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Early Loading of Sandblasted and Acid-Etched

Titanium Implants in the Edentulous Mandible:


A Prospective 5-Year Study
Bernd Lethaus, MD, DMD1/Jrg Klber, DDS2/Guido Petrin, DDS3/
Anita Brandsttter, PhD4/Dieter Weingart, MD, DMD, PhD5

Purpose: The aim of this prospective cohort study was to determine the 5-year implant survival and
success rates associated with early loading (6 weeks after nonsubmerged placement) of sandblasted
and acid-etched (SLA) Straumann implants in the edentulous mandible. A secondary objective was
to determine the peri-implant tissue response and measure alterations in peri-implant crestal bone
levels. Materials and Methods: SLA implants were placed and primarily loaded 6 weeks later
with 35 Ncm during abutment placement. The peri-implant bone and mucosal conditions of the
participants were monitored radiographically and clinically over a 5-year period. Results: Fourteen
patients received 60 implants. Thirteen patients and 54 implants were examined at the 5-year
appointment. Two of 60 implants failed during the healing period, and four implants were lost
during follow-up and considered as dropouts. The remaining implants showed favorable clinical
and radiographic findings and were considered successfully integrated at the 5-year examination.
The mean loss of crestal bone height after 5 years was 0.77 mm (SEM 0.09). This resulted in a
5-year cumulative success rate of 96.7%. Conclusion: In this prospective study, the early loading
of Straumann implants with the SLA surface in the edentulous mandible after a healing time of
6 weeks provided successful osseointegration with high predictability. Successful integration was
maintained for 5 years. Int J Oral Maxillofac Implants 2011;26:887892
Key words: dental implant, early loading, edentulous mandible, surface properties

he importance of endosseous implants for rehabilitation in edentulous patients has grown in


recent decades. Dental implants are considered to
be safe and predictable rehabilitation tools, even
1S enior

Lecturer, Department of Cranio-Maxillofacial Surgery,


Maastricht University Clinics, Maastricht, The Netherlands.
2S enior Lecturer, Maxillofacial Surgery and Plastic and
Reconstructive Surgery, Katharinenhospital, Stuttgart,
Germany.
3 Private Practice in Implantology and Periodontics, Stuttgart,
Germany.
4 S tatistician, Division of Genetic Epidemiology, Innsbruck
Medical University, Innsbruck, Austria.
5Professor and Head, Maxillofacial Surgery and Plastic and
Reconstructive Surgery, Katharinenhospital, Stuttgart,
Germany.
Correspondence to: Dr Bernd Lethaus, Department of
Cranio-Maxillofacial Surgery, Maastricht University Clinics, P.
Debelyaan 25, 6202 AZ Maastricht, The Netherlands.
Fax: +31-43-3872020. Email: bernd.lethaus@mumc.nl

for elderly patients. The longevity and endurance of


inserted implants have always been topics of concern; several long-term studies have examined and
confirmed the characteristics of Straumann dental
implants (Institut Straumann).18 These studies have
demonstrate cumulative survival rates of 90% and
higher. With such positive results concerning longevity, the focus of interest has moved to shortening
the overall rehabilitation time. Different approaches
have been attempted to reduce implant healing time.
In a biomechanical study in minipigs, Buser et al9,10
demonstrated sufficient stability of sandblasted and
acid-etched implants after 4 weeks of healing. These
results encouraged the initiation of a multicenter
study with loading as early as 6 weeks. Cochran et al11
published promising preliminary results after 3 years.
The present study reports on the results of a 5-year
study at the Katharinenhospital Stuttgart. Patients
received Straumann implants with a sandblasted/
acid-etched (SLA) surface in the edentulous mandible.
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Lethaus et al

Although numerous studies have investigated early loading of SLA titanium implants, to the authors
knowledge there are few English-language studies
investigating SLA implants over the long term in the
edentulous mandible.

