Published online: 06.06.2019
THIEME

Original Article

Do the New Hydrophilic Surface Have Any Influenceon Early Success Rate and Implant Stability during
Osseointegration Period? Four-Month Preliminary
Results from a Split-Mouth, Randomized Controlled Trial
Marco Tallarico1 Nicola Baldini2
Silvio Mario Meloni6

Matteo Martinolli3

1 Implantology and Prosthetic Aspects, Master of Science in

Dentistry Program, Aldent University, Tirana, Albania
2 Department of Periodontics and Implantology, University of Siena,
Siena, Italy
3 Private Practice, University of Padova, Porto Viro, Italy
4 Department of Oral and Maxillofacial Surgery, Insan Apsun Dental
Clinic, South Korea
5 Department BIOMORF, School of Dentistry, University of Messina,
Messina, Italy
6 Department of Surgical, Microsurgical and Medical Science,
University of Sassari, Sassari, Italy

Erta Xhanari1

Yong-Jin Kim4

Gabriele Cervino5

Address for correspondence Marco Tallarico, Adjunct professor,
Implantology and Prosthetic Aspects, Master of Science in Dentistry
Program, Aldent University, Rr.e Dibrës, Nr. 235, Tirana, Albania(e-mail: me@studiomarcotallarico.it).

Eur J Dent 2019;13:95–101

Abstract

Keywords►►dental implant►►early loading►►implant stability

quotient►►implant surface►►osseointegration

Objective The objective of this study is to compare the implant stability of Hiossen
ET III implants with its new hydrophilic (NH) surface and Hiossen ET III implants withthe sandblasted and acid-etched (SA) surface.
Materials and Methods Patients required at least two teeth to be rehabilitated with afixed, implant-supported restoration, consecutively enrolled. Patients randomly received
SA surface implants (SA group) or SA implants with a newly developed bioabsorbableapatite nanocoating (NH group). Outcome measures were implant and prosthetic survivalrate, complications, insertion torque, and implant stability quotient (ISQ) measured at
implant placement and every week up to 8 weeks after implant placement. Comparison between groups was made by unpaired t-test, while the comparison between each­follow-up will be made by paired t-tests to detect any change during the follow-up. Complications and failures were compared using Fisher’s exact test.
Results A total of 14 patients were treated with 28 implants (14 SA and 14 NH). No
implant and prosthesis failed 4 months after implant placement. No complications
were experienced. At the 2nd week after implants placement, two implants in the SAgroup showed discontinuous measurements versus none in the NH group (p = 0.4815).
Implants unscrewed during ISQ measurements and were rescrewed. Data recording
stopped for 6 weeks. Both implants osseointegrated without any further complication.
The NH implants did not show physiological ISQ decrease between 2nd and 4th week
after implant placement, showing a more even pattern of ISQ values compared withSA implants (77.1 ± 4.6 vs. 72.9 ± 11.5; difference: 4.2 ± 12.1; p = 0.258). High ISQ
values were found in both groups at each time point.
Conclusions NH implants are a viable alternative to SA surface, as they seem to avoid
the ISQ drop during the remodeling phase.

DOI https://doi.org/
10.1055/s-0039-1688737
ISSN 1305-7456.

©2019 Dental Investigation
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Introduction
Nowadays, the use of dental implants has become an accepted treatment modality in clinical dentistry in both fixed andremovable solutions.1,2,3,4,5 Over the years, implant designs
and surgical techniques have undergone significant improvements, resulting in current survival rates surpassing 95%
after 5 years of follow-up.6
Today, clinical research is focusing on shorter and lessinvasive procedures. Different implant designs,7,8 as wellas, placement and loading protocols are currently used to­shorten treatment times and decrease the amount of surgicalinterventions, enabling clinicians to choose between a one(nonsubmerged) and a two-stage (submerged) approach.
Against different loading protocol, it has been showed thatthe submerged technique is not a prerequisite for osseointegration,9 even if one-stage implant placement might
be at a slightly higher risk of early failures. Primary implant­stability is still considered to be a prerequisite for the longterm success of an implant-supported prosthesis.10 Primary­stability depends mainly on the macro- and micro-design ofthe implant including the functional length, besides surgical
technique and properties of local bone.11,12
The more their applications increase, the greater theclinical interest becomes in the implants integrating quickly with the bone to be functional. In the last decade, there
was an ongoing effort to improve the interface between bone
and implant to speed up the process of osseointegration andimprove its quality.13 These efforts have been concentrating in improving this interface chemically (by incorporating
inorganic phases on or into the titanium oxide layer) or physically (by increasing the level of roughness).14
Different techniques have been utilized to alter the surface
topography of dental implants. These techniques are usually
applying either additive or subtractive concepts. Long-term
studies showed that additive surfaces have a higher ­incidenceof complications which was attributed to the delamination of
the thick HA layer and to the uncontrolled rate of dissolutionof deposited phases.15 Consequently, subtractive surfaces
have become more popular by clinicians.
Although shorter healing period was presented in many
experimental and clinical studies using sandblasted and acidetched (SLA) surfaces,16,17 modification of this surface seems
to presents a stronger bone response than its predecessor.18,19
The purpose of this split-mouth randomized controlled
trial was to compare early implant failure and implant­stability of one-stage Hiossen ET III implants with its newhydrophilic (NH) surface, compared with Hiossen ET III
implants with the well-known SA surface. The null hypothesis was that there is no difference between groups. The null
hypothesis was tested against the alternative hypothesis ofdifferences between them. The following trial was reported
according to the STROBE statement.

