A Meta-Analysis Examining the Clinical
Survivability of Machined-Surfaced and
Osseotite Implants in Poor-Quality Bone
Renée M. Stach, DDS,* Sean S. Kohles, PhD**
n oral implantology, analysis of
I implant failures focuses on patient
variables recorded at the time of
implant placement. These variables
describe biologic and mechanical pa-
rameters that influence implant lon-
gevity and include the patient’s smok-
ing habits, the amount and quality of
available bone determining the need
for implants of short or wide dimen-
sions, initial fixation of the implant in
the osteotomy, the elapsed time be-
tween placement and loading, and the
density of the bone found at the os-
teotomy site. In general, dense bone is
regarded as “good” bone and this qual-
ity diminishes as the density de-
creases. Of the baseline variables,
poor-quality bone has been well doc-
umented as having a high correlation
with implant failure.1–7 For this reason
clinicians may hesitate to place im-
plants in sites of soft bone and con-
sider alternative treatments in an effort
to avoid a poor prognosis for implant
integration, or place additional im-
plants in anticipation of some failures.
Bone density scoring as described
by Lekholm and Zarb8 is a four-rank
scoring system. Type I bone is most
dense having a thick cortical bone
plate and dense trabeculation, whereas
Type IV bone has a thin cortical plate
and low trabecular density. Types II
and III are gradients between Types I
and IV. Several publications have cor-
related standardized rankings of bone
*Medical Writer, Implant Innovations, Inc., 4555 Riverside Drive,
Palm Beach Gardens, FL 33410
**Director, Kohles Bioengineering, 1731 SE 37th Avenue, Port-
land, OR 97214
ISSN 1056-6163/03/01201-087$3.00
Implant Dentistry
Volume 12 • Number 1
Copyright © 2003 by Lippincott Williams & Wilkins, Inc.
DOI: 10.1097/01.ID.0000042507.37401.6F
Purpose: A frequently cited
cause of dental implant failure is the
inadequate quality of bone found at
the implant site during osteotomy
preparation. Although bone quality
clearly can affect integration rates,
additional variables, such as the im-
plant surface conditioning, can also
influence long-term implant perfor-
mance success. The following report
examines outcomes of clinical stud-
ies that monitored the performance
of machined-surfaced implants and
dual acid-etched Osseotite (Implant
Innovations, Inc., Palm Beach Gar-
dens, FL) implants isolating the ef-
fect of bone quality and implant sur-
face conditioning. Materials and
Methods: Implant data are derived
from eight prospective multicenter
clinical studies representing 2614
machined-surfaced implants and
2288 Osseotite implants. All implant
placement surgeries followed a two-
stage surgical approach with an un-
loaded healing period of 4 to 6
months. Bone quality was assessed
by operator perception of resistance
during drilling and ranked as dense,
normal, or soft. At the time of this
analysis, implant follow-up from
placement ranged up to 66 months
for the Osseotite and 84 months for
the machined-surfaced implants. To
quality with the resulting implant suc-
cess rates: in 1991 Jaffin and Berman1
showed that the success rate for
Bränemark implants was 97% in the
more dense Types I to III bone,
whereas in Type IV bone the success
IMPLANT DENTISTRY / VOLUME 12, NUMBER 1 2003
isolate the effect of bone quali-
ty,other baseline variables were
compared to ensure equal distribu-
tion between groups. Baseline vari-
ables included patient demograph-
ics, locations, dimensions of
implants, and types of restorative
cases. Implant performance was an-
alyzed using nonparametric survival
analysis (Kaplan-Meier estimator).
Cumulative success rates (CSR)
were calculated and differences be-
tween implant-bone quality combi-
nations were assessed using the log-
rank method. Results: For the
machined-surfaced implants, the
4-year CSR in all bone sites is
92.7%. For the implants placed in
good (dense and normal) bone, the
4-year CSR is 93.6% compared with
the 4-year CSR in poor (soft) bone of
88.2% (P ⬍ 0.05). For Osseotite im-
plants in all sites, their overall
4-year CSR was 98.4%, 98.4% in
good bone, and 98.1% in poor bone.
Conclusions: Bone quality therefore
seems to have a definitive impact on
machined-surfaced implants, but
this effect was not observed in the
Osseotite implant series. (Implant
Dent 2003;12:87–96)
Key Words: endosseous implants,
osseointegration, bone quality, cu-
mulative success rate
rate was 65%. They observed that the
quality of bone stands out as the single
greatest determinant of implant loss.
In a study of overdenture performance
by Hutton et al,9 implants in Type IV
bone demonstrated a cumulative suc-
87
cess rate of only 55% in comparison to
implants in Types I to III with a suc-
cess rate of 91%. A literature review
by Goodacre et al5 found a signifi-
cantly lower implant success rate of
85% in Type IV bone as compared
with a 97% rate in Types I to III.
Bryant3 also discusses the history of
implant failures in Type IV bone in an
extensive review published in 1998.
He states that “. . .a combination of
poor bone quantity and quality has a
negative influence on the establish-
ment of osseous implant anchorage,
and this effect seems to be most no-
ticeable in the maxilla.”
