Transcrestal Maxillary Sinus Membrane Elevation using Osseodensification Compared with Alveolar Ridge Augmentation using the Lateral Window or Osteotome Technique: a Systematic Review and Meta-Analysis

Objectives: The objective of the present systematic review was to test the hypothesis of no difference in implant outcome following transcrestal maxillary sinus membrane elevation using osseodensification compared with osteotome-mediated sinus floor elevation or maxillary sinus floor augmentation applying the lateral window technique.

Material and Methods: MEDLINE (PubMed), Embase, and Cochrane Library search combined with hand-search of relevant journals were conducted through March 19, 2025. Randomised controlled trials with an observation period of at least six months were included. Survival of suprastructures and implants were primary outcome, while duration of surgery, implant stability quotient (ISQ), peri-implant marginal bone loss, complications, endo-sinus bone gain, bone density, and patient-reported outcome were secondary outcome, as evaluated by descriptive statistics and meta-analysis including 95% CI.

Results: Six short-term randomised controlled trials characterised by high risk of bias and low GRADE fulfilled inclusion criteria. Comparable high implant survival was revealed. Transcrestal maxillary sinus membrane elevation using osseodensification (TSMEOD) disclosed statistically significant higher ISQ, at implant placement and abutment connection compared with osteotome-mediated sinus floor elevation (OMSFE) and maxillary sinus floor augmentation (MSFA). Duration of surgery, complications, and days using analgesics were diminished following TSMEOD. Endo-sinus bone gain was statistically significant reduced following TSMEOD compared with MSFA, while no statistically significant difference was revealed between TSMEOD and OMSFE.

Conclusions: Transcrestal maxillary sinus membrane elevation using osseodensification is associated with equivalent implant survival compared with osteotome-mediated sinus floor elevation and maxillary sinus floor augmentation, in short-term studies. Long-term randomized controlled trials are, therefore, needed before one treatment may be considered superior to another.

J Oral Maxillofac Res 2025;16(2):e1

doi: 10.5037/jomr.2025.16201

Accepted for publication: 30 June 2025

Keywords: alveolar ridge augmentation; dental implants; oral surgical procedures; sinus floor augmentation.

INTRODUCTION

Placement of standard-length implants in the posterior maxilla is frequently compromised or impossible due to atrophy of the alveolar ridge and pneumatization of the maxillary sinus. Osteotome-mediated sinus floor elevation (OMSFE) or maxillary sinus floor augmentation (MSFA) applying the lateral window technique are the most used surgical procedures to increase the alveolar ridge height of the atrophic posterior maxilla in conjunction with simultaneous placement of standard-length implants [1]. High long-term survival of suprastructures and implants, limited peri-implant marginal bone loss (PIMBL), endo-sinus bone gain, low frequency of complications, and improvement of oral-health-related quality of life have previously been reported in systematic reviews following OMSFE and MSFA [2-5]. However, devastating complications such as brain abscess, orbital and periorbital emphysema, severe bleeding, and benign paroxysmal positional vertigo have been reported following OMSFE and MSFA [6-8]. Moreover, application of a grafting material underneath the elevated Schneiderian membrane implies a risk of membrane perforation, infections, immunologic reactions, disease transmission, and donor site morbidity depending on the selected grafting material [9,10]. From a professional and patient’s point of view, it would, therefore, be an advantage if standard-length implants could be inserted in the atrophic posterior maxilla by a minimally invasive surgical approach without extensive alveolar ridge augmentation.

Osseodensification (OD) is a novel surgical technique, which was introduced by Huwais and Meyer [11]. OD involves counterclockwise rotating of specially designed drills with a progressive increasing diameter combined with a negative cutting angle, whereby the implant bed is slowly expanded, and the density of the surrounding trabecular bone is enhanced [12]. Simultaneous placement of standard-length implants in conjunction with transcrestal maxillary sinus membrane elevation using OD (TSMEOD) have been advocated to simplifying the surgical procedure, enhancing the primary implant stability, and avoiding extensive alveolar ridge augmentation [13]. TSMEOD is performed by counterclockwise rotating of the specially designed drills in a pumping motion under copious saline irrigation, generating a hydrodynamic compression of the bone debris underneath the Schneiderian membrane, which is gradually elevated during the drilling process [13]. A long-term retrospective multicentre study has demonstrated high implant survival, radiographic endo-sinus bone gain, and low frequency of complications following TSMEOD [14]. A resent published systematic review documented a statistically significant higher primary implant stability quotient (ISQ), while no difference in endo-sinus bone gain was shown following TSMEOD compared with OMSFE [15]. However, TSMEOD has never been compared with MSFA in a systematic review.

