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Ioannis K.

Kaioussis
Urs Brdgger
Giovanni E. Scdvi
Walter Buigin
Niklaus P. Lang

Autbors' affitiation:
loannis K. Kaioussis, Urs Briiggei. Giovanni E.
Salvi, Walter BtiigiJi, Niklaus P. Lang, Department
of Periodontology and Fixed Prostbedcs, University
of Beme, Scbool of Dental Medicine, Beme,
Switzerland
Correspondence to:
Prof. Dr N.P Lang

University of Beme
Sebool of Dental Medicine,
Freiburgstrasse 7 CH 3010 Beme
Switzerland
Tel.: +41 31 632 25 77
Fax; 4-41 31 63J 49 15
e-mail: nplangdial.eunet.cb

Effect of implant design on survival and


success rates of titanium oral implants: a
io-year prospective cohort study of the
ITI'^ Dental Implant System

Key words: implant design, peri-implantitis, success, survival


Abstract
Aim: The aim of this 10-year study (observation time 8-12 years, mean: 10 years) was to
compare the survival rates, success rates and incidences of biological complications using
three different implant designs of the ITI" Dental Implant System.
Material and methods: In 89 dental patients treated comprehensively, a total of 112 hollow
screw (HS), 49 hollow cylinder (HC) and 18 angulated hollow cylinder (AHC) implants were
installed depending on the available bone volume and according t o prosthetic needs. One
and 10 years after surgical placement, clinical and radiographic parameters were assessed.
The incidences of peri-implantitis according to various thresholds were registered over 10
years of maintenance.
Results: Success criteria at 10 years were set at: pocket probing depth (PPD) s; 5 mm, bleeding
on probing (BoP)--, bone loss < 0.2 mm annually. The survival rate for HS was 95.4%, for HC
85.7% and for AHC 91.7%. Ninety percent of all the HS, 71 % of the HC and 88% of the AHC
did not present with an incidence of peri-implantitis over the 10 years, HC having
significantly higher incidence of peri-implantitis than HS (P< 0.004). With the success criteria
set above, a success rate for HSof 74%, for HCof 63% and for AHC of 6 1 % was identified at
10 years. However, including a definition of PPD^Gmm, BoP - and bone loss < 0.2mm
annually for success, the rates for HS were 78%, for HC 65% and for AHC 67%, respectively.
Basing success criteria purely on clinical parameters (without radiographic analysis), such as:
PPD^5 mm and BoP-, the success rates increased to 90%, 76% and 89%, respectively. With
PPD^6mm and BoP- as success criteria chosen, the respective rates were 94%, 82% and
94% for HS, HC and AHC implants, respectively.
Conclusions: A significantly higher survival rate as well as a significantly lower incidence of
peri-implantitis was identified for hollow screw design ITI" Dental Implants after 10 years of
service when compared to hollow cylinder design ITI " Dental Implants (95.4% vs. 85.7%;
10% vs. 29%). Depending on the setting of the threshold criteria for success, success rates
are highly variable and hence, reporting of success rates with elaboration on the criteria set
appears crucial for comparison of different studies.

Date:

Accepted io fanuary 1003


To dte this article:
Kaioussis (K, Bragger U, Salvi GE, BOrgin W, Lang NP.
Effect of implant design on survival aiid succc^ rates of
titanium oral implants: a lo-year prospective cohort
study of the m * Dental Implant System.
Clin. Orai Impl. Res. 1$, 2txi4.j B-17

Ccqjyri^t Blackwell Munksgaard 2004

Although osseointegrated oral implants


have heen documented to yield high survival rates, biological implant complications
occasionally leading to implant loss do
occur (AdeU et al. 1990; Buser et al. 1997;
Bragger et al. 2001). The overwhelming
evidence points to the infective nature of
biological complications leading to muco-

sids and peri-implantitis (Mombelli et al.


1987; Ericsson et al. 1996; Persson et ill.
1996; Rutaretal. 2001), while mechanical
overload has also heen speculated to ct)ntrihute to implant failure (Rosenheig et al.
1991; Isidor T996). Obviously, several
factors may provide risks for peri-implant
complications (Tonetti & Schmid 1994).

Karoussis et ai . Long-tenn impbnt prognosis of m'^ Denul Implants


These faetnrs may include smoking, uncontrolled diabetes, colonization of the
peri-implant sulcus with specific virulent
micnKirganisms.
Some systemic conditions such as osteoporosis, radiation therapy, etc. have also
|-)een imphcated (Genco et al. 1998). However, the true significance and the clinical
impact oi these factors for the longevity of
osseointegrated oral implants is - at the
present time - still a matter of debate
(Tonetti 1998).

Defining the clinical criteria for periimplant conditions and hence, determining
criteria for implant success has hitherto not
been luiifonn. Even the terms survival,
success, comphcation and failure rates have
been employed with a wide range of
interpretation {Sehnitman & Shulman
1978; Albrektsson et al. 1986; Buser et al.
1990; van Steenberghe 1997; van Steenberghe et al. 1999I. However, for most
clinicians, implant failure represents the
complete loss of the implant.

