University of Groningen
Two-stage dental implants inserted in a one-stage procedure
Heijdenrijk, Kees
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Chapter 8 / Clinical and radiological evaluation on one-stage and two-stage implant placement; two-years’ results of a prospective comparative study
Chapter 8
Clinical and radiological
evaluation on one-stage and
two-stage implant placement;
two-years’ results of a prospective comparative study
This chapter is an edited version of the manuscript: Heydenrijk K, Meijer H.J.A.,
Raghoebar G.M. & Stegenga B. Clinical and radiological evaluation on one-stage
and two-stage implant placement; two-years’ results of a prospective comparative
study. International Journal of Oral and Maxillofacial Implants. Submitted for
publication.
113
114
Chapter 8 / Clinical and radiological evaluation on one-stage and two-stage implant placement; two-years’ results of a prospective comparative study
INTRODUCTION
earlier because there is no wound healing period involved
related to a second surgical procedure;
Many different endosseous implant systems are currently
•
during the osseointegration period, the implants are
accessible for clinical monitoring.
applied in oral implantology. Roughly, a distinction can be
made between implants inserted in a one-stage approach and
However, there are situations in which it is more favourable to
implants inserted in a two-stage approach. In a two-stage
insert implants in a two-stage procedure (Røynesdal et al.
approach, the implant is submerged during the first surgical
1999), i.e.,
procedure. During the second surgical procedure the soft tissue
•
in combination with a bone augmentation procedure and
covering the implant is reflected and, after removing the cov-
guided bone regeneration when the wound has to be closed
ering screw, a transmucosal abutment is connected. The micro-
tightly to prevent bone or membrane exposure;
gap at the junction between implant and abutment is situated
•
to prevent undesirable loading of the implants during the
at crestal level. By contrast, in a one-stage implant system the
osseointegration period when the temporary suprastructure
transmucosal part is usually integrated into the implant. After
cannot be adjusted effectively;
inserting the implant the transmucosal part is exposed in the
•
level, giving the possibility for a more flexible emergence
oral cavity. The microgap in this implant type is situated a few
profile of the transmucosal part;
millimetres above crestal level. It has been proposed that periimplant marginal bone loss is more extended around two-stage
when the coronal part of the implant is located at crestal
•
to provide the possibility to remove supramucosal and
implants than around one-stage implants as a result of the
transmucosal parts when the patient is not able to perform
location of the microgap (Hermann et al. 1997, Buser et al.
a sufficient oral hygiene and when possible infections endanger the general health;
1999).
Despite the differences in implant design, one-stage and two-
•
when implants are inserted in patients who will receive
stage implant systems have been demonstrated to have highly
radiotherapy in the implant region in the foreseeable
predictable favourable clinical outcomes (Adell et al. 1990,
future.
Lindquist et al. 1996, Haas et al. 1996, Batenburg et al. 1998a,
Applying two-stage dental implants in a single surgical proce-
Buser et al. 1999, Noack et al 2000). Insertion of implants in a
dure has been reported to be promising (Bernard et al. 1995,
one-stage procedure has several advantages (Buser 1999):
Ericsson et al. 1994, 1996, 1997, Becker et al. 1997, Collaert &
•
only one surgical intervention is required, which is much
De Bruin 1998, Abrahamsson et al. 1999, Røynesdal et al. 1999,
more convenient for the patient;
Fiorellini et al. 1999). In this way the advantages of both sys-
•
there is a cost-benefit advantage;
tem types are combined. Moreover, there are two additional
•
there is a time-benefit since the prosthetic phase can start
advantages. First, the surgeon only needs to have a two-phase
115
Chapter 8 / Clinical and radiological evaluation on one-stage and two-stage implant placement; two-years’ results of a prospective comparative study
implant system in stock for executing both submerged and
•
no history of radiotherapy in the head and neck region;
non-submerged procedures. Second, there is a possibility to
•
no history of pre-prosthetic surgery or previous oral
switch from a non-submerged procedure to a submerged pro-
implants.
cedure if this appears to be preferable per-operatively or during
Eligible patients were informed about the three different treat-
the osseointegration period.
