Three-Year-Analysis of Peri-Implant Bone Level After Allogenic Bone-Block Augmentation
Tilman Fritsch1,5, Alexander A. Dolgalev6, Ingmar Schau3, Katharina Schaper4, Marco V. Vukovic2,5, Wolf-Dieter Grimm2,3,5,*
1Department of Surgical Stomatology,
Institute of Stomatology, First Moscow State Medical University‚ Russian
Federation
2Praxisteam Hasslinghausen GbR, Sprockhövel, Germany
3Periodontology, School of Dental Medicine,
Faculty of Health, Witten/Herdecke University, Germany
4Institut for Medical Biometry and
Epidemiology (IMBE), Department Human Medicine, Faculty of Health,
Witten/Herdecke University, Germany
5Stem Cell Lab, Institute of Regenerative
Medicine, Medical Faculty, Stavropol State Medical University, Russian Federation
6Pediatric and General Dentistry, Dental
Faculty, Stavropol State Medical University, Russian Federation
*Corresponding author:
Wolf-D. Grimm, Praxisteam Hasslinghausen GbR, Sprockhövel, Faculty of Health, Witten/Herdecke
University, Germany. Tel: +491731428909; Email: prof_wolf.grimm@yahoo.de
Received Date: 11 March,
2019; Accepted Date: 15 April, 2019;
Published Date: 23 April, 2019
Citation: Fritsch T, Dolgalev AA, Schau I, Schaper K, Vukovic MV, et al. (2019) Three-Year-Analysis
of Peri-Implant Bone Level After Allogenic Bone-Block Augmentation. Dent Adv
Res 7: 156. DOI: 10.29011/2574-7347.100056
Purpose: Allogenic bone blocks may be utilized as an alternative
pre-implant augmentation procedure for the reconstruction of deficient alveolar
bone in cases, in which the transplantation of autogenous bone is impossible or
not desired. The present study investigates radiologically detectable changes
of peri-implant bone level around dental implants placed into allogenic bone-
block augmentations compared to implants placed into non-augmented bone.
Material and methods: 14
patients of the study-group received 40 allogenic bone-blocks and 60 implants
in both, maxilla and mandible in a two-step approach. The human study was
approved by the ethics-commission of the Wilhelms-Universität Münster, Germany.
Radiologic examinations were carried out directly after implant insertion,
after prosthetic restoration plus one and three years after prosthetic loading.
All radiographs were digitalized, calibrated and measured computer- assisted.
The control group contained 14 patients who had received 53 implants without
augmentation. Data of the two groups were compared statistically, using the
non-parametric Wilcoxon-test (α=0.05/4=0,0125). The two primary end-points of
the study were defined as
a) total
bone loss 3 years after prosthetic loading and
b) bone
loss in the years 2 and 3 after prosthetic loading
Results: The radiological
peri-implant bone loss at the distal sites after 36 months was 0.72 mm in the
study group (median; 25-Q: 0.27 mm; 75-Q: 1.11 mm) and 0.37 mm in the control
group (25-Q: 0.15 mm; 75-Q: 0.71 mm). The difference between the groups is
statistically significant (p=0.004). At the mesial sites (study-group: 0.52 mm;
control-group: 0.41 mm; p=0.179) and at all other examination intervals the
differences between the two groups were not significant. Neither did we find
any statistically significant differences within the study-group between
implants placed in the maxilla versus the mandible or in the anterior versus
the posterior region.
Conclusion: Loss of peri-implant
bone around dental implants with previous allogenic bone block augmentation
seems to be slightly greater compared to implants placed into native bone.
However, the detected median values for both groups are within the
physiological range and are in accordance with data recently published for
implants with autogenous bone grafts, GBR and without augmentation.
1. Introduction
For a prosthetically driven dental implant
placement, bone augmentation is often required in order to increase bone volume
and to create proper anatomical conditions for a functionally and esthetically
satisfying prosthetic result. Several methods and techniques have been
described, but for large defects and severe atrophy of the alveolar ridge,
autogenous bone blocks are regarded as golden standard [1-10]. Several intra-
and extra oral donor sites can be considered, delivering bone transplants of
different qualities and limited quantity but each of them is associated with an
additional operation site and a raise of complication rates and morbidity
[11-13].
