Article published online: 2020-11-26
THIEME

Original Article

Role of New Hydrophilic Surfaces on Early Success
Rate and Implant Stability: 1-Year Post-loading
Results of a Multicenter, Split-Mouth, Randomized
Controlled Trial
Marco Tallarico1 Nicola Baldini2 Fulvio Gatti3 Matteo Martinolli4 Erta Xhanari1
Silvio Mario Meloni5 Cervino Gabriele6 Lumbau Aurea Immacolata5
1 School of Dentistry, University of Sassari, Sassari, Italy
2 Department of Periodontics and Implantology,

University of Siena, Siena, Italy

3 Department of Biomedical, Surgical and Dental Sciences,

Address for correspondence Silvio Mario Meloni, DDS, MSc, PhD,
Medical Surgical and Experimental Science Department,
University of Sassari, Viale San Pietro 43 B, 07100 Sassari, Italy(e-mail: melonisilviomario@yahoo.it).

Unit of Oral Surgery, San Carlo and San Paolo Hospital,
University of Milan, Milan, Italy
4 Private Practice in Porto Viro, Porto Viro, Italy
5 Medical Surgical and Experimental Science Department,
University of Sassari, Sassari, Italy
6 Department of BIOMORF, School of Dentistry,
University of Messina, Messina, Italy
Eur J Dent:2021;5:1–7

Abstract

Keywords► dental implants► implant surface► osseointegration► bone quality

Objective To compare early implant failure and implant stability of one-stage
Hiossen ET III implants with its new hydrophilic (NH) surface, compared with Hiossen
ET III implants with the sandblasted and acid-etched (SA) surface at 1-year follow-up.
Materials and Methods This study was designed as a split-mouth, multicenter
randomized controlled trial aimed to compare SA surface implants (SA group) andNH surface, (NH group). Outcomes were implant and prosthetic survival rates, complications, the insertion torque at implant placement, and implant stability quotient(ISQ) values.
Results Twenty-nine patients (mean age 59.9 ± 11.3 years) were treated and followed up to 1 year after loading. No patient dropped out. Fifty-eight implants(29 SA group and 29 NH group) were placed. No implants or prostheses failed andno complications were experienced during follow-up. The mean insertion torque was
40.5 ± 3.23 (38.17–41.83) Ncm in the SA group and 40.48 ± 3.49 (38.02–41.98) Ncm
in the NH group (p = 0.981). There was a statistically significant difference at thesecond week (T2) with higher values in the NH group (p = 0.041). Similar results
were found in the maxilla (p = 0.045), but not in the mandible (p = 0.362). A positive
correlation was found between initial insertion torque and ISQ with higher value in the
NH group (0.73 vs. 0.66).
Conclusions NH implants are a viable alternative to SA surface, as they seem to avoid
the ISQ drop during the bone remodeling phase.

DOI https://doi.org/
10.1055/s-0040-1713952
ISSN 1305-7456.

© 2020. European Journal of Dentistry.
This is an open access article published by Thieme under the terms of the Creative
Commons Attribution License, permitting unrestricted use, distribution, andreproduction so long as the original work is properly cited. (https://creativecommons.
org/licenses/by/4.0/)

Thieme Medical and Scientific Publishers Pvt. Ltd., A-12, 2nd Floor,
Sector 2, Noida-201301 UP, India