Materials and Methods


Patients

Patients were consecutively admitted to the study


between October 1998 and January 2001. The local
ethical committee approved the research protocol.
Inclusion criteria were edentulism in the mandible,
agreement of the patient to take part in a study using a reduced healing time, and sufficient bone quality (types I to III according to the classification of
Lekholm and Zarb12). Patients with severe systemic
health problems, uncontrolled diabetes, or local
bone defects requiring bone augmentation, as well as
heavy smokers, were excluded. In addition, patients
with intraoperatively classified bone quality type IV
were excluded.
All implants were inserted by the same surgeon.
According to the protocol, the implants were loaded
after 6 weeks of healing. A torque of 35 Ncm was applied to the implant-bone interface upon insertion of
the abutment and is hence considered as the initiation of loading.

Surgical Procedure

All surgical procedures were carried out under local anesthesia. Two hours preoperatively all patients
received a single shot for antibiotic prophylaxis
(1.2 Mio IU phenoxymethylpenicillin). The implants
(SLA, Institut Straumann) were inserted according to
a strict surgical protocol following the manufacturers
instructions and as described by Buser et al.13 The alveolar ridge was flattened, and care was taken that
the border of the SLA surface approximated the alveolar bone crest, with only the machined neck portion
left in the transmucosal area.
Abutments were connected to 58 implants with
an insertion torque of 35 Ncm after a healing time of
6 weeks without any masticatory exposure. Torque
was applied without the use of any countertorque to
test the rotational stability of the implants, which if
absent would have classified the implant as not yet
osseointegrated. Postoperatively, radiographs were
obtained to measure the bone crest height, which
was considered as the baseline level.
According to the protocol, prosthetic rehabilitation was carried out with a definitive restoration between 42 and 63 days after implant placement. All
patients received overdentures.

Follow-up Protocol
The patients returned for recall examinations and
radiographs 6, 12, 24, 36, 48, and 60 months after
abutment placement. The following parameters were
evaluated to document the current implant status.
Modified Plaque Index (mPI)14 was measured at
four aspects around the implant. The mPI value
for each implant was based on the average of the
four measured values. A score of 0 = no plaque detected; 1 = plaque recognizable by running a probe
across the smooth marginal surface of the implant;
2 = plaque visible to the naked eye; 3 = abundance
of soft matter.
Modified Sulcus Bleeding Index (mSBI)14 was assessed at four aspects of each implant. The average
of the four measured values was used as the mSBI
value for that implant. A score of 0 was used to indicate no bleeding when a periodontal probe was
passed along the sulcus adjacent to the implant;
1 = isolated bleeding spots were visible; 2 = blood
formed a red line in the sulcus; 3 = heavy or profuse
bleeding from the sulcus.
Probing depth (PD)14 was assessed at four aspects
of each implant in millimeters. The average of the
four measured values was used as the PD for that
implant.
Width of keratinized gingiva (WKG) was measured
on the midlingual and midfacial of each implant.
The average of the two measured values was used
as the WKG for that implant.
General satisfaction was surveyed at each recall
appointment. The patient could classify his or her
general satisfaction as excellent, good, fair, or poor.
The crestal bone level (BL) was measured by examining the panoramic radiographs and comparing them with the initial measured BL (abutment
placement). The distance between the implant
shoulder and the first visible bone-implant contact was measured in millimeters at the mesial and
distal aspect of every implant.15 To compensate for
distortion on the panoramic radiographs, the measured distance was adjusted with respect to the
known total length of the implant, which was also
measured. The radiographs were digitized with an
Epson Expression 1600 scanner with 300 pixels/
inch and the region of interest was measured with
the Adobe Photoshop 6.0 measurement tool. All
measurements were performed twice by two independent examiners. Each examiner calculated the
value for each implant from the average of the two
measured values. The average of the two examiners results was used as the final BL value.

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Lethaus et al

Cumulative success rate (%)

100

80
60
40
20
+

Survival function
Dropout
10 20 30 40 50 60
Time since placement (mo)

Table 1Soft Tissue Peri-implant Parameters


(Means SEMs)
Time
(mo)

mPLI

mSBI

PD

WKG

0.26 0.05

0.11 0.05

2.16 0.06

1.86 0.13

12

0.43 0.07

0.23 0.08

2.31 0.08

2.02 0.18

24

0.34 0.05

0.11 0.03

2.32 0.07

1.95 0.14

36

0.35 0.09

0.16 0.04

2.20 0.09

1.78 0.09

48

0.63 0.10

0.32 0.08

2.33 0.06

1.94 0.11

60

0.68 0.13

0.23 0.06

2.18 0.07

1.78 0.12

Only mPLI showed a statistically significant difference between the 6-month and
60-month measurements (P < .05).