These efforts demonstrate some
consistent trends regarding the signif-
icance of bone quality. To date, there
is no work that examines the manner
in which surface conditions interact
with poor-quality bone. It has been
demonstrated that an increase in sur-
face roughness is related to an increase
in bone-to-implant contact and os-
seointegration.10,11 These relative im-
provements are, however, also propor-
tional to the initial state of the bone
environment.12 These were experi-
mental implants that were not loaded.
To draw a clinical correlation between
implant type (surface conditioning)
and bone quality, a large number of
implants are required to overcome the
artifacts generated by other baseline
variables. Only a large implant study
could identify the interaction between
bone quality and the implant surface
while overcoming the statistical vari-
abilities that influence other biological
and mechanical factors.
The purpose of this report is to
describe a pooled analysis of similar
clinical trial results evaluating the in-
tegration success and longevity of
both machined-surfaced implants and
implants that have a dual acid-etched
surface while isolating the effect of
bone quality. All study data were de-
rived from implants having a similar
screw-type, self-tapping design with
the exception of a surface treatment.
The consistency in the available orig-
inal data allows the following report to
isolate bone quality as the dependent
variable and determine if a difference
in long-term success is observed be-
tween implants with different surface
preparations.
88 CLINICAL SURVIVABILITY OF MACHINED-SURFACED
MATERIALS AND METHODS
The series of implants analyzed in
this report include those from Implant
Innovations, Inc., (3i). The machined-
surfaced implants (Fig. 1A) include
the, ST, II, and ICE implants. Data
from these implants were derived from
three prospective, multicenter stud-
ies13,14 (n ⫽ 2614). The patients en-
rolled in these studies were treated at
15 private practice centers and 7 uni-
versity centers after meeting admis-
sion criteria and providing informed
consent. The dual acid-etched im-
plants (Fig. 1B) were Osseotite im-
plants. Data for the implants were de-
rived from 6 prospective studies13,15,16
(n ⫽ 2288) and were conducted at 22
private practice centers and 3 univer-
sity centers. Before surgery, demo-
graphic data were recorded that in-
cluded concomitant diseases (eg,
diabetes, cancer) and smoking habits.
Exclusion criteria consisted of active
periodontal infection, uncontrolled di-
abetes, pregnancy, a greater than 10
cigarettes/day smoking habit, the need
for bone augmentation, radiation to
the head or neck within the past year,
and evidence of parafunctional habits.
All implants were placed according to
a two-stage surgical protocol that al-
lowed at least 4 months of submerged
healing in the mandible and 6 months
in the maxilla. Prosthetic determina-
tion was based on individual patient
needs for incorporating implants into
their dental treatment and included
single-tooth replacement, short-span
fixed partial dentures, and implant-
supported full-arch restorations.
Bone quality was determined dur-
ing preparation of the osteotomy based
on the operator’s hand-felt perception
of resistance during drilling. Bone was
classified according to three grades of
relative bone density and recorded as
dense, normal, or soft. All surgical
operators found the three-rank system
easy to determine, classify, and
record. For this report “good” bone
refers to the dense (Type I) and normal
(Type II and III) classifications, and
“poor” bone refers to the soft (Type
IV) class. Follow-up evaluations were
scheduled at 6-months postloading
following prosthesis insertion and
1-year intervals to assess both implant
and prosthesis functions. The evalua-
AND OSSEOTITE IMPLANTS
tion criteria for designating implant
success included all of the following:
passing digital mobility testing, lack
of periimplant radiolucency, no persis-
tent or irreversible signs and symp-
toms of pain, infection, neuropathies,
paresthesia, or violation of the man-
dibular canal.
Data were generated from 3i-
sponsored multicenter studies that be-
gan in 1992 and continue to be audited
by clinical study monitors. All studies
use similar definitions, nomenclature,
standards, and ranges in the individual
field variables allowing for accurate
analysis of pooled data. Data analysis
was performed using a relational data-
base management system maintained
by the Clinical Research Department
at Implant Innovations, Inc.
In the meta-analysis of the in-
cluded clinical studies, statistical im-
plant success was evaluated using
nonparametric survival analysis. The
data were organized such that the
event variable (in units of time) is
matched for each implant at times
when it is still viable, has failed, or is
lost to follow-up. Cumulative success
rates (CSR) were calculated using the
Kaplan-Meier method. Differences
between survival distributions charac-
terizing the success of various combi-
nations in implant-to-bone quality
were evaluated using the log-rank
(Mantel-Cox) method, which gives
equal weight to all observations. A
statistical difference between suc-
cesses was noted at P ⬍ 0.05. An
initial qualification evaluation ensured
that all implant-to-bone quality groups
maintained similar distributions of
other relevant baseline variables in-
cluding smoking, demographics, loca-
tion of implants, dimensions of im-
plants, and types of prostheses. All
statistical analyses were performed us-
ing commercially available software
(Statview v.5.0; SAS Inc., Cary, NC).