In order to avoid bone harvesting, several
solutions can be taken into account:
Allogenic bone blocks are available and have
been described in the literature [5,8,14-16], presenting high success rates in
terms of graft incorporation and implant survival, especially for allogenic
bone block transplants [2,17]. However, most studies represent case series with
only few numbers of patients and randomized controlled clinical trials are
still missing [17]. Avoiding augmentative surgery by using short implants may
be an alternative procedure in vertical defects of the lateral mandible [4],
but the available data are still limited, especially under a long- term aspect.
Nerve transposition and distraction
osteogenesis must be regarded as specialties which cannot generally be
recommended and demand specific anatomical requirements and high surgical
capability. Guided bone regeneration using barrier membranes and particulate
bone or bone substitute material is also well documented, but predictable
results can only be expected in small and intra- bony defects, whereas large
and discontinuity defects must be provided with block transplants [1,4,18]. The
use of allogenic bone blocks is well documented and allows a minimally-invasive
approach to three-dimensional bone reconstruction. The availability of
pre-operative digital cone- beam tomography allows an exact three-dimensional
analysis of the defect morphology and the virtual computer-aided construction
of a block-dummy, which can thereafter be transferred into the allogenic graft
under sterile conditions. Thus, the actual surgical procedure is reduced to the
preparation of a surgical access, conditioning of the recipient bed, fixation
of the graft and wound closure [7]. Since allogenic bone blocks are highly
available, the reconstruction of complete edentulous jaws becomes possible in
local anesthesia and without hospitalisation.
The additional use of palatal-derived
ecto-mesenchymal stem cell homing from the human palate, as recently published
by Grimm et al. could be a future trend to induce osteogenic processes and
therefore enhance the healing capabilities in critical size defects of the jaw
[19,20]. Disadvantages of allogenic bone blocks are the theoretical risk of
transmitting infectious diseases, immunological aspects [21] and the lack of
osteoinductive and osteogenic properties. By being solely osteoconductive, it must
be assumed that graft incorporation and remodeling is slower and less effective
compared to autogenous bone blocks, thus resulting in higher resorption rates.
Since the implant shoulder is usually located at the outer surface of the
grafted site, where most of the resorption takes place, it must be assumed,
that crestal bone loss is higher in implants placed into bone grafted with
allogenic blocks than in implants placed into non-augmented bone. The purpose
of the present study is to identify and compare differences in the change of
peri-implant bone levels and clinical parameters of inflammation between
implants placed into allograft bone and implants placed into native bone over
three years.
2. Materials
and Methods
2.1. Study
group
14 Patients who required bone block
augmentation for subsequent implant placement but refused harvesting of
autogenous bone received 40 allogenic bone blocks (Tutogen Spongiosablock-P,
Tutogen Medical, Neunkirchen, Germany) [22] Figures 1-2. Written consent with
reference to the utilized allograft material and the participation in the study
(Figure 3) was obtained from all patients and the human study was approved by
the ethics commission of the Wilhelms-Universität Münster, Germany. Defect
morphologies were categorized according to the CCARD classification [23] Table
1.
Prior to surgery, all patients received
full-mouth disinfection and systemic antibiosis with amoxicillin 1000 mg plus
metronidazole 400 mg, which was continued for 5 to 10 days, according to the
duration and severity of the intervention. In case of allergy or intolerance,
clindamycin 600 mg was prescribed.
After local anaesthesia (Ultracain DS forte,
Sanofi-Aventis, Frankfurt a.M., Germany), recipient sites were surgically
opened via crestal incisions and bleeding points were set in order to provide
proper nutrition of the grafts. All allogenic grafts were rewetted with sterile
saline solution under vacuum conditions and adapted extraorally until congruent
coverage to the recipient bed was perfectly fulfilled, Figure 2. Rigid fixation
of the block grafts was executed using at least two osteosynthesis screws
(Mondeal Medical Systems, Germany) for each graft. For a tension-free wound
closure, the periosteum had to be slit, and the buccal portion of the mucosa
flaps was undercutting prepared with blunt scissors until the wound edges
attached freely. Single and continuous sutures were performed, using
monofilament material (Prolene 5/0, Ethicon / Johnson & Johnson Medical
GmbH, Norderstedt, Germany), Figures 4-7. After a 4-months healing period,
grafted sites were reopened, osteosynthesis material was removed and a total of
60 implants (MIS Seven, MIS Implant Technologies, Minden, Germany) were
inserted manually into the augmented bone and panoramic radiographs were made,
Figures 8-13. Implant lengths and diameters are shown in Table 2 for the study
group, and in Table 4 for the control group. The number of allogenic blocks,
implants and type of restoration within the study group (ffd: fixed full
denture, fpd: fixed partial denture; sc: single crown, rd: removable
implant-supported denture) is shown in Table 3.