one center, 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(3/2018). Surgical and prosthetic procedures were performedby one expert clinician.
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 as follows: positive m­ edicalfindings (such as stroke, recent cardiac infarction, severe
bleeding disorder, uncontrolled diabetes, or cancer), psychiatric therapy, pregnancy or nursing, smoking > 10 cigarettes
per day, insertion torque < 35 Ncm, untreated periodontitis,
acute and chronic infections of the adjacent tissues or naturaldentition, previous radiotherapy of the oral and maxillofacial
region ­within the past 5 years, postextractive implants (at least
3 months after tooth extraction), absence of teeth in the opposing jaw, severe clenching or bruxism, severe m­ axillomandibular
skeletal discrepancy, and poor oral hygiene.
Patients were informed about the clinical procedures, thematerials to be used, the benefits, potential risks and complications, as well as any follow-up evaluations required forthe clinical study. Patients had to sign the informed 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 aflapless or a mini-flap approach (►Figs. 1 and 2). Bone d­ ensity
was assessed, according to the Lekholm and Zarb classification,
during the drilling phase, based on the clinician’s experience andjudgment. Implant site was prepared s­ imultaneously, according
to the drilling protocol recommended by the manufacturer. SA

Materials and Methods
This study was designed as a split-mouth, randomized controlled trial of parallel groups with two arms, conducted at
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Fig. 1 Computer-assisted template-based implant placement (Osstem OneGuide Kit, Osstem, Seoul, South Korea): occlusal view.

ISQ of Hiossen ET III NH versus SA Implants: An RCT

Tallarico et al.

Fig. 2 Digital impression (3M true definition scanner, 3M Italia):
occlusal view.

Fig. 4 Definitive, single, screw-retained crowns: occlusal view. The
distal implant was left to heal submerged.

surface implants (SA group) or SA surface implants with a newly
developed bioabsorbable apatite nanocoating (NH group) wererandomized after implant site preparation, immediately before
implant placement. Implants used in every group were identical except for the surface treatment. After implant placement,
the insertion torque values of the implants were measured
and recorded during surgery using a surgical unit (iChiroPro,
Bien Air, Italy). Then, a smart peg (Type 47 cod. 100478, Osstell,Gothenburg, Sweden) was connected to the implants, and theimplant stability quotient (ISQ) was measured and recorded
using the Osstell Mentor device (Osstell), at implant placement,
and every week up to 8 weeks after implant placement.
Implants were placed according to a one-stage protocol
and measured every week up to 8 weeks. Then implants were
measured again 12 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 wasleft to heal submerged for at least 6 weeks.
Postsurgical analgesic treatment was performed withibuprofen 600 mg, which was administered twice a day for
2 days after the surgery, and later on, if required. Periapicalradiographs were taken with a customized holder at implant
placement, at the definitive prosthesis delivery, and thenyearly. Two to three months after implants placement patients
receive single screw-retained restorations (►Figs. 3–9).

Fig. 5 Definitive, single, screw-retained crowns: lateral view. The
distal implant was left to heal submerged.

Fig. 6 Periapical radiograph at definitive crowns delivery. The distal
implant was left to heal submerged.

Fig. 3

Periapical radiograph at implant placement.

The outcome measures were implant and prosthetic survival rates, any biological or mechanical complications at
implants that occurred during the entire observation period.
Success rates of the implants and prostheses were­evaluated by an independent assessor (EX). An implant wasconsidered 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
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Fig. 7

Definitive restorations at 6-month of follow-up: occlusal view.