Illustrations of survival distributions
were generated using the life table
method.
RESULTS
The numbers of patients, cases
(prosthetic type), and implants are tab-
ulated to summarize the distribution of
these baseline variables (Table 1).
Data on bone quality were not avail-
Fig. 1. A machined-surfaced ICE (Incremental Cutting Edge) implant (A). An Osseotite implant with a hybrid design: the implant is machined-
surfaced to the level of the third thread and dual acid-etched to the apex (B).
Fig. 2. Bone quality assessments for machined-surfaced and Osseotite implants. Similar percentages of the implant types were inserted into
each bone quality.
Fig. 3. Life table analysis of machined-surfaced implants illustrates a 5.4 percentage point difference between implants placed in good-quality
and poor-quality bone.
Fig. 4. Life table analysis of Osseotite implants shows no significant difference in survival distribution between implants placed in good-quality
and poor-quality bone.
Fig. 5. Osseotite implant performance in poor-quality bone is higher than the machined-surfaced implant performance in good-quality bone.

IMPLANT DENTISTRY / VOLUME 12, NUMBER 1 2003 89

Table 1. Distribution of Patients, Cases, and Implants According to Bone Qualities
Bone Quality
Machined All
Good
Poor
Osseotite All
Good
Poor
able for 29 machined-surfaced im-
plants and 52 Osseotite implants,
whereas 2585 machined-surfaced im-
plants and 2236 Osseotite implants
qualified for inclusion in the analysis.
Patient demographics of the study
populations show a similar percent of
occurrence for female/male ratio, age,
and smoking habits (Table 2). Within
the Osseotite groups, the gender ratio
(females/males) is 1.56 for good bone
and 1.33 for poor bone. Within the
machined-surfaced groups, the gender
ratio is 1.22 for good bone and 1.70
for poor bone. Mean patient age dis-
tributions among groups are 54.2 ⫾
11.7 for Osseotite good bone; 54.5 ⫾
11.3 for Osseotite poor bone; 50.9 ⫾
11.1 for machined-surfaced good
bone; and 54.5 ⫾ 10.9 for machined-
surfaced poor bone. Implant dimen-
sions of diameter and width also show
similar percentages for the machined-
surfaced and Osseotite implants (Ta-
ble 3). The most common implant di-
ameter for all groups is 3.75 mm with
some implants of all categories repre-
sented in each group.
Implants in each series are sorted
according to the quality of bone into
which they were placed (Fig. 2). Of
the machined-surfaced implants,
18.6% were inserted into poor-quality
bone, as were 22.4% of the Osseotite
implants. The proportion of implants
by anatomical location (Table 4) also
show a similar distribution for each
implant type. For the Osseotite im-
plants, the ratio of mandibular to max-
illary implants is 1.70 overall with a
2.12 ratio for good bone and 0.84 ratio
Table 2. Demographics of Study Populations According to Bone Qualities
Bone Females
Machined All 57%
Good 55%
Poor 63%
Osseotite All 59%
Good 61%
Poor 57%
90 CLINICAL SURVIVABILITY OF
and 19.5% are in single-tooth
Patients Cases Implants restorations.
1162 1397 2585 The CSR for all data series were
934 1126 2105 calculated according to life table sur-
228 271 480 vival analysis methods and are pre-
931 1108 2236 sented in Table 6. The CSR for the
710 846 1735 entire 2585 machined-surfaced series
221 262 501 after an average of 60 months from the
time of Stage I surgery is 92.7%. For
for poor bone. For the machined- the machined-surfaced implants the
surfaced group, the overall mandibular CSRs by bone quality are depicted in
to maxillary ratio is 1.33 with a 1.59 the distribution in Fig. 3. For the good-
ratio for good bone and 0.74 ratio for quality bone series and the poor-
poor bone. The ratios of anterior to quality bone series the CSRs are
posterior implants is 0.47 overall for 93.6% and 88.2%, respectively. There
Osseotite with 0.51 for good bone and is a 5.4 percentage point difference
0.34 for poor bone. The anterior/ between good-quality and poor-
posterior ratios for machined-surfaced quality bone which is statistically sig-
implants are 0.33 overall, 0.36 for nificant (P ⬍ 0.05). The survival dis-
good bone, and 0.22 for poor bone. tributions of the Osseotite implants are
Implants in poor-quality bone are pre- illustrated in Fig. 4 with a CSR of
dominantly located in the posterior 98.4% at 48 months for all implants as
(82.3% of the machined implants and well as for the good-quality bone se-
74.7% of the Osseotite) and in the ries. The CSR for the poor-quality
maxilla (57.5% of the machined im- bone series is only 0.3 percentage
plants and 54.3% of the Osseotite). points lower at 98.1%, an insignificant
The predilection for the posterior max- difference. Overall, the survival of
illa typically corresponds with the machined-surfaced implants in good-
presence of poor-quality bone in this quality bone is lower than the CSR for
region. Osseotite implants in poor-quality
The mean elapsed times from bone (P ⬍ 0.05, Fig. 5).
