (American Society offits either on hard and soft tissues giving stability. Cylinders works as

Anesthesiologist, ASA, class III or IV); irradiation in the head and necka drill guides orienting the drill in the exact location and direction.

area less than 1 year before implantation; psychiatric problems; alco-

Additive manufacturing, including stereolithography, is becoming

hol or drug abuse; pregnant or nursing; untreated periodontitis; needpredominant for the fabrication of surgical templates, because of theto bone reconstruction; severe bruxism or clenching; uncontrolled dia-

upcoming technological developments. Conventionally, the polymeric

betes; poor oral hygiene and motivation; and inability to complete theprototype contains holes for metallic (stainless steel or titanium) drill-

follow-up.

guiding sleeves, which accommodate a vast majority of guided surgical

All patients received preoperative photographs, periapical radio-

kits. Recently, new in-built sleeve-designed templates have beengraphs or panoramic x-rays for initial screening and evaluation.

introduced with the aim to make guided surgery work-flow faster andEnrolled patients receive a cone beam computed tomography (CBCT)

easier. One of the advantages of this templates is the less mesio-distal

scan, by using a wax bite to separate dental arches and a complete

space required for its fabrication because of the lack of steel or tita-

digital impression (3M True Definition Scanner, 3M Italia, Pioltello,nium drill-guiding sleeves. Moreover, sleeve-designed templates can

Milano), according to a previously published manuscript.10 Afterwards,

be produced with a vestibular or buccal slot (open site) that allows thea virtual wax-up was performed, according to the functional andhorizontal insertion of the drills, reducing the need of inter-arches

esthetic requirements. Then, the DICOM (Digital Imaging and COm-

space and also reducing the bone heating because of a direct saline

munications in Medicine) data derived from the CBCT scan and theirrigation on the drill. Furthermore, sleeve-designed templates should

STL (STereo Lithography interface format, STL) data derived from thebe easier to produce and probably less expensive because of theimpression and the virtual wax-up, were imported in a 3-dimensionalabsence of stainless steel or titanium drill-guiding tubes. For thesesoftware planning program (3Diagnosys ver. 4.2, 3DIEMME srl, Cantù,reasons too, cost-effective high quality desktop 3-dimensional

Italy at centre one and Implant studio, 3Shape A/S, Copenhagen, Den-

printers, recently introduced to the dental market, make in-house sur-mark at centre two). At this point, prosthetic-driven implants/abut-

13

gical templates production affordable.

Nevertheless, there is stillments size and location were planned taking into account the bonequality and quantity, soft tissue thickness, anatomical landmarks, aslack of data in their accuracy.
The aim of the present study is to compare early implant failure,

well as, type, volume and shape of the final restoration. After careful

template-related complications, and virtual planning accuracy offunctional and esthetic evaluation and final verification, thecomputer-assisted template-based implant placement using computer-prosthetic-driven plan was approved. Finally, a stereolithographic sur-

aided design (CAD)/computer-aided manufacturing (CAM) stereolitho-

gical template was designed and then fabricated by an independentgraphic surgical templates with or without metallic sleeves. Further-certified center not previously involved in the study (New Ancorvis

more, to compare open versus closed holes in case of sleeve-designed

srl, Bargellino, Italy). All the surgical templates were designed with atemplates. The null hypothesis was that there would be no differences

minimum of three inspection windows of 4-5 mm of diameter. The

between these interventions. This trial is reported in accordance withthickness of the surgical templates was 2.5  0.5 mm. Dental LT

the STROBE (STrengthening the Reporting of OBservational studies inClear (Formlabs Inc, Somerville, Massachusetts) was print resolutions

Epidemiology)

statement(https://www.strobe-statement.org/)for

improving the quality of reporting of observational studies.

of 100 μm. After printing, all the surgical templates were cleaned withisopropyl alcohol and then dried. Finally, postcuring was performedfor 8 minutes. At centre one, the surgical templates were sleevedesigned with closed hole in case of implants to be place between

2 | MATERIALS AND METHODS

premolars, while, open holes were designed for molars replacement.
While, at centre two, all the surgical templates were sleeve-designed

This investigation was designed as multicenter single cohort prospec-with closed holes (Figure 1,B).

tive study conducted according to the principles embodied in the Hel-One hour before implant placement, all patients underwent pro-sinki Declaration of 2008. Surgical and prosthetic procedures werefessional oral hygiene, prophylactic antiseptic with 0.2% chlorhexidine

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TALLARICO ET AL.