Fig 1Kaplan-Meier survival graph. Sixty implants


were followed for 5 years. One patient with four
implants did not show up at the last examination and
was considered a dropout.

On the basis of the radiologic and clinical findings,


the authors determined whether each implant was
successful. The following success criteria were used,
as suggested by Buser et al16:
1. Absence of persistent subjective complaints, such
as pain, foreign-body sensation, and dysesthesia
2. Absence of peri-implant infection
3. Absence of mobility
4. Absence of continuous radiolucency around the
implant

Statistical Analysis

Means and standard errors of the mean (SEMs) were


reported for all parameters described. Because the
data were not normally distributed, the Wilcoxon
signed rank test was performed to compare measurements between 6 and 60 months after implant
placement. In addition, Kaplan-Meier analysis was
performed to obtain the survival rate. All statistical
analyses were done with SPSS software (version 17).

Results
Between October 1998 and January 2001, 14 patients
(3 men, 11 women; mean age, 64.2 years; range, 49 to
81 years) received a total of 60 implants to support
prostheses in the edentulous mandible. All but one
patient received a removable bar-retained overdenture; in the remaining patient, the overdenture was
retained by telescopic attachments.

Healing and Follow-up Period


During the 6-week healing period before early loading, two implants failed to osseointegrate and had
to be removed. All other implants healed normally.
Some patients had minor complaints and discomfort,
but none reported hyperesthesia.
All implants could easily be reached for abutment
placement, which was uneventful. No instability was
apparent in any of the remaining 58 implants.
During the follow-up period, none of the patients
had further complaints. All implants were free of signs
of mucositis and were firmly anchored in the bone.
Panoramic radiographs showed no radiolucency or
other signs of substantial bone loss.
One patient did not attend the 60-month followup visit and was regarded as a dropout (Fig 1).

Gingival Parameters

The mean mPI showed a statistically significant increase between 6 months and 60 months (P < .05;
Table 1). There were no statistically significant differences between 6 months and 60 months for the parameters mSBI, PD, or WKG. The assessments of the WKG
showed that most implants had only a small zone of
keratinized mucosa on the buccal and lingual aspects.

Radiographic Findings

The panoramic radiographs obtained from each patient showed no sign of continuous radiolucency
within the 5-year observation period. There was a statistically significant increase in crestal bone loss between
abutment placement and 60 months (P < .05; Table 2).
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Table 2 Bone Loss (Means SEMs)


Months since placement of
healing abutment
6

Bone loss
0.35 0.05

Table 3Success Rates for 60 Implants Over a


60-Month Period
Time
interval (mo)

Implants
at start

Dropouts

Failures

Implants
at risk

Success
rate

12

0.49 0.07

Healing time

60

60

96.7%

24

0.63 0.07

06

58

58

96.7%

36

0.68 0.07

612

58

58

96.7%

60

0.77 0.09

Bone loss was measured on radiographs. The difference in bone level between abutment placement and 60
months was statistically significant (P < .05).

1224

58

58

96.7%

2436

58

58

96.7%

3648

58

58

96.7%

4860

58

54

96.7%

Survival and Success Rates


During the 60-month period, two implants in two
different patients failed to osseointegrate during the
healing period (fourth and fifth weeks). Both patients
received an overdenture on the remaining three
implants. No further implants were lost during the
observation period. One patient did not attend the
60-month visit. According to the clinical and radiographic findings and the aforementioned success criteria, 54 implants were considered successful after 60
months. The overall implant success rate was therefore
96.7% (Table 3).