Stage I to Stage II surgery are 6.6 A failure mode summary deter-
months for the machined-surfaced im- mined the reason of failures for each
plants and 6.1 months for the Osseo- series of implants and for each sub-
tite implants. Implants were loaded af- series of poor-quality and good-
ter a mean elapsed time from Stage I quality bone (Table 7). The main rea-
surgery of 10.1 months for the son for failure is mobility followed by
machined-surfaced implants and 9.4 periimplant infection accounting for a
months for the Osseotites. The distri- greater proportion of Osseotite failures
bution of restorative cases (Table 5) (27.8%) than machined-surfaced fail-
indicates a prevalence of short-span ures (14.9%). The differences between
fixed bridges for both the machined the series failures according to bone
(66.6%) and the Osseotite implants density are not significant with more
(57.1%). For the machined-surfaced than half of all failures having oc-
implants in poor-quality bone, 74.9% curred in normal quality bone. There
are restored as short-span fixed is no increase in percentage of smok-
bridges, and 16.5% are restored as ing in the failed implants as compared
single-tooth restorations. For the Os- with the baseline population except for
seotite implants in poor-quality bone, the Osseotite implants in poor-quality
64.1% are in short-span fixed bridges, bone in which 3 of the 10 failed im-
Males F/M Age SD Smokers Cigarettes/Day
43% 1.33 51.6 11.1 20% 12.5
45% 1.22 50.9 11.1 19% 12.6
37% 1.70 54.5 10.9 22% 12.1
41% 1.44 54.3 8.3 17% 12.2
39% 1.56 54.2 11.7 17% 12.0
43% 1.33 54.5 11.3 14% 13.1
MACHINED-SURFACED AND OSSEOTITE IMPLANTS
Table 3. Distribution of Machined and Osseotite Implants by Diameter and Length
Implant Length (mm)
7.0 8.5 10.0 11.5 13.0 15.0 18.0 20.0 Total %
Machined
Implant Diameter (mm) 3.25 0 2 14 2 64 42 1 0 125 4.9
3.75 26 72 491 61 491 344 30 1 1,516 59.1
4.00 14 27 101 26 75 40 1 0 284 11.1
5.00 53 101 229 28 126 1 0 0 538 21.0
6.00 11 14 48 3 24 1 0 0 101 3.9
Total 104 216 883 120 780 428 32 1
% 4.0 8.4 34.4 4.7 30.4 16.7 1.2 0
Osseotite
Implant Diameter (mm) 3.25 0 1 4 4 27 17 5 0 58 2.6
3.75 0 84 264 89 372 320 111 10 1,250 56.0
4.00 0 47 133 61 177 78 37 10 543 24.3
5.00 36 56 123 47 71 5 4 0 342 15.3
6.00 0 10 15 4 11 2 1 0 43 1.9
Total 36 198 539 205 658 422 158 20 2,236
% 1.6 8.9 24.1 9.2 29.4 18.9 7.1 0.9

plants were in smokers (30%). The
failure mode analysis also included lo-
cations of the failed implants, which
reveals that for the machined implants
more failures are located in posterior
regions (83.0% versus 72.2%) and for
the Osseotite implants more failures
are located in the maxilla (58.3% ver-
sus 44.7%).
DISCUSSION
The purpose of this study is to
report the results of a meta-analysis of
machined-surfaced implants and Os-
seotite implants in which baseline
variables are compared. One baseline
variable was isolated and its impact on
implant performance was character-
ized. The baseline variable of bone
quality was isolated to determine if
poor-quality bone correlates with a
difference in success rates. The avail-
ability of a large number of implants
placed under similar conditions and
their results all managed in one rela-
tional database system presented an
opportunity to make such an analysis.
Normally, analyzing data from inde-
pendent studies requires using meta-
analysis methods in which only sum-
mary data are used. For this effort,
actual data were used because of stan-
dardization of terminology for all
studies, standard definitions of out-
comes, and perhaps most importantly,
consistency of the patient admission
criteria (inclusion-exclusion criteria)
across all studies.
To effectively compare two
groups on the basis of one baseline-
dependent variable (ie, bone quality),
all other baseline variables that impact
the independent variable (implant sur-
vival) must be balanced or even for
both groups. Often some manipulation
of cases is required to achieve this
balance, but this effort is fraught with
potential bias. To balance the patient
baseline variables, strict adherence to
biometric procedures must be kept to
avoid the perception of bias. In our
analysis we found in our first round of
data processing that our variables of
concern, demographics, smoking, im-
plant dimension, mean time to load-
ing, and restorative type, were not ex-
cessively imbalanced between the
poor and good bone quality groups.
All cases from the indicated studies
were included in the analyses so that
an effort to create balanced groups
was unnecessary.
Presurgical assessment of bone
quality is not always possible be-
cause conventional radiographs are
inadequate for assessing the quality
of bone.17 Although computed to-
mography (CT) can expose the qual-
ity of bone, it is not routinely avail-
able, and the clinician may have to
wait until placement surgery to eval-
uate bone quality based on hand-felt
perception of drilling into the bone.