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Introduction
Modern dentist has an excellent solution to solve patient’s
edentulism using dental implants. It has been shown thatdental implants have long-term successful outcomes, representing a viable option for clinicians to rehabilitate completeor partial edentulous patients with both fixed and removable
solutions.1 Albrektsson et al introduced the concept of foreign
body equilibrium, applied to the osseointegration of titanium
dental implants. This equilibrium is an immune-mediatedforeign body reaction balance during the biological integration of dental implants into the bone. When this equilibrium
moves to a disadvantage periimplant bone loss can occur.2
Nevertheless, implant failures could still happen in a reduced
number of compromised patients, due to the lack of enoughunderstanding of related risk factors.
The causes of bone loss around dental implants and theconsequent implant failure may be different and related to
implant macro-/microdesign and surface chemical composition, biologic issues, bone quality, surgical technique,host-related factors, and iatrogenic factors.3-5 The failure of a dental implant has been classified as early or latedepending on its time of occurrence.6 Early dental implantfailures occur prior to the abutment connection, as consequence of a lack of integration with the bone,5-7 and late
failures occurs after prosthetic loading, as consequence of
plaque-induced peri-implantitis and/or to occlusal overloading.8 Osseointegration around titanium implants is acomplex biological phenomenon not yet clearly understood.
Nevertheless, the surface modifications of titanium dental
implants play important roles in the enhancement of osseointegration. With the aim of accelerating and improving theosseointegration process many implant surface treatments
were proposed. The surface modification is focused mainly
to chemically enhance the roughness of dental implants toincrease the appropriate biological response between theliving tissues and the dental implants.9,10 Furthermore, asideof improving osseointegration, these implant surface modifications have been shown to increase cell viability andbiocompatibility.11
This topographical change is achieved by acid treatments,
sandblasting, or different mechanisms of oxidization.8
Sandblasted acid-etched surface (SA) dental implants havea macroroughness achieved with abrasive particles (sandblasting) and micropits obtained by acid etching to improve
osseointegration.8,10 The SA surface provides an appropriate
space for osteoblast adhesion, proliferation, and differentiation.12 This result can be further improved by using a double
etching process increasing the surface available for new bone
ingrowth, hence greatly improving the mechanical fixation.13
The more the dental implants used in daily dental practice, the greater the clinical interest becomes in the implants
integrating quickly with the bone to be functional. In thelast decade, there was a continuous commitment to improve
the implant surface to quicken the process of osseointegration and improve its quality.14,15 Today, the goal is reducing
the healing period from 6 to 8 weeks down to 3 to 4 weeks

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in all the indications. These efforts have been concentrating
in improving the bone to implant interface chemically (byincorporating inorganic phases on or into the titanium oxide
layer) or physically (by increasing the level of roughness).16,17
Although shorter healing period was presented in many
experimental and clinical studies using sandblasted, large
grit, and acid-etched (SLA) surfaces,18,19 modification of thissurface seems to present a stronger bone response than its
predecessor.20,21
The aim of this split-mouth randomized controlled trial
was to compare early implant failure and implant stability of
one-stage Hiossen ET III implants with its new hydrophilic(NH) surface, compared with Hiossen ET III implants with thewell-known SA surface at 1-year follow-up. The null hypothesis was that there is no difference between groups. The null
hypothesis was tested against the alternative hypothesis ofdifferences between them. A preliminary report from one
center has been published.10 The following trial was reported
according to the CONSORT statement guidelines (http://
www.consort-statement.org/).