Fig. 8

Definitive restorations at 6-month of follow-up: lateral view.

ISQ values were recorded each week up to 8 weeks, andthen, after 12 weeks, using resonance frequency analysis (Osstell Mentor device, Osstell, Gothenburg, Sweden),according to a previously published study.2 A blind outcome­assessor collected the data (EX).
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 therandomization codes were sequentially numbered and sealed.
According to a pregenerated list, an independent consultant,
not previously involved in the trial, prepared all the envelopes
and then opened immediately after implant sites preparation.
Site one was defined the site with the lower sextant number
and the most mesial. 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). Comparison between groups wasmade by unpaired t-test, while the comparison between eachfollow-up will be made by paired t-tests to detect any change
during the follow-up. Complications and failures were compared using the Fisher’s exact test. 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

Fig. 9Periapical radiograph at 6-month of follow-up.

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 (MT).
Insertion torque was recorded at implant placement by
the same surgeon (MT) using the iChiropro surgical unit
(Bien-Air, Bienne, Switzerland).

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A total of 14 patients (13 females and 1 male, with a men age of
58.3 ± 11.9) were screened as they were consecutively enrolled
for the trial. All patients were originally treated according to
the allocated interventions and no patient dropped out. A totalof 28 implants (14 with SA surface and 14 with SA surface with
the newly developed bioabsorbable apatite nanocoating) wereplaced. Four patients were rehabilitated in the mandible and
10 in the maxilla. Four-month after definitive prosthesis delivery, no implant and no prosthesis failed. Two weeks after placement, two Hiossen ET III SA implants showed a small mobility
with ISQ values lower than 55 (49 and 51, respectively) while
no complications were reported in the NH group. Nevertheless,no statistically significant difference was reached (p = 0.4815).
In both the implants, the healing abutments were replacedwith a cover screw and the implants were left to heal submerged for 6 weeks.
The overall insertion torque ranged between 35.0 and 45.0
Ncm (mean of 41.5 ± 3.3 [39.7–43.5] Ncm in the SA group and41.4 ± 3.2 [40.3–43.9] Ncm in the NH group). The difference
was not statistically significant (p = 0.936).
The ISQ values between groups and within time werereported in ►Table 1. Although there is no statistically­significant difference between groups, NH implants did notshow physiological ISQ decrease between 2nd and 4th week
after implant placement, showing a more even pattern of ISQ
values (►Fig. 10). At the 2nd week, Hiossen ET III implants
with its NH group showed a mean ISQ value of 77.1 ± 4.6

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Table 1 Implant stability quotient value between groups
Weeks

SA (n = 14)

NH (n = 14)

p -Value

077.9 ± 5.9 (76.2–82.8)

76.7 ± 5.6 (71.6–78.4)

0.611

1

77.2 ± 5.6 (76.4–82.6)

77.4 ± 5.3 (73.3–79.2)

0.941

2

72.9 ± 11.5a (71.5–84.5)

77.1 ± 4.6 (73.4–78.6)

0.258

3

76.9 ± 4.6 (72.9–78.1)

77.3 ± 4.7 (74.8–80.2)

0.863

4

78.4 ± 3.6 (76.0–80.0)

77.5 ± 4.3 (75.1–79.9)

0.582

5

78.6 ± 3.1a (76.3–79.8.8)

77.8 ± 4.1 (75.7–80.3)

0.604

6

a

78.7 ± 3.9 (76.0–80.5)

78.0 ± 4.2 (75.6–80.4)

0.694

8

78.1 ± 5.1 (75.9–81.2)

79.2 ± 3.9 (77.8–82.2)

0.576

a
a

Abbreviations: NH, new hydrophilic; SA, sandblasted and acid-etched.
a
Two implants were left to heal submerged and were not measured (n = 12).

Fig. 10 Development of the implant stability quotient values inthe sandblasted and acid-etched and new hydrophilic surface groupduring the 8 weeks of study period. ISQ, implant stability quotient;NH, new hydrophilic; SA, sandblasted and acid-etched.

(73.4–78.6) compared with 72.9 ± 11.5 (71.5–84.5) of the
Hiossen ET III implants with the well-known SA surface.
The difference was not statistically significant (4.2 ± 12.1[–6.3–7.3]; p = 0.258). Compared with the baseline (implant
placement), at the last follow-up examination the NH­
implants showed a little improvement in the ISQ values (76.7± 6.0 [71.6–78.4] compared with 79.2 ± 3.9 [77.8–82.2]; difference 2.5 ± 4.3 [0.1–4.9]; p = 0.246) compared with the SA
implants (78.0 ± 5.9 [76.2–82.8] compared with 78.1 ± 5.1[75.9–81.6]; difference 0.2 ± 2.3 [–1.1–1.6]; p = 0.941). The
differences were not statistically significant.