Ideally, in a multicenter study, a cen-
tral laboratory would histologically
evaluate bone density using tre-
phined bone core samples. Although
the four-rank bone scoring method is
widely accepted, Trisi and Rao 18
used trephined bone sample histo-
morphometrics to correlate clinician
bone density scoring and determined
that it was not possible for clinicians
to routinely distinguish the differ-
ence between Types II and III bone.
These findings support the use of a
three-rank system of dense, normal,

Table 4. Proportions of Implants by Location According to Bone Qualities

Bone Mandible Maxilla Mand/Max Anterior Posterior Ant/Post
Machined All 57.1% 42.9% 1.33 24.6% 75.4% 0.33
Good 60.4% 39.6% 1.53 26.2% 73.8% 0.36
Poor 42.5% 57.5% 0.74 17.7% 82.3% 0.22
Osseotite All 63.0% 37.0% 1.70 32.0% 68.0% 0.47
Good 68.0% 32.0% 2.12 33.9% 66.1% 0.51
Poor 45.7% 54.3% 0.84 25.3% 74.7% 0.34

IMPLANT DENTISTRY / VOLUME 12, NUMBER 1 2003 91

Table 5. Distribution of Restorative Cases by Bone Quality
Bone Quality STR SSFB
Machined All 25.8% 66.6%
Good 28.1% 64.6%
Poor 16.5% 74.9%
Osseotite All 22.2% 57.1%
Good 23.0% 55.0%
Poor 19.5% 64.1%
STR ⫽ single tooth restoration; SSFB ⫽ short span fixed bridge (ⱕ 5 units); LSFB ⫽ long span fixed bridge (⬎ 5 units).
or soft employed in the studies ana- chined surface (33.98%). This study
lyzed here. suggests that Osseotite implants can
In a human study, histomorpho- achieve higher degrees of integration
metrics indicated a greater degree of sooner than machined-surfaced im-
osseointegration for the Osseotite sur- plants, specifically in poor-quality
face as compared with opposing ma- bone.
chined surfaces on the same implant (a An important part of restorative
two-surfaced implant) in the same pa- planning is identifying patient condi-
tient at the same location.12 After 6 tions that might preclude the use of
months of healing in poor-quality dental implants or that may suggest a
bone of the posterior maxilla, the two- low probability of their success. Con-
surfaced implants were removed by ditions such as uncontrolled diabetes,
trephine with surrounding hard tissue. smoking, and periodontitis may be
The mean bone-to-implant contact identified during routine examination,
values for the Osseotite surface and their presence may affect treat-
(72.96%) were significantly higher ment decisions. Some patient condi-
than for those on the opposing ma- tions may only be assessed during sur-
gery. Bone quality, a function of bone
LSFB density and cortical thickness, can
7.6%
only be practically assessed during
7.4% surgical preparation of the osteotomy.
8.5% Whereas Jaffin and Berman1 advise
20.7% using an alternative treatment plan that
22.0% does not include implants when poor-
16.4% quality bone is detected, the authors of
this study suggest the use of the Os-
seotite implants in soft bone because
the data show that performance, dura-
tion of failure-free function, is not
compromised.
CONCLUSIONS
The integration potential provided
by the Osseotite surface condition may
provide an advantage to long-term im-
plant success in anatomical areas of
poor-quality bone as compared with
machined-surfaced implants. Further-
more, this study suggests that Osseo-
tite implants can achieve a higher de-
gree of integration sooner than
machined-surfaced implants, specifi-
cally in poor-quality bone.

Table 6. Life Table Results in 6-Month Intervals for Machined-Surfaced and Osseotite Implants
Implants at Failed Extent of Death/Lost to Interval Cumulative
Interval (months) Risk at Start Implants Duration Follow-up Success Success
Machined
0–6 2,614 64 6 10 97.5% 100.0%
6–12 2,534 76 10 5 97.0% 97.5%
12–18 2,443 33 5 11 98.6% 94.6%
18–24 2,394 6 4 25 99.7% 93.3%
24–30 2,359 2 6 19 99.9% 93.1%
30–36 2,332 1 55 46 100.0% 93.0%
36–42 2,230 2 93 26 99.9% 93.0%
42–48 2,109 2 241 26 99.9% 92.8%
48–54 1,840 0 335 47 100.0% 92.8%
54–60 1,458 0 219 36 100.0% 92.8%
60–66 1,203 1 139 13 99.9% 92.8%
66–72 1,050 0 155 12 100.0% 92.7%
72–78 883 0 207 0 100.0% 92.7%
78–84 676 0 411 1 100.0% 92.7%
85–90 171 0 170 1 100.0% 92.7%
Osseotite
0–6 2,236 21 10 4 99.1% 100.0%
6–12 2,201 6 15 28 99.7% 99.1%
