Received: 3 February 2024 Revised: 20 June 2024 Accepted: 22 June 2024

DOI: 10.1111/cid.13360

ORIGINAL ARTICLE

Accuracy of navigation guided implant surgery for immediate

loading complete arch restorations: Prospective clinical trial

Alessandro Pozzi 1,2,3,4 | Paolo Carosi 1,5 | Andrea Laureti 5 |

6,7 6
Nikos Mattheos | Atiphan Pimkhaokham | James Chow 8 | Lorenzo Arcuri 9
1
Department of Clinical Science and Translational Medicine, University of Rome Tor Vergata, Rome, Italy
2
Department of Periodontics and Oral Medicine, University of Michigan School of Dentistry, Ann Harbor, USA
3
Department of Restorative, Sciences Augusta University, Augusta, Georgia, USA
4
Department of Restorative Dentistry and Biomaterials Sciences, Harvard School of Dental Medicine, Boston, Massachusetts, USA
5
Department of Chemical Science and Technologies, University of Rome Tor Vergata, Rome, Italy
6
Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, Chulalongkorn University, Bangkok, Thailand
7
Department of Dental Medicine, Karolinska Institute, Stockholm, Sweden
8
Brånnemark Osseointegration Centre, Hong Kong, China
9
Department of Odontostomatological and Maxillofacial Sciences, Sapienza University of Rome, Rome, Italy

Correspondence
Alessandro Pozzi, Department of Clinical Abstract
Science and Translational Medicine, University
Objectives: To assess navigation accuracy for complete-arch implant placement with
of Rome Tor Vergata, Rome, Italy.
Email: [email protected] immediate loading of digitally prefabricated provisional.
Materials and Methods: Consecutive edentulous and terminal dentition patients
requiring at least one complete-arch FDP were treated between December 2020 and
January 2022. Accuracy was evaluated by superimposing pre-operative and post-
operative cone beam computed tomography (CBCT), recording linear (mm) and angu-
lar (degrees) deviations. T-tests were performed to investigate the potential effect of
the registration algorithm (fiducial-based vs. fiducial-free), type of references for the
fiducial-free algorithm (teeth vs. bone screws), site characteristic (healed vs. post-
extractive), implant angulation (axial vs. tilted), type of arch (maxilla vs. mandible) on
the accuracy with p-value <0.05.
Results: Twenty-five patients, 36 complete-arches, and 161 implants were placed.
The overall mean angular deviation was 2.19 (SD 1.26 ). The global platform and
apex mean deviations were 1.17 mm (SD 0.57 mm), and 1.30 mm (SD 0.62 mm).
Meaningful global platform (p = 0.0009) and apical (p = 0.0109) deviations were
experienced only between healed and post-extraction sites. None of the analyzed
variables significantly influenced angular deviation. Minor single-axis deviations were
reported for the type of jaw (y-axis at implant platform and apex), registration algo-
rithm (y-axis platform and z-axis deviations), and type of references for the fiducial-

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© 2024 The Author(s). Clinical Implant Dentistry and Related Research published by Wiley Periodicals LLC.

954 wileyonlinelibrary.com/journal/cid Clin Implant Dent Relat Res. 2024;26:954–971.

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POZZI ET AL. 955

free algorithm. No statistically significant differences were found in relation to

implant angulation.
Conclusions: Within the study limitations navigation was reliable for complete-arch
implant placement with immediate loading digitally pre-fabricated FDP. AI-driven sur-
face anatomy identification and calibration protocol made fiducial-free registration as
accurate as fiducial-based, teeth and bone screws equal as references. Implant site
characteristics were the only statistically significant variable with healed sites report-
ing higher accuracy compared to post-extractive. Live-tracked navigation surgery
enhanced operator performance and accuracy regardless of implant angulation and
type of jaw. A mean safety room of about 1 mm and 2 should be considered.

KEYWORDS
accuracy, complete-arch, dental implants, dynamic navigation, guided surgery, immediate
loading

Summary Box

What is known
Although the accuracy of dynamic computer-assisted implant surgery (CAIS) is shown to be at
least equal to static CAIS, there is a scarcity of prospective studies investigating complex clinical
scenario as terminal dentition and edentulous jaws to be rehabilitated with immediate loading
digitally prefabricated provisionals. In addition, the level of accuracy required from implant
placement to allow for adequate fit of such prefabricated fixed dental prosthesis (FDP) is at pre-
sent unknown.

What this study adds

Dynamic CAIS might provide adequate accuracy for complete-arch implant placement to facili-
tate immediate loading with prefabricated FDP. AI-driven surface anatomy identification and
calibration protocol made fiducial-free calibration registration as accurate as fiducial-based.
Dynamic navigation guidance improved operator performance and accuracy regardless of
implant angulation and type of jaw. The implant site characteristics were the only variable
shown to affect deviation, with implants at healed sites reaching higher accuracy than in post-
extractive sockets.

1 | I N T RO DU CT I O N However, the lack of anatomical references and strategic teeth, bone,