The objective of the present systematic review is, therefore, to test the hypothesis of no difference in implant treatment outcome following transcrestal maxillary sinus membrane elevation using osseodensification compared with osteotome-mediated sinus floor elevation or maxillary sinus floor augmentation applying the lateral window technique.

MATERIAL AND METHODS

Protocol and registration

The present systematic review was conducted in accordance with the Preferred Reporting Items for Systematic reviews and Meta-Analyses (PRISMA) statement for reporting systematic reviews [16]. The methods of the analysis and inclusion criteria were specified in advance and documented in a protocol and registered in PROSPERO, an international prospective register of systematic reviews.

Registration ID: CRD420251019164.

The protocol can be accessed at: www.crd.york.ac.uk/PROSPERO/view/CRD420251019164

Focus question

The focus question was designed according to the Patient, Intervention, Comparison and Outcome (PICO) framework as described in Table 1.

Eligibility criteria for considering studies for this review

Randomized controlled trials (RCTs) assessing implant treatment outcome following TSMEOD compared with OMSFE or MSFA applying the lateral window technique.

Types of outcome measures

The primary outcome is usually considered as the most important measure for assessment of implant treatment outcome. However, secondary outcomes were also included in this systematic review as supplementary measures, since secondary outcomes may influence the primary outcome. The primary and secondary outcome measures are outlined in Table 2.

Information sources

The search strategy incorporated examinations of electronic databases, supplemented by a thorough hand-search page by page of relevant journals including “British Journal of Oral and Maxillofacial Surgery”, “Clinical Implant Dentistry and Related Research”, “Clinical Oral Implants Research”, “European Journal of Oral Implantology”, “Implant Dentistry”, “International Journal of Oral and Maxillofacial Implants”, “International Journal of Oral and Maxillofacial Surgery”, “International Journal of Periodontics and Restorative Dentistry”, “International Journal of Prosthodontics”, “Journal of Clinical Periodontology”, “Journal of Dental Research”, “Journal of Oral Implantology”, “Journal of Oral & Maxillofacial Research”, “Journal of Periodontology”, “Journal of Prosthetic Dentistry”, “Journal of Craniofacial Surgery”, “Journal of Cranio-Maxillo-Facial Surgery”, “Journal of Oral and Maxillofacial Surgery”, “Periodontology 2000”, “Oral and Maxillofacial Surgery” and “Oral Surgery Oral Medicine Oral Pathology Oral Radiology”. The manual search also included the bibliographies of all articles selected for full-text screening as well as previously published reviews relevant for the present systematic review. Two reviewers (K.B.Ø. and I.L.S.) independently performed the search. In the event of disagreement, another reviewer was consulted (T.S-J.).

Search strategy for identification of studies

A MEDLINE (PubMed), Embase, Cochrane Library, and Web of Science search was conducted. Human studies published in English through March 19, 2025, were included. The search strategy was performed in collaboration with a librarian and utilized a combination of Medical subject heading (MeSH) and free text terms. A detailed description of the search strategy is presented in Appendices 1, 2, 3, 4, 5.

Grey literature, unpublished literature, and reference list from previously published papers as well as other databases like Scopus, Google Scholar, and ResearchGate were meticulously reviewed for publications fulfilling the inclusions criteria.

Selection of studies

Titles of identified reports were initially screened with duplicates removed. Abstracts were assessed when titles indicated that the study was relevant. Full-text analysis was obtained for those with apparent relevance or when the abstract was unavailable. References of papers identified and previously published systematic reviews assessing TSMEOD were cross-checked for unidentified articles. Study selection was performed by two reviewers (K.B.Ø. and I.L.S.). In the event of disagreement between the reviewers, another reviewer was consulted (T.S-J.). The level of agreement between the reviewers was tested using the Cohen´s kappa coefficient (k).

Inclusion criteria

Studies with at least five patients assessing implant treatment outcome following TSMEOD compared with OMSFE or MSFA applying the lateral window technique were included by addressing the previous described primary and secondary outcome measures. Moreover, the applied surgical technique and observation period after implant placement had to be clearly specified.