12–18 2,152 4 6 29 99.8% 98.8%
18–24 2,113 3 11 24 99.9% 98.6%
24–30 2,075 0 59 31 100.0% 98.5%
30–36 1,985 0 190 11 100.0% 98.5%
36–42 1,784 0 318 2 100.0% 98.5%
42–48 1,464 1 225 11 99.9% 98.5%
48–54 1,227 1 364 2 99.9% 98.4%
54–60 860 0 445 0 100.0% 98.3%
60–66 415 0 376 0 100.0% 98.3%
66–72 39 0 39 0 100.0% 98.3%

92 CLINICAL SURVIVABILITY OF MACHINED-SURFACED AND OSSEOTITE IMPLANTS

Table 7. Failure Mode Summary of Machined and Osseotite Implants in Poor-Quality Bone (PQB) and in Good-Quality Bone (GQB)
All Implants PQB GQB
MACH OSS MACH OSS MACH OSS
N ⫽ 2585 N ⫽ 2236 N ⫽ 480 N 501 N ⫽ 2105 N ⫽ 1735
F ⫽ 188 F ⫽ 36 F ⫽ 57 F ⫽ 10 F ⫽ 131 F ⫽ 26
REASON FOR FAILURE % % % % % %
Mobility 62.8 58.3 68.4 90.0 60.3 46.2
Consistent Radiolucency 5.8 2.8 8.8 10.0 4.6 0
Persistent Pain 6.9 5.5 5.2 0 7.6 7.7
Infection 14.9 27.8 8.8 0 17.6 38.5
Violation of Mandibular 1.6 2.8 0 0 2.3 3.8
Canal
Other 8.0 2.8 8.8 0 7.6 3.8
BONE QUALITY
Dense 17.0 13.9 0 0 24.4 19.2
Normal 52.7 58.3 0 0 75.6 80.8
Soft 30.3 27.8 100 100 0 0
SMOKING
Yes 17.6 16.7 10.5 30.0 20.6 11.5
No 82.4 83.3 89.5 70.0 79.4 88.5
LOCATION
Anterior 17.0 27.8 19.3 40.0 15.9 23.1
Posterior 83.0 72.2 80.7 60.0 84.1 76.9
Maxilla 44.7 58.3 61.4 100 37.9 42.3
Mandible 55.3 41.7 38.6 0 62.1 57.7
MACH ⫽ machined-surfaced implants; OSS ⫽ Osseotite implants; N ⫽ the total number of implants in the series; F ⫽ the number of implants that failed.

Disclosure
The clinical studies pooled for
analysis in this report were sponsored
by Implant Innovations, Inc. The au-
thors claim to have no financial inter-
est in any company or any of the prod-
ucts mentioned in this article.
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Reprint requests and correspondence to:
Renée M. Stach, DDS
Implant Innovations, Inc.
4555 Riverside Drive
Palm Beach Gardens, FL 33410
Phone: 561–776 – 6723
Fax: 561–776 – 6852
E-mail: rstach@3implant.com

IMPLANT DENTISTRY / VOLUME 12, NUMBER 1 2003 93

 Abstract Translations [German, Spanish, Portuguese, Japanese]
AUTOR(EN): Renée M. Stach, DDS*, Sean
S. Kohles, PhD**. *Medizinische Dokumenta-
tion, Implant Innovations, Inc., 4555 Riverside
Drive, Palm Beach Gardens, FL, 33410.
**Direktor, Kohles Bioengineering, 1731 SE
37th Avenue, Portland, OR 97214. Schrift-
verkehr: Renée M. Stach, DDS, Implant Inno-
vations, Inc., 4555 Riverside Drive, Palm
Beach Gardens, FL 33410. Telefon: 561 – 776
– 6723, Fax: 561 – 776 – 6852; eMail:
rstach@3implant.com
AUTOR(ES): Renée M. Stach, DDS*, Sean S.
Kohles, PhD**. *Escritor Médico, Implant In-
novations, Inc., 4555 Riverside Drive, Palm
Beach Gardens, FL 33410. **Director,
Kohles Bioengineering, 1731 SE 37th Avenue,
Portland, OR 97214. Correspondencia a:
Renée M. Stach, DDS, Implant Innovations,
Inc., 4555 Riverside Drive, Palm Beach Gar-
dens, FL 33410. Teléfono: 561-776-672, Fax:
561-776-6852; rstach@3implant.com
94 CLINICAL SURVIVABILITY OF MACHINED-SURFACED
ZUSSAMENFASSUNG: Zielsetzung: Häufig wird als Grund für das Fehlschlagen einer
Implantierungsbehandlung durch Nichtanwachsen eines Implantats die minderwertige
Knochenqualität im um den Implantierungsbereich liegenden Knochen benannt. Diese
wird oftmals bei den Vorbereitungen zur Osteotomie entdeckt. Eine unzureichende
Knochenqualität kann die Integration des Implantats behindern und somit zu schlechteren
Integrationsquoten beitragen; zusätzlich sollten aber weitere Faktoren wie beispielsweise
die Implantatoberfläche Berücksichtigung finden, die den langfristigen Erfolg der Implan-
tation gefährden können. Die folgende Abhandlung greift die Ergebnisse klinischer
Studien auf, die sowohl Implantate mit maschinell bearbeiteter Oberfläche als auch
doppelseitige, säuregeätzte Osseotite (Implant Innovations Inc., Palm Beach Gardens, FL,
USE) Implantaten untersuchten. Hierbei wurden die Faktoren der Knochenqualität und der
Konditionierung der Implantatoberfläche gesondert betrachtet. Materialien und Metho-
den: Die Daten zur Analyse wurden aus acht repräsentativen klinischen Studien mehrerer
Kliniken zusammengestellt, so dass insgesamt 2614 Implantate mit maschinell bearbe-
iteter Oberfläche und 2288 Osseotite Implantate zur Auswertung genutzt werden konnten.