and soft tissue architecture deformities, full thickness flap elevation
Complete-arch implant fixed dental prostheses (FDP), represent a sur- may infringe template stability affecting the overall accuracy of static
gical and prosthetic challenge to the clinician, even when empowered computer-assisted implant surgery (CAIS) for complete arch implant
by digital technologies.1,2 Technological advancements have signifi- placement.1,2,8,10–14 The major limitation of static CAIS is the lack of
cantly improved data acquisition and integration with a highly realistic real-time visualization of recipient site preparation.15 No intraopera-
overview of residual anatomy and his relationship with future pros- tive position changes can be made with a fully guided static sys-
thetic rehabilitation.3–6 Artificial intelligence7 (AI) driven automatic tem.16,17 Dynamic CAIS or navigation implant surgery allows constant
superimposition and 3-dimensional rendering of the facial skeleton, visual inspection of implant site characteristics, live tracking full guid-
soft tissue, and remaining dentition by fusing different digital data sets ance and “real-time” adjustments in case any deviation may occur,
(digital imaging and communications in medicine [DICOM]) and with no template hiding the surgical field or hampering the soft tissue
stereolithography (STL) files, simplified the creation of virtual dental handling.1,8,18 The sophisticated algorithms of modern CAD/CAM
patient. Bone segmentation and mandibular joint movement allowed software integrated surgical plan with digital design of a prefabricated
to plan the implant placement and design the immediate temporary prosthetically and biologically driven complete arch temporary FDP,
FDP according to a 3-dimensional evaluation of centric relation, verti- to be delivered immediately.19 This integration extended the guided
8,9
cal dimension, and skeletal relationship between the jaws. concept to the positioning of the temporary immediate FDP in the
 17088208, 2024, 5, Downloaded from https://onlinelibrary.wiley.com/doi/10.1111/cid.13360 by Readcube (Labtiva Inc.), Wiley Online Library on [04/01/2025]. See the Terms and Conditions (https://onlinelibrary.wiley.com/terms-and-conditions) on Wiley Online Library for rules of use; OA articles are governed by the applicable Creative Commons License
956 POZZI ET AL.

3-dimensional planned position, to act as a prosthetic scaffold and 0.39 and 2.27; SD 0.56 mm). With a significance level (alpha) of 0.05
enhance soft tissue interface reconfiguration and maturation.6 The and 90% power test, the minimum required sample size was n = 92
optimal design of the prosthesis is an important key to long-term peri- implants (G*Power version 3.1.9.7).
implant tissue health and successful clinical outcomes and must con-
sider optimal implant position, the soft tissue height, and the distance
to the bone, aiming to achieve a healthy restorative interface.9,20,21 2.2 | Inclusion and exclusion criteria
To limit the intraoperative adjustments of the prefabricated immedi-
ate temporary FDP, an accurate implant placement is mandatory. At The following inclusion criteria were used: (1) Healthy patients.
present, most of the investigated navigation systems have demon- (2) Adequate bone height for placement of at least 10 mm-long
strated similar performance levels and potential clinical implants. (3) Healed sites with bone width of at least 5 mm and 6 mm
22–28
applications, with significantly higher accuracy than freehand for narrow (NP 3.75 mm) and regular (RP 4.3 mm) implants, respec-
implant placement and at least as much as static CAIS.29–34 However, tively. (4) Fresh extraction sockets with at least 4 and 5 mm of bone
a scarcity of well-designed clinical trials investigating dynamic CAIS in beyond the root apex in the mandible and maxilla. (5) Minimal inser-
complex clinical scenarios such as terminal dentition and edentulous tion torque of 40 Ncm. (6) Minimal ISQ mean value of 64 per each
patients remained to be addressed (Data S1). implant. Exclusion criteria were general medical (American Society of
The primary aim of this study was to investigate the accuracy of Anesthesiologists [ASA] class III or IV) and/or psychiatric contraindica-
dynamic CAIS for complete-arch implant placement with immediate tions; pregnancy or nursing; any interfering medication such as steroid
loading of digitally prefabricated FDPs. Secondary aims were to assess therapy or bisphosphonate therapy; alcohol or drug abuse; heavy
the influence on accuracy of certain dichotomous variables of the pro- smoking (>10 cigarettes/day), radiation therapy to head or neck
cess: (a) calibration registration algorithm (fiducial-based vs. fiducial- region within 5 years, untreated periodontitis; acute and chronic
free), (b) type of references for fiducial-free algorithm (teeth vs. bone infections of the adjacent tissues or natural dentition; severe maxillo-
screws), (c) implant site (healed site vs. extraction socket), (d) implant mandibular skeletal discrepancy; high and moderate parafunctional
intended angulation (axial vs. tilted) and (e) type of arch (maxilla activity,35 absence of opposite teeth; unavailability to attend regular
vs. mandible). The null hypothesis was that no significant difference in follow-up visits.
the overall linear and angular deviations would be found between all
five pairs of characteristics.
2.3 | Digital workflow

2 | MATERIALS AND METHODS All patients received a comprehensive examination including an

intraoral optical surface scanning (IOS) (IS 3800W, Dexis, Quaker-
The study was approved by the ethical committee of the University of town, PA, USA) and a high-speed cone beam computed tomography
Rome Tor Vergata (202.20) and registered with protocol number (CBCT) (i-CAT FLX V17 Dexis) with large field of view (FOV 160 mm
ISRCTN95404312. The study was conducted in compliance with the height, 130 mm width) and high resolution (voxel size 0.25 mm). The
Declaration of Helsinki for biomedical research involving human sub-
jects as amended in 2008 and revised in Fortaleza in 2013 and,
according to the industry regulations (the International Conference
for Harmonization Guideline for Good Clinical Practice and
ISO14155). Patients of both sexes, aged 18 years, requiring at least
one complete-arch implant-supported FDP, in either jaw, after signa-
ture of the informed consent were enrolled. Patients were informed
of the nature of the study, benefits, risks, and possible alternative
treatments and provided consent prior to inclusion in the study, as
well as any follow-up evaluations required for the clinical study.
Patients were recruited and consecutively treated in one rehabilitation
center between December 2020 and January 2022.

