Efficacy of simultaneous placement of dental implants in osteotome-mediated sinus floor elevation with and without bone augmentation: A systematic review and meta-analysis : Journal of Indian Society of Periodontology

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Efficacy of simultaneous placement of dental implants in osteotome-mediated sinus floor elevation with and without bone augmentation: A systematic review and meta-analysis

Rahate, Priyanka Sunil; Kolte, Rajashri Abhay; Kolte, Abhay Pandurang; Bodhare, Girish Haripal; Lathiya, Vrushali Nilesh

Author Information
Journal of Indian Society of Periodontology 27(1):p 31-39, Jan–Feb 2023. | DOI: 10.4103/jisp.jisp_196_21
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Abstract

INTRODUCTION

Osseointegrated dental implants are an established treatment modality for restoration of masticatory apparatus involving restoration of missing teeth and edentulous ridges. Implant therapy in the maxillary posterior region is often challenging due to inadequate vertical bone height and maxillary sinus pneumatization which further complicates the situation.[1] Over the years, augmentation of maxillary sinus has been adopted to mitigate the alveolar bone deficiency in this region. In 1977, Dr. Hilt Tatum developed the sinus augmentation technique by crestal approach to gain access to the sinus floor.[2] Later, Boyne and James developed the lateral window sinus elevation method to manage severe cases of bone deficiency using autogenous bone graft.[3] A minimally invasive alternative to lateral window approach was proposed by Summers in 1994 in which a set of tapered osteotome with increasing diameters was used and thus it became widely accepted due to its simplicity and long-term predictability.[4] Later on, a modified osteotome-mediated sinus floor elevation (OMSFE) technique was introduced by Lazzara et al., which employed the combined use of osteotome, drills, and bone graft enabling elevation of the sinus floor membrane, thereby resulting in an adequate vertical height and width of alveolar bone for simultaneous implant placement.[5]

It has been documented that OMSFE technique offers several advantages over the others in terms of sinus augmentation in localized area which makes the procedure more conservative with a reduced rate of postoperative morbidity, a shorter period required for implant loading, no risk of wound dehiscence, and survival rates of over 90%.[67] To perform a sinus floor elevation with or without bone augmentation is a matter of clinical judgment of the operator where factors such as medical condition of the patient, presence of periodontal disease, and other local factors can influence the clinical decision. The protocol utilized for grafting is a crucial aspect in decision making as it may alter the cost of treatment, operating time, loading practices, as well as selection of the prostheses.[8]

Various augmentation materials in maxillary sinus floor elevation procedures have been tried including autogenous bone, allografts, and xenografts; however, these materials are considered to possess varied potential for osteoinduction or osteoconduction. Pjetursson et al.[9] evaluated the pattern of tissue remodeling after OMSFE with and without bone augmentation and found just a moderate gain of new bone in mesial and distal aspects to the implants in the nonaugmented group. On the contrary, when augmentation material was used, a considerable amount of newly formed bone was evident radiographically.[9] Similarly, several studies have also revealed that the use of bone graft materials can be efficient in maintaining space and can potentially lead to bone formation beneath the elevated sinus.[10-12] One of the systematic reviews recorded an average 3-year survival rate of 92.8% for OMSFE; however, due to immense heterogeneity, no inference could be drawn with regard to augmentation materials.[13] Another systematic review compared the mean cumulative survival rates by OMSFE with and without augmentation and inferred that using the augmentation material was not significant in ascertaining a long-term survival and even the meta-analysis could not be performed as included studies had low evidence level case series.[14]

Literature search indicated that there is a lack of data in the form of systematic reviews and meta-analyses on the efficacy of OMSFE implants with and without bone augmentation. Hence, considering all the above actualities and paucity of knowledge, the present systematic review and meta-analysis aimed to determine the survival rate, endosinus bone gain (ESBG), and marginal bone loss (MBL) in simultaneous placement of implant in OMSFE with and without bone augmentation.

MATERIALS AND METHODS

Reporting format

The systematic review was undertaken in conformance with the guidelines of Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) statement[15] and Cochrane collaboration.[16] The protocol for the systematic review has been registered under number (CRD42019138699) with PROSPERO (The International Prospective Register of Systematic Reviews).

Focused question

The focused question was designed on the basis of population intervention control outcome[1718] principle, “In patients with deficient alveolar ridges in posterior maxilla requiring implant placement (population), what are the benefits of OMSFE procedure using a bone augmentation material (intervention) compared to OMSFE procedure without bone augmentation (control) on implant survival as well as radiographic parameters like ESBG and MBL (outcome).”