Alle Implantierungen folgten einem zweistufigen Operationsansatz mit einer an-
schließenden Heilungsphase von vier bis sechs Monaten ohne Belastung. Die Knochen-
qualität wurde vom durchführenden Chirurg gemäß dem beim Bohren auftretenden
Widerstand beurteilt und dementsprechend als fest, normal oder weich eingestuft. Bei
Erstellung der vorliegenden Analyse betrug der Zeitraum vom Eingriff bis zur Nachunt-
ersuchung bei den Osseotite Implantaten bis zu 66 Monate und bis zu 84 Monate bei den
Implantaten mit maschinell bearbeiteter Oberfläche. Um eine gleichmäßige Verteilung
zwischen den Gruppen zu erreichen und die Knochenqualität isoliert betrachten zu
können, wurden Vergleiche anderer grundlegender Variablen vorgenommen. Diese um-
fassten unter anderem Patientenherkunft und sozialen Status, Lage und Umfang der
Implantate sowie die jeweils angewendete Wiederherstellungsmethodik. Der Implan-
tierungserfolg wurde anhand einer nicht-parametrischen Überlebensstatistik (Kaplan-
Meier-Schätzung) analysiert; außerdem wurden die kumulativen Erfolgsquoten berechnet
und mittels Logarithmus-Reihen-Bildung die Unterschiede bezüglich der Implantat-
Knochen-Qualität bei den unterschiedlichen Varianten ermittelt. Ergebnisse: Bei den
Implantaten mit maschinell bearbeiteter Oberfläche beträgt die kumulative Erfolgsquote,
ohne Berücksichtigung der unterschiedlichen Knochengewebsqualität 92,7 %. Die für vier
Jahre nach Implantation projizierte kumulative Erfolgsquote beläuft sich bei den in gutem
(d.h. festem oder normalem) Knochen eingepflanzten Implantaten auf 93,6 %, während
die entsprechende Erfolgsquote für die in minderwertigem (d.h. weichem)
Knochengewebe eingesetzten Implantate bei nur 88,2 % (p⬍ 0,05) liegt. Die Osseotite
Implantate weisen gesamt eine kumulative 4-Jahres-Erfolgsquote von 98,4 % auf; 98,4 %
bei gutem Knochengewebe und 98,1 bei unzureichender Knochenqualität.
Schlussfolgerungen: Während sich eine unterschiedliche Knochenqualität offensichtlich
auf den Implantierungserfolg bei Implantaten mit maschinell bearbeiteter Oberfläche
auswirkt, war ein solcher Zusammenhang bei den Osseotite Implantaten nicht zu
beobachten.
SCHLÜSSELWÖRTER: in das Knochengewebe eingebettete Implantate, Integration in
den Knochen, Knochengewebsqualität, kumulative Erfolgsquote
ABSTRACTO: PROPÓSITO: Una causa citada con frecuencia de la falla de los implan-
tes dentales es la calidad inadecuada del hueso que se encuentra en el lugar del implante
durante la preparación de la osteotomía. Mientras que la calidad del hueso puede
claramente afectar las tasas de integración, variables adicionales, tales como la condición
de la superficie del implante también pueden influenciar el éxito del rendimiento del
implante a largo plazo. El siguiente informe examina los resultados de estudios clínicos
que verificaron el rendimiento de los implantes con superficies pulidas a máquina y
implantes Osseotite dobles grabados preparados con ácido (Implant Innovations, Inc.,
Palm Beach Gardens, FL, EE.UU.) para aislar el efecto de la calidad del hueso y la
condición de la superficie del implante. MATERIALES Y MÉTODOS: Los datos de los
implantes se derivaron de ocho estudios clínicos posibles en distintos centros que repre-
sentaron a 2.614 implantes con superficies pulidas a máquina y 2.288 implantes Osseotite.
Todas las cirugías para la colocación de los implantes siguieron a un método quirúrgico
AND OSSEOTITE IMPLANTS

AUTOR(ES): Renée M. Stach, DDS*, Sean S.
Kohles, PhD**.* Escritor de medicina, Im-
plant Innovations, Inc., 4555 Riverside Drive,
Palm Beach Gardens, FL, 33410. ** Diretor,
Kohles Bioengineering, 1731 SE 37th Avenue,
Portland, OR 97214. Correspondências de-
vem ser enviadas a: Renée M. Stach, DDS,
Implant Innovations, Inc., 4555 Riverside
Drive, Palm Beach Gardens, FL 33410.