2.1 | Sample size calculation

The sample size was calculated using Wilcoxon-Mann–Whitney test

based on means and standard deviation (SD) of 3-dimensional devia-
F I G U R E 1 Three-dimensional planning file including implant
tions at implant platform and apex of dynamic guided surgery previ- coordinates, prosthetic components, and personalized CAD/CAM
ously published in a randomized clinical trial (RCT) study24 (1.24; SD immediate temporary FDP.
 17088208, 2024, 5, Downloaded from https://onlinelibrary.wiley.com/doi/10.1111/cid.13360 by Readcube (Labtiva Inc.), Wiley Online Library on [04/01/2025]. See the Terms and Conditions (https://onlinelibrary.wiley.com/terms-and-conditions) on Wiley Online Library for rules of use; OA articles are governed by the applicable Creative Commons License
POZZI ET AL. 957

implant planning software (DTX Studio™, Nobel Biocare AG, Kloten, Technologies). The CBCT examination was performed without any
Switzerland) with an AI algorithm process automatically detects the clip in the mouth, with patient wearing wax rims or complete remov-
remained dentition, design any missing teeth, overlay DICOM with able dental prostheses to stabilize the jaws in centric relation. The
STL data and a virtual dental patient (VDP) according to the “Smiling navigation software allowed to identify digital landmarks onto
Scan Technique”5 was created. The approved 3-dimensional planning the DICOM and STL 3-dimensional surface anatomy, that were num-
file including the implant coordinates was exported into the dynamic bered and coupled with the real patient anatomy touching with a ded-
navigation system (X-Guide, X-Nav Technologies, LLC, Lansdale PA, icated calibration probe the equivalent points onto the bone or tooth
USA) to execute the surgery and into prosthetic software (DTX Stu- surface. In case of edentulous patients or terminal dentition with not
dio™ Lab 1.10.6, Nobel Biocare AG) to produce a personalized adequate tooth stability, 3 to 5 self-drilling titanium bone screws
CAD/CAM immediate temporary FDP (Figure 1). (1.5 mm diameter, 4 to 5 mm in length) (Maxdrive screws, KLS Martin
SE & Co. KG, Tuttlingen, Germany) were placed into the bone along
the arch to be treated prior the CBCT to act as landmarks for the
2.4 | Calibration and registration protocol fiducial-free registration. The navigation algorithm automatically
related the patient tracking array geometry to the CBCT or STL
The surgical navigation system dynamically tracked the motion of two images of the landmarks coupled with the corresponding tooth and
dynamic reference frames (DRFs), 1 firmly secured to the patient's bone-screw references in the patient's mouth. Therefore, the registra-
anatomy (teeth or bone) and 1 rigidly attached to the surgical hand- tion process aligned the virtual patient including the planned implant
piece. The Navigation system algorithm tracked data to compute guid- coordinates to the live patient's anatomy. Moreover, in case of com-
ance information, displayed in real-time to assist surgical drilling plete edentulism of one or both dental arches the integration of the
according to the CBCT implant planned coordinates. According to the planned prosthesis within the craniofacial model was achieved
intraoral status of the jaw to be treated, two different registration through the double scan technique.
protocols were performed.8 In case of terminal dentition with stable
subsequent residual adjacent teeth >3 and located in an area of the
dental arch not infringing the implant drilling a fiducial-based registra- 2.7 | Surgical protocol
tion protocol was executed. Otherwise, in the case of edentulous
patients or terminal dentition with subsequent residual teeth <3, a Calibration of the surgical handpiece and patient tracking arrays was
fiducial-free registration protocol was conducted and the CBCT scan performed prior to surgery. The handpiece calibration determined the
was taken without any clip in the mouth. relationship between the geometry of the handpiece tracking array
and the axis of the drill. In the case of edentulous patients or dentate
patients with high tooth mobility the patient tracking array was
2.5 | Fiducial-based registration connected to the bone with a dedicated metal arm secured with self-
tapping bone fixation screws. In the case of dentate patients with sta-
Fiducial-based registration protocol used a prefabricated thermoplas- ble teeth, the tracking array was connected to the clip. The surgical
tic device (clip) with three radiopaque fiducials (X-Clip, X-Nav Tech- handpiece and patient tracking arrays must be within the line of sight
nologies) positioned on the residual teeth of the dental arch involved of the overhead stereo cameras to be accurately tracked on the moni-
in the implant surgery or prior to the acquisition of the CBCT scan. tor. Hence, a link between the preoperative planning coordinate sys-
The clip device was removed after the CBCT, appropriately labeled, tem and the tracking coordinate system is automatically generated.
and stored for later use during implant surgery to hold the patient This stereo tracking algorithm triangulated the two arrays continu-
tracking array. Thereafter, the clip with the fiducial markers and the ously, to determine their precise position and orientation in a common
connected patient tracking array cylinder, properly oriented extrao- coordinate frame during the surgery. The dynamic connection of the
rally, was secured onto the teeth in the same location as during CBCT drill body and tip with the patient's CBCT anatomy and the implant
acquisition. Fiducial-based registration related the geometry of the coordinates pre-planned into the software is visualized with high mag-
patient tracking array to the CBCT images of the clip fiducials repre- nification on a dedicated screen to guarantee an accurate navigation
sented by the three radiopaque landmarks of the prefabricated ther- through a real-time coordination of the surgeon's hands and eyes22
moplastic device positioned in the patient mouth before CBCT (Figure 2). One expert clinician performed all the surgical and pros-
acquisition. thetic procedures after having received two full days of over-
the-shoulder training and completed 20 dynamic navigation implant
surgeries. All the implants were positioned by means of a dynamic
2.6 | Fiducial-free registration navigation surgery system (X-Guide, X-Nav Technologies). Depending
on the recipient site characteristics, conventional (with flap) or flapless
In the case of edentulous patients or terminal dentition with subse- surgical procedure was performed. The drilling protocol and sequence
quent residual teeth <3, a fiducial-free registration protocol was exe- for healed and post-extractive sites followed the criteria described by
cuted with a dedicated software algorithm (X-mark, X-Nav the authors in the previously published study.36
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POZZI ET AL.

Fiducial-free calibration registration in a complete edentulous patient.