After a second healing period of another 3 to 4
months, implants were uncovered and provided with fixed or removable full- or
partial dentures Figure 11. Radiographs were made immediately after restoration
and patients were informed about the correct maintenance, care and follow-up
intervals Figure 12. After 12 and 36 months of functional loading, radiologic
and clinical examinations were conducted, documenting probing depths, bleeding
indices, width of keratinized mucosa and periotest-values (Periotest, Gulden
Medizintechnik, Modautal, Germany) Figures 14,15, Table 5. This approach is in
accordance with Salvi et Lang, who suggest radiologic controls of dental
implant after 12 and 36 months [24].
All radiographs were digitalised and imported
into a scientific image analysis software (Image J 1.46r, Wayne Rasband,
National Institutes of Health, USA) Figure 13. Thus, a total of 240 digital
image files was created within the study group (60 implants × 4 time-points:
implant insertion, prosthetic restoration, 12 months and 36 months follow-up).
The digital image files were rotated into an
exact vertical position of the corresponding implant and then calibrated, using
the “calibration tool” of the software and the known implant length as a
reference. Auxiliary lines were drawn to explicitly define the apical and
crestal borders of the implant bodies and the bone level at the mesial and
distal aspects of the implants. The distance between the implant neck and the
bone level was defined as “region-of-interest” for both, mesial and distal
aspects of each implant and measured and recorded digitally for all images. The
actual bone-loss was calculated by subtraction of t1-values (implant insertion)
from t2- or t3-values (12 months / 36 months) Figure 16.
2.2. Control
group
14 patients who had received a total of 53
MIS-Seven implants within the same period of time but without augmentation were
included in the control group. Age, gender, health status, periodontal
diseases, implant sizes and prosthetic restorations were similarly to the study
group. Radiographic controls were conducted after implant surgery, immediately
after restoration plus at 12 and, 36 months’ follow-up examinations. The clinical
parameters probing depths, bleeding index, width of keratinized tissue and
periotest values were recorded at 12 (t2) and 36 month-checkups (t3).
Radiographs were digitalized, post processed and measured as described above.
2.3. Clinical
parameters
Probing depths were measured at t2 and t3 on 4
sites per implant, using a periodontal resin-probe (Hawe Perio Probe, Kerr
Dental, Rastatt, Germany). Only the largest value was documented. Presence or
absence of subgingival plaque and bleeding-on-probing were recorded in a binary
fashion, using the same probe. The width of keratinized mucosa was registered
using by a different periodontal probe (Parodontometer, Hu-Friedy, Tutlingen,
Germany) and for periotest- values, the Periotest-M device (Gulden
Medizintechnik, Modautal, Germany) was applied.
2.4. Statistics
For the comparison of the two groups relating
to the change of bone level, two primary end-points were defined:
- the
change of bone level 36 months after functional loading and
- the
change of bone level within the last 24 months.
Medians and quartiles were calculated, since a
normal distribution of the collected data could not be expected. The software
SPSS Statistics (IBM Corporation, Armonk, NY, USA) was used and the
non-parametric Wilcoxon test was chosen for inductive statistics. Due to the
two primary end- points and two measuring points per implant, we had to adjust
the level of significance in terms of α=0.05/4=0,0125.
3. Results
All patients completed the study and all
implants survived, thus resulting in a total of 60 implants (study group, SG)
and 53 implants (control group, CG) which could be examined over the complete
follow-up period of 36 months.