It has been hypothesized that implant


design may also play a role for the
preservation of jwri-implant marginal bone
(Borchers ik Reichart 1983). The design of
;m implant should allegedly not cause highstrain concentrations at the implant neck
in order to avoid crestal bone resorption
(Rieger et al. 19S9). It has been postulated
in in vivo studies (Pilliar et al. 1991) that
different strain charaeteristies were manifested in the supporting bone around
various implant designs.
Cylindrical, conieal, stepped, tapered,
serew-shaped and hollow cylinder (HC|
implant designs yielded variations in strain
distribution in vitro m fitiite-element studies [Siegele &. Soltesz 1989). Screwshaped and full-bcxiy cylindrical implants
pnxluced less strain than implants with
small radii of curvature (eonieal), with
geometric discontinuities (stepped), or HC
implants. For cylindrical implants horizontal loading induced maximum strain in the
crestal aspects, while for screw-shaped implants maximum strain was ctineentrated
in the regions helow the uppermost threads.
The m ^ Dental hnplant System has
evolved through several generations of
implant designs originating from basket
types and ranging from eccentrie to rotary
symmetrical HCs and hollow screws (HSs),
the latest mcxst ctimmonly installed implant being the full-btxiy screw. Varying
success rates have been reported for the
previous HC Type F implant (ten Bruggenkate et al. 199OJ Versteegh et al. 1995;
Mericske-Stem et al. 2001). Over 7 years of
function the novel ITI" Dental Implant
System with its hollow cylinders presented
a higher cumulative failure rate (8.7%)
than the solid screw of the same ITI*
Dental Implant System (3.2%). On the
other hand, 4.2% of the HS implants were
lost over 7 years in the same study (Buser et
al. 1997).

Nevertheless, implant failures have also


been defined as circumstances in which the
conditions of the peri-implant tissues were
clinically not satisfactory (Mombelli 1994I.
Implant failures may better be addressed
as biological comphcations which may or
may not lead to tbe loss of the implant.
These may be classified according to
chronological criteria as 'early' or 'late'.
Early comphcations occur during the healing period following implant installation
and up to obtaining elinieally successful
stability, usually 6 months following installarion. A variety of factors may be
responsible for early complications, such
as damage of the bone due to overbeating
during prepararion of the recipient site, lack
of primary stabihty of the implant, bacterial
contamination by improper surgical technique, overloading by temporary reconstrucrion. Late complicarions, however,
are observed after loading and are generally
associated with the development of a periimplant infeerion or peri-implantitis.
Previously, an implant system was accepted to be 'successful' if the implants on an average - lost not more than 1.5 mm
of alveolar bone height in the first year of
function and not more than 0.2 mm
annually in the subsequent years (Albrektsson et al. 1986; Albrektsson & Isidor 1994).
In more recent years, clinical parameters
have been added to describe implant complications and included bleeding on probing
of tbe peri-implant suleus and/or probing
depth exeeeding 5 mm (MombeUi & Lang
1994)As defined at the ist European Workshop on Periodontology in 1993, periimplant mucositis represents a 'reversible
inflammatory reaction in the soft tissues
surrounding a functioning implant' and
peri-implantitis represents an 'inflammatory reaction with lass of supporting kme
in the tissues surrounding a functioning

implant' (Albrektsson & Isidor 1994). It is


evident that such definitions portray biological complications which may be treated
successfully (Lang et al. 2000) in order to
prevent total kws of the implant. If such
interceptive treatment does not reach a
status of healthy peri-implant tissues the
implant may have to be explanted leading
to complete failure.
The aims of the present study were to
assess and compare the io-year survival
and comphcation rates of HS, HC and
angulated hollow cyhnder (AHCj m ' ^
Dental Implants. To define criteria for
success of surviving implants, a hierarchy
of various clinical threshold parameters was
applied.

Material and methods


Subjects
Patients of a prospective, longitudinal,
cohort study (Braver et al. 1997) of the
Department of Periodontology and Fixed
Prasthodontics University of Beme Sehool
of Dental Medicine, were examined at i
and 10 years after implant installarion. The
patients had been treated for existing
periodontal disease according to a comprebensive treatment strategy (Lang 1988)
prior to the installation of implants and
the incorporation of suprastructures.
All the implants installed were implants
of the m * Dental Implant System (Institute Straumann AG, CH-4437, Waldenburg Switzerland). They were placed
according to the manufacturer's guidelines
(Sutter et al. 1988). The suprastructures
consisted of single crowns or fixed partial
dentures (FPD), which were seated between
4 and 6 months postsurgjcally. The patients were incorporated into the supportive
periodontal therapy (SPT) program that was
provided either at the Clinic for Periodontology and Fixed Prosthodonties, University of Beme, Switzerland, or in referring
private dental practices at intervals between
3 and 6 months.
At every recall examination during the
io-year follow-up period, all biological
comphearions (peri-implanritis) were recorded and treated according to the implant
maintenance and treatment protocol (cumulative interceptive supporrive therapy CIST) (Lang et al. 2000).
9 I Clin. Oral Impl Res. 15, 2004 / 8-17

Karoussis et al. Long-term implant progaosis of m Dental Implants


Clinical examination

Clinical i- and io-year evaluations included the following parameters:


modified plaque index (mPII) (Mombelli
etal. 1987I,
modified bleeding index (mBII) [Mombelli etal. 1987I,
distance between the implant shoulder
and the mucosal margin |DIM] in millimeters [recession scored as negative
value),
pocket probing depth (PPD) in millimeters,
probing attachment level (PAL) in millimeters, which was calculated by subtracting PPD from DIM,
bleeding on probing (BoP).
Ail measurements were performed at
four aspects of eacb implant using a HuFriedy PGF-GFS periodontal probe (HuFriedy, Chicago, IL, USA). Readings were
done to tbe nearest millimeter.
Radiographic examination

Radiographs were obtained using a customized Rinn filmholder (XCP" Instruments, Rinn Corporation Elgin, IL, USA)
with a rigiti film-object-X-ray source being
coupled to a beam-aiming device in order to
achieve reproducible expostire geometry.
The radiographs were captured using a
hiack-and-white video camera (Canon,
Still Video Products Group, Tokyo, Japan)
and viewed on a light box. The images were
transferred to a personal computer (Compaq 386/20, USA) and digitized with a
frame grabber hardware card [Matrox Electronic Systems MVP/AT, Dorval Quebec,
Canada). Using an image-processing software, digitized images were stored with a
resolution of 511 x 512 x 8 hit pixels (256
shades of gray). Stored images were displayed on a monitor and linear measurements were performed with the help of a
cursor (Bragger et al. 1996).
All radiograpbic measurements were
performed in the 1 - and : o-year radiographs
by one calibrated examiner (l.K.K.). Tbe
distances in millimeters between tbe
shoulder of tbe implant and the first clear
hone to implant contact, mesially and
distally were noted. Changes in bone beight
over tbe observation period as well as
annual rates of change were calculated.
10