FIGURE 1

A, Surgical templates designed with open holes used formolars replacement. B, Surgical templates designed with closed holein case of implants to be place between premolars

FIGURE 3

Template with lateral open hole used for molar region

FIGURE 4

Temporary crown delivery lateral viewfor 1 minute, and prophylactic antibiotic therapy (2 g of amoxicillin orclindamycin 600 mg if allergic to penicillin). The fit of the surgical templates were tried directly in the patient mouth to achieve a stable fit(Fit Checker, GC – Tokyo, Japan). All patients were treated under local
anesthesia using articaine with adrenaline 1:100.000 administered
20 minutes before surgery. The surgical templates were stabilized inrelation to the opposing arch using a rigid surgical index derived fromthe virtual plan, and with two to four preplanned anchor pins. Planned
implants (Osstem TSIII, Osstem, Seoul, South Korea) were placed
flapless or with a minimally invasive flap using dedicated drills(OsstemGuide Kit[Taper], Osstem). The implant site was preparedbased on the bone density evaluated by the surgeon at the first drill.7
The flaps (if present) were then sutured with Vicryl 4.0 sutures (Vicryl,
Ethicon J&J International, Sint-Stevens-Woluwe, Belgium). Immediately after implant placement, patients of both groups received a digital impression taken at implant level using dedicated abutments, tocheck the position of the placed implants. Hopeless teeth wereextracted at the end of the intervention in order to improve the stability of the surgical template and to provide more reference point in the
postoperative STL files, for measurements of the implant accuracy.
Following implant placement, preplanned provisional restorations

FIGURE 5

Post-delivery x-ray. Final screwed restoration. B, Definitive
restoration: Lateral view

solution. Occlusion was adjusted avoiding any premature contact.
Patients were followed every three to 6 months for hygiene maintenance and occlusion controls (Figures 2–6).

were immediately delivered to the patients, according to an immediateloading protocol. Finally, all patients received oral and written recom-

3 | OUTCOME MEASUREMENTS

mendations about medication, oral hygiene maintenance and diet.
Suture (if present) were removed 10-14 days later, after local cleaning
by using 0.2% chlorhexidine.
Three to four months after implant placement, definitive impressions were taken using a customized open tray. Definitive restorations
were delivery 1 month later. Investigators were free to deliver cemented or screw-retained prostheses, which could be either stock or fabricated with CAD/CAM technology, including angle screw channel

1. Implant failure: an implant was considered to be a failure if it had
to be removed because of lack of stability, implant mobility, progressive marginal bone loss or infection, and any mechanical complications (eg, implant fracture) rendering the implant unusable.
The stability of individual implants was assessed during the delivery of definitive crowns by tightening the abutment screw with a

FIGURE 6
FIGURE 2

Preclinical situation. Posterior edentulism

The horizontal (lateral), vertical (depth), and angulardeviation between virtual and placed implants were calculated along
the long axis of each implants

4

TALLARICO ET AL.

implant placement [range 3-24 months]). Three implants failed at centre two. Implants were replaced after 3 months of healing period. One
complication was experienced at centre one resulting in limited accessin posterior areas during the placement of an implant in the rightlower second molar position. In this case, a shorten drill (7 mm insteadof 10 mm) was used to sign the entry point, then the implant wasplaced free-end. All the implants were inserted according to the manufacturer's instructions, with an insertion torque ranged between
35 and 45 Ncm. There were baseline imbalances between the two
FIGURE 7