Materials and Methods
This study was designed as a split-mouth, randomized controlled trial of parallel groups with two arms and independent outcome assessment when possible, conducted at four
centers between November 2017 and May 2018. The protocol
was registered in the clinicaltrial.gov (NCT03649100). The
2013 Helsinki declaration was adhered too. The study was
performed after approval was received from the Institutional
Review Board of the Aldent University, Tirana, Albania (March2018). All the surgical and prosthetic procedures were performed by one expert clinician at each center.
Any healthy patients, aged 18 years or older, required
at least two implants to be rehabilitated with a fixed
implant-supported restoration, with a full mouth bleeding
and full mouth plaque index ≤25%, with a sufficient bone
to allow placement of at least 11.5-mm-long implants, andbone width of at least 6 to 8 mm for the placement of a regular platform Hiossen ET III implant (Deutsche Osstem GmbH,
Eschborn, Germany) were included in this study. The exclusion criteria were in ►Table 1.
Patients were informed about the clinical procedures,the materials to be used, the benefits, potential risks andpotential complications, as well as any follow-up evaluations required for the clinical study. Patients had to sign theinformed consent before including in the study.
A single dose of antibiotic (2 g of amoxicillin and clavulanic acid or clindamycin 600 mg if patients were allergic topenicillin) was administered prophylactically 1 hour before
surgery. Patients rinsed with 0.2% chlorhexidine for 1 minute.
Local anesthesia will be induced using a 4% articaine solution with epinephrine 1:100,000 (Ubistesin; 3M Italia, Milan,
Italy). Implants were placed in the planned anatomic sites
using a flapless or a mini-flap approach. Bone density wasassessed, according to the Lekholm and Zarb classification,
during the drilling phase, based on the clinician’s experienceRCT on Different Implant Surfaces
and judgment. Implant site was prepared simultaneously,according to the drilling protocol recommended by the
manufacturer (placed at 0.5-mm subcrestal level or deeper
according to the bone quality and the soft tissue thickness).
The SA surface implants (SA group) or SA surface implants
with a newly developed bioabsorbable apatite nanocoating(NH group) were randomized after implant site preparation,
immediately before implant placement. Implants used inevery group were identical except for the surface treatment.
Implants were placed according to a one-stage protocol.
Postsurgical analgesic treatment was performed with ibuprofen 600 mg, which was administered twice a day for 2 days
after the surgery, and later on, if required. Periapical radiographs were taken with a customized holder at implant placement, at the definitive prosthesis delivery (►Figs. 1 and 2),
and then yearly (►Figs. 3 and 4). Two to three months after
implants placement patients receive single screw-retained
restorations.

Tallarico et al.

The outcome measures were implant and prosthetic survival rates, any biological or mechanical complications at
implants that occurred during the entire observation period,
the insertion torque at implant placement, and the implantstability quotient (ISQ).
Success rates of the implants and prostheses were evaluated by an independent assessor (E.X.). An implant was considered a failure if it presented mobility, assessed after theosseointegration period by tapping or rocking the implant
head with the metallic handles of two instruments, progressive marginal bone loss or infection, or any mechanical

Table 1 Exclusion criteria
Positive medical findings (such as stroke, recent cardiac
infarction, severe bleeding disorder, uncontrolled diabetes,or cancer).

Fig. 2 Clinical picture at the definitive prosthesis delivery.

Psychiatric therapy.
Pregnancy or nursing.
Smoking >10 cigarettes/d.
Insertion torque <30 Ncm.
Untreated periodontitis and/or poor oral hygiene.
Acute and chronic infections of the adjacent tissues or naturaldentition.
Previous radiotherapy of the oral and maxillofacial region within
the past 5 y.
Postextractive implants (at least 3 mo after tooth extraction).
Absence of teeth in the opposing jaw.
Severe clenching or bruxism.
Severe maxillomandibular skeletal discrepancy.

Fig. 3 Periapical radiograph at the 1-year follow-up.

Fig. 1 Periapical radiograph at the definitive prosthesis delivery.

Fig. 4 Clinical picture at the 1-year follow-up. ISQ, implant stability
quotient.
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complications rendering the implant unusable, although stillmechanically stable in the bone. A prosthesis was considereda failure if it needed to be replaced with another prosthesis.
Biological (pain, swelling, suppuration, etc.) and/or
mechanical (screw loosening, fracture of the framework, theveneering material, etc.) complications occurred during thefollow-up period. Complications were evaluated and treatedby the same surgeon (M.T.).
Insertion torque was recorded at implant placement by
the same surgeon (M.T.) using the iChiropro surgical unit
(Bien-Air, Bienne, Switzerland).
The insertion torque values of the implants were measured and recorded at implant placement, using the same
surgical unit used to place the implants.
The ISQ was measured and recorded using a smart peg(Type 47 cod. 100478, Osstell, Gothenburg, Sweden) connected to the implants, and the Osstell Mentor device(Osstell). Measurements were taken at implant placement,
and every week up to 8 weeks after implant placement. In
case of ISQ value <55 or in case of implant mobility, healing
abutment was replaced with a cover screw and the implant
was left to heal submerged for at least 6 weeks.
A blind outcome assessor collected the data (E.X.), according to a previously published study.3
A pregenerated random list, consisting of a randomized
sequence of consecutive numbers matching the two different procedures within group A or group B, was created using
random number generator pro 1.91 for Windows (Segobit
Software; www.segobit.com). Opaque envelopes containing
the randomization codes were sequentially numbered andsealed. According to a pre-generated list, an independent consultant, not previously involved in the trial, prepared all theenvelopes and then opened immediately after implant sites
preparation. Site one was defined the site with the lower sextant number and the most mesial. Patients and statistician
were blinded, while doctor not due to the different opacityof the implant surface. Patient data were collected in an Excel
spreadsheet (Microsoft) that reflected the parameters in thepatient records. The data were exported into SPSS software for
Mac OS X (version 22.0; SPSS, Chicago, Illinois, United States),
for the statistical analysis. Descriptive analysis was performed
for numeric parameters using means and standard deviations(95% confidence interval). Complications and failures werecompared using the Fisher’s exact test. Comparisons between
groups (SA vs. NH), and between jaws (maxilla vs. mandible)