I Clin. Oral Imp!. Res. i<i, 1004 / S-17

Success criteria for the implants at 10


years were set according to the following
hierarchy;
Success criteria I

'Success' tben characterized an implant


presenting no annual bone loss >o.2 mm
mesially or distally, no site witb
PPD>6 mm and no site with PPD ^ 6 mm
and BoP-f (successful implant).
Success criteria IV (Clinical success)

1. Ahsence of mobility [Buser et al. 1990).


2. Absence of persistent subjective complaints (pain, foreign body sensation
and/or dysaestbesia) (Buser etal. 1990).
3. No PPD>5 mm (PPD>s mm] (Mombelli & Lang 1994; Bragger et al. 2001).
4. No PPD = 5 mm (PPD = 5 mm) and
BoP + [Momhetli &. Lang 1994).
5. Absence of a continuous radiolucency
around tbe implant (Buser ct al. 1990).
6. After the first year of service the annual
vertical hone loss should not exceed
0.2 mm [Alhrektsson et al. 1986; Albrektsson &. Isidor 1994).
If a mesial or distal armual bone loss was
>o.2mm, or a PPD [even at one implantsite) was >5mm, or PPD (even at one
implant-site) was 5mm with BoP -!-, the
implant was characterized as 'unsuccessful'
(implant witb a complication). 'Success'
characterized an implant fulfilling Ixith the
clinical and the radiograpbic criteria for
success mentioned [successful Implant).

Again, the criteria defined for this analysis


were the same as those specified above
(Success criteria IE), but without including
radiographic parameters.
Statistical analysis
Survival rates

Descriptive statistics for all clinical and


radiographic parameters were performed
after grouping tbe implants into HS, HC
and AHC implants. For the comparisons of
the clinical parameters and the bone loss
within the three groups, Kruskal-Wallis
tests were used.
For the estimation of survival rates and
incidences of peri-implantitis, Kapl;in-Meier analyses were used (Kaplan & Meier
1958). By means of life-table statistics, the
cumulative survival rates were aUculated,
using the following formula (van Steenherghe et al. 1999):
CSR = {PCRS+{ISRxIOO-PCSR)}/^00
where i? Race, C Cummulative,
/ =Interval, P Previous,

Success criteria II (clinical success)

The criteria defined for this analysis were


the same as those specified alxjve [Success
criteria 1), but without including radiographic parameters.
Success criteria HI

Elevated threshold were defined as follows:


1. Ahsence of mohility [Buser et al. 1990).
2. Ahsence of persistent subjective complains [pain, foreign body sensation and/
or dysaestbesia) (Buser et al. 1990).
3. No PPD >6nim (PPD>6mm) (Momhelli &. Lang 1994; Bragger et al. 2001).
4. No PPD = 6 mm (PPD = 6 mm) and
Bop + (Mombelli & Lang 1994).
5. Absence of a continuous radiolucency
around the implant (Buser et al. 1990).
6. After the first year of service, tbe annual
vertical hone loss should not exceed
0.2 mm (Albrektsson et al. 1986, Alhrektsson & Isidor 1994).

and S Survival.

All implants that were not lost until the


end of the observation period bave heen
considered as censored according to the lifetable statistics.
The sum of time periods of service in the
denominator is expressed as person-years,
person-time or risk time. For each subject,
the time at risk is the time during which
this subject remains free of tlie disease, hut
is at risk to develop disease (Ahlbom &
NoreU 1992).
The definition mentioned may be transformed as follows:
Incidence of implant loss - number of
cases of implant loss in the study p<ipulation (13 implants) divided by the sum of
lengths of time at risk for each implant. All
implants were in danger either until they
were lost or until - more favorably - the end
of the observation period. During the
ohservation period, all implant losses as
well as the exact time of service until the
failure was noticed were recorded. There-

Raioussis et ai . Long-term implant prognosis of ITI* Dental Implants

fore, the survival time for each implant


could be accurately estimated, since both
implantation and explantadon dates were
available. The incidences were calculated
as follows:
Incidence (I) forimplantioss
= number of losses/
y (time in service for each implant)

incidence of peri-implantitis during maintenance

Peri-implantitis was defined as an incidence of P P D ^ s m n i with BoP+ and


ratliographic signs of hone loss. For estimations of incidences of peri-implantitis,
implants not affected until the end of the
observation period, were also considered as
censored. For the estimation of incidences
of pcriimplantitis the Kaplan-Meier analysis was used (Kaplan & Meier 1958). After
stratification for implant types (HS, HC,
AHC), the homogeneity of survival curves,
I.e. differences hetween the groups for the
survival rates and incidences of peri-im[ilantitis, were tested hy log-rank test and
Wilcoxon test.

