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List of authors: Yang Jing 1,2, *, Xia Ting2, *, Wang Hui3, Cheng Zhigang1, Shi Bin2
Affiliation: 1. The Central Hospital of Wuhan, 26 Shengli street, Wuhan, 430014, People’s
Republic of China
2.The State Key Laboratory Breeding Base of Basic Science of Stomatology (Hubei-MOST)
and Key Laboratory of Oral Biomedical Ministry of Education, School and Hospital of
Stomatology, Wuhan University, 237 Luoyu road, Wuhan, 430079, People’s Republic of
China
This article has been accepted for publication and undergone full peer review but has not
been through the copyediting, typesetting, pagination and proofreading process, which may
lead to differences between this version and the Version of Record. Please cite this article as
doi: 10.1111/joor.12753
Affiliation: The State Key Laboratory Breeding Base of Basic Science of Stomatology
Accepted Article
(Hubei-MOST) and Key Laboratory of Oral Biomedical Ministry of Education, School and
Hospital of Stomatology, Wuhan University, 237 Luoyu road, Wuhan, 430079, People’s
Republic of China
Affiliation: The Central Hospital of Wuhan, 26 Shengli street, Wuhan, 430014, People’s
Republic of China
Affiliation: The State Key Laboratory Breeding Base of Basic Science of Stomatology
(Hubei-MOST) and Key Laboratory of Oral Biomedical Ministry of Education, School and
Hospital of Stomatology, Wuhan University, 237 Luoyu road, Wuhan, 430079, People’s
Republic of China. Tel.: +86 27 87686222; fax: +86 27 87683260
Abstract
Background: Maxillary sinus floor augmentation without grafts has been more
Purpose: The aim of this review was to systematically evaluate the effectiveness
conducted by Review Manager 5.1. The quality of evidence was assessed using
(GRADE).
critical selection, only 6 studies were eligible. Five studies with 336 implants
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were included in the meta-analysis compared sinus augmentation with grafts to
without grafts. No significant differences were found between the two groups in
implant survivals (P=0.94), marginal bone loss (P=0.73) and new bone density
(P=0.54). There was significantly more endo-sinus bone gain in the grafting
moderate (implant survival and marginal bone loss), low (endo-sinus bone
survivals; marginal bone loss; endo-sinus bone gain; new bone density
• Introduction
loss lead to big challenge in successful implant placement and excellent long-
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term result achievement.
Solutions for patients with atrophic maxilla include maxillary sinus lift, guided
short implants.1,2 Among those solutions, maxillary sinus lift is one of the most
grafting materials are needed to maintain the space and induce bone
surgical techniques, studies have shown that sinus lift without grafts can also
induce bone formation in the maxillary sinus and result in favorable success
rate, which is considered less invasive, traumatic and costly.6-9 Recently several
effectiveness of two surgical options - sinus lift with and without grafts.10-12 But
whether to do the sinus lift without grafts alone is enough for the implant
success in the atrophic maxilla is still controversial. The aim of this systematic
review was to evaluate the efficacy of sinus lift without grafts in atrophic
maxilla. The null hypothesis was there were no significant differences between
graft group and without graft group in implant survivals, marginal bone loss,
PubMed, EMBASE via OVID and the Cochrane Central Register of Controlled
based on the PICO principle. The most recent electronic search was undertaken
Inclusion criteria were: 1) Any studies with data on outcomes of sinus lift
inclusion criteria through title and abstract screening, then made the final
Referred to the successive reports on the same patients, the most recent
5.1.0, the quality assessment procedure was done by two independent review
other bias.
Statistical analysis
using the Review Manager (RevMan) 5.1. Risk ratios were applied to
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discontinuous variable and mean difference were applied to continuous variable.
When there was substantial heterogeneity that could not readily be explained,
heterogeneity.
Overall quality assessment of the evidence was performed by using the GRADE
profiler 3.6. The GRADE system classifies the quality of evidence into four
important impact on our confidence in the estimate of effect and may change
the estimate. 3) Low: further research is very likely to have an important impact
on our confidence in the estimate of effect and is likely to change the estimate.
A total of 707 studies were retrieved by the electronic and hand searches, of
which 17 papers10-26 were remained for full-text reviewing, and the flow
compared sinus lift with and without grafts, included 3 trials12,14-15 which were
successive reports on the same patients. One trial17 compared osteotome sinus
assessment the judgment of “unclear risk of bias” was given in one trial 10. In
blinding of participants and personnel, two trials10,13 presented the “unclear risk
of bias”.
All the included studies reported on the survival rate of the implants. The test
survival between graft and without graft is illustrated as a forest plot (Fig 3).
There was no statistically significant difference between the two groups, with a
RR (risk ratio) of 1.00 (95% confidence interval (CI) 0.96 to 1.04, P=0.94).