were made by unpaired t-test, while the comparison between
baseline (T0) and the last follow-up (T8) was made by paired
t-tests to detect any change during the follow-up. Pearson’s
correlation coefficient was used to evaluate the correlation
between insertion torque at implant placement and ISQ value
8 weeks after implant placement. All statistical comparisonswere two-tailed and conducted at the 0.05 level of significance. The patient was used as the statistical unit of analysis.

Results
Only three out of four centers managed to recruit and treat
patients according to the study protocol. Initially, 39 patientswere screened but six patients were not included because
they did not have sufficient bone to allow placement of
11.5-mm-long and 4-mm diameter implants; two patientswere not included because they did not want to participate
in the study; and the other two patients were heavy smokers.
A total of 29 patients (22 females and seven males, with amean age at implant insertion of 59.9 ± 11.3 years) weretreated according to the allocated interventions and followed up to 1 year after loading. No patient dropped out.
A total of 58 implants (29 with SA surface and 29 with SA
surface with the newly developed bioabsorbable apatite
nanocoating) were placed. Eighteen patients were rehabilitated in the maxilla and 11 in the mandible. One-year after
loading, no implant and no prosthesis failed. Two weeks after
implant placement, two Hiossen ET III SA implants showeda small mobility with an ISQ values lower than 55 (49 and51, respectively). The healing abutments were replaced withcover screws and the implants were left to heal undisturbed
up to 8 weeks after their placement. Nevertheless, no statistically significant difference was reached (p = 0.491). In boththe implants, the healing abutments were replaced with acover screw and the implants were left to heal submerged for
6 weeks (up to 8 weeks after implant placement).
The mean insertion torque ranged between 35.0 and
45.0 Ncm (mean of 40.5 ± 3.23 [38.17–41.83] Ncm in the SAgroup and 40.48 ± 3.49 [38.02–41.98] Ncm in the NH group).
The difference between groups was not statistically significant (p = 0.981).
The comparison between ISQ values was reported in►Table 2 and ►Figs. 5 to 7.
There was a statistically significant difference between
groups at the second week after implant placement (T2) with

Table 2 The ISQ values between and within groups
T0 (n = 29) T1 (n = 29) T2 (n = 29) T3 (n = 27) T4 (n = 27) T5 (n = 27) T6 (n = 27) T8 (n = 29) Difference p-Value
T8–T0
SA

77.8 ± 5.7 76.1 ± 6.0 72.7 ± 9.0 75.0 ± 7.0
77.7 ± 4.9 78.3 ± 3.6 78.8 ± 3.7 78.7 ± 4.3 1.0 ± 4.4
0.266(75.8–82.2) (74.1–80.9) (68.9–79.1) (71.0–79.0) (75.3–80.7) (75.9–80.1) (76.1–80.4) (76.8–81.7) (2.0 to 3.0)

NH

76.4 ± 5.7 77.0 ± 5.5
76.9 ± 4.9 76.9 ± 4.9
77.1 ± 4.7 77.5 ± 4.2 78.1 ± 4.3 78.6 ± 3.8 1.9 ± 3.9
0.019a(71.8–78.2) (71.9–78.1) (72.2–77.8) (75.2–80.8) (75.3–80.7) (75.6–80.4) (75.6–80.4) (77.8–82.2) (−1.2 to 3.2)