Possible implant mount driver pressure on the templateproducing a distortion and reducing the final implant accuracy

groups for the presence of more treated female at the centre one(68.8% vs 30.4%); more implants placed in the anterior region at thecentre two (60.6% vs 16.7%); more implants placed in the maxilla attorque of 20 Ncm, and then 1 year after implant placement by

centre one (66.7% vs 46.5%); more implants placed thought open

the percussion test.

holes at centre one (31.3% vs none); and longer follow-up at centre

2. Early surgical and template-related complications (limited accessin posterior areas, buccal bony dehiscence because of a mis-two (17.3 vs 5.3 months). Patients and implant characteristics
between groups were reported in Table 1.

matching of the surgical template, insertion of different implant

Overall, the analysis of the final accuracy revealed a total

than planned, and fracture of surgical template) were recorded.

mean error of 0.53  0.46 mm (range 0.05-3.38 mm; 95% CI

All the complications were recorded during follow-up by the same

0.32-0.48 mm) in the horizontal plan (mesio-distal); 0.42  0.37 mm

expert clinicians that perform the implant surgery (MT and J-YK).

(range 0.0-1.53 mm; 95% CI 0.26-0.40 mm) in the vertical plan (apico-

3. Measurements of accuracy. Three deviation parameters (horizon-

coronal); and 1.43  1.98 (range 0.03-11.8 ; 95% CI 0.31-1.01 ) intal, vertical, and angular) were defined and calculated between

angle.

the planned and placed implant positions. The postoperative STL

In the horizontal plan (mesio-distal), the mean error was

file, derived from the intra-oral scan, was geometrically aligned

0.61  0.49 mm (95% CI 0.36-0.64 mm) at centre one andwith the files exported from the planning, by automated image

0.48  0.44 mm (95% CI 0.27-0.47 mm) at centre two (P = 0.1508);

registration using maximization of mutual information (Dental

in the vertical plan (apico-coronal), the mean error was 0.37 

SCAN, ver.6, Open Technologies srl, Brescia, Italy). The horizontal

0.28 mm (95% CI 0.23-0.39 mm) at centre one and 0.45  0.42 mm(lateral), vertical (depth), and angular deviation between virtual(95% CI 0.23-0.43 mm) at centre two (P = .2108). The mean error inand placed implants were calculated along the long axis of eachangle was 1.98  2.38 (95% CI 0.13-1.47 ) at centre one andimplants. An expert blinded mechanical engineer performed all

1.06  1.56 (95% CI 0.13-1.856 ) at centre two (P = .0221)

the measurements (Figure 7).

(Table 2).
Excluding open holes, at centre one, the analysis of the final accuracy revealed a total mean error of 0.50  0.37 mm (95% CI

4 | STATISTICAL ANALYSIS
Patient data was collected in a numbers spreadsheet (Version 3.6.1
for Mac OS X 10.11.4). A bio-statistician with expertise in dentistry
analyzed the data using SPSS software for Mac OS X (version 22.0;
SPSS Inc, Chicago, Illinois) for statistical analysis. Descriptive analysis
was performed for numeric parameters using mean  SD and median

0.28-0.53 mm) in the horizontal plan (mesio-distal); 0.33  0.25 mm(95% CI 0.22-0.38 mm) in the vertical plan (apico-coronal); and1.30  1.56 (95% CI 0.18-1.22 ) in angle. The differences between
centers were not statistically significant (P > .05; Table 2).
Subgroup comparison of implants' accuracy between maxilla andmandible relived no statistically significant differences between
groups (Table 3). Otherwise, subgroup comparison of implants' accuracy between anterior and posterior implants relived statisticallywith confidence interval (95% CI). Complications between the twogroups were compared using Fisher's exact probability test. The mean

TABLE 1

Patient and implant characteristics between centersdifferences of the overall deviation in the clinical outcomes comparedto the virtual plan, were compared between groups using the nonparametric Mann-Whitney U test. All statistical comparisons wereconducted at the .05 level of significance.