ment options and written informed consent was obtained from
Many studies have reported the long-term results of implants
all participants. They were randomly assigned to one of three
inserted for mandibular overdenture treatment. Most studies
groups:
describe a single implant system. Long-term studies comparing
•
a group receiving IMZ implants (two-stage 4 mm IMZ cylin-
a one-stage and a two-stage implant system are sparse. No stu-
der implants with a TPS coating (Friedrichsfeld AG,
dies have been published comparing a one-stage implant sys-
Mannheim, Germany)) inserted in the traditionally sub-
tem and a two-stage implant system inserted in a one-stage
merged procedure
procedure. The aim of the present study was to explore the
•
stage approach by comparing the clinical outcome and peri-
a group receiving the same two-stage IMZ implants inserted
in a non-submerged single-stage procedure
feasibility of inserting a two-stage implant system in a one•
a group receiving ITI implants (one-stage 4.1 mm solid
implant radiographic bone. Furthermore, the aim was to evalu-
screw ITI dental implants with a TPS coating (Straumann
ate the impact of the microgap between implant and abutment.
AG, Waldenburg, Switzerland).
MATERIALS AND METHODS
Treatment procedures
All patients received two implants in the canine region of the
116
Patients selection
mandible. The implants were inserted under local anaesthesia,
From the patients referred to the Department of Oral and
each about one centimetre from to the midline. An experienced
Maxillofacial Surgery and Maxillofacial Prosthetics of the
maxillofacial surgeon, according to a strict surgical protocol,
University Hospital Groningen, 60 consecutive edentulous
inserted all implants. The IMZ implants in the two-stage group
patients were selected on the basis of the following inclusion
were inserted as described by Kirsch (1983). The IMZ implants
criteria:
in the single-stage group also were inserted as described by
•
the presence of a severely resorbed mandible (class V-VI,
Kirsch (1983) but with the modification for a single-stage
Cawood & Howell 1988) with a reduced stability and insuf-
implantation procedure using a labial mucosa flap and imme-
ficient retention of the lower denture;
diate connection of healing abutments as previously described
an edentulous period of at least two years;
(Heydenrijk et al. 2000). The surgical procedure used for the ITI-
•
Chapter 8 / Clinical and radiological evaluation on one-stage and two-stage implant placement; two-years’ results of a prospective comparative study
implants has been previously described (Sutter et al. 1988). In
weeks after insertion of the new prosthesis (T0), and 6 months
none of the patients, palatal mucosa grafts were placed. Post-
(T6), 12 months (T12) and 24 months (T24) later.
operatively, analgesics and chlorhexidin 0.2% mouth rinse were
prescribed for 14 days. Systemic or local antibiotics were not
Clinical outcome measures
prescribed. Patients were not allowed to wear the mandibular
The following clinical parameters were assessed:
denture during the first two weeks post-operatively.
•
Gingiva-score: the modified Löe and Silness index (score 0
Two, six and twelve weeks after the surgical procedure, the
– 3) was used to quantify the degree of peri-implant in-
patients were recalled. At the first recall visit, sutures were
flammation (Löe & Silness 1963). The gingiva score was
removed and the lower denture was adjusted by selective grind-
measured at four aspects of the implants, the highest
ing at the implant location and relining with Coe-soft (Coe
score per implant being used for data-analysis;
laboratories, Inc. Chicago, U.S.A.). At all recall visits, patients
•
Plaque-score: the Mombelli index (score 0 – 3) was used to
received oral hygiene instructions.
quantify the amount of plaque retained on the surface of
Three months after implant insertion, second stage surgery for
the supra-gingival part of the implant (Mombelli et al.
connection of 5 millimetre high titanium prosthetic abutments
1987). The plaque score was measured at four aspects of
was performed in the two-stage IMZ group. Two weeks later
the implants, the highest value per implant being used for
manufacturing of a new maxillary denture and a mandibular
overdenture was initiated. In the one-stage IMZ group and the
data-analysis;
•
ITI group the prosthetic procedure was started three months
after implant insertion. A uniform prosthetic procedure
Calculus: the presence (score 1) or absence (score 0) of
calculus per implant was scored;
•
Bleeding-score: the Mühlemann index (0-3) modified by
(Batenburg et al.1993) was performed for all patients by one
Mombelli et al. (1987) was scored at four aspects of the
experienced prosthodontist. In the IMZ group, the healing
implants, the highest value per implant being used for
abutments were replaced by 5 mm high titanium connectors. A
data-analysis (Mühlemann & Son 1971);
Dolder bar with subsequent clip attachment supported the
•
Probing pocket depth: the depth of the peri-implant ‘sul-
overdentures. A balanced occlusion and monoplane articula-
cus’ was measured, to the nearest millimetre, mesially and
tion concept with porcelain teeth was used.