Three of the included trials reported on the endo-sinus bone gain.11,13,14 The test
revealed statistically more endo-sinus bone gain in the graft group than in the
I2=0%). The meta-analysis was applied by using the fixed-effects model (Fig
5). There was no statistically significant difference between the two groups
model (Fig 6). There was no statistically significant difference between the two
Table 2 shows the GRADE summary of findings for the levels of the four main
marginal bone level, new bone density). Reasons for upgrade and downgrade
• Discussion
the groups of implants placed with or without grafting in implant success rate,
the changes of peri-implant marginal bone level and the density of newly
formed bone around implants. However, in sinus lift, the bone grafts group
showed more endo-sinus bone gain than no grafts group. According to GRADE
,the quality of the evidence about implant success rate and the changes of
peri-implant marginal bone level was moderate. The quality of evidence about
endo-sinus bone gain was low. And the quality of the evidence about the density
have been published. Moraschini et al. found there was no significant difference
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in the implant success rate and endo-sinus bone gain by comparing using and
not using bone grafts material.27 The study included 18 articles, of which only 4
sequential studies for the same patient12,15) and non-randomized control trials
were not eliminated, and the quality grade of the evidence was not evaluated.
Nasr et al.28 included 6 papers, two of which were serial reports of the same
research objects. But in the meta-analysis, the authors did not eliminate repeated
reports from the same research objects. Furthermore, the grade evaluation of
evidence is different from the present article because it concerned the overall
evaluation of the study, but not for each outcome index. In addition, Nasr
included Esposito et al. and Felice et al’ s research, which compared using bone
grafts materials and using rigid inion membrane in sinus lift. 29,30
Among the four-outcome index, the success rate of implant was the ultimate
detail, two of them reported a success rate of 100%. One failure was observed in
the patient who presented sinusitis13. Three implants were lost because of peri-
implantitis 11,15. Two early failures were related to the placement of implants in
fused corticals (mono-cortical bone), where the implant primary stability was
difficult to achieve12. None of the failed implants was directly caused by the
presence or not of the graft. This meta-analysis showed that between graft and
success rate. But at the same time, two points must be pointed out. First, this
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conclusion is based on the data of only five clinical trials10,11,13,14,16, the follow-
up time of two trials10,13 lasted for only 6 months, only one14 follow-up period of
the five trials lasted for 5 years (the overall sample size in this study was 37
implants); Second, as for the short-term (less than 1year) success rate of the
implant the quality of the evidence has not reached a high level. Therefore, we
to graft in order to get better implant survival rate, that doesn’t mean graft has
no benefit for sinus lift. The bone graft material can better support the sinus
floor mucosa and maintain the stability of the osteogenesis space. Especially
when the diameter of the apical segment of the implant is small, the use of the
bone graft material can disperse the pressure of the sinus membrane, and
The results of the meta-analysis showed that there was no statistical difference
between the graft group and no graft group. This result was consistent with the
no significant difference in the long-term (≥5 years) success rate between the
bone formation in maxillary sinus. Some authors reported that the amount of
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newly formed bone depends on maxillary residual bone height. Nedir et al. was
the first to report a strong correlation between higher endo-sinus bone gain and
study over two years by Kim et al, the mean gain in alveolar height was
inversely related to the residual bone height32. However, Si et al. claimed the
opposite that the endo-sinus new bone formation was not significantly
correlated with the residual bone height in their 3-year randomized controlled
clinical trial22. Yang et al. reported also no significant correlation between the
new bone formation and the residual bone height33. The residual bone height is
critical in obtaining initial stability and selecting which program to operate, but
may not directly influenced the amount of new bone formation. Furthermore,
some authors believe that maxillary sinus elevation without grafting can provide
technique should be used without grafting only when a small amount of new
cavity 34,35. However, other study has shown that maxillary sinus elevation
new bone formation than the no grafting group. This result was in line with
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previous studies12,14,34. However, it might be premature to draw a conclusion
that the amount of the new bone formation in the bone grafting group is greater
than that in the non-bone grafting group. First, according to the GRADE rating,
the quality of the evidence is low. Secondly, the results were based on only
three clinical studies11,13,14, the follow up period of which were six months, three
researchers stated that the amount of new bone formation reduced from
group11. In the long-term (≥5years) clinical study, Nedir et al. have reported a
slight decrease in dome height above the implant apex, the mean ESBG
group 14. However, in the no grafting group was a growth process. Si et al.
was mainly gained during the first year, with no significant change thereafter 14.