Search strategy for identification of studies (data sources)

The search strategy comprised a review of electronic databases MEDLINE (PubMed), Cochrane library search, and Google Scholar accompanied by a meticulous hand-search of relevant journals [Supplementary Table 1]. The bibliographies of the identified articles were also hand searched to access maximum data available. The search strategy for MEDLINE utilized the following key words and MeSH terms (Medical Subject Headings) and a combination as well for efficient search results.(“Osteotome Mediated Sinus Floor Elevation”[MeSH Terms] OR “Sinus Floor Elevation”[MeSH Terms] OR “Sinus Floor Augmentation”[MeSH Terms] OR “Osteotome Mediated Sinus Floor Elevation”[All Fields] OR “Sinus Floor Elevation”[All Fields] OR “Sinus Lift”[All Fields]) AND (“Dental Implant”[MeSH Terms] OR “Immediate Implants”[MeSH Terms]) OR “Dental Implant”[All Fields] OR “Immediate Implant”[All Fields] OR “implantation”[All Fields] OR “implant”[All Fields] OR “implant s”[All Fields] OR “implantated”[All Fields]) AND (“Bone Graft”[All Fields]) OR “Bone Augmentation”[All Fields]). For Cochrane library and Google Scholar similar search terms were used “sinus floor elevation” OR “osteotome mediated sinus floor elevation” OR “transalveolar sinus floor elevation” OR “indirect sinus lift” AND “dental implants” OR “immediate implants” OR “simultaneous implants” AND “bone grafts” OR “bone grafting” OR “bone augmentation” AND “randomised clinical trials” OR “randomised controlled trials” OR “clinical study” OR “clinic-radiographic study” OR “cone beam computed tomographic study” OR “CBCT.” In order to screen all the relevant studies, individual as well as combined search strategy was used for the terms.

T1
Supplementary Table 1

Screening and study selection

Three reviewers (PR, RK, and AK) individually searched the articles in details based on titles and abstracts in consonance with inclusion and exclusion criteria. Abstracts of all appropriate and related studies and their likely significance was obtained which was then scrutinized by the reviewers. The variance of opinion and possible understanding among the authors was analyzed by kappa statistics. To resolve any discrepancies, fourth author (GB) was conversed. In addition, full text of the manuscripts was obtained to identify the studies meeting the inclusion criteria. At this point, any discrepancy between the reviewers was resolved by the fifth reviewer (VL). General patient and study characteristics, implant systems, survival rate, and clinical outcomes were retrieved and assessed independently and together by the reviewers.

Eligibility criteria

The following selection criteria were formulated for this systematic review:

Inclusion criteria

  1. Articles in English language
  2. Randomized control trials involving OMSFE with simultaneous implant placement with and without bone augmentation
  3. Studies involving at lest 10 patients
  4. Mean follow-up period of a minimum of 1 year
  5. Studies with distinctly defined survival rate or success criteria.

Exclusion criteria

  1. Studies with multiple publications on the same cohort of patients
  2. Studies failing to report detailed information on surgical procedures
  3. Studies with insufficient sample size, extremely short follow-up, and inadequate data reporting
  4. Study designs such as case series, literature reviews, case reports, retrospective studies, and studies with unavailable data.

Outcome variables

The primary outcome variable measured was the survival of dental implant and was considered as the most important aspect to determine long-term consequence of the treatment. Moreover, in the present systematic review, secondary outcome variables measured and included as surrogate measures were ESBG and crestal/MBL.

Data extraction

During the search and screening of the titles and abstracts, a predetermined data extraction was used to include the selected articles after screening their full texts. Each step was performed by three calibrated reviewers (PR, RK, and AK). The general characteristics of included trials is tabulated in Table 1 in the following manner: (1) author and year of the study, (2) follow up, (3) number of patients, (4) age range, (5) number of implants, (6) implant system used, (7) residual bone height (RBH), and (8) bone graft material used in respective studies. Table 2 comprises data such as treatment covariates and clinical and radiographic outcomes which were independently assessed by the same reviewers and analyzed thoroughly for further statistical analysis.