Of these, 112 were HS, 49 were HC and 18


AHC m " Dental Implants.
Forty-Six of the 179 implants were
placed in the anterior maxilla (10 HS, 26
HC and 10 AHC), 5 in the anterior
mandihle (2 HS and 3 HC| 58 in the
posterior maxilla (40 HS, 14 HC and 4
AHC), and 70 in the posterior mandible (60
HS, 6 HC and 4 AHC).
At the io-year follow-up examination,
the patient's ages ranged hetween 28 and 88
years (mean age 58.9 years). The observation period ranged from 8 to 12 years with a
mean of 10 years of service. Fiity-five
implants had been in function for 8-9
years, 47 for 9-1 o years, s 3 for i o-i i years
and 24 for 11-12 years.
The means for PPD, PAL, BoP, mPII,
mBn, A Bone loss for mesial and distal
aspects are presented in Tahle i. Significant
differences were observed between HS and
HC implants regarding mean PPD
(1.60mm for HSy3.i4mm for HC,

Survival and failure rates

A total of 13 of 179 implants were lost


(failed implants) during the ohservation
period resulting in a survival of 92.7% , or
an incidence of implant loss of 7.3% in 10
years.
With the Kaplan-Meier methtxl, the
survival rates were properly estimated as
heing 92.4% (SE: 0.02). For HSs, the
cumulative survival rate was 95.4% (SE:
0.02), for HCs 85.7% |SE: 0.05), and for
angulated hollow cylinders (AHC) 91.7%
(SE: 0.08) (Fig. i) (Table 2). Consequently,
the failure rate of all implants was 7.6%
after 10 years. For HSs it was 4.6%, for
HCs 14.3%, and for AHCs 8.3% (Fig. i).

Table 1. Means, standard deviations (SD) and statistical test results (Kruskal-Wallis test) of
clinical and radiographic parameters measured for each implant
HS,

Success rates at 10 years


x' and Fisher's exact test were used to
evaluate differences in the success rates
hetween the various groups of implant types.
Morawer, frequency analyses were perfonned for PPD around all implants at i
;md 10 years of service. The evaluation of
success rates included all 179 implants
installed at the lieginning of the stutiy (Sicilia
Felechosaetal. 1999). The data analyses were
conducted hy means of the SAS statistical
software (SAS Institute, Inc., 1999).

P<o.oi8) and mean BoP (0.38 for HS/0.51


for HC, pKO.oij,] as well as between HC
and AHC with respect to mean mPII (0.42
forHC/o.i8 for AHC, P<o.oi).

112

Mean
mPII mean
mBII mean
PPD mean
PAL mean
BoP mean
ABone loss mes
ABone l05s dist

0.35
0.19
3.20
0.38""
0.57
0.58

HC, n
SD

49

Mean

0.41
0.28
0.89
0.89
0.34
1.17
1.04

AHC,n
SD

0.42*
0.19
3-14
3.59
0.51
0.77
0.84

Mean

0.35
0.27
1.36
1.62
0.31
1.07
112

0.18
0.21
3.12
3.43
0.46
1.46
1.71

SD
0.21
0.34
1.07
1.04
0.31
2.22
2.42

HS: hollow screw, HC; hollow cylinder, AHC: angulated hollow cylinder of the ITI" Dental Implant
System.
Represents statistically significant difference compared to AHC (Kruskal-Wallis test: P<0.05).
"Represents statistically significant difference compared to HC.

Results
100

Of the 127 patients examined at baseline, 9


17% (had passed away, 29 (23%) had moved
,iway during the observation peritKi or were
not available for a complete re-evaluation.
Hence, 89 patients (70%) of the original
cohort were available for the io-year
tollow-up examination. Of those, 34 were
male (38.2%) and 55 female {61.8%). At
the time of implantation, the age of the
patients ranged from 19 to 78 years (mean
age 49.33 years). A total number of 179
implants were placed. Seventy-four of them
were placed in males and 105 in females.

40

60

80

100

120

140

months after implantation

Fig. I. The Kaplan-Meier estimate of survival rates oi ITI" Dental Implants as a function iif time since
installation. HS: hollow screws, HC: hollow cylinders, AHC: angulated hollow cylinders.
II

I Clin. Oral Imp!. Res. 1$, 100^ I fi-17

Karoussis et al. Long-tenn implant piogQosis of m"^ Dental Implants


The homogeneity of the survival curves
was also tested (Altman 1991,- Hiisler &
Zimmermaim 2001). Log-rank test showed
a trend for significant {P<o.o6] differences
between HS and HC implants, with the HS
to present a higher survival rate (95.4 vs.
85.7). Wilcoxon test showed a statistically
significantly higher survival rate for HS
compared to HC implants iP<o.O4).
In other words, the incidence (7) of
implant loss (implant failure), calculated
by the Kaplan-Meier method, is:
/ 0.076 at 10 years or
/ 0.0076/iinplant-years or
7=0.0076 implant losses per implantyear or
7.6 of 1000 m"^ implants are to be lost
per year.
This evaluation reflects the mean risk for
the impiants of the study population to be
lost per year of observation (Ahlbom &.
Norell 1992],
Similarly, the incidences of implant loss
(implant failure) for HS, HC and AHC
implants were:
4.6 of 1000 HS type m " implants are to
he lost per year.
14.3 of 1000 HC type m * ' implants are
to he lost per year.
8.3 of 1000 AHC type ITI* implants are
to be lost per year.
Incidences of biological
during maintenance

complications

84.6% (SE: 0.03) of all implants were free of


biological complications throughout the
observation period. 90% (SE: 0.03] of the
HS implants did not present hiological
complications, while 71% (SE: o.oi) of
the HCs and 88% (SE: 0.08) of the AHC
remained free of any hiological comphcations (Fig. 2) (Table 3).
In order to test the homogeneity of the
incidence curves, log-rank and Wilcoxon
tests were used. Both tests showed a
statistically significantly lower incidence
of biological comphcations for HSs compared to HCs (log-rank test: P<o.ooo4 and
Wilcoxon test; P<o.oo3).
Success rates

Differences in the success rates between


the implant types were calculated using x^
and fisher's exact tests. With the first set of
success criteria chosen (success criteria I), a
1 2 I Clin. Oral Impl. Res. i$, 2004/8-17

Table2. Survival and failure rates of ITI^ dental implants


Implants
placed

Implant
type
HS
HC
AHC

112

5
7
1

49
^8
179

All implants

Survival

Implants
lost

95.4*
85.7
91.7
92.4

13

Failure

Standard
error

4.6'
14.3

0.02
0.05
0.08
0.02

8.3
7.6

H5: hollow screw, HC: hollow cylinder, AHC: angulated hollow cylinder of the ITI* Dental Implant
System.
Represents 3 statistically significant difference compared to HC (Wilcoxon test, P<0.04).