Accuracy evaluation Step 1: Pre-operative implant planning.

FIGURE 2

FIGURE 3
958
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POZZI ET AL. 959

F I G U R E 4 Accuracy evaluation Step 2: Implant library geometries were aligned in the postoperative cone beam computed tomography
(CBCT) to the respective images of the placed implants.

2.8 | Prosthetic protocol the XYZ implant coordinates as a standard tessellation language (STL)
file. Using the X-Guide Accuracy Analysis software tool, the implant
The temporary screw-retained complete arch FDP was milled out by a characteristics (diameter and length) and position were detected and
five-axis milling machine (DWX-51D, Roland DG, Shizuoka-ken, recorded. The second mesh file was obtained uploading the postoper-
Japan) from a multilayered polymethylmethacrylate (PMMA) disk ative CBCT into the X-Guide software, then digital geometries of the
(Whitepeaks, Whitepeaks Dental Solutions GmbH & Co). The tempo- placed implants were aligned to the respective radiopaque images,
rary prosthesis was digitally designed according to the XYZ coordi- and finally exported as an STL file.
nates of the planned implants and their angulation eventually adjusted The exported preoperative and postoperative mesh files
using multi-unit abutments. The FDP prosthetic channels were digi- (Figure 5) were then merged with a “point based gluing” function in a
tally designed with a diameter of 4.5 mm to preserve the occlusal sur- dedicated software (MeshLab, Visual Computing Lab, ISTI-CNR, Italy).
face and at the same time house the temporary cylinders and Common anatomic references made by thick cortical bone were
facilitate the chairside relining.37 selected on both meshes to achieve an accurate superimposition.
Visual feedback of the alignment was performed aiming to obtain a
marble-like appearance of the merged file (Figure 6). The file was then
2.9 | Accuracy evaluation exported in a MLP format (MeshLab file format) and opened in
X-Guide.
After the surgery, a post-operative CBCT scan was executed with the The tool “X-Guide Accuracy Analysis” allowed to select and open
same FOV and resolution of the pre-operative CBCT examination. the three files (the preoperative plan, the postoperative plan, and the
The accuracy analysis required two meshes (STL files) to be superim- merged file) to analyze the case and produce a .txt file with implant
posed: the first one was represented by the implant planning deviation data.
(Figure 3) and the second was achieved from the postoperative CBCT Finally, the .txt file was launched in a programming language
scan (Figure 4). for scientific computing software (GNU Octave, GNU General Pub-
The first mesh file was obtained exporting from the X-Guide soft- lic License, University of Texas, TX, USA) that converted the script
ware (X-Guide, X-Nav Technologies) the implant planning including in a spreadsheet (Microsoft Excel, Microsoft, Redmond, WA, USA)
 17088208, 2024, 5, Downloaded from https://onlinelibrary.wiley.com/doi/10.1111/cid.13360 by Readcube (Labtiva Inc.), Wiley Online Library on [04/01/2025]. See the Terms and Conditions (https://onlinelibrary.wiley.com/terms-and-conditions) on Wiley Online Library for rules of use; OA articles are governed by the applicable Creative Commons License
960 POZZI ET AL.

F I G U R E 5 Pre-operative and
post-operative meshes (STL files)
segmented from the respective
cone beam computed
tomography (CBCT) examinations
(DICOM files).

• Platform depth deviation (mm): depth distance between the plat-

form centroids of the planned and placed implants on the z-axis.
• Global apical deviation (mm): overall 3-dimensional distance
between the apex centroids of the planned and placed implants.
• Apical B/L deviation (mm): buccolingual distance between the apex
centroids of the planned and placed implants on the x-axis.
• Apical M/D deviation (mm): mesiodistal distance between the apex
centroids of the planned and placed implants on the y-axis.
• Apical depth deviation (mm): depth distance between the apex
centroids of the planned and placed implants on the z-axis.

2.11 | Statistical analysis

Statistical analysis was performed using IBM SPSS Statistic software.

The normality of the distribution of the data was controlled with Kur-
F I G U R E 6 Pre-operative and post-operative meshes are properly tosis test. Descriptive analysis, including mean and standard deviation
aligned with a marble-like appearance. (SD) was calculated. The sample was divided into five dichotomous
variables (fiducial-based vs. fiducial-free; teeth vs. bone-screw; healed
vs. post-extractive; axial vs. tilted; maxilla vs. mandible) to investigate

containing the angular ( ) and linear deviations (mm) of each potential effect by means of independent samples t tests on calibra-
implant. tion registration algorithm, implant site characteristic, implant angula-
tion, type of jaw for each outcome value. p-value <0.05 was
considered the threshold for statistical significance.
2.10 | Outcomes This study is reported in accordance with the Strengthening the
Reporting of Observational Studies in Epidemiology (STROBE) state-
The following outcomes were then analyzed: ment for improving the quality of observational studies (http://www.
strobe-statement.org).38

• Angular deviation ( ): angle formed by the vertical axes of the
planned and placed implants.
• Global platform deviation (mm): overall 3-dimensional distance 3 | RE SU LT S
between the platform centroids of the planned and placed
implants. One hundred and sixty-one implants (59 NobelParallel TiUltra,
• Platform bucco-lingual (B/L) deviation (mm): buccolingual distance 55 NobelActive TiUltra, 47 N1, Nobel Biocare) were placed in
between the platform centroids of the planned and placed implants 25 patients (mean age 59.72). A total of 36 complete arches were
on the x-axis. treated and immediately loaded. No deviations from the original digi-
• Platform mesiodistal (M/D) deviation (mm): mesiodistal distance tal, surgical, and prosthetic protocol occurred and all the prefabricated
between the platform centroids of the planned and placed implants complete-arch FDPs were delivered with no or minimum adjustments
on the y-axis. at the prosthetic channel level. The main characteristics of the sample
 17088208, 2024, 5, Downloaded from https://onlinelibrary.wiley.com/doi/10.1111/cid.13360 by Readcube (Labtiva Inc.), Wiley Online Library on [04/01/2025]. See the Terms and Conditions (https://onlinelibrary.wiley.com/terms-and-conditions) on Wiley Online Library for rules of use; OA articles are governed by the applicable Creative Commons License
POZZI ET AL. 961