T2
Table 1:
Overview of basic and general characteristics of the reviewed studies
T3
Table 2:
Clinical and radiographic outcomes considered for data analysis

Quality assessment of the included studies

The quality assessment of each of the studies was performed by two reviewers (PR and AK). The probability of bias assessment was realized through the Cochrane Collaboration Guidelines,[19] which was estimated under six domains: (1) sequence generation, (2) allocation concealment, (3) blinding of participants and outcome assessors, (4) incomplete outcome data, (5) selective outcome reporting, and (6) other sources of bias. All through the estimation each “Yes” or “No” pointed toward low and high risk of bias, respectively, whereas “Unclear” meant ambiguous risk of bias. A study was categorized as “Low risk of bias” when all the specific elements were of low risk of bias and as high or uncertain when one or more elements were of “High or Unclear risk of bias.”

Data analysis

The derived data were synthesized using the evidence table, and meta-analysis was used to conduct quantitative synthesis. The mean and standard deviation values for ESBG and MBL were considered for estimating the respective standardized mean differences (MD) between two groups, at nearly 1-year follow-up. Risk ratio (RR) was obtained for survival rate. Fixed effect model was considered to cope-up with the differentials among studies and the degree of contradiction was calculated by I2 and Q statistics. Since there was heterogeneity among the studies, the random effect model was also applied. Meta-analysis was performed using the meta library from R-programming tool (R-4.1.1 Core Team (2020): A language and environment for statistical computing. R foundation for Statistical Computing, Vienna, Austria.)

RESULTS

Included studies

A comprehensive search and screening were done, which is explained in Figure 1 (PRISMA flow chart). Altogether 1245 relevant studies were retrieved from the electronic search (1175 articles were obtained from PubMed, 20 from Cochrane Central, 47 from Google Scholar, and 1 from manual search), of which 1195 manuscripts were chosen for the screening of the titles and abstract. The clinical trials that were not in coherence with the treatment protocol were removed and 15 articles were selected for full text assessment by the reviewers. Further, four studies[20-23] were nonrandomized clinical trials and were excluded. Out of the 11 studies that were shortlisted for thorough evaluation, two more were excluded[2425] due to unmatched parameters. One study[26] was excluded due to unpublished results, while two studies[2728] were not included because they reported the use of lateral approach procedure [Table 3]. Finally, an inclusion of 6 studies[29-34] was possible for meta-analysis [Supplementary Table 2].

F1
Figure 1:
Figure explains preferred reporting items for Systematic review and Meta-analyses flow diagram. n – Number
T4
Table 3:
List of articles excluded
T5
Supplementary Table 2

Risk of bias assessment

The risk of bias for each study was assessed and is demonstrated in Figure 2. Quality risk assessment exhibited low risk of bias for random sequence generation,[30-34] allocation concealment,[30313334] blinding of participants and personnel,[29-34] blinding of outcome assessment,[29-34] inadequate outcome data[293132] and also selective reporting[30-34] while high risk of bias was shown for allotment concealment[29] and incomplete outcome data[34] whereas unclear risk of bias was seen for random sequence generation,[29] allocation concealment,[32] incomplete outcome data[3033] and selective reporting.[29]

F2
Figure 2:
Risk of bias assessment (a) Risk of bias summary (b) Risk of bias graph

Implant survival rate

All the six studies were analyzed implant survival rates after OMSFE with and without bone augmentation. Nedir et al.[32] and Marković et al.[33] applied the success criteria put forth by Buser et al.[35] while Si MS. et al.[31] used those proposed by Buser et al.[35] and Cochran et al.[36] to describe overall clinical survival rate. Figure 3 provides the descriptive statistics for survival rate, along with RR disparity and weight of each study in the analysis. The approximals of heterogeneous elements for survival rate dependent on six studies were: t2 = 0, I2 = 0% and H = 1. The test of heterogeneity resulted into a Q-statistic of 0.52 indicating statistical insignificance with P value of 0.9717 for 4 degrees of freedom. The relative risk difference for fixed effects (1.0446) were same for random effect. However, they showed insignificant effect of treatment, as indicated by P values of 0.6849. The forest plot elucidates the visualization of mean disparities across studies.