Difference 1.3 ± 6.5
0.8 ± 5.1
4.2 ± 9.1
1.9 ± 4.4
0.5 ± 4.1
0.7 ± 3.1
0.5 ± 2.7
0.1 ± 3.9–(−1.7 to 5.7) (−1.0 to 2.9) (−7.2 to 3.2) (−4.0 to 1.0) (−3.3 to 1.3) (−1.7 to 1.7) (−1.5 to 1.5) (−2.5 to 2.0)
p-Value

0.393

0.597

0.041a

0.258

0.662

0.473

0.550

Abbreviations: ISQ, implant stability quotient; NH, new hydrophilic; SA, sandblasted and acid etched.
aStatistically significant.
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0.919

–

–
–

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Fig. 5 Overall comparison of mean ISQ values between groups. ISQ,
implant stability quotient.

Fig. 6 Comparison of mean ISQ values between groups (in the mandible). ISQ, implant stability quotient.

Fig. 7 Comparison of mean ISQ values between groups (in the maxilla). ISQ, implant stability quotient.

higher values in the NH group (p = 0.041). Similar results
were found in the maxilla (p = 0.045), but not in the mandible(p = 0.362). Overall, the ISQ values improved in both groups
during the entire follow-up (8 weeks), with statistically significant difference in the NH group (p = 0.019), but not in
the SA group (p = 0.266). A positive correlation was foundbetween initial insertion torque and ISQ with higher value in
the NH group (0.73 vs. 0.66). Correlation was stronger in themandible (SA = 0.71; NH = 0.86) compared with the maxilla(SA = 0.52; NH = 0.55).

Discussion
Nowadays there is a strong effort in improving the bone
to implant interface modifying dental implant surface toimprove bone integration and reduce the timing of this process to help clinician in the treatment of edentulous patients.
Exactly in this context our study was oriented, in fact thissplit-mouth randomized controlled trial was aimed to compare early implant failure and implant stability of one-stage
Hiossen ET III implants with its NH surface, compared with

Tallarico et al.