3.1. Socio-demographic
data
Patient’s median age was 57 (21-77) years in
the study-group and 49.5 (29-70) years in the control- group, which is a
non-significant difference (p=0.403). Within the study-group, 10 patients were
male (71.4%) and 4 were female (28.6%). In the control- group, there were 7
females (58.3%) and 5 male patients (51.7%). Two patients took part in both
groups, so their socio-demographic data were assigned exclusively to the study
group.
3.2. Primary
outcome
The radiological peri-implant bone loss at the
distal sites after 36 months was 0.72 mm in the study group (median; 25-Q: 0.27
mm; 75-Q: 1.11 mm) and 0.37 mm in the control group (median; 25-Q: 0.15 mm;
75-Q: 0.71 mm). The difference between the groups is statistically significant
(p=0.004). At the mesial sites (study-group: 0.52mm; control-group: 0.41 mm;
p=0.179), the median bone loss is not significantly larger in the study group
compared to the control group, Table 6. Regarding only the years 2 and 3 after
prosthetic loading, the median bone loss in the study-group amounts 0.17 mm at
mesial sites and 0.22 mm at distal sites. Within the control-group, the
corresponding median-values are 0.15 mm at mesial and distal sites, the
difference to the study- group being not statistically significant (p=0.583
mesial / p=0.149 distal).
3.3. Secondary
outcome
Within in the first 12 months of functional
loading, median bone loss was 0.28 mm at mesial sites and 0.35 mm at distal
sites in the study-group and 0.19 mm / 0.15 mm in the control-group. The result
is not statistically significant (p=0.503 mesial / p=0.067 distal), Figures
17-20. The 60 implants of the study group were additionally analyzed for
detectable differences in peri- implant bone loss between maxilla versus
mandible and anterior versus posterior region. No statistically significant
results were obtained at t2 (maxilla 0.34 mm vs. mandible 0.23 mm; p=0.149 /
anterior 0.26 mm vs. posterior 0.31 mm; p= 0.923) or t3 (maxilla 0.61 mm vs.
mandible 0.41 mm; p= 0.338 / anterior 0.70 mm vs. posterior 0.41 mm; p= 0.146).
3.4. Clinical
parameters
Median probing depths were 2 mm at t2 (12
months) and 2 mm at t3 (36 months) in the study group versus 2 mm at t2 and 3
mm at t3 in the control group, which are non-significant results. At t2, 23.6%
(SG) versus 26.4% (CG) were accounted for positive bleeding-on-probing. At t3,
26.7% versus 30.2% of implants showed bleeding on probing. Plaque was found on
36.4% versus 32.1% of implants at t2 and on 56.7% versus 37.7% of implants at
t3. When comparing the groups, no statistically significant differences were
found for probing depths, bleeding index or presence of plaque, Tables 5,7. The
median width of keratinized mucosa was 1 mm (SG) versus 2 mm (CG) at t2 and 0
mm (SG) versus 2 mm (CG) at t3. These findings are statistically significant
(t2: p=0.007; t3: p=0.004). Periotest values were not analyzed since those
implants provided with fixed dentures are permanently interlocked, thus
delivering unexploitable data.
4. Discussion
The radiologic evaluation of peri-implant bone
loss is a key determinant for the definition of implant health and successful
Osseo integration, especially under a long-term aspect [24,25]. Lots of studies
have been published regarding the reliability and informative value of
panoramic versus intraoral x-rays [26-28] and the influence of different
implant designs and implant-abutment connections on the peri-implant bone and
soft-tissue [29-31].
In the present study, we investigated 60
tapered screw-form implants with an internal hexagon- connection (MIS Seven),
which were inserted into 40 allogenic bone-block grafts in 14 patients in a
two-step approach. The hypothesis was, that allogenic bone blocks suffer higher
resorption rates and less effective graft revitalization than autogenous
grafts, which are regarded as golden standard, thus leading to a greater decrease
of marginal bone level after functional loading. In order to eliminate
implant-dependent factors on the peri-implant bone like surface characteristics
and implant-abutment connection, an internal control-group was established,
containing 14 patients who had received the same implant system within the same
time period, but without augmentation.
Age, gender and periodontal preconditions were
similarly to the study group. The detected median bone loss after 1 year of
functional loading was 0.35 mm in the study group and 0.19 mm in the
control-group. After 36 months, the bone loss amounted 0.72 mm in the study-
group and 0.37 mm in the control-group, which is statistically significant.