distally of each implant by using a periodontal probe
(Merrit B, Hu Friedy, Chicago, U.S.A.) after removal of the
bar (Quirynen et al. 1991). The distance between the mar-
OUTCOME MEASURES
ginal border of the gingiva and the tip of the pocket probe
was scored as the ‘probing pocket depth’. The deepest pock-
Data collection was performed at baseline assessment (four
et per implant was used for data-analysis;
117
Chapter 8 / Clinical and radiological evaluation on one-stage and two-stage implant placement; two-years’ results of a prospective comparative study
•
Mobility: the Periotest® (Siemens, Bensheim, Germany)
assess the course of clinical and radiographic parameters
device was used to evaluate the mobility of the implants
during the evaluation period within the groups. To evaluate
(Teerlinck et al. 1991); mobile implants were considered as
possible differences between the groups with regard to normal-
being lost and were removed.
ly distributed quantitative variables, a one-way analysis of
variance was performed. When the criteria for using parametric
Radiographic outcome
tests were not fulfilled, Kruskal-Wallis test (independent data)
Standardised intra-oral radiographs were made using the long
or Friedman’s test (dependent data) was applied. In all analy-
cone technique with an aiming device (Meijer et al. 1992). The
ses, a significance level of 0.05 was chosen.
distance from a fixed reference point of the implants to the first
bone-to-implant contact was measured with a digital calliper
(Digitcal SI, Tesa SA, Renens, Switzerland) (Meijer et al. 1993).
RESULTS
The measurements were made at the two approximal implant
sites. The site showing most bone loss was used for data-ana-
Patients
lysis. In the ITI group the neck of the implant and in the IMZ
Thirty-four women and 26 men (mean age of 58 ± 11 years) par-
groups the implant/connector interface was used as the refer-
ticipated in this study. Twenty patients were included in each
ence point. From a previous study, addressing intra and inter-
group. An IMZ implant of the one-stage group had to be re-
observer agreement of measurement of the level of bone, it was
moved at T6 because of mobility. Three weeks after removal,
concluded that the reproducibility is more consistent if one
two new implants (one mesially and one distally of the former
experienced observer performs the measurements twice rather
implant location) were successfully inserted. At T12, an IMZ
than two observers performing the measurements once
implant of the two-stage group appeared to be mobile and was
(Batenburg et al. 1998a). Therefore, the measurements were
removed after the standardised radiographs were taken and
performed twice by the same observer with a two weeks time
after collecting the clinical data. Therefore, the data of this
interval and averaged.
implant were included in the T12 results. New implants were
inserted mesially and distally of the former implant location,
but they have not been in function because the patient died a
118
Data analysis
few months later.
Qualitative data and quantitative data after categorisation were
Because of the death of this patient and the loss of the implant
analysed using the Kruskal-Wallis analysis of variance between
in the IMZ one-stage group, the 2-years evaluation (T24) com-
the three groups. Possible associations between variables were
prised 117 implants in 59 patients.
analysed with chi-square tests. The Friedman test was used to
Chapter 8 / Clinical and radiological evaluation on one-stage and two-stage implant placement; two-years’ results of a prospective comparative study
Periodontal parameters
Frequency distributions of the clinical parameters are depicted
in Figures 8.1-8.5. At T0, significant differences between the
Figure 8.1. Frequency distribution of the plaque scores at the baseline examination (T0) and 12 (T12) and 24 months (T24) after insertion of the overdenture.
Score 0: no plaque, score 1: plaque detected by running a probe across the
implant, score 2: plaque can be seen by the naked eye, score 3: abundance of
plaque.
three groups with regard to the bleeding scores and to the
amount of probing pocket depths > 3 mm, were found (KruskalWallis tests). At T12, a significant differences between the
groups were found with regard to the plaque score and the
amount of probing pocket depths >3 mm (Kruskal-Wallis test).
Significant differences between the three groups at T24 were
found for the plaque score, gingiva score and calculus score
(Kruskal-Wallis test). The periotest values (mean -5, ±1.3) were
comparable for all three groups throughout the observation
period.
