Immediate Loading of Brånemark System TiUnite and

Machined-Surface Implants in the Posterior Mandible, Part II:

A Randomized Open-Ended 9-Year Follow-up Clinical Trial
Antonio Rocci, MD, DDS1/Marta Rocci, DDS1/Cecilia Rocci, DDS1/Andrea Scoccia, DDS1/
Marco Gargari, DDS2/Massimiliano Martignoni, DDS3/Jan Gottlow, DDS, PhD4/Lars Sennerby, DDS, PhD4

Purpose: To present clinical results with 9 years of follow-up of a protocol of immediately loaded implants
with two different surfaces. Materials and Methods: A total of 44 patients received 66 Brånemark System
TiUnite and 55 Brånemark machined implants, all immediately loaded. Control examinations were performed
on the day of surgery and at 1-, 3-, and 9-year follow-up visits. Results: All implant sites had intact buccal
and lingual bone walls. The prefabricated provisional restorations showed an excellent fit. Three TiUnite and 8
machined implants failed within 7 weeks of loading, resulting in a cumulative survival rate of 95.5% and 85.5%
respectively after 9 years of load. The survival rate for implants in a partial prosthesis was 98.8% and 92.2% for
single restorations in the TiUnite group, and 87.8% and 83.2%, respectively, for partial and single resorations
in the control group. The marginal bone resorption in the first year was on average 0.9 mm in the TiUnite group
and 1.0 mm in the machined group; at the third year it was 0.4 and 0.5 mm, respectively. On examination at
9 years, there was a general settlement of the bone, with a negligible further loss in height. Conclusions: The
unchanged survival rate and the low bone loss after 9 years confirm the feasibility of an immediate loading
protocol in the mandible, which included flapless surgery. TiUnite implants obtained a 10% higher success rate
compared with machined fixtures. Int J Oral Maxillofac Implants 2013;28:891–895. doi: 10.11607/jomi.2397

Key words: dental implants, immediate loading, machined surfaces, oxidized TiUnite surfaces, poor bone quality

T he immediate loading of dental implants has be-

come a widely reported practice in implant dentist-
ry.1 Treatment time can be reduced and bone volume
can be partially preserved through this protocol, pro-
viding a good esthetic result and increasing patient
comfort.2 In earlier work, it was shown that splinting
of implants was of great benefit in cases of immedi-
ate loading. This led to a much higher success rate
compared with loading individual implants. 3,4 In the
first part of this previous study, TiUnite and machined-
surfaced Brånemark System implants (Nobel Biocare)
were compared in a protocol of immediate loading
of fixed partial dentures in the posterior mandible.3
Today, it is known that in cases of soft bone and early
1Private practice, Chieti, Italy.
2DDS,
Professor Department of Clinical Sciences, University
Tor Vergata, Rome, Italy.
3 Private practice, Rome, Italy.
4Professor, Department of Biomaterials, University of
Gothenburg, Gothenburg, Sweden
Correspondence to: Dr Antonio Rocci, Via Benedetto Croce
158, 66013 Chieti, Italy. Email: anrocci@tin.it
©2013 by Quintessence Publishing Co Inc.
loading, treated surfaces promote better and faster os-
seointegration, are ostoconductive, and promote os-
teogenesis both in distance and contact. 5–8
However, the literature is lacking regarding the
clinical results and the peri-implant bone response of
immediately loaded implants compared with conven-
tional loading in different bone qualities.9
Thus, the purpose of this study was to present clini-
cal results with 9 years of follow-up for immediately
loaded implants with two different surfaces.
MATERIALS AND METHODS
This randomized, open-ended, clinical trial was per-
formed according to the Declaration of Helsinki. The
study was performed in 44 patients (30 men and 14
women) with a mean age of 51 years (range, 20 to
69 years). In the test group, 22 patients received 66
Brånemark System TiUnite surface implants (Nobel
Biocare) supporting 24 fixed partial dentures (FPDs)
all of which were connected on the day of implant in-
sertion. In the control group, 22 patients received 55
Brånemark System (Nobel Biocare) machined-surface
implants supporting 22 FPDs, which were also con-
nected on the day of implant insertion. Twelve patients