Discussion
This split-mouth randomized controlled trial was designed
to evaluate if the new SA surface with a newly developed
bioabsorbable apatite nanocoating has any influence on early success rate and implant stability during osseointegration
period. The results of the present study have not shown any
statistically significant difference in ISQ measurements eventhough NH implants did not show physiological ISQ decrease
between 2nd and 4th week after implant placement, showing a more even pattern of ISQ values.

Primary stability and absence of micromovements are twoof the main prerequisites for obtaining a stable osseointegration and the achievement of long-term high-success rates
for dental implants.20,21 In fact, if primary stability is absent
during the early healing period, implant mobility can occur,and this could lead to a soft-tissue interface promoting its
failure.22,23 In the last decades to reduce the risk of soft-­tissue
encapsulation, it has been recommended that implants be
kept load-free during a healing period of 3 to 4 months inmandibles and 6 to 8 months in maxillae.24
Nowadays, the more implants are used in clinical routine,
the greater the clinical interest becomes in the implants integrating quickly with the bone to be functional. An ongoing
effort to improve the interface between bone and implantsurface to speed up the process of osseointegration has been
proposed by researcher and dental implant companies.
Commonly, implant surface roughness is divided, depending on the dimension of the measured surface features,
into macro-, micro-, and nanoroughness. Typically, these­different roughness features are related to distinct effects
during wound healing and osseointegration.25 Titanium
nanostructures have been created by different approaches
such as ­oxidative nanopatterning by acid etching in mixturesof sulfuric acid and hydrogen peroxide, by exposing titanium
samples to flowing synthetic air, electrochemically by a
­ nodic
oxidation, by processing samples after acid etching underprotective gas and storing them in saline, by plasma etching,or by physical vapor deposition techniques.26
It is well known that roughness increases implant osseointegration, and several implant types are sandblasted and/or acid-etched to increase their surface texture.22 Nevertheless, surfaces coated with hydroxyapatite (HA) were reported
to have a higher incidence of complications,15 even if ­evidence
for the influence of the implant surface characteristics as arisk indicator for peri-implantitis is very limited.27
Vice versa, the nanometer roughness plays an importantrole in the adsorption of proteins, adhesion of osteoblastic
cells, and thus the rate of osseointegration.28 In fact, the deposition through dip coating of nanocomposite (HA-ZrO2-Al2O3)
on titanium substrate showed the highest adhesion strengthcompared with the HA coatings.29 Furthermore, Schwarz etal showed that angiogenesis was enhanced on hydrophilic
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surfaces during early stages of osseointegration.30,31 Actually, fast vascularization seems beneficial for bone formation
because osteogenic cells have been observed to arise frompericytes adjacent to small blood vessels.21,32
In the present study, implants with the hydrophilic surface seem to avoid the ISQ drop during the remodeling phaseallowing accordingly benefits in immediate loading, poorbone quality, postextractive, smoking, and immunosuppression disease. Looking for a deeper understanding of thedifferent bioresponses to SLActive versus SLA, a very recent
study found thinner carbon contamination films on SLActive(0.8 nm) compared with SLA (1.6 nm) suggesting an impactof the different contamination films on the blood response,
leading to accelerated osseointegration.33
In a review of the available human studies, Wennerberg
et al have found little clinical evidence so far to clearly statea preference for SLActive over SLA implant.34 In a splitmouth study, SLActive implants were compared with SLA
implants with early loading protocols in irradiated patients.
One-hundred two implants were placed in 20 patients inboth jaws. 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 in both groups with no significant difference.35

5

6

7

8

9

10

11

12

Conclusions
High ISQ values were found in both groups at each time
point. NH implants are a viable alternative to SA surface,as they seem to avoid the ISQ drop during the remodelingphase. It can be beneficial in immediate loading, poor bonequality, postextractive, smoking, and immunosuppression.
Further trials with larger sample size and longer follow-up
are n­ eeded to confirm these preliminary results.
Financial Support and Sponsorship
Nil.
Conflicts of Interest
DEUTSCHE OSSTEM GmbH donated the implants.
­However, data belonged to the authors and by no means
did the company interfere with the conduct of the trial or
the publication of its results.

14

15

16

17

18

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