5 | RESULTS
A total of 39 patients with 119 implants were evaluated. Sixteen
patients with 48 implants were treated in the centre one and23 patients with 71 implants in the centre two. No patients dropped
out during the study period (mean follow-up 12.4  7.1 months afterCentre one

Centre two

P value

Female

11

7

.0253

Mean age (years)

55.9

54.1

.4429

Maxilla

32

33

.0391

Anterior maxilla

4

28

.0001

Mandible

16

38

.0391

Anterior mandible

4

15

.3652

Open holes

15

0

.0001

Implants failure

0

3

.2781

Complications

1

0

.4034

Mean follow-up (months)

5.3

17.3

.0000

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TALLARICO ET AL.

TABLE 2Overall analysis of the final accuracy
Centre one

Centre two

P value

Horizontal plan (mm)0.61  0.49 (0.36-0.64)

0.48  0.44 (0.27-0.47).1508

Vertical plan (mm)0.37  0.28 (0.23-0.39)

0.45  0.42 (0.23-0.43).2108

Angle

1.98  2.38 (0.13-1.47)

1.06  1.56 (0.13-0.85).0221

Only closed holes

Centre one

Centre two

P value

Horizontal plan (mm)0.50  0.37 (0.28-0.53)

0.48  0.44 (0.27-0.47).8562

Vertical plan (mm)0.33  0.25 (0.22-0.38)

0.45  0.42 (0.23–0.43).0779

Angle

1.30  1.56 (0.18-1.22)

1.06  1.56 (0.13–0.85).4739

significant differences between groups with more accurate results forwith open holes were used14. In fact, when considering only closed

anterior implants in both horizontal plan and angle. Viceversa, no sta-sleeve-designs template with closed holes, data on accuracy improved

tistically significant differences between groups were reported for(Table 2).

vertical plan accuracy. Data were reported in Table 3.

Our results are in line with Naziri et al. 16 who verified that thelocation of the implant, whether in the upper or lower jaw, did not significantly affect deviations and also implantation in a free-end dental

6 | DISCUSSION

arch has a statistically significant negative influence on the precisionof implant insertion compared to implantation in an interdental gap.

This multicenters prospective study was conducted with the aim to

In the present study, the maximum angle deviation (11.8 ) was

evaluated the implant accuracy using a newly developed sleeve-found in a free-hand saddles maxilla. In this cases, the implant mountdesigned template to place dental implants according to a computer-

driver can create a pressure touching the template that could produce

assisted template-based protocol.

a distortion, reducing the final implant accuracy. The most likely ex-

To the best of our knowledge, at the time of writing this manu-

planation for this is that the surgical guide is only partially tooth-

script, there were no published randomized controlled trials evaluating

supported in free-end dental arch implantation.16 According to Tallar-

the accuracy of the newly developed sleeve-designed templates.

ico et al.,10 the maximum acceptable value for angle discrepancy

Looking at the gray literature, the same authors suggested thatshould range between 5.9 and 16.7 depending of the implant length

sleeve-designed templates with open sleeves may be used with cau-and diameter. Nevertheless, the clinicians can choose between open

tion in molar region only when the inter-arches space is reduced,

or closed holes, limiting the use of the open holes only in case withbecause of less accuracy compared with closed sleeves.14

limited access in the posterior areas.

Schnutenhaus et al.,15 in a prospective study on the accuracy ofIn the present study, nine maxillary lateral incisors and 15 lower

sleeveless 3-dimensional drill guides, experienced a mean deviation ofincisors were treated. Another benefit of the sleeve-designed tem-

0.52 mm (95% CI 0.37-0.67 mm) at the crestal position of the implant;

plate was the lower mesio-distal space required. In fact, metallic tubes

0.82 mm (95% CI 0.56-1.08 mm) at the apical tip of the implant;presented a thickness of 0.5 mm that reduce its use in case of limited

0.35 mm (95% CI: 0.01-0.68 mm) in the vertical plan; and a mean

mesio-distal space, such as lower incisor and maxillary lateral incisors.