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Rocci et al
smoked more than 10 cigarettes per day (7 smokers in
the test group and 5 in the control group).
Inclusion criteria were the following: adequate
amount of bone height for placement of implants with
a minimum length of 7 mm, implant site free from
acute infection, and sufficient primary implant stability.
A presurgical three-dimensional mapping system of
each patient’s soft tissue and underlying alveolar bone
anatomy was used; this allowed the clinician to accu-
rately place the implants in predetermined positions
and connect them to prefabricated provisional restora-
tions.4 The system involves the use of a series of sur-
gical guides for positioning of the implants, soft tissue
punching, and drilling sequences for the designated
implant length and diameter. The alveolar bone cast,
together with conventional radiographic examina-
tion, was used to determine the bone quantity at each
implant site.
No flaps were elevated. The soft tissue was punched
at each planned implant site to preserve the exist-
ing soft and hard tissue and to minimize postop-
erative bleeding and soft tissue swelling. Brånemark
System MK II, MK III, and MK IV implants with the TiUnite
(oxidized) (test group) or machined surface (control
group) were used. The bone quality was registered for
each implant site during surgery. A reduced diameter
of the final drill was choosen in soft bone situations to
achieve increased primary stability. The accuracy of the
bone mapping procedure was evaluated during sur-
gery by examining if the prepared implant site showed
intact buccal and lingual bone walls. After insertion of
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Fig 1 (left)  Radiograph of a restoration
in the test group taken at the 1-year fol-
low-up.
Fig 2 (right)  Radiograph of a restoration
in the control group taken at the 1-year
follow-up.
Fig 3 (left)  Radiograph of a restoration
in the test group taken at the 9-year fol-
low-up.
Fig 4 (right)  Radiograph of a restoration
in the control group taken at the 9-year
follow-up.
the implants and abutments, provisional restorations
were positioned and cemented. TiAdapt preparable
titanium abutments and, in a few cases, CeraOne abut-
ments (Nobel Biocare) were used. Minor adjustments
of the abutments and the provisional restoration were
made chairside. This was facilitated by the flapless sur-
gical protocol, which minimized bleeding.
Implant lengths of 7 to 18 mm were inserted in the
premolar and molar areas of the mandible in different
bone qualities. The majority of sites were of bone qual-
ity 3. All implant sites showed good bone quantity. All
prepared implant sites had intact buccal and lingual
bone walls. All restorations were two- to four-implant
FPDs. Two patients in the test group received two res-
torations.
Weekly checkups were carried out for the first
month; subsequently, patients were recalled monthly
up to 6 months after implant insertion. The definitive
restorations were delivered after 6 to 12 months. Stan-
dard intraoral radiographs were taken using a classic
radiographic stent at the end of the insertion proce-
dure and after 1, 3, and 9 years. Radiographs were
analyzed by an independent radiologist. A clinical ex-
ample is illustrated in Figs 1 to 6.
Success and Failure Criteria
The success criteria for the implants were: no radio-
lucent zone around the implant; implants acting as
anchorage for the functional prosthesis; confirmed in-
dividual implant stability at the time of cementing the
definitive restoration (minimum 6 months loading of
 Rocci et al

Fig 5 (left)  Clinical status of a restora-

tion in the test group at 9 years.

Fig 6 (right)  Clinical status of a restora-

tion in the control group at 9 years.

Table 1   Life Table Analyses

Time period Test group (failed) Control group (failed) Test cumulative survival rate Control cumulative survival rate
Loading–6 mo 66 (3) 55 (8) 95.5% 85.5%
6–12 mo 63 47 95.5% 85.5%
12–24 mo 63 47 95.5% 85.5%
24–36 mo 63 47 95.5% 85.5%
9 years 51 39 95.5% 85.5%

the provisional prosthesis); and no suppuration, pain,

or ongoing pathologic processes. Implants that did
not fulfill the success criteria were classified as failures.
Statistical Analysis
Implant success was calculated based on all implants
placed. Means and standard deviations (SD) of margin-
al bone resorption were estimated. Analysis of variance
was used when evaluating the influences of implant
surface, bone quality, and smoking on treatment out-
come. Significance tests were two-tailed and were con-
ducted at the 5% significance level. All analyses were
based on the implant as the computational unit.
RESULTS
All patients healed with minor or no swelling. In the
test group, 3 of the 66 placed TiUnite implants failed,
resulting in a cumulative success rate at 1 and 9 years
of 95.5%. In the control group, 8 of the 55 placed ma-
chined implants were lost, and the corresponding suc-
cess rate was 85.5% (Table 1). Moreover, the survival
rate for implants in a partial prosthesis was 98.8% and
for single restorations was 92.2% in the test group; and
87.8% and 83.2% respectively, for partial and single re-
sorations in the control group.
There was a significantly higher success rate in the
test group compared with the control (P = .0575). Five
of 11 machined implants placed in bone quality 4
failed (46%; P = .001), as did 1 of 12 TiUnite implants
(8%; P = .49). Smoking significantly influenced the fail-
Table 2   Marginal Bone Resorption
Test group Control group
Time period mean (SD) mean (SD)
Baseline–1 year 0.9 (0.7) 1.0 (0.9)
1–3 years 0.4 (0.7) 0.5 (0.9)
3–9 years 0.1 (0.4) 0.2 (0.5)
SD = standard deviation.
ure rate of the machined implants (P = .02) but it did
not influence the outcome for the TiUnite implants
(P = .15). Three of four patients in the control group
who lost implants were smokers. One patient lost all
four implants. All failures occurred within the first 7
weeks of loading. The failed implants were removed
and, after a healing period of 6 weeks, were replaced
successfully and loaded immediately, all with TiUnite
surface implants. All patients finally received their
planned reconstructions.
The radiographic analysis of marginal bone loss af-
ter the first year of loading was on average 0.9 mm (SD,
0.7 mm; maximum, 2.3 mm) in the TiUnite group and
1.0 mm (SD, 0.9 mm; maximum, 3.25 mm) in the ma-
chined group. In the third year, it was 0.4 mm for the test
implants and 0.5 mm for the control group (Table 2).
On examination at 9 years, the trend was that of a gen-
eral settlement of the bone, with a negligible further
loss in height. Several cases observed slight bone gain
for the test implants (Figs 1 to 6). The difference be-
tween test and control implants was not significant.