Hiossen ET III implants with the well-known SA surface up
to 1-year of follow-up. The null hypothesis of no difference
was partially rejected in favor of the alternative hypothesis ofdifference between groups.
Overall, the mean ISQ improved in both groups during
the 8 weeks of follow-up, but the values were with statistically significant difference only in the NH group (p = 0.019).
The reason was partial due to the fact that 2 weeks after
implants placement the mean ISQ value was statistically significant higher in the NH group compared with the SA group(p = 0.041). A possible explanation could be the unexpectedvalues of ISQ in the SA implant group caused by two implantsthat showed values <55 with slightly implant mobility. As aconsequence, implants were left to heal submerged for the
next 6 weeks. Nevertheless, it can therefore be assumed
that implants with the hydrophilic surface (NH) seem toreduce complications avoiding the ISQ drop back during theremodeling phase allowing accordingly benefits in immediate loading, poor bone quality, post-extractive and maxilla.
The main limitations of the present randomized controlled
trial are the small sample size and the short-term follow-up.
Unfortunately, one center did not participate to the study,
contributing to the small sample size.
The ongoing effort of dental companies to improve the interface between bone and implant surface to speed up the processof osseointegration has been proposed by researcher and dental implant companies, and data underlined in this paper, especially for the NH surface, confirm the chance to reduce time in
implant therapy. Today, primary implant stability and absenceof micromovements still remain two of the main prerequisites
for obtaining a stable osseointegration and the achievementof long-term high-success rates.22,23 On the contrary, if during
the first healing period of the implant the primary stability is
insufficient, early implant failure can occur.24,25
In the present study, similar statistically significancewas found in the maxilla (p = 0.045), but not in the mandible (p = 0.362). To minimize the change of early implantfailure, during the last decades it has been suggested that
implants should be kept load-free during a healing periodof 3 to 4 months in mandibles and 6 to 8 months in maxillae.26 Nowadays, the more the implants are used in clinical routine, the greater the clinical interest becomes in theimplants integrating quickly with the bone to be functional.
An ongoing effort to improve the interface between bone andimplant surface to speed up the process of osseointegration
has been proposed by researcher and dental implant companies, modifying implant surface roughness and topography.26
To better understand dental implant roughness it is commonly divided, depending on the dimension of the measured
surface features, into macro-, micro-, and nano roughness.
All these kinds of roughness and topography have direct consequences on bone response during the healing period of tissues around dental implants.27-29 Nowadays, it is well known
that the implant roughness improves osseointegration andthe majority of implant types are sandblasted and/ or acidetched to increase their surface texture.24 Furthermore thenanometer roughness has the main role in the adsorptionof proteins, adhesion of osteoblastic cells, and thus the rate
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of osseointegration.30 Furthermore, Schwarz et al showedthat hydrophilic surfaces enhance the angiogenesis process
when early stages of osseointegration occur.31-33 Actually, fast
vascularization seems beneficial for bone formation because
osteogenic cells have been observed to arise from pericytes
adjacent to small blood vessels.23,34 In a review of Wennerberg
et al, a little clinical evidence was found to clearly state apreference for SLActive over SLA implant.35,36 At 1-year follow-up, there was a high survival rate (100% for SLActive vs.
96% for SLA implants) and low crestal bone loss <0.4 mm inboth groups with no significant difference.
Recent literature suggest that an optimal insertion torquecould be around 30 Ncm to obtain a successful and durable osseointegration, which is also sufficient to allow bothconventional and immediate occlusal loading of dental
implants.37 The reason why dental implant companies andresearchers are focused on implant design improvements andsurface modification is to help both clinicians and patients tofasten implant surgery and prosthetic timing,26,38-44 for same
reasons, researchers are focused on digital dentistry and indeveloping guidelines in implant dentistry.45-47
In the present study, a positive correlation was foundbetween initial insertion torque and ISQ with higher value
in the NH group (0.73 vs. 0.66). Correlation was stronger
in the mandible (SA = 0.71; NH = 0.86) compared with themaxilla (SA = 0.52; NH = 0.55). The clinical implication fromthis randomized controlled trial may be that implants with
NH surface modification could be an important option whentreating patients, especially when the timing of loading is
crucial. Considering the positive correlation found between
high torque insertion and an increased ISQ level, and better
results in the maxilla, this surface treatment could be a viable treatment option in case of immediate loading, poor bonequality (such us posterior maxilla), postextractive implants,
or high risks patients, such us immunocompromised patientsor heavy smokers.

Conclusions
Considering the limitation of this multicenter, split-mouth,
randomized controlled trial, NH implants are a viable alternative to SA surface, as they seem to avoid the ISQ drop
during the remodeling phase. It can be beneficial in immediate loading, poor bone quality, postextractive implants,
smoking, and immunosuppression. Further studies areneeded to improve the number of patients and long-term
follow-up.
Ethical Approval
The study performed after approval was received fromthe Institutional Review Board of the Aldent University,
Tirana, Albania (March 2018). Informed consent (written)
was obtained from all patients before the samples were
definitively enrolled.
Consent for Publication
The patients signed an informed consent form agreeing
with the publication of this study.
European Journal of Dentistry Vol. 15 No. 1/2021 © 2020. European Journal of Dentistry.

Availability of Data and Material
The datasets used during the current study are available
from supplementary file.
Authors’ Contributions
M.T. performed all the cases at center 1, contributed to theconception of the work and to the acquisition of the data,
and finally given final approval of the version to be published. M.M. and E.X. drafted the manuscript and gave their
final approval of the version to be published. N.B. and F.G.
performed all the cases at centers 2 and 3, respectively.
S.M.M.revisited the manuscript critically for important
intellectual content. L.A.I. contributed to the analysis of thedata and revisited the manuscript critically.
Funding
This publication was supported by University funding(L.A.I.): grant FAR2019.
Conflict of Interest
None declared.

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