angular deviation of 2.85 (95% CI 2.18-3.51 ). Comparing this results

Both centers were able to achieve successful results. Despite thewith the data from the present research, similar values were found inevident benefits related to higher accuracy with the sleeve-designed

the horizontal and vertical plan. Nevertheless, half the value were

templates, there is still the need to clinically evaluate the long-term

reported for the angle accuracy.

esthetic and functional advantages. High accuracy with sleeve-

In the present study, no statistically significant difference on

designed templates could be explained with a larger template/implant accuracy was found between implants placed in the maxilla

drill contact during the implant site development, reducing the wob-and in the mandible. On the contrary, statistically higher accuracy wasbling of the drills. In fact, the sleeve-designed templates presented

experienced for anterior implants rather than posterior, on both hori-

5 mm high guidance, compared to 3.5 mm in the metallic sleeve.

zontal plan and angle. A possible explanation for this results could be

Furthermore, the implant mount drivers of the sleeve-designed tem-that in the posterior area, at centre one, sleeve-designed templates

plates (NoMount Driver and Fixture Driver, OneGuide Kit, Osstem)

TABLE 3Subgroup analyses of implants' accuracy between maxilla and mandible and anterior and posterior implants
Maxilla (n = 65)

Mandible (n = 54)

P value

Horizontal plan (mm)0.57  0.41(0.34-0.54)

0.49  0.52(0.19-0.46).3527

Vertical plan (mm)0.42  0.36(0.24-0.42)

0.41  0.39(0.20-0.40).8989

Angle

1.44  2.12(0.09-1.11)

1.42  1.81(0.22-1.18).9469

Anterior (n = 32)

Posterior (n = 87)

P value

Horizontal plan (mm)0.42  0.23(0.29-0.45)

0.57  0.52(0.30-0.52).0299

Vertical plan (mm)0.43  0.40(0.19-0.47)

0.41  0.36(0.24-0.40).8305

0.51  0.37(0.32-0.58)

1.77  2.21(0.24-1.16)

.0000

Angle



6

TALLARICO ET AL.

are designed without any stop. In case of an angle discrepancy, the inbuild stop of the implant mount driver (OsstemGuide Kit, Osstem)
should touch the metallic sleeve on a side, not allowing for an accurate flat-to-flat matching.
The main limitation of the present study was that a priori sample
size calculation was not performed, thus, the limited power of theanalysis, because of a limited number of participants, could have hidden some differences between groups. This can only be solved byconducting more similar trials with larger sample sizes, calculated
based on this preliminary result. Another limitation could be the baseline imbalances between the two groups that reflect the different
population between Korea and Italy. Nevertheless, implant failure,complications and accuracy were similar between the two centers
expect for better accuracy on angle at centre two. This difference
could be explained with the use of open sleeve at centre one rather
than to different population. Hence, taking into account both cohortof patients, the overall results can be generalized to different populations, even worldwide.

7 | CO NC LUSIO N
With the limitations of the present study, high accuracy was found in
all the parameters measured. The results were thus in a range equal toor better than the mean precision found in numerous clinical trials
described in the literature. Posterior implants were less accurate
because of the use of sleeve-designed templates with open holes.
Further randomized controlled trials are needed to confirm this result.

CONF LICT OF IN TE RE ST
Both authors are speakers of the Osstem, nevertheless, this study was
self-supported. Data belonged to the authors and by no means did
the company interfere with the conduct of the trial or the publicationof its results.

ORCID
Marco Tallarico
Silvio Mario Meloni

https://orcid.org/0000-0001-9206-0454
https://orcid.org/0000-0002-3317-0124

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2. Tallarico M, Meloni SM. Retrospective analysis on survival rate,
template-related complications, and prevalence of Peri-implantitis of
694 anodized implants placed using computer-guided surgery: results
between 1 and 10 years of follow-up. Int J Oral Maxillofac Implants.
2017;32:1162-1171.

How to cite this article: Tallarico M, Kim Y-J, Cocchi F,
Martinolli M, Meloni SM. Accuracy of newly developed
sleeve-designed templates for insertion of dental implants: A
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