100

20

40
60
80
100
months after implantation

120

Fig. 2. The Kapian-Meier estimate of incidences of biological complications Iperi-implantitis) as a function of


time since implant installauon, HS: holtow screws, HC: hollow cylinders, AHC: an^ukted hollow cylinders.

Table3. Incidence of biological complications in ITI " dental implants


Implant
type
HS
HC
AHC

All implants

Implants
placed
112

49
18
179

Implants with
complications

Complication-free
implants (%)

11
14
2
27

90'
71
88

84.6

Incidence of
complication (%)
10*

29
12
15,4

Standard
error
0.03
0.01
0.08
0.03

HS: hollov*/ screw, HC: hollow cylinder. AHC: angulated hollow cylinder of the ITI* Dental Implant
System.
Represents statistically significant difference compared to HC (Wilcoxon test, P<0.003, log-rank test.
P<0.0004).

success rate of 74% for HS, of 63% for HC


and of 61 % for AHC implants was found
(Fig. 3 and Tahle 4). HS implants demonstrated a higher success rate when compared to cylinders. However, this difference
was not statistically significant.
Applying the second set of success
criteria (success criteria II), success rates
increased to 90,2% for HS, 76% for HC
and 86% for AHC implants, respectively.
As shown in Table 4, HS implants presented a significantly higher success rate
compared to HCs when relying only on
clinical parameters (Fisher's exact test:
P<O,O25).

If P P D ^ 6 m m in.stead o f ^ s m m was
chosen as the definition of success (success
criteria HI), success rates of 78% for HS,
65% for HC and 67% for AHC implants
were calculated (Table 5 and Fig. 3), Again,
HS implants demonstrated a higher success
rate compared to HC implants (78% vs.
65%), However, this difference was not
statistically significant.
Relying on cUnical parameters only, hut
with the higher threshold for disease
(success criteria IV: PPD<6mm and
BoP-), the success rates increased to 94%
for HS, 82% for HC and 94% for AHC
implants, respectively. HS implants pre-

KaiDussis et al . Long-temt implant prt^osis of ITI'^ Dental Implants

Tabte4. Success rates using 5mm as borderline for PPD and annual bone loss<0.2 mm.
Implant type

HS
HC
AHC

All implants

'

Implants
placed
112
49
18
179

Success

Clinical
success'

83 (74%)
31 (63%)
11 (61 %)
125(69.8%)

101 (90,2%'l
37 (76%)

16 (89%)
154(86%)

HSi hollow screw, HC: hollow cylinder, AHC: angulated hollow cylinder of the ITI" Dental Implant
System,
'Clinical success meaning that the implant fulfilled the clinical criteria,
"Represents statistically significant difference compared to HC (Fisher's exact test, P<0.025).

Tables. Success rates using 6mm as borderline for PPD and annual bone loss<0.2mm.
Implant Type

HS
HC
AHC

All implants

Implants
placed
112
49
18
179

Success

Clinical
Success*

87 (78%)
32 (65%)
12(67%)
131 (73.2%)

105 {94%'*)
40 (82%)
17(94%)
162 (85%)

HS: hollow screw, HC: hollow cylinder, AHC: angulated hollow cylinder of the ITI" Dental Implant
System.
'Clinical success meaning that the implant fulfilled the clinical criteria.
"Represents statistically significant difference compared to HC (Fisher's exact test, P<0.024),

HS
HC
AHC
B Clin. and Rx Success for PPD<5nim or PPD=5mm with BoP neg.
and annual bone ioss<0.2mm
Clin. Success (or PPD<5mm or PPD=5mm with BoP neg.
B Clin. and Rx Success tor PPD<6mm or PPD=6mm with BoP neg.
and annual bone loss<0.2mm
Clin. Success for PPD<6mm or PPD=6mm with BoP neg.

Pig. J. Success rates of m"^ Dental Implants for various thresholds of clinical and radiographic criteria for the
definition of success.

sented a significantly higher success rate


compared to HC implants (Fisher's exact
test: P<o.o24).
Figure 4 reveals the cumtdative percentage of sites with various PPDs at i and 10
years of service. The curve with the PPD
values for the i o-year foUow-up was shifted
to the right compared to the i-year evaluation. The two lines at 5 and 6 mm define

the two thresholds set for the definition of


success/complication criteria.

Discussion
In the present study, m ' * HS implants
demtinstrated
higher survival
rates
(95,4%), lower incidence of biological