Discussion
Although dental implants are considered to be a reliable tool for oral rehabilitation, various techniques
have been tried to improve the attractiveness and
patient acceptance of implants. Many recent studies
have sufficiently proven their longevity and stability.16,8,17 Therefore, reducing the healing time has become one major focus of implant research.
The aim of the present study was to examine the
outcome of SLA Straumann implants loaded as early
as 6 weeks in the edentulous mandible and functioning for 5 years. Cochran et al18 described in their consensus statement that a healing time of 6 weeks could
be appropriate when at least four implants are used.
The gingival parameters such as mPI and mSBI
showed excellent results during the 5-year period, although slight increases in both parameters were seen
after 60 months, which was statistically significant for
mPI. Reduced home care after 5 years could be a reason for these data. This finding stresses the importance
of good home care, as previously mentioned by other
authors.11,19 However, despite these results, the periimplant soft tissue showed no significant changes, as
demonstrated by the stable PD and WKG. The obtained
mean values are comparable to similar studies.2023

More important in evaluating the long-term success of dental implants is the measurement of the
peri-implant crestal BL, which can give good predictability of the osseointegration quality.24 An accurate
and repeatable measurement is difficult to establish and has therefore been discussed extensively.
The measurement of the distance from the implant
shoulder to the bone is regarded as an adequate tool
to observe any peri-implant bone loss.16 Usually the
long-cone technique is used to determine the exact
BL in a reproducible way. This technique seems to be
superior to panoramic radiographs, which can distort
actual distances by up to 30%. However, all implants
in this study were inserted in the edentulous mandible. The superficial muscle insertions on the floor of
the mouth can, especially in the atrophic mandible,
interfere with the positioning of the radiographs.25
The lingual aspect of the mandible is sometimes not
deep enough to place the film correctly for the longcone technique. The authors therefore used panoramic radiographs to measure crestal BL. Mean marginal
bone loss was 0.49 mm during the first year after loading. The phenomenon of up to 1 mm of bone loss
has been described previously.26 It has been hypothesized that the bones maturation and adaptation to
withstand functional forces is responsible for this primary bone loss. An annual bone loss of 0.2 mm after
this period has been recognized as acceptable.27 In
the present study, bone loss did not exceed this given
margin within the first year or after 4 years of observation. These results can be regarded as favorable, and
they are in line with other studies. Visser et al,23 who
treated edentulous patients in the mandible with two
or four implants, reported bone loss in the first year of
0.4 mm, followed by an average annual bone loss of
less than 0.1 mm. In a more recent study, Meijer et al28
described a continuous bone loss of 0.2 mm after the
first year, which stabilized after 5 years.

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Lethaus et al

In the current study, overall survival and success


rates of 96.7% were observed. This good result is supported by other studies that examined the influence
of early loading of implants with a sandblasted/acidetched surface.11,19,20,2933 Bornstein et al20 examined
104 implants in partially edentulous patients. Abutments were placed after 6 weeks of healing. Only one
implant failed to integrate during the healing period,
resulting in a cumulative survival rate of 99.03% after
5 years. Arvidson et al34 observed a 95.88% cumulative success rate 3 years after early loading of mandibular full-arch prostheses in the edentulous mandible.
Eliasson et al35 obtained a cumulative success rate
of 94.4% following early loading of three different implant systems in the mandible. He compared these
patients with patients in whom delayed loading was
applied and could not confirm any statistically relevant difference concerning implant survival rates
after 5 years.
The authors regard the reduction of healing time
to 6 weeks as a true benefit for the patient. However,
other groups have investigated further reductions in
healing time, down to immediate loading. Quinlan et
al36 reported results of a canine model study with SLA
implants. They compared four different healing times,
varying from 3 months to immediate loading. No significant differences could be seen between the different loading protocols. In a clinical follow-up report,
Luongo et al37 presented favorable 3-year results of a
prospective multicenter study with healing times between 0 and 11 days.
The present study confirms the hypothesis that
Straumann implants with the SLA surface can be loaded successfully as early as 6 weeks in bone types I to III.
All implant failures occurred during the healing period, and no further implant losses were observed after
the onset of loading. After a healing time of 6 weeks,
the implants provided stable osseointegration, which
was maintained over the 5-year observation period.
The authors regard the sandblasted and acid-etched
surface, which positively influences osseointegration,
to have resulted in an improved bone-metal interface.
Further surface improvements, eg, the addition of a
chemical layer, are the topics of ongoing research.38,39

Conclusion
On the basis of the present results, functional early
loading of Straumann implants with a sandblasted/
acid-etched surface in the edentulous mandible after
6 weeks can be suggested as an adequate therapy for
dental rehabilitation with high predictability. These
results should encourage a further reduction in the
healing period in future studies.

Acknowledgment
The study was supported and sponsored by Institut Straumann, Basel, Switzerland.

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