In the ITI group there was a significant increase in the bleeding
score throughout the observation period (Friedman test,
p=0.02, Figure 8.4). In the IMZ two-stage group, a significant
reduction of the number of probing pocket depths > 3 mm was
found (Friedman test, p=0.01, Figure 8.5). The time course of
the other periodontal parameters was comparable for the three
Figure 8.2. Frequency distribution of the gingiva scores at the baseline examination (T0) and 12 (T12) and 24 months (T24) after insertion of the overdenture.
Score 0: normal peri-implant mucosa, score 1: mild inflammation, score 2:
moderate inflammation, score 3: severe inflammation.
groups (Friedman test, p>0.05).
The plaque score was associated with the gingiva score at T24
in the IMZ two-stage group (chi-square p=0.005). No other significant associations between the clinical parameters were
found (chi-square test, p>0.05).
Radiographic parameters
In three patients (one of each group) the Dolderbar was placed
labially to the implants to prevent interference with the floor of
the mouth. As a result, no standardised radiographs could be
made of these implants. Therefore, including the lost implants,
119
Chapter 8 / Clinical and radiological evaluation on one-stage and two-stage implant placement; two-years’ results of a prospective comparative study
Figure 8.3. Frequency distribution of the calculus scores at the baseline examination (T0) and 12 (T12) and 24 months (T24) after insertion of the overdenture. Score 0: no calculus, score 1: presence of calculus.
Figure 8.5. Frequency distribution of the pocket probing depths at the baseline
examination (T0) and 12 (T12) and 24 months (T24) after insertion of the overdenture.
Figure 8.4. Frequency distribution of the bleeding scores at the baseline examination (T0) and 12 (T12) and 24 months (T24) after insertion of the overdenture. Score 0: no bleeding after probing, score 1: isolated bleeding spots, score
2: confluent line of blood, score 3: heavy or profuse bleeding.
radiographic observations were made of 113 implants in 57
patients at T12, and of 111 implants in 56 patients at T24.
A small radiolucent line was visible along the implants that
appeared to be mobile.
The mean amount of bone loss was comparable for the three
groups during the observation period (one-way analysis of
variance, p>0.05, Table 8.1). Comparable number of implants in
each implant group were found showing bone loss exceeding 1
millimetre in the first year of functioning and exceeding 0.2
millimetre in the second year (Kruskal-Wallis test, p>0.05,
Figures 8.6 and 8.7). No associations between the amount of
bone loss and clinical parameters were found (chi-square test,
p>0.05).
120
Chapter 8 / Clinical and radiological evaluation on one-stage and two-stage implant placement; two-years’ results of a prospective comparative study
Figure 8.6. Frequency distribution of the amount of bone loss between baseline examination (T0) and one year later 9(12). Score 0: bone loss ≤ 1 mm;
Score 1: bone loss > 1 mm.
DISCUSSION
This prospective randomised study is the first in which the twoyear clinical and radiographic results of two-stage non-submerged implants are compared with two-stage submerged
implants and with one-stage implants. This study showed no
major differences between the three groups, suggesting that a
two-stage implant system can be used for implant insertion in
a non-submerged procedure.
After two years of loading, 97.5% of the IMZ implants and all ITI
implants were functioning uneventful. The implants that had to
be removed were lost during the first year of functioning.
Insertion of new implants at mesial and distal locations of the
previous implant site resulted in successful re-implants.
The clinical results are comparable with the results in studies
in which one-stage or two-stage implant systems were evalu
Figure 8.7. Frequency distribution of the amount of bone loss between T12 (1
year after functioning) and T24 (2 years after functioning). Score 0: bone loss ≤
0,2 mm; Score 1: bone loss > 0,2 mm.
Table 8.1. Mean amount of bone loss (in mm.) between T0 (baseline) and T12
(1 year after functioning) and between T0 (baseline) and T24 (2 years after functioning).