TABLE 1 Sample size characteristics. However, the paucity of well-designed clinical trials investigating
No. of patients (female, male) 25 (15, 10) dynamic navigation-guided surgery for complete-arch, advised the

Mean age (y) 59.72 need to assess its accuracy in these complex clinical scenarios. There-
fore, the primary aim of this study was to investigate the accuracy of
Implants evaluated 161
dynamic CAIS for complete-arch implant placement with subsequent
Complete arches rehabilitated 36
immediate loading with a prefabricated fixed dental prosthesis. To the
Fiducial-free: implants + (No. of arches) 107 (22)
best of the authors' knowledge, this is the first in vivo prospective
Fiducial-based: implants + (No. of arches) 54 (14)
study investigating dynamic CAIS accuracy in such a complex clinical
Post-extractive implants 73
procedure, based on an a priori sample size calculation.
Healed site implants 88 The overall results of this study indicate the maturity of the tech-
Axial implants 90 nology, workflow, and clinical protocol, as all implants were placed as
Tilted implants 71 planned with adequate stability and accuracy to allow for the immedi-
Maxilla: implants + (No. of arches) 59 (16) ate loading with prefabricated complete-arch FDPs. Accurate and pre-
Mandible: implants + (No. of arches) 102 (20) dictable implant placement is fundamental not only to avoid damage
to sensible anatomical structures but also to streamline the temporary
prosthetic workflow. The high correspondence between the planned
were summarized in Table 1. The mean and SD of all the platform and and placed implants, reported in the present study, allowed to prefab-
apex linear (Global, B/L, M/D and depth) and angular deviations strati- ricate congruous temporary FDPs with narrow diameter prosthetic
fied according to the analyzed variables are reported in Table 2. The channels, facilitating the chairside relining with minor adjustments and
results related to potential effect of five dichotomous variables (cali- reducing the amount of relining material.
bration registration algorithm, implant site characteristic, implant However, the results of the present study should be seen under
angulation, type of jaw) are reported in Tables 3–6. The fiducial-based the light of the limitations of the protocol and technology utilized. The
algorithm implants showed significant differences in the y-axis plat- reported outcomes are inherent to the investigated navigation system
form deviations ( 0.18 mm SD 0.63 mm, p = 0.0066), compared to and specific workflow and shall be extrapolated with caution to any
the fiducial-free algorithm (0.18 mm SD 0.84 mm) (Figure 7). For what other devices. Furthermore, one expert clinician performed all the sur-
it concerns depth z-axis deviation, the fiducial-based algorithm geries, which might inhibit generalization of such outcomes to opera-
implants showed significant differences ( 0.64 mm SD 0.78 mm, tors of different experience levels. Moreover, in the investigation
p = 0.0118) compared to the fiducial-free algorithm ( 0.31 mm SD method the accuracy analysis was based on a manual superimposition
0.77 mm) (Figure 8). Moreover, the fiducial-free algorithm did not of specific implant library geometries on the placed implants silhou-
report any significant differences in terms of global linear ( p = 0.610 ettes of postoperative CBCT scan. This manual matching could be
and p = 0.918) and angular (0.833) deviations between teeth and considered a limitation, even though the same procedure was adopted
bone-screws landmarks (Table 7). For the site characteristics, signifi- by other accuracy studies and performed by a well-trained
cant differences were found at the global platform ( p = 0.0009) and operator.1–40
global apical deviation (p = 0.0109) levels between healed and post- In the present study, the global platform and apex deviation were
extraction sites. In healed sites, significant deviations were found on 1.17 mm (SD 0.57 mm) and 1.30 mm (SD 0.62 mm) and an overall
the y-axis platform deviations ( 0.31 mm SD 0.73 mm, p = 0.0272) mean angular deviation was 2.19 (SD 1.26 ). A total of 36 complete
compared to implants placed in fresh extraction sockets ( 0.03 mm arches were treated and immediately loaded with no deviations from
SD 0.81 mm). Post-extractive implants resulted significantly different the original digital, surgical, and prosthetic protocols. Such positive
in the depth z-axis deviations (0.61 mm SD 0.89 mm, p = 0.0046) outcomes may be related to the specific navigation software target
than implant placed in healed sites ( 0.26 mm SD 0.67 mm). that allow a dynamic and easy-to-follow live tracking of the linear and
(Figures 9–11) For implant angulation (axial vs. tilted), no significant angular trajectories during the drilling, facilitating a fast adjustment in
differences were found concerning x- y- and z-axis and angular devia- case deviation occurs. A recent systematic review on static complete-
tion. For what it concerns the type of jaw, significant differences were arch computer-guided implant surgery showed average global plat-
found on the y-axis at implant platform and apex ( p = 0.0405 and form deviation, global apex deviation, and angular deviation of
p = 0.0410, respectively) (Figures 12, 13). 1.23 mm (95% CI 0.97–1.49), 1.46 mm (and 95% CI 1.17–1.74) and
3.42 (95% CI 2.82–4.03) suggesting that dynamic CAIS accuracy
could be similar or even higher compared to static CAIS.17 Neverthe-
4 | DISCUSSION less, accuracy data on dynamic navigation for complete-arch scenarios
are scarce with only two prospective clinical studies having investi-
The harmonic integration of miniaturized video-optical navigation gated the dynamic CAIS for such clinical cases. A prospective study by
trackers and a comprehensive 3-dimensional implant planning soft- Jaemsuwan and colleagues1 compared the accuracy of implant placed
ware may lead to a more efficient and accurate dynamic CAIS in the in 13 completely edentulous patients by means of freehand
daily routine with a temporary FDP to be delivered immediately.8 (6 patients), static (4 patients), and dynamic (3 patients)
 962

TABLE 2 Mean and SD of all the platform and apex linear (Global, B/L, M/D, and depth) and angular deviations stratified according to the analyzed variables.