comphcations (10%) and higher success


rates compared to ITI" HC itnplants.
Lower success rates for HC implants
(91,3%) compared to HS implants
(95.8%) had already been reported over an
observation period up to 7-years (Buser et
al. 1997). In that study, however, cumtilative success rates for HS were similar to the
ones obtained with full screw m"^' implants (95,8% vs, 96.8%, respectively).
The stirvival rates over 10 years of the
present study are, therefore, in excellent
agreement with those reported for up to 7
years, althotigh a variety of stirgeons had
installed the ITT^ implants in the present
study as opposed to only one surgeon in the
Buser et al. (1997) study. The possible
reasons for inferior survival rates of HC
implants in comparison to HS implants are
largely unknown and may only be speculated upon.
It is stirprisitig that no statistically
significant differences in survival rates
were found in the present study between
HS and AHC implants. Lack of statistical
sigtiificance may be explained by the small
ntunber of AHC ( n = i 8 l incorporated in
the present study. If nonaxial loading woidd
have compromised osseointegration, more
failures and complications with AHC
would have heen expected. In the context
of an argument on loading forces the restilts
of the present study to agree with those
reported by Bnlshi et al. (1997), who
questioned the role of nonaxial loading as
an etiologic factor for implant failure.
Using the definition of incidence for
implant loss, it can he concluded that only
4.6 of 1000 HS implants, but 14.3 of 1000
HC and 8.3 of 1000 AHC implants are
expected to be lost per year. Tbese expectations appear quite satisfying, especially for
the HS implants and are in agreement with
previous reports on the same systerm
[j-j-jH] [Busei- 1999; Buser et al. 1997,
1999; Brocard et al. 2000; Hellem et al.
2oot). Survival rates of implants fn)m this
and other implant systems were subjected
to a meta-analysis of 19 publications performed by Lindb et al. (1998). A total of
2116 implants were included in this analysis. After 6-7 years of service, the survival
rate for implant-supporting fixed partial
dentures |FPD) was 93.6%.
A distinction between different reasons
for implant failtires is only made in a few
studies. Usually, the number of implants
1 3 I Clin. Oral Imp!. Res. 15, 1004 / 8-17

Karoussis et al . Long-term implant prognosis of m * Dental Implants

100

1B

80

sites may reflect a condition of periimplantitis recommended to be treated


according to a CIST protocol (MombeUi &
Lang 1998). In histologic samples, Lang et
al, [1994) documented tbat tbe measurement error of PAL readings depended on the
peri-implant healtb conditions. It is tliercforc important to assess both inflammatory
and pocket probing status. Both 5 mm and
6 mm PPD were therefore chosen to set
thresholds. Either as clinical parameter
alotie or in combination witb radiographicaUy assessed loss of peri-implant bone.

11

60

--lOyrs

40

20

J
0 1

10

11

PPD in mm
fig. 4. Cumulative percentages of number of sites with respective mm of PPD at four sites of each impiant at i
and 10 years after implant installation.

reported to he lost due to peri-implantitis


appears low. On tbe basis of 73 selected
studies, Esposito et al. (1998) published
combined data on early and late complications of Branemark implants. Over a 5-year
period, a biologically related failure rate
(implaiit loss) of 7.7% was noted.
Ellegaard et al. [1997) evaluated the
success of implant therapy in periodontally
compromised patients. After s years, 70%
of the m implants were free of pockets
> 6 m m , while after 3 and i year 92.3%
and 96.3% of the implants had heen free of
sucb pockets (S 6 mm). Setting tbe threshold for the definition of a biological
complication at PPD ^ s mm and BoP + ,
Bragger et al. (20Q1) found a prevalence of
peri-implantitis of 9.6% at implants examined after 8 years. With a threshold of
^ 6 mm and BoP + as the definition for
peri-implantitis, tbe prevalence was reduced to 5 % at 8 years.
During the present study, all incidences
of biological complications (peri-implantitis) were noted. 15.4% of all implants
placed presented a complication during
the 10 years of observation. Complications
occurred at 10% of hollow screw implants,
while at HC implants, the prevalence of
peri-implantitis in lo years was almost
three times higher (29%). AHCs presented
a complication rate of 12% (Fig. 2) [Table
3). HSs, therefore, presented a lower chance
to be affected hy biological complications.
Success rates depended on tbe thresholds
cbosen to distinguish hetween success and
1 4 ' Clin. Oral Imp!. Res. 15, 2004 / 8-17

complications (Fig. 3). Tbe diagnostic


information to set different thresholds
included the assessments of BoP, PPD and
cbange in radiograpbic bone height. The
rationale for selecting these criteria as
relevant parameters for continuous evaltiation ratber than only survival rates, lies
witbin tbe fact that hiological complications may or may not lead to the loss of an
implant: Provided tbat the diagnosis of the
complication is made soon after the hiological onset of tbe event, the complication
may he dealt witb early enougb in order to
avoid further progression of the lesion.
After I year of function, the frequency of
Bop was twice as bigh at implant sites
compared to matching control tootb sites in
a group of patients similar to those incorporated in the present study [Bragger et al.
1997). Periodontal sites reveahng repeated
BoP were at bigber risk to loose attachment, whereas the absence of BoP documented high negative predictive values for
teeth (Lang et al, 1994). Similar diagnostic
input may he expected from tbe evaluation
of BoP at implant sites [Luterhacber et al.
2000).

PPD reflects tbe amount of tissue resistance to probing. Deptb force pattems
revealed cbaracteristic differences at teeth
compared to implants and depending on the
probing forces apphed [van der Velden et al.
1979; MombeUi 6L Graf 1986; MombeUi et
al. 1997). Peri-implant sites with increased
PPD were associated witb a patbogenic
microflora (Kalyakakis et al. 1994). These

With the success criteria set, a success


rate of 74% for HS, of 63% for HC and of
61% for AHC was found [Table 4). This is
in contrast to the findings of Buser et al.
(1997), who found a cumulative success
rate of 95.8% at 7 years for HS and of
91.3% for HC. Brocard et al. [2000),
however, reported on a cumulative success
rate of 83.4% at 7 years. Buser etal. (1999)
presented a cumulative success rate reaching 91.4% at i - i o years, while HcUem et
al. [2001) noted a success rate of 91.4%
after 5 years.
Differences in success rates were the
result of the different criteria used for the
definition of success. As an example from
the hterature, HeUem et al. [2001) considered an annual hone loss 0,5 mm as
acceptable, while studies that used the
criteria of success for m implants as
suggested hy Buser et al, (1990) did not
include any PPD measurements. The present study utilized strict and objective
criteria, i.e. P P D ^ 5 m m and BoP-.
Furthermore measurements of peri-implant
crestal hone loss were included in the
evaluation [bone loss <o.2 mm annually).
If one site of an implant did not fulfiU the
predefined criteria, the implant was characterized as nonsuccessful (implant witb a
complication). Another possible infltience
on variations within the success rates of
similar studies may be attributable to
various patient pools being evalated. A
history of periodontal disease in some
patient groups may indeed affect the incidence of peri-implantitis as demonstrated
recently (Karoussis et al. 2003).
Owing to the lack of standardized and
internationally recogtiized criteria for tbe
definition of success [van Steenhergheetal.
1999), tbresbolds for peri-implantitis and
other biological complications will continue to be disctissed. In the present study.