Exclusion criteria

Following exclusion criteria were applied: OMSFE performed by piezoelectric surgery or hydraulic pressure, insufficient description of the surgical procedure, and unspecified length of the observation period as well as studies involving medically compromised patients. Letters, editorials, PhD theses, letters to the editor, case reports, abstracts, technical reports, conference proceedings, cadaveric studies, animal or in vitro studies and literature review papers were excluded.

Data extraction

Data were extracted by one reviewer (T.S-J.) according to a data-collection form ensuring systematic recording of the outcome measures. In addition, relevant characteristics of the studies were recorded. Corresponding authors were contacted by e-mail in the absence of important information or ambiguities.

Data items

Following items were collected and arranged in following fields: author, surgical methods, number of patients, alveolar ridge height, applied grafting material, number of inserted implants, duration of surgery, follow-up period after implant placement, survival of suprastructure and implant, ISQ, PIMBL, complications, endo-sinus bone gain, bone density, and patient-reported outcome measures (PROMs).

Quality and risk of bias assessment

Quality assessment was undertaken by one review author (T.S-J.) as part of the data extraction process. Cochrane Collaboration’s tool for assessing the risk of bias suggested in the Cochrane Handbook for Systematic Reviews of Interventions was used for included RCTs (version 5.1.0) [17]. Following items were evaluated:

• Random sequence generation (selection bias);

• Allocation concealment (selection bias);

• Blinding of participants or personnel (performance bias);

• Blinding of outcome assessment (detection bias);

• Incomplete outcome data (attrition bias);

• Selective reporting (reporting bias).

Publications were grouped into the following categories [18]: low risk of bias (possible bias not seriously affecting results) if all criteria were met, high risk of bias (possible bias seriously weakening reliability of results) if one or more criteria were not met, and unclear risk of bias when too few details were available for classification as high or low risk.

The included studies were also assessed according to the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) system for quality of evidence [19].

Statistical analysis

Parametric data involving preoperative alveolar ridge height, duration of surgery, implant survival, ISQ, PIMBL, endo-sinus bone gain, bone density, and PROMs are presented as mean and standard deviation (M [SD]) in the tables. The meta-analysis was performed using a random effect model with Sidik-Jonkman weights. Forest plots and Funnel plots are reported. Eggers test for small study effects was reported in the Funnel plots. Stata 18 (StataCorp LP; College Station, Texas, USA) was used for the analysis.

Assessment of heterogeneity

The significance of any discrepancies in the estimates of the treatment effects of the different studies was assessed by means of Cochran’s test for heterogeneity and the I² statistic, which describes the percentage of total variation across studies that is due to heterogeneity rather than chance. Heterogeneity was considered statistically significant if P < 0.1. A rough guide to the interpretation of I² given in the Cochrane Handbook for Systematic Reviews of Interventions is as follows: (1) at 0 to 40% the heterogeneity might not be important, (2) 30 to 60% may represent moderate heterogeneity, (3) 50 to 90% may represent substantial heterogeneity, and (4) 75 to 100% may represent considerable heterogeneity [17,18].

RESULTS

Study selection

Search results are outlined in Figure 1. Electronic search resulted in 175 entries. Of these articles, 52 were excluded due to being retrieved in more than one search. A total of 18 abstracts were reviewed and full-text analysis included 11 papers. A total of six RCTs were included [20-25], as identified by the search strategy [20,25], or through the hand-searching, grey literature, and reference lists of previous publications [21-24]. The level of agreement between the two authors (K.B.Ø. and I.L.S.) in selecting abstracts and studies to be read in full text were measured at k = 1.0 and k = 1.0, indicating perfect reliability of agreement.

Exclusion of studies

Reasons for excluding five studies after full-text assessment were: conference abstracts (n = 2) [26,27], and an observation period less than six months (n = 3) [28-30].