F3
Figure 3:
Forest plot showing descriptive statistics for implant survival rate along with risk ratio values, 95% confidence interval for individual studies along with I 2 value, Q value and P value. TE – Total error, se – Standard error, RR – Risk ratio, CI – Confidence interval, I 2 – Variation across studies due to heterogeneity, t2 – Estimated standard deviation of underlying effects across studies, P value – Significance value

Radiographic outcomes

Only five studies[29-32,34] reported the radiographic outcomes i.e., ESBG and MBL. The mean RBH ranged from 2.1-8.1mm in nonbone augmentation groups and 2.3 to 6.5 mm in bone augmentation groups. The mean ESBG ranged from 1.9 to 3.7 mm in nonbone augmentation groups while in augmentation groups it was between 3.12 and 5.5 mm at 3 years follow up period. Only one study by Nedir et al.[30] reported significant ESBG in bone augmentation group as compared to nonbone augmentation group while other four studies reported insignificant results. Nedir et al. also reported that an ESBG >2 mm was seen in 93.8% in nonbone augmentation group and 100% with bone augmentation group. Meta-analysis was done across four studies[30-32,34] to assess the ESBG at 1 year follow up of implant placement in OMSFE with and without bone augmentation.

Figure 4 provides the descriptive statistics for ESBG obtained in 4 studies,[30-32,34] including the mean disparity and weight of each study in the estimation. The probable elements of heterogeneous measures for bone fill based on four studies were: t2 = 0.0039, I2 = 67.3% (95% confidence interval [CI]: 0%–90.6%] and H = 1.75 [95% CI: 1, 3.25). The test of heterogeneity resulted into a Q-statistic of 6.12 indicating statistical significance with P value 0.0468 for 3 degrees of freedom. A high Q value shows significant heterogeneity in the mean values of ESBG across studies. The MD for fixed effects (0.8358) and random effects (0.8189) were different; however, they showed significant effect of treatment, as indicated by P values of 0 and <0.0001 respectively. The forest plot furnishes the mean divergence across studies.

F4
Figure 4:
Forest plot showing descriptive statistics for endosinus bone gain along with mean difference values, 95% confidence interval for individual studies along with I 2 value, Q value and P value. SD – Standard deviation, MD – Mean deviation, CI – Confidence interval, I 2 – Variation across studies due to heterogeneity, t2 – estimated standard deviation of underlying effects across studies, P value – Significance value, P value<0.05

Two studies[3132] reported acceptable crestal bone loss while two studies[3034] showed insignificant difference between bone augmentation and nonbone augmentation groups. Meta-analysis was done to evaluate MBL across four studies at 1 year follow-up of implant placement in OMSFE with and without grafting procedure. Figure 5 provides the descriptive statistics for MBL obtained in four studies,[30-32,34] together with the MD and weight of each analysed study. The estimates of measures of heterogeneity for bone fill based on four studies were: t2 = 0, I2 = 0% (95% CI: 92.6%–98.3%) and H = 1. The test of heterogeneity resulted into a Q-statistic of 0 indicating statistical insignificance with P value of 0.9998 for 3 degrees of freedom. A high Q value shows significant heterogeneity in the mean values of MBL.

F5
Figure 5:
Forest plot showing descriptive statistics for marginal bone loss along with mean difference values, 95% confidence interval for individual studies along with I 2 value, Q value and P value. SD – Standard deviation, MD – Mean deviation, CI – Confidence interval, I 2 – Variation across studies due to heterogeneity, t2 – estimated standard deviation of underlying effects across studies, P value – Significance value, P value<0.05

DISCUSSION

The present meta-anlysis aimed to assess and compare the survival rate, ESBG and MBL in implants placed with OSFE with and without bone augmentation. Based on six studies[29-34] documenting 640 implants placed in 349 patients, out of which 343 implants were implanted with bone graft and 297 without grafting, the survival rate was seen to be over 90% in both the groups. The meta-analysis found an insignificant difference between graft and nongrafted groups. This finding is in agreement with the previous systematic reviews and meta-analyses by Del Fabbro et al.[14] and Chen and Shi[37] where a survival rate of 98% and 90% repectively was reported but an insiginifcant difference in relation to the use of grafts. In the present review, the implant systems used in all included studies were of Straumann, however a caution is required on part of the clinicians to extrapolate this outcome to other implant systems. Four studies[29313334] among the six included studies had a longitudinal follow-up of a minimum of 3 years and a maximum of 10 years, and only two studies[3032] had a follow-up span of upto 1 year. However it is further desired to have more RCTs evaluating the parameters to provide an evidence of long-term survival rates with and without grafting.