Overall Fiducial-based Fiducial-free Healed Post-ex Axial Tilted Maxilla Mandible


Angular deviation mean (SD) 2.19 (1.26) 2.13 (1.30) 2.30 (1.26) 2.25 (1.30) 2.25 (1.28) 2.10 (1.22) 2.42 (1.36) 2.38 (1.42) 2.09 (1.15)
Global platform deviation mean (SD) mm 1.17 (0.57) 1.27 (0.58) 1.17 (0.58) 1.07 (0.52) 1.37 (0.61) 1.24 (0.57) 1.19 (0.63) 1.26 (0.67) 1.21 (0.54)
Platform BL mean (SD) mm 0.05 (0.55) 0.06 (0.60) 0.05 (0.53) 0.03 (0.52) 0.09 (0.58) 0.06 (0.56) 0.01 (0.63) 0.15 (0.67) 0.01 (0.45)
Platform MD mean (SD) mm 0.18 (0.78) 0.18 (0.63) 0.18 (0.84) 0.31 (0.73) 0.03 (0.81) 0.14 (0.80) 0.27 (0.76) 0.02 (0.82) 0.27 (0.69)
Platform depth mean (SD) mm 0.39 (0.78) 0.63 (0.77) 0.30 (0.77) 0.25 (0.66) 0.60 (0.88) 0.14 (0.80) 0.34 (0.82) 0.47 (0.75) 0.35 (0.80)
Global apical deviation mean (SD) mm 1.30 (0.62) 1.37 (0.70) 1.32 (0.65) 1.22 (0.65) 1.49 (0.68) 1.38 (0.64) 1.33 (0.77) 1.35 (0.71) (1.27 (0.57)
Apical BL mean (SD) mm 0.09 (0.65) 0.16 (0.71) 0.07 (0.64) 0.15 (0.65) 0.04 (0.68) 0.06 (0.66) 0.07 (0.78) 0.10 (0.78) 0.08 (0.56)
Apical MD mean (SD) mm 0.12 (0.93) 0.09 (0.87) 0.13 (1.03) 0.23 (0.94) 0.02 (1.02) - 0.08 (0.98) 0.18 (0.98) 0.09 (0.98) 0.23 (0.89)
Apical depth mean (SD) mm 0.41 (0.79) 0.64 (0.78) 0.31 (0.77) 0.26 (0.67) 0.61 (0.89) 0.44 (0.80) 0.36 (0.82) 0.49 (0.75) 0.35 (0.80)

TABLE 3 Potential effect of calibration registration algorithm (fiducial-based vs. fiducial-free) (independent sample t test) on each outcome value.

Fiducial-based versus fiducial-free Angular deviation Global platform Platform BL Platform MD Global Apical Apical BL Apical MD Depth
Mean difference 0.170 0.100 0.010 0.360 0.050 0.090 0.039 0.330
SE 0.215 0.097 0.093 0.131 0.112 0.112 0.165 0.129
95% CI 0.5937; 0.2537 0.0918; 0.2918 0.1742; 0.1942 0.6184; 0.1016 0.1705; 0.2705 0.1308; 0.3108 0.2868; 0.3648 0.5857; 0.0734
p-value 0.4293 0.3048 0.9148 0.0066 0.6548 0.4220 0.8134 0.0118

Note: Bold indicates statistically significant values.

POZZI ET AL.

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 POZZI ET AL.

TABLE 4 Potential effect of implant site characteristics (healed vs. post-extractive) (independent sample t test) on each outcome value.

Healed versus post-extractive Angular deviation Global platform Platform BL Platform MD Global apical Apical BL Apical MD Depth
Mean difference 0.010 0.300 0.050 0.270 0.270 0.100 0.250 0.350
SE 0.203 0.089 0.087 0.131 0.105 0.105 0.154 0.122
95% CI 0.4109; 0.3909 0.1247; 0.4753 0.2225; 0.1225 0.5092; 0.0308 0.0630; 0.4770 0.1070; 0.3070 0.5546; 0.0546 0.5906; 0.1094
p-value 0.9608 0.0009 0.5678 0.0272 0.0109 0.3414 0.1070 0.0046

Note: Bold indicates statistically significant values.

TABLE 5 Potential effect of implant angulation (axial vs. tilted) (independent sample t test) on each outcome value.

Axial versus tilted Angular deviation Global platform Platform BL Platform MD Global apical Apical BL Apical MD Depth
Mean difference 0.320 0.050 0.060 0.130 0.050 0.010 0.100 0.070
SE 0.205 0.095 0.095 0.124 0.112 0.114 0.156 0.128
95% CI 0.0843; 0.7243 0.2381; 0.1381 0.1280; 0.2480 0.3758; 0.1158 0.2709; 0.1709 0.2355; 0.2155 0.4081; 0.2081 0.1827; 0.3227
p-value 0.1200 0.6002 0.5293 0.2978 0.6554 0.9303 0.5223 0.5850
963

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 17088208, 2024, 5, Downloaded from https://onlinelibrary.wiley.com/doi/10.1111/cid.13360 by Readcube (Labtiva Inc.), Wiley Online Library on [04/01/2025]. See the Terms and Conditions (https://onlinelibrary.wiley.com/terms-and-conditions) on Wiley Online Library for rules of use; OA articles are governed by the applicable Creative Commons License
964 POZZI ET AL.