Karoussis et al. Long-term implant prognosis of m * ' Dental Implants

completely different success rates were


obtained depending on the criteria chosen.
The choice of PPD < 6 mm instead of
affected the success rates
. Furthermore, relying on purely
clinical instead of a combination of clinical
and radiographic parameters, the success
rates further increased. Setting of thresholds for success criteria is crucial for
reporting success rates or incidences of
biological complications in longitudinal
studies. In the present study, HSs demonstrated higher success rates compared to
HC implants at any threshold chosen.

Conclusions
Within the limits of this prospective cohort
study, the following conclusions are to be
made:
1. A lO-yearstuvival rate of 95.4% for HS,
of 85,7% for HC, and of 91.7% for AHC
m " Dental Implants was found.
2. HS presented a significantly higher survival rate, lower incidence of biological
complications, and higher success rates,
compared to hollow cyhnder implants.
Acknowledgements: This study was
supported by the Clinical Research
Foundation (CRF) for the Promotion of
Oral Health, University of Berne, Berne
Switzerland and by the Papavramides
Foundation, Universities of Athens,
Greece and Berne, Switzerland. The
senior author is the recipient of an ITIScholarship for 2001-2002.

Resume
Lc but lie ce suivi li'unc decennic a Otc dt comparer
les taux de survie, les taiix de aucccs et les incidences
ties complications biologlques de l'utilisation de trois
[iiodclcs implantaires differents du systeme ITI^''
Denwl Implant. Chez Sg patients, 111 vis creuses
|HS|, 49 cylindies creux |HC| et 18 cytindns crcux
angiilcs (AHC) ont ete places suivant !e volume
iisst'ux disponible et les necessites protlietiques. Une
ui dix ;innecs aprte leur plaeemeni. des parametres
i:liniques el radiii^raphiques ont ete definis, Les
incidences de paroiniplantitc relatives aux differents
sculls ont ete enregistrees durant ces dix annees de
maintenance. Les succes des chtcres a dix ans ctaient
places a : PPD^s mm, BoP-, perte osseuse <o,2
mm/an. Le taux dc suivie pour HS ctait de 9s,4%,
|x)ur HC de 86% et pour AHC de 92%. Nonante
(Xjur cent dc tous les HS, 71% des HC et 88% des
AHC ne prcsentaient pas d'incidences de paroimplantite durant ces dix annees, HC ayant une plus

importante incidence de paroifmplantitc que HS


(p<o,oo4). Grace aux criteres de succes indiques,
un taux de succes de 74% pour HS, de 63% pour HC
ct de 61 ?'o pour AHC a etc identifie apres dix ans .
Cependant, en dcHnissant le succes avec
PPD ^ 6mm, BoP- et pcrtc osseuse <o,2mm/an, les
taux ctaient de 787u pour HS, de 65 % pour HC et de
67% f>our AHC. En basant les taux de sucets
uniquement sur les parametres ctiniques (sans
['analyse radiograpliiqucl tels que PPD^5 mm et
BoP-, les taux de succes augmentaient respective'
mem a 90, 76 et 89%. Avec PPD^Sfemm et BoPcomme criteres de succes, les taux s'clevaient
respcctivcment a 94, 8a et 94%, Un taux de survie
signiticativemcnt plus important ainsi qu'une incidence significativement plus faible de paroimplantite etaient constates au niveau des implants vis
creuses apH:s dix ans de mise en fonction compares
aux cylindres creux, Suivant l'etablissement du seuil
pour les criteres du succcs, les uux de ce succes sont
extrernement variables et rapporter les taux dc succes
suivant I'elahoration des criteres est done crucial
pour comparer differentes etudes.

Zusammenfassung
Der Einflass des Implantatdesigns auf die Oberlebens- und Erfolgsrate von Titanimplantaten: Eine
Langzeitstudie des ITr^'-Systems ufaer /o lahre.
Ziel: Das Ziel dieser io-Jahresstudie IBeobachtungszeit 8-12 lahre, Mittelwert: 10 lahre) war es, bei
m^-Implantaten mit drei verschiedenen Designs,
die Erfolgs- und Oberlebensrate zu vergleichen, und
tlas Auftrcten vou biologischen Zwischenfallen zu
unteisuchen.
Material und Methiide: Bei 89 synoptisch behandelten Patienten implanticrtc man in Abhangigkeit des
vorbandenen Knochenvtilumens und der pnithetischen Anfordemngen insgesamt 11 j Hoblschraubenimplantate (HS], 49 HohlzylinderimpLmtate
(HC) und 18 abgewinkelte Hohlzylindenmplantate
(AHC). Ein und zehn Jahre nach der Implantation
nahm man die klLnischen und radiologisehcn Parameter auf. Eine Periijnplantitis registricrte wahrend
der lo-jahrigen Eriialtungspliase anhand verschiedencr C.renzwerte.
Resultate: Die Kriterien fiir einen Erfolg nach 10
lahren legtc man bei den folgenden Werten fest: PPD
<5mm, BOP-, jahrlicher Knochenverlust <o.2mm.
Die Oberlebensrate far ein HS lag bei 95.4%, filr ein
HC bei 85.7% und fur ein AHC bei 91.7%. 90%
aller HS, 71 % aller HC und sa % aller AHC zeigte
wahrend den lo Jahren nie Anzeicben einer Periimplantitis, wohei die HC signiBkant haufiger Periimplantitis hatten. als die HS (p:o.oo4). Mit den oben
festgelegten Erfolgskriterien crgab sich nach 10
Jahren for die HS eine Erfolgsrate von 74%, fflr die
HC eine von 63% und fur die AHC eine von 61%.
Veranderte man die Definition auf "PPD<6mm,
BOP -, jahrlicher Kochenverlust <o.2mm", so
betrugen die Erfolgsraten ftlr die HS 7R%, fur die
HC 6s% und fOr die AHC 67%. Basierten die
Erfolgskriterien rein auf kiinischen Parametem |PPD
<smm, BOP-, keine rontgcnologische Aniyse), so
stiegen die Erfolgsraten auf 90%, 76% und 89% an.
Wahlte man die Erfolgskriterien "PPD temm und