N implants
IMZ
IMZ
one-stage
two-stage
37
38
ITI
38
Bone loss
Mean
0.6
0.6
0.6
SD
0.9
1.3
0.8
T0-T12
N implants
37
36
38
Bone loss
Mean
1.1
0.8
1.2
SD
1.0
1.1
1.1
T0-T24
121
Chapter 8 / Clinical and radiological evaluation on one-stage and two-stage implant placement; two-years’ results of a prospective comparative study
122
ated (Quirynen et al. 1991, Mericske-Stern et al. 1994, Åstrand
changes. The mean bone loss of 0.6 mm between T0 and T12 in
et al. 1996, Batenburg et al. 1998b). At T0 and T12, more IMZ
our three groups is below the limits of 0.9 to 1.6 mm as reported
implants than ITI implants had pockets > 3 mm. This might be
by Brägger et al. (1998) to be acceptable as a radiographic
attributed to the cup shaped transmucosal part of the ITI
criterion for implant success. Bone loss during the first year of
implants, which may hamper easy insertion of the probe into
functioning has been described previously, and is related to
the pocket (Spiekermann et al. 1995). At T24 a higher plaque
maturation of bone after implant insertion and adaptation of
and gingiva score were found in the IMZ two-stage group com-
bone to withstand functional forces (Adell et al. 1981,
pared to the other groups and the IMZ two-stage group showed
van Steenberghe et al. 1999). An annual bone loss of 0.2 mm
a higher calculus score compared to the IMZ one-stage group.
after this period has been recognised as acceptable
Differences in scores of periodontal parameters between to dif-
(Albrektsson et al. 1986). Several studies described the peri-
ferent implant types can be explained by different implant
implant bone changes in the second year of functioning reporting
characteristics, but differences in scores of periodontal para-
a mean bone loss of approximately 0.1 mm (Adell et al. 1986,
meters between the two IMZ groups are harder to explain. We
Cox & Zarb 1987, Bower et al. 1989, Quirynen et al. 1991,
presume that it is by coincidence that the IMZ two-stage group
Versteegh et el. 1995, Lindquist et al. 1996, Weber et al. 2000).
contains more patients with poorer oral hygiene maintenance,
In our three groups the peri-implant bone loss between T12
illustrated by higher plaque, calculus and gingiva scores.
and T24 was more extended (Table 8.1). However, when looking
No significant associations between the peri-implant mucosal
at the amount of bone loss between T0 and T24, the values are
aspects and the amount of bone loss between T0 and T12 or
within the limits of 0.9 to 1.6 mm considered to be acceptable
between T12 and T24 were found, which has been reported ear-
for the first year functioning (Brägger et al. 1998). It does not
lier (Quirynen et al. 1991, Mericske-Stern et al. 1994, Batenburg
seem to be a coincidence to find relatively low amounts of
et al. 1998b, Weber et al. 2000). Reproducible radiographs of
bone loss in the first year and high amounts of bone loss in the
sufficient quality are necessary in a longitudinal trial to accurate-
second year of functioning in the present study compared to
ly detect the first bone to implant contact. The intra-oral radio-
the findings from the literature, since comparable amounts of
graphs used in the present study have been shown to satisfy
bone loss were found in all of the three groups. Probably, the
this criterion (Batenburg et al. 1998a). The landmarks necessary
high quality of the standardised radiographs used in the present
for the evaluation were easy to identify. A major drawback of
study is responsible for the different outcomes. Long-term fol-
this technique is that the first radiograph can be obtained no
low-up evaluations have to show whether bone loss continues
sooner than after placement of the bar, which was at least
in the subsequent years.
4 months after implant insertion. Therefore, no information
It has been proposed that marginal bone loss is more extended
was available considering the initial peri-implant bone level
around two-stage implants as compared with one-stage
Chapter 8 / Clinical and radiological evaluation on one-stage and two-stage implant placement; two-years’ results of a prospective comparative study
implants (Buser et al. 1999). Therefore, it could have been
CONCLUSIONS
expected that the implants in both IMZ groups would show
more bone loss compared with the ITI group. ITI implants lack
The results of this study indicate that:
a microgap between implant and abutment at the crestal level.
1.
Dental implants designed for a submerged implantation
The microgap between the implant and the abutment at the
procedure can be used in a single-stage procedure and
crestal level has been suggested to play a prominent role in the
may be as predictable as used in a two-stage procedure or
development of bone loss (Hermann et al. 1997). In the present
one-stage implants.
study, a comparable amount of bone loss was found between
2.
The microgap at crestal level in two-stage implants does
the three groups suggesting that the microgap at crestal level
not appear to have an adverse effect on the amount of
does not influence the amount of peri-implant bone loss.
peri-implant bone loss.
123
Chapter 8 / Clinical and radiological evaluation on one-stage and two-stage implant placement; two-years’ results of a prospective comparative study
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