computer-assisted navigation systems. Average global platform devia-

0.1227; 0.3827
tion, global apex deviation, and angular deviation for dynamic naviga-
tion were 1.73 (0.43) mm, 1.86 (0.82) mm, and 5.75 (2.09 ). No

0.3111
0.130
0.128
significant difference was found between static and dynamic surgery

Depth
in terms of accuracy, while the freehand protocol expressed signifi-
cantly higher deviation values. However, within the sample, the eden-

0.0128
tulous patients treated with dynamic CAIS were less represented.
Another proof-of-concept prospective study by Pomares and
colleagues,2 merging static and dynamic computer-guided surgery,
Apical MD

0.6072;
0.0410
0.310
0.150
was executed on 12 complete-arch cases, reporting global platform
deviation, global apex deviation, and angular deviation of 1.42 mm
(SD 0.64), 1.25 MM (SD 0.55), and 3.74 (SD 2). Even though the
0.1896; 0.2296

accuracy was similar to the present study, a direct comparison is not

advisable as the implant placement was performed with a combination
Apical BL

of static and dynamic surgery instead of a pure navigation protocol.

0.8508
0.020
0.106

It is not surprising that dynamic CAIS can reach high levels of

accuracy of implant placement in the light of recent systematic
reviews, which have shown not only superior accuracy compared to
0.2818; 0.1218

freehand placement but also slight decrease the angular deviation in

Global apical

comparison with the static CAIS.33,40 The present study results of

0.4348
0.080
0.102

accuracy are in line with the ones described by a recent systematic

review with meta-analysis, which evaluated five clinical and five simu-
Potential effect of type of jaw (maxilla vs. mandible) (independent sample t test) on each outcome value.

lation studies in terms of average global platform deviation, global

apex deviation, and angular deviation.26 According to the average
0.0109

accuracy values, dynamic CAIS could be considered as acceptable for

Platform MD

most situations. Still, the maximum deviation measurements recorded

0.4891;
0.0405

by Wei and colleagues26 (4.55 mm and 11.94 ) must be considered

0.250
0.121

with caution to prevent damage to vital anatomical structures. In the

present study, the maximum linear and angular deviations (3.08 mm
and 5.3 ) were considerably lower. This could be attributed to the
0.0247; 0.3247

placement of all the implants by only one skilled operator with a long
Platform BL

experience in computer-guided surgery. In fact, the operator experi-

0.0918
0.150
0.088

ence and learning curve in dynamic navigation was found to be a sig-

nificant factor in influencing the implant placement accuracy.17
Furthermore, the maximum deviation reported by Wei and
0.2408; 0.1408
Global platform

colleagues,25 are related to an old in vitro study testing a prototype

dynamic CAIS system, which might be not of relevant with current
0.6055

protocols.41 Moreover, the systematic review with meta-analysis by

0.050
0.097

Yu and colleagues40 assessing the accuracy of dynamic CAIS in clinical

studies reported only one complication (failed osseointegration in four
Note: Bold indicates statistically significant values.

implants), while more serious complications (e.g., nerve damage and

Angular deviation

0.6955; 0.1155

large-scale deviations) were not observed. In the present study, no

complications during the navigation-guided implant surgery were
0.1598
0.290
0.205

reported, all the implants were placed, and the digitally prefabricated
prosthesis fit on the temporary cylinders with minor or no adjust-
ments at the prosthetic channel level.
Maxilla versus mandible

The secondary aim was to evaluate the potential influence of cer-

tain variables as calibration registration algorithm, type of reference
Mean difference

for fiducial free registration, implant site characteristics, implant angu-

lation, and type of jaw on the on the linear and angular accuracy. The
TABLE 6

null hypothesis that no significant difference in the overall linear and

p-value
95% CI

angular deviations would be found between fiducial-based versus

SE

fiducial-free registration algorithms, teeth versus bone screws

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POZZI ET AL. 965

F I G U R E 7 Platform deviation distributions on M/D, B/L stratified per calibration registration algorithm (green dots = fiducial-free; yellow
dots = fiducial-based). M/D shifting was statistically significant toward the distal side ( p = 0.006).

F I G U R E 8 Depth deviation distributions stratified per calibration registration algorithm (green dots = fiducial-free; yellow dots = fiducial-
based). Implants with fiducial-based protocol were placed deeper than the pre-planned coordinates ( p = 0.011).
 17088208, 2024, 5, Downloaded from https://onlinelibrary.wiley.com/doi/10.1111/cid.13360 by Readcube (Labtiva Inc.), Wiley Online Library on [04/01/2025]. See the Terms and Conditions (https://onlinelibrary.wiley.com/terms-and-conditions) on Wiley Online Library for rules of use; OA articles are governed by the applicable Creative Commons License
966 POZZI ET AL.

references for fiducial free protocol, maxilla versus mandible, healed

43 068; 15 786
versus post-extractive and axial versus tilted implants was partially
rejected. Significant differences were found only between healed and
post-extraction sites at the global platform ( p = 0.0009) and global

0.136
Depth

0.149

0.363
apical deviation ( p = 0.0109) levels. For implant angulation, no signifi-
cant differences were found concerning global x- y- and z-axis and

0.2236
angular deviation.
However, even though no other significant differences were
Apical MD

found at global level between the investigated dichotomous variables,

0.9808;
0.602
0.190

0.002
Independent sample t test to assess significant differences in fiducial-free subgroup between tooth-based and bone screw-based calibration algorithm.

navigation tracking algorithm showed a partial significant effect as

M/D platform ( p = 0.006) and apical depth ( p = 0.012) deviations
and the type of jaw as M/D platform ( p = 0.040) and M/D apical
0.1871; 0.3046

(p = 0.041) deviations levels.