These findings can be interpreted as a verification of the hypothesis, that
implants after allogenic block grafting suffer higher bone loss than implants
in non-augmented bone. Nevertheless, these results compare favorably to values
formerly published by Bratu, et al. [32], who investigated MIS Lance and MIS
Seven implants without augmentation and found an average bone loss of 0.57 mm
after 6 months and 0.9 mm after 12 months of loading for the Seven-implant. The
marginal bone loss around implants following allogenic bone augmentation was
previously investigated by Nissan et al., although not being a primary outcome.
Values amounted 0.5 mm +/- 0.2 mm after an average test period of 37 months
[33]. Chiapasco, et al. reported marginal bone loss of 0.42 mm in implants
placed into autogenous mandibular grafts after 12 to 36 months [34]. Boronat,
et al. found an average bone loss of 0.64 mm after 1 year for implants inserted
into autogenous bone block grafts [3].
Dasmah, et al. compared the bone loss of
implants placed into autogenous mandibular block grafts versus particulate
material plus PRP over a 5-year period. They found no statistically significant
difference between the groups but a significantly higher degree of marginal
bone alteration in the first year of loading [35]. This is consistent with our
findings. In a recently published meta-analysis concerning marginal bone loss
around single versus multiple prostheses, Firme, et al. reported bone loss
values of 0.58 mm (95% CI, 0.37 to 0.80 mm) for single and 0.9 mm (95% CI, 0.49
to 1.32 mm) for multiple prostheses after follow-up periods of 1 to 20 years
[31]. Measuring- and interpretation errors must be assumed and lots of
different influencing factors must be regarded, when comparing different
studies on the radiologically detected marginal bone loss around dental
implants. According to Braegger, et al, an error of +/- 0.2 mm must be
estimated when interpreting dental radiographs [30]. Peñarrocha, et al. discuss
the “intra-observer error” to be 0.25 mm for panoramic x-rays and 0.11 mm for
intraoral x-rays [28]. Cone beam computed tomography still seems unsuitable for
detecting changes in peri-implant bone level [36]. Concerning clinical
parameters, the obtained data do not deliver significant differences between
the groups, except for the width of keratinized gingiva, which is less present
in the study-group. This is due to the proceeded grafting procedure and the
involved wound closure technique outlined above. Gobbato, et al. found out that
gingival index, plaque index, modified plaque index and modified bleeding index
were significantly higher in groups with keratinized mucosa widths < 2 mm
than in groups with keratinized mucosa widths > 2 mm [37]. According to
these findings, it could have been expected that our study-group suffers more
bleeding on probing and shows more plaque accumulation than our control-group,
but this suspicion cannot be confirmed.
Due to the anatomy of peri-implant tissues,
probing depths around dental implants lack repetitious accuracy. According to
Mombelli, et al. recorded probing depths are direct proportional to probing
forces and reproducibility of values rises with increased probing forces [38].
Hence, the recorded probing depths should be considered with caution. With the
hereby presented data, it is impossible to draw conclusions regarding the utilized
allogenic grafting material and its influence on the marginal bone level.
However, the marginal bone loss around implant inserted into allogenic bone
block grafts coincides well with data formerly published for the same implant
system but without augmentation [32], implants inserted into auto grafts [3,34]
and implants inserted with simultaneous GBR [35].
Disclosure
Figures 1,2: Sample of the utilized Tutogen Spongiosablock-P (1) and rehydration of the allogenic bone block under vacuum condition (2).
Figure 3: Study design.
Figures 4-11: Bone-block augmentation (4-7), re-entry after 4 months (8-10) and final prosthetics (11).
Figures 12,13: Intraoral rectangular radiograph after crown cementation (12; left) and computer-aided measurement of marginal peri-implant bone loss (13; right).
Figures 14,15: Measuring of pocket depth with a peril-probe (14) and “Roll-test” for measuring width of keratinized mucosa (15).
Figure 16: Computer-aided measurement of marginal peri-implant bone loss.