It is suspected that RBH plays an important role in clinical survival of implants in the atrophic posterior maxilla. Previous research suggests restricting the use of the osteotome technique to cases where RBH <5mm.[1338] However, several clinicians have attempted to broaden the osteotome technique to include more impaired cases (RBH <5mm). Nedir et al. investigated and contrasted the survival of implants placed with and without OMSFE in the severely atrophic maxilla (RBH <4mm), which was systematically lower than the approved RBH values of 5 mm (Misch 1987), with a survival rate of 100% in bone augmented group versus 90% in non augmented group which was higher than the predicted values.[3033] However, relying on nine studies using the OMSFE technique, a meta-regression analysis study showed no association between mean RBH and implant survival rate.[39] This seemed to suggest that limited RBH could still provide sufficient osseointegrated bone to implant surfaces to help implant prosthesis, but additional appropriately designed RCT’s with longitudinal observation period are required to provide evidence of predictability of OMSFE in severe atrophic maxilla.

Four studies[30-32,34] included in this meta-analysis indicated that there was adquate ESBG in a range of 1.9 to 5.6 mm which is thought to permit stress distribution in the tissues which will not be detrimental to the health of the tissues. Bone augmentation materials have been documented to act as a role of scaffold in preserving the space beneath the sinus membrane as well as promote the ESBG. In addition, a similar ESBG benefit was reported in another study, regardless of the treatment with or without grafting at 3 years examination.[31] This finding was similar to the animal study published by Si et al.[40] It was comprehended by Nedir et al. in 2010[41] that sufficient amount of ESBG may be correlated with greater sinus protrusion by the implant and additionally the implants with sandblasted large grit acid etched implant surface tend to demonstrate this benefit over the others. It is postulated and revealed that the osseointegration events are modified or accelerated using the SLActive implant surface.[42-44] The plausible basis for ESBG include osteogenic activation following the sinus floor mini-fracture and the bone marrow stroma, periosteum and microvascular walls derive the osteogensis potential required through the progenitors. When the sinus floor is fractured and pushed upward by the osteotome, it stimulates the bone healing process and further leads to neobone formation from the original sinus floor to the implant apex and then reaches the displaced bone core to form a new cortical lining of the sinus floor.[45]

Meta-analysis was performed to assess and compare MBL between bone augmented and nonaugmented groups, suggesting that MBL substantially correlated with a nonbone augmentation group relative to a bone augmented one. Nedir et al., 2012[30] reported that implant placement done deeper than usual was necessary to bring the flared implant neck resting on crestal bone, beyond the smooth-rough boundary. Based on this data, deeper implant placement, indicated to recompense for the effects of MBL, is also a factor that promotes MBL in non bone augmentation group.[46] Another reason to speculate is the lesser bone density in posterior maxilla, as it is characterized by thin cortical bone which offers less resistance to compressive forces compared to shear forces, and is more vulnerable to lateral forces transmited across the implant collar where MBL can be comparatively greater and predicted.

This meta-analysis, as far as the reviewers are aware, offers the first assessment of ESBG as well as MBL for implants placed with and without bone augmentation in combination with OMSFE. It should be however, noted that the planning of implant surgery and estimation of bone height were based on two-dimentional radiographs. Only two studies[3334] used 3D CBCT (cone-beam computed tomography) which not only measured volumetric changes in bone, but also offered complex information on the surgical sites.

The few limitations in this systematic review include the outcome of current analysis has shown that there is paucity of long-term RCT’s which led us to draw conclusions in the analysis only on six RCTs. Additional studies with high level evidence would enable us to evaluate the clinical as well as radiographic outcomes following OMSFE with and without bone augmentation more precisely and conclusively. In addition, the potential impact of surface characteristics such as the stimulatory effect of surface type (SLA vs. SLActive) could not be assessed due to scarcity of available studies. Further longitudinal studies based on CBCTs using three-dimensional measurements are desirable. Also, SCOPUS, EMBASE, LILACS databases and grey literature was not included in our search strategy for identification of studies.

CONCLUSIONS

Within limitations of the present systematic review and meta-analysis, with a moderate strength of evidence it can be concluded that the OMSFE procedure with bone augumentation is a successful treatment modality in deficient alveolar ridges in posterior maxillary region for restoring the masticatory apparatus. The procedure has been found to have dual advantage as it encourages greater ESBG and limits the MBL as compared to the OMSFE without bone augmentation. With acceptable survival rates of dental implants using OMSFE with bone augmentation, it can be considered as a therapeutic modality with high predictability.

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.

Acknowledgements

The authors would like to thank Dr. Dhananjay Raje, Ph.D.

Statistician, MDS Bioanalytics, Nagpur, for performing statistical analysis.

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Keywords:

Key words:; Bone grafting; dental implants; endosinus bone gain; marginal bone loss; osteotome-mediated sinus floor elevation

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