Considering the global platform and apex deviations, implants in
Apical BL
0.058
0.124

0.637

healed sites were more accurate than those in post-extraction

sockets ( p = 0.0009 and 0.0109, respectively). However, the M/D
shifting toward the distal side was more pronounced in the healed
0.2626; 0.2367

sites at platform ( p = 0.0272), and in the mandibular implants at

Global apical

platform ( p = 0.0405) and at apex ( p = 0.0410) levels. This may be

0.012
0.125

0.918

related to the drill tip engagement to the cortical zone of the bone,
which may provoke a displacement caused by the drill rotation itself,
while it is not affecting the drilling trajectory in post-extraction
0.8045; 0.1865

sockets. On the contrary, implants placed by means of fiducial-free

Platform MD

algorithm slightly tending on the mesial shifting of the platform

0.495
0.155

0.002

( p = 0.0066) than implants placed by means of fiducial-based algo-

rithm. Moreover, the fiducial-free algorithm was divided into tooth-
based and bone screw-based calibration protocol, reporting no sig-
0.2670; 0.1408

nificant differences in terms of global linear ( p = 0.610 and

Platform BL

p = 0.918) and angular (0.833) deviations between the two groups.

0.0630
0.102

0.541

Such outcome was related to the latest implementation of the AI

machine learning process in the fiducial-free registration algorithm,
that allowed to automatically detect the screws into the bone with-
0.2792; 0.1646

out the need to of a physical calibration probe-based marking. Other

Global platform

significant differences were related to implant depth. Implants

placed in post-extraction sites tended to be deeper than implants in
0.057
0.111

0.610

healed sites ( p = 0.0046), most likely because of the need to achieve

higher primary stability by engaging more native bone. Despite that,
Angular deviation

the fiducial-based implants were placed deeper ( p = 0.0118) than

0.4322; 0.5354

the fiducial-free ones.

Different variables have been reported to influence the overall
0.051
0.244

0.833

Note: Bold indicates statistically significant values.

deviation of the implant positioning compared to the digital plan-

ning.33 These factors are linked to the preoperative dynamic naviga-
tion workflow (misfit of the radiological fiducial markers, patient
Tooth based versus bone-screw based

and/or fiducial markers movement during CBCT, CBCT low quality/

resolution, or registration issues of the radiological markers through
the planning software), to intraoperative procedures (patient and/or
handpiece optical marker movement, improper drill axis and/or tip cal-
ibration) and to patient and implant factors (number/lack of teeth,
Mean difference

type of jaw, implant site characteristics, implant type and

length).26,42–44 Thus, the control of each step of the dynamic naviga-
TABLE 7

tion workflow is strongly advised, in particular the use of a large CBCT

p-value
95% CI

FOV to avoid stitching procedures that could potentially decrease the

SE

accuracy of the anatomical information included in the DICOM file.

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POZZI ET AL. 967

F I G U R E 9 Platform deviation distributions on M/D, B/L stratified per implant site characteristic (red dots = post-extraction sites; blue
dots = healed sites). M/D shifting was statistically significant toward the mesial side ( p = 0.027).

F I G U R E 1 0 Apical deviation distributions on M/D, B/L stratified per implant site characteristic (red dots = post-extraction sites; blue
dots = healed sites). M/D shifting was statistically significant toward the mesial side ( p = 0.010).

Considering the reported outcomes in terms of global linear account by the expert operator to execute navigation-guided com-
angular deviations and all the disclosed limitations of this study, a plete arch surgery with immediate loading of digital
mean safety room of about 1 mm and 2 degrees should be take into prefabricated FDP.
 17088208, 2024, 5, Downloaded from https://onlinelibrary.wiley.com/doi/10.1111/cid.13360 by Readcube (Labtiva Inc.), Wiley Online Library on [04/01/2025]. See the Terms and Conditions (https://onlinelibrary.wiley.com/terms-and-conditions) on Wiley Online Library for rules of use; OA articles are governed by the applicable Creative Commons License
968 POZZI ET AL.

F I G U R E 1 1 Depth deviation distributions stratified per implant site characteristic (red dots = post-extraction sites; blue dots = healed sites).
Post-extraction implants were placed deeper than the pre-planned coordinates ( p = 0.004).

F I G U R E 1 2 Platform deviation distributions on M/D, B/L stratified per type of jaw (light blue dots = maxilla; gray dots = mandible). M/D
shifting was statistically significant toward the distal side ( p = 0.040).
 17088208, 2024, 5, Downloaded from https://onlinelibrary.wiley.com/doi/10.1111/cid.13360 by Readcube (Labtiva Inc.), Wiley Online Library on [04/01/2025]. See the Terms and Conditions (https://onlinelibrary.wiley.com/terms-and-conditions) on Wiley Online Library for rules of use; OA articles are governed by the applicable Creative Commons License
POZZI ET AL. 969

F I G U R E 1 3 Apical deviation distributions on M/D, B/L stratified per type of jaw (light blue dots = maxilla; gray dots = mandible). M/D
shifting was statistically significant toward the distal side ( p = 0.041).

5 | C O N CL U S I O N S DATA AVAILABILITY STAT EMEN T

The data that support the findings of this study are available from the
Within the study limitations, dynamic CAIS was reliable for corresponding author upon reasonable request.
complete-arch implant placement and immediate loading of digi-
tally pre-fabricated FDP. AI-driven surface anatomy identification OR CID
and calibration protocol made fiducial-free registration as accurate Paolo Carosi https://orcid.org/0000-0002-2442-1091
as fiducial-based and teeth and bone screws equal as references. Nikos Mattheos https://orcid.org/0000-0001-7358-7496
Implant site characteristics were the only statistically significant Atiphan Pimkhaokham https://orcid.org/0000-0002-0170-243X
variable affecting global platform and apical deviation, with healed
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