Figures 17-20: Boxplot displaying crestal bone loss 36 months after loading (t3-t1) / comparison of groups (17); boxplot displaying crestal bone loss in the years 2+3 after loading (t3-t2) / comparison of groups (18); boxplot displaying crestal bone loss 12 months after loading (t2-t1) / comparison of groups (19); change of peri-implant bone level between t0 (implant insertion), t1 (prosthetic restoration), t2 (12 months’ follow-up) and t3 (36 months follow-up) / comparison of groups (20).
DeFeKt- Code |
Description |
Number of Cases |
H2e |
horizontal defect
of 4-8 mm, outside the ridge contour |
5 |
H3e |
horizontal
defect, larger than 8 mm, outside the ridge contour |
1 |
V2i |
vertical defect of 4-8
mm, inside the
ridge contour |
1 |
V2e |
vertical defect of 4-8
mm, outside the ridge contour |
2 |
V3i |
vertical defect,
larger than 8 mm, inside the ridge contour |
1 |
K2i |
combined defect
of 4-8 mm, inside the ridge contour |
2 |
K2e |
combined defect
of 4-8 mm, outside the ridge contour |
2 |
Implant Diameters |
Implant Lengths |
|||||
8 mm |
10 mm |
11.5 mm |
13 mm |
16 mm |
||
3.3 mm |
0 |
0 |
1 |
1 |
3 |
|
3.75 mm |
1 |
3 |
8 |
12 |
2 |
|
4.2 mm |
1 |
6 |
4 |
12 |
4 |
|
5.0 mm |
0 |
0 |
0 |
1 |
0 |
|
6.0 mm |
0 |
0 |
0 |
1 |
0 |
Patient (Number) |
Number of Allogenic Blocks |
Number of Implants |
Prosthetic Restorations |
1 |
3 |
8 |
ffd |
2 |
14 |
18 |
ffd |
3 |
1 |
2 |
fpd |
4 |
1 |
2 |
sc |
5 |
1 |
2 |
sc |
6 |
1 |
1 |
sc |
7 |
1 |
2 |
sc |
8 |
2 |
3 |
fpd |
9 |
1 |
2 |
fpd |
10 |
2 |
3 |
ffd |
11 |
3 |
6 |
ffd |
12 |
2 |
2 |
fpd |
13 |
6 |
4 |
rd |
14 |
2 |
5 |
rd |
Sum |
40 |
60 |
|
Implant Diameters |
Implant Lengths |
|||||
8 mm |
10 mm |
11.5 mm |
13 mm |
16 mm |
||
3.3 mm |
0 |
1 |
0 |
1 |
0 |
|
3.75 mm |
3 |
2 |
4 |
15 |
6 |
|
4.2 mm |
0 |
0 |
4 |
8 |
6 |
|
5.0 mm |
0 |
0 |
1 |
2 |
0 |
|
6.0 mm |
0 |
0 |
0 |
0 |
0 |
Periodontally Comprised |
Periodontally Healthy |
Edentulous |
|
study-group |
9 |
4 |
1 |
control-group |
9 |
4 |
1 |
Measuring Site |
Study Group |
Control Group |
P |
|
Total Bone Loss
After 12 Months |
mesial |
0.28 mm |
0.19 mm |
0.503 |
distal |
0.35 mm |
0.15 mm |
0.067 |
|
Total Bone Loss
After 36 Months |
mesial |
0.52 mm |
0.41 mm |
0.179 |
distal |
0.72 mm |
0.37 mm |
0.004 |
|
Cumulated Bone
Loss in The Years 2+3 |
mesial |
0.17 mm |
0.15 mm |
0.583 |
distal |
0.22 mm |
0.15 mm |
0.149 |
Study-Group |
Control-Group |
Wilcoxon-Test |
||||||
t2 |
t3 |
t2 |
t3 |
p (t2) |
p (t3) |
|
||
probing depths |
2 mm |
2 mm |
2 mm |
3 mm |
0.367 |
|
||
bleeding-on-
probing |
23.60% |
26.70% |
26.40% |
30.20% |
0.825 |
0.683 |
|
|
presence of
plaque |
36.40% |
32.10% |
56.70% |
37.70% |
0.688 |
0.059 |
|
|
width of
keratinizes mucosa |
1 mm |
0 mm |
2 mm |
2 mm |
0.007 |
0.004 |
|
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