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Rocci et al
DISCUSSION
The results showed a 10% higher success rate fpr
TiUnite implants immediately loaded with FPDs in
the posterior mandible compared with machined im-
plants. The authors were unable to locate all patients
originally participating in the study at the time of the
9-year follow-up due to factors such as death or change
of residence. A total of 51 test group and 39 control
group implants were able to be assessed at the 9-year
follow-up. However, none of the implants followed-up
with at 9 years failed or underwent considerable bone
loss, and therefore, the overall success rate remained
unchanged. In the control group, the number of failed
implants was significantly higher in bone quality 4 sites
and in smokers. Such similar findings were not seen for
TiUnite implants despite the fact that there were more
smokers and more implants placed in bone type 4 in this
group. A total of 46% of machined implants (5 of 11) in
bone type 4 failed, but only 1 of 12 TiUnite implants
(8%) failed. Similar results are confirmed in the litera-
ture. Two studies by Glauser et al show a high failure
rate of smooth-surfaced, immediately loaded implants
in bone type 4 compared with a high success rate of
TiUnite implants under the same conditions.10,11 Oth-
er studies, including several conducted by Rocci et al,
have already demonstrated the ability of TiUnite im-
plants to encourage a faster osseointegration process
compared with smooth-surfaced implants. The bone
healing period required to obtain secondary stability
was diminished.12,13 Histologic findings of the TiUnite
surface reveal newly formed bone directly on the sur-
faces during healing, whereas the bone formation on
the machined surfaces is more appositional to the old
bone in the osteotomy.13 In light of current knowledge
and progress made over the years in implant bioen-
gineering, it is certain that machined and nontreated
surfaces in poor bone quality affected the failure in
the present study, especially in posterior areas. It is in
this bone type that treated surfaces direct their func-
tion, promoting better and faster osseointegration,
being ostoconductive, and promoting osteogenesis in
both distance and contact.5–8 Early bone formation is
dependent on platelet activation and fibrin retention
by the implant surface. Platelet activation precedes
and accelerates osteogenic cell migration through the
fibrin network.14 Thus, the ability of the implant surface
to retain a stable blood clot and fibrin network is cru-
cial and is favored by a microtextured surface.
A critical factor for successful immediate loading
is load control. This is the most difficult parameter to
evaluate because objective measurement tools are
lacking. One patient showing failure of TiUnite im-
plants lost two 18-mm implants, both acting as the
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posterior support at the first molar in a two-implant
restoration. The anterior implant (in the premolar re-
gion) in both constructions had a shorter implant
length and was successful. Thus, the outcome cannot
be attributed only to patient smoking habits but rather
to uncontrolled load factors.
The accuracy of the bone mapping procedure and
the resulting alveolar bone cast model used in this
work was confirmed during surgery: All prepared im-
plant sites showed intact buccal and palatal bone
walls. This particular technique has been entirely
designed and introduced by one of the authors (AR)
and can be seen as a precursor of modern methods of
computed diagnosis and treatment planning.15–18 The
flapless surgery minimized bleeding and swelling.
These factors and the fit of the restorations facilitated
soft tissue adaptation and healing,4 as in accordance
with the authors’ previous work. In that work, there
was an overall success rate of 90.7% for immediate
loaded machined implants in the maxilla. The present
study had a success rate of only 85.5% in the posterior
mandible for the same implants. This can be explained
by the increased number of distal (molar) sites, where
there is soft bone and increased occlusal forces.
The marginal bone remodeling after 1 year of load-
ing was similar in the test and control groups. The mean
annual resorption tended to decrease from the first
and third year of loading for both implant types. On ex-
amination at 3 and 9 years, the trend has been that of a
general settlement of the bone, with negligible further
loss in height. Several cases were observed of slight
bone gain for the test implants. However, differences
between the two groups were still not significant. This
trend is in accordance with other studies3,10 and with
success criteria established by Albrektsson et al.19
CONCLUSIONS
The current study obtained a 10% higher success rate
following immediate loading of FPDs in the posterior
mandible supported by TiUnite implants compared
with that obtained with machined implants. The un-
changed survival rate and the low mean bone loss
after 9 years confirm the feasibility of an immediate
loading treatment protocol in the mandible, which
included flapless surgery, implants and abutments
placed in predetermined positions, and prefabricated
provisional restorations. All failures occurred within
the first 7 weeks of loading. The number of failed im-
plants in the machined group was significantly higher
in smokers and in sites of poor bone quality. Such find-
ings were not seen in the group treated with anodized
TiUnite surface implants.

ACKNOWLEDGMENT
The authors reported no conflicts of interest related to this study.
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