BOP ", so betrugen die Erfoigaraten filr die HS 94%,


fQrdieHC8i% und fdr die AHC 94%.
Zusammenfassung: Verglich man nach lo-jahriger
Funktion die Hiihlsciiraubcn des ITI"-ImplantatSystems mit den Hohlzylindeni dessclbcn Systems,
so ergah sich filr die HS sowohl eine signiflkant
hflher Oberlebensrate, wie auch ein seltencres
Auftretcn von Penimplantitis 195.4% vs. 85.7%)
10% vs. 29%). Die Erfolgsraten variieren in Abhdngigkeit der in der Definition eines Erfolgcs festgelegten Grenzwerten enomi stark. Dies erweist sich
im Vergleich von verschiedenen Studien als hinderlich, weil die Definition der Erfolgsraten meist auf
verschiedenen Kiiterien beruhen.

Resumen
Intendon: La intencion de este estudio de ro aflos
(tiempo de observacion 8-12, media: 10 aftos) fue
comparar las indices de supervivencia, intliees de
exito e indices de complicaciones biologicas usando
tres diferentes diacfios de impkntes del Sistema de
Implantes Dentales m"^.
Material y Metodos: Se instalaion en 89 pacientes
dentales tratados completamentc un total de t n
tomill(s huccos (HS], 49 cilindros huecas (HC) y 18
cilintiros huccos anguladris (AHC) dependicndo de la
disponibiLdad de voUuiicn osco y df acucrdo con las
necesidades protesicas, Sc vaK>ramn parametros
clinicos y radiografictis uno y <iiez afios trati la
colocacinn quinxi;gica. Se registramn Us incidencias
de periimplantitis de acuerdo con varios umbrales a
lo largo de to anos de mantenimiento.
Resultados: Los criterios de exito a los 10 aAos se
situaron en PPD^^mm, BoP-, perdida (isea <
0,1mm por ano. El indice de supervivencia para los
HS fue del 95-4%, para los HC del 8 s,7% y para ioa
AHC del 91-7%. El 90% de los HS, el 71% de los
HC y el 88% de los AHC no presentanin ninguna
incidencia de periimplantitis a lo largo de los r o aAos,
HC tuvo una significativamente mayor incidencia
de periimplantitis que HS (p< 0.004). Con los
criterios dc exito antes mencionados, se identifier
un indice de exito para HS del 74%, para HC del
6}% y para AHC de! 61% a los 10 artos.
De t(xias modtKS, incluyendo una definieion dc
PPD^6mm, BoP- y pcrdida osea <o.2mm al aflo
para tener exito, los indices para HS fueron del 78%,
para HC 65% y para AHC 67%, respectivamente.
Basando los criterios de exito puramente en parametros clinicos (sin analisis radiograflcos), tales
como: PPD^^mm y BoP-, los indices de ^ t o
subieron hasta el 90%, 76% y 89%, respcctivametite. Con cl PPD ^ 6mm y BoP - como criterios de
exito elegidos, los indices respectivos fueron del
94%,82% y 94% para implantea HS, HC y AHC,
respectivamente.
Condusiones: Se identified un significativamente
mayor indice de superviveneia al igual que una
menor incidencia de pedimpiantitis para et disefto de
tomillo hueco Implante Dental m " . (9S.4% vs.
8s.7; 10% vs. 29%). Dependiendo de la definieion
del criterio del umbral de exito, los indices de exito
son altamente variables y ]X)r tanto, los informcs de
los indices de exito con elaboracion de la definieion
de criterios parece scr crucial para la comparacion de
los diferentes estudios.

15 I Clin. Oial Impl. Res. is, J004 / 8-17

Karoussis et al. Long-term implant prognosis of m ^ Dental Implants


teS : 1 0 ^g^miS-aiJK^Ii : P P D:<.5 mm,
B o P - , ip^-t!lf5';*< 0. 2mmTfc':>fc.
t 1 ? ^ * ) H S 9 5 . 4 % , H C 8 5 . 7%, AH
C9 1- 7 % - C t . o t . ^ T : m H S m 9 0 % . H
C ! D 7 1 % , AHCC0 8 8%(i 1 O^rai;t>ft:)

, 7 6 % t 8 9%-Cfcofc^ P P D
o P-*ia5!)ftflS,fe
4%, HC82%.
1
> ITI -i y/y

u s iztt-^-i y
A>ot ( p < 0 . 0 0 4).
-iv^fc 1 O ^ ^ ^ * H S 7 4 % , H C 6
3 % , A H C 6 I %-C*)oft;. LTJ'L''.*! fj h5ft

. B o P-AtT^Rfl-t9^
t , ^ 5 ! i ^ ( i # * HA 7 8%,
H C 6 5 % , AHC67%T*-ofc. P P D <.5
mmt B o P -

7%,

(95
If f j o $

y Vit,

j);

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