Because of the amount of the new bone formation in the maxillary sinus derives
from the radiological imaging data, it was impossible to conclude that the bone
in the grafting group was completely transformed into autogenous bone. Since
have suggested that the amount of new bone formation and the length of the
implant protruding into the maxillary sinus in the process of the lift were
positively correlated.11,18 But it doesn't mean to pursue too much length of the
implant protruding into the sinus. An animal study by Sul et al38 showed that
there was no difference between the 4mm protruding implant and 8mm
protruding implant regarding new bone height in the sinus. The excessive IPL
(8mm protruding into the sinus) might lead to excessive tension of the maxillary
sinus mucosa. The integrity of the mucosa might be destroyed, with no bone
tissue around the apical segment of the implant, and even debris accumulated on
the exposed surfaces of the implants. Therefore, comparing the amount of new
bone formation in groups of implants placed with and without grafting, the
length of the implant protrusion into the sinus should be taken into account
during the experimental design process. Unfortunately, this factor in the studies
The last outcome indicator was the bone mineral density of the new bone
in the maxillary sinus. The conclusion was that there was no significant
difference in the peri-implant bone density between the grafting group and no
grafting group. The level of evidence was very low. The results were very
uncertain because the study included a small sample size --- only two studies
reason for this quality grade result was that limited evidence comes from 5
randomized controlled trials. And other reasons: 1. moderate risk of bias in two
studies10,13; 2. the study controlled the main factors (sinus lift with and without
grafts), but not the other factors such as operation mode in sinus lift (lateral
materials, the length of the implant protruding into the maxillary sinus in the
studies. The heterogeneity here might come from the obvious distinction
between these studies:the operation mode in sinus lift, follow up time, types of
bone grafts materials in sinus lift, the length of the implant protruding into the
maxillary sinus in the process of the lift, implant length and diameter, etc. 2.
potential selective bias, the number of studies and overall sample size of the
and without grafts in the short-term success rate, the changes of peri-implant
marginal bone level and the density of newly formed bone around implants. But
the grafting group had more new bone formation than the no grafting group in
bone grafts during sinus lift. However, these findings are based on a few
larger pool of patients and longer follow-up (at least more than 5 years).
marginal bone level and the density of newly formed bone around implants.
However, in sinus lift, the bone grafts group showed more endo-sinus bone gain
Acknowledgment
The authors declare no conflicts of interest associated with this study and
there has been no significant financial support for this work. We further confirm
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Marković A 2016
【16】
45/180 prospective randomized 56.7 OSFE 6.59± 0.45 100% (success) N/A N/A N/A 29.7m
【 】
Nedir R2017 14 12/37 prospective randomized 57.6±4.7 OSFE 2.4± 0.9 94.1% (no grafting) 0.6±0.9(no grafting) N/A 3.8±1(no grafting) 60m
90.00% (grafting) 0.7±1.4(grafting) 4.8±1.2(grafting)
【11】
Si MS 2013 41/41 double-blind 48.5(19-78) OSFE 4.63±1.31 95.0% (no grafting) 1.38±0.23(no grafting) N/A 3.07±1.68(no grafting) 36m
randomized 95.2% (grafting) 1.33±0.46(grafting) 3.17±1.95(grafting)
Label: “OSFE”: osteotome sinus floor elevation; " N/A “: not available; “m": month.
across outcomes
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sinus floor elevation without grafting versus grafting for atrophic sinuses
Outcomes Illustrative comparative risks* (95% CI) Relative effect No of Participants Quality of the evidence
(95% CI) (studies) (GRADE)
Assumed risk Corresponding risk
Moderate
new bone gain The mean new bone gain in the 126 ⊕⊕⊝⊝
intervention groups was 0.69 lower (3 studies) low2,3
(1.28 to 0.11 lower)
crestal bone loss The mean crestal bone loss in the 74 ⊕⊕⊕⊝
intervention groups was 0.08 higher (2 studies) moderate4
(0.13 lower to 0.28 higher)
average bone density The mean average bone density in the 77 ⊕⊝⊝⊝
intervention groups was 73.16 higher (2 studies) very low5,6,7
(160.32 lower to 306.63 higher)
*The basis for the assumed risk (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95%
confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).
CI: Confidence interval; RR: Risk ratio;
1
Altintas NY 2013, Borges FL 2011 showed unclear risk of bias, which indicated serious limitations; this will downgrade the quality of evidence for this
outcome by 1 level.
2
Borges FL 2011showed unclear risk of bias, which indicated serious limitations; this will downgrade the quality of evidence for this outcome by 1 level.
3
total (cumulative) sample size is less than 400, downgrades 1 level.
4
total (cumulative) sample size is less than 400, downgrades 1 level.
5
Altintas NY 2013, Borges FL 2011 showed unclear risk of bias, which indicated serious limitations; this will downgrade the quality of evidence for this
outcome by 1 level.
6
(P=0.09, I2=65%), downgrades 1 level.
7
total (cumulative) sample size is less than 400, downgrades 1 level.
Figure 2. Risk of bias summary: review authors' judgements about each risk of
Figure 3. Forest plot comparing implant survival between graft and without
graft groups.
Figure 4. Forest plot comparing endo-sinus bone gain between graft and without
graft groups.
Figure 5. Forest plot comparing peri-implant marginal bone level between graft
Figure 6. Forest plot comparing endo-sinus new bone density between graft and