Telefone: 561 776-6723, Fax: 561 776-
6852; Email: rstach@3implant.com
de dos etapas con un período de curación sin carga de 4 a 6 meses. Se evaluó la calidad
del hueso a través de la recepción del operador a la resistencia durante la perforación y
fueron clasificados como denso, normal, o suave. En el momento de este análisis, el
seguimiento del implante de la colocación varió hasta los 66 meses para el Osseotite y 84
meses para los implantes con superficies pulidas a máquina. Para aislar el efecto de la
calidad del hueso, otras variables de base fueron comparadas para asegurar una distri-
bución similar entre los grupos. Las variables de base incluyeron información demográfica
de los pacientes, lugares, dimensiones de los implantes y tipos de casos de restauración.
El rendimiento de los implantes se analizó usando el análisis de supervivencia no
paramétrico (estimación de Kaplan-Meier). Las tasas de éxito acumulativas (CSR) se
calcularon y las diferencias entre las combinaciones de la calidad del hueso del implante
se evaluaron usando el método de rango por logaritmo. RESULTADOS: Para los
implantes con superficies pulidas a máquina, el CSR a cuatro años en todos los lugares del
hueso fue del 92,7%. Para los implantes colocados en hueso bueno (denso y normal), el
CSR a cuatro años fue de 93,6% comparado con el CSR a cuatro años en hueso pobre
(suave) de 88,2% (p⬍0,05). Para los implantes Osseotite en todos los lugares el CSR
general a cuatro años fue de 98,4%; 98,4% en hueso bueno y 98,1% en hueso pobre.
CONCLUSIONES: La calidad del hueso parece tener un impacto importante en los
implantes pulidos a máquina pero este efecto no se observó en la serie de los implantes
Osseotite.
PALABRAS CLAVES: implantes endoóseo, oseointegración, calidad del hueso, tasa
acumulativa del éxito
SINOPSE: OBJETIVO: uma causa de insucesso de implante odontológico freqüente-
mente citada é a qualidade óssea imprópria encontrada no local do implante durante a
preparação para a osteotomia. Enquanto a qualidade óssea claramente afeta as faixas de
integração, as variáveis adicionais, como o condicionamento da superfície do implante,
também podem influenciar o sucesso de seu desempenho a longo prazo. O relatório a
seguir examina os resultados dos estudos clínicos que monitoram o desempenho dos
implantes de superfície usinada e os implantes Osseotite com ataque ácido duplo (Implant
Innovations, Inc., Palm Beach Gardens, FL, EUA), isolando o efeito da qualidade óssea
e o condicionamento da superfície do implante. MATERIAIS E MÉTODOS: as infor-
mações a respeito dos implantes são derivadas de oito estudos clínicos multicentrados
prospectivos representando 2,614 implantes de superfície usinada e 2,288 implantes
Osseotite. Todas as cirurgias de colocação de implante seguiram uma abordagem cirúrgica
de duas fases, com um período de cicatrização de descarga de 4 a 6 meses. A qualidade
óssea foi avaliada pela percepção da resistência por um operador durante a perfuração e
foi classificada como densa, normal ou mole. O acompanhamento do implante no
momento desta análise foi realizado a partir da colocação até 66 meses para os implantes
Osseotite e 84 meses para os implantes de superfície usinada. A fim de isolar o efeito da
qualidade óssea, outras variáveis de base foram comparadas para assegurar a distribuição
equivalente entre os grupos. As variáveis de base a respeito do paciente incluem: a parte
demográfica, localizações, dimensões dos implantes e tipos de casos restauradores. O
desempenho do implante foi avaliado utilizando-se a análise de sobrevivência não
paramétrica (estimativa Kaplan-Meier). As faixas de sucesso cumulativas (CSR, ou
Cumulative Success Rates) foram calculadas e as diferenças entre as combinações da
qualidade do implante ósseo foram avaliadas utilizando-se o método Log-Rank. RE-
SULTADOS: para os implantes de superfície usinada, o CSR de quatro anos em todos os
locais ósseos foi 92,7%. Para os implantes colocados em osso de boa qualidade (denso e
normal), o CSR de quatro anos foi 93,6%, em comparação ao CSR de quatro anos em osso
de qualidade inferior (mole), que foi 88,2% (p⬍0.05). Para os implantes Osseotite em
todos os locais, seu CSR geral de 4 anos foi 98,4%, enquanto em osso de boa qualidade
foi 98,4% e em osso de qualidade inferior foi 98,1%. CONCLUSÕES: a qualidade óssea
no entanto aparenta causar um impacto definitivo nos implantes de superfície usinada, mas
este efeito não foi observado na série de implantes Osseotite.
PALAVRAS-CHAVES: implantes endósseos, osseointegração, qualidade óssea, faixa de
sucesso cumulativo
IMPLANT DENTISTRY / VOLUME 12, NUMBER 1 2003 95
96 CLINICAL SURVIVABILITY OF MACHINED-SURFACED AND OSSEOTITE IMPLANTS