Characteristics of the studies included

The included studies of the present systematic review consisted of six RCTs [20-25]. TSMEOD was compared with OMSFE in four studies [20-23], and MSFA applying the lateral window technique in two studies [24,25]. Partial edentulous patients in need of an implant-supported fixed restoration in the atrophic posterior maxilla were enrolled in all the included studies [20-25]. Two studies described that they were performed in accordance with CONSORT Guidelines for RCTs [22,25], and one study included the CONSORT flow diagram [20]. A detailed description of the sample size calculation was reported in four studies [20,22,24,25], in which radiographic endo-sinus bone gain [20,22], or pain was chosen as the outcome variable [25], while one study has no description of the outcome variable [24]. Procedure for randomization was reported in four studies [20,22,24,25] using online software Research Randomizer version 4.0 (Urbaniak GC and Plous S - Social Psychology Network; Wesleyan University, Connecticut, USA [www.randomizer.org]) [20,25], (Random.org - Randomness and Integrity Services Ltd.; Dublin, Ireland [www.random.org]) [22,24]. Procedure for allocation concealment was specified in three studies using an external department faculty member who was unaware of the study process [20], or by sealed opaque numbered envelopes [22,25]. Blinding of participants were reported in one study [25]. Age and gender distribution as well as inclusion criteria and exclusion criteria were specified in the included studies [20-25]. The preoperative alveolar ridge height at the implant site was reported in the included studies as evaluated by cone-beam computed tomography (CBCT) measurements [20-25]. The surgical procedure was performed under local anaesthetics by a single qualified surgeon [25], or an unknown number of surgeons and qualifications [20-24]. Duration of surgery was measured from the beginning of the drilling process to the end of implant placement [21], from the beginning of the surgery to the completion of the final suture [24], or from the initial incision to completion of the final suture [25]. A single preoperative prescription of antibiotic was used in one study [25], and postoperative antibiotics were prescribed for five days [21], or seven days [20,25], while information’s about pre- or postoperative antibiotics were not provided in three studies [22-24]. Simultaneous implant placement was performed in the included studies [20-25]. Various implant systems were used including NucleOSS™ T6 standard bone-level implants (Şanlılar Ltd. Şti.; Izmir, Turkey) [20], Dentium^® implant system (Dentium Co., Ltd.; Seoul, South Korea) [21], Spectra-System^® implant system (ScrewPlant - Implant Direct LLC; Malibu Hills, California, USA) [23], or IDCAM ST implant (Implant Diffusion International; Montreuil, France) [25], while three studies did not specify the used implant system [22,24]. A xenograft was used in one study involving Tutobone^® (Tutogen Medical GmbH; Neunkirchen am Brand, Germany), while an alloplastic bone substitute was used in two studies involving Nanobone^® (Artoss, Inc.; Minnesota, USA) [24], or NovaBone Dental Putty^® (Novabone Products LLC; Florida, USA) [25]. The ISQ value was measure at implant placement and abutment connection (six months after implant placement) using Osstell™ ISQ device (Integration Diagnostics AB; Göteborg, Sweden) [20,21,23-25]. The follow-up period after implant placement was six months [20-22,24], or 12 months, including six months of functional implant loading [23]. Prosthetic solution included screw-retained zirconia crowns [25] or was not specified [20-24]. PIMBL was reported in two studies using linear CBCT-scan measurements on the mesial and distal implant surface from the alveolar bone crest to the implant apex [20,23]. Endo-sinus bone gain was measured by radiographic linear measurement on CBCT [22-24]. Bone density changes was assessed on CBCT-scans using Hounsfield units (HU) [20,24]. Postoperative pain response was assessed by pain intensity scale from 0 to 10 (0 = no pain; 1 to 3 = mild pain; 4 to 6 = moderate pain, 7 to 10 = severe pain) [21], or by visual analogue scale from 0 to 10 (no pain to worst pain ever experienced) [25]. Edema was measured by finger pitting on the cheek for 5 seconds and graded from 1 to 4 (1 = slight dipping rapid return to normal; 2 = the dipping returns to normal in few seconds; 3 = 6 mm dipping return to normal in 10 to 20 seconds; 4 = 8 mm dipping return to normal in more than 30 seconds) [21] or self-reported using a 5-point Likert scale (none, little, moderate, intense, and very intense) [25]. PROMs were assessed by Oral Health Impact Profile-14 (OHIP-14) questionnaire, which was filled out daily for a week. Endo-sinus bone gain was assessed by trained and blinded radiologist in two studies [22,23], while no information’s were provided about examiner, training, or calibration in three studies [20,21,24]. Numbers of dropouts including plausible explanation were reported in one study [25].

Data synthesis

Meta-analyses were to be conducted only if there were studies of similar comparison, reporting identical outcome measures. However, the included studies in the present systematic review revealed considerable heterogeneity, and different outcome measures. Meta-analysis (with random effect) was, therefore, solely applicable for ISQ and endo-sinus bone gain.

Methodological quality

The quality of the included studies is summarized in Figure 2. The included studies were characterised by high risk of bias and low grade [20-25].

Outcome measures

Results of TSMEOD compared with OMSFE or MSFA applying the lateral window technique are presented below and outlined in Table 3 and 4. All reported numerical values are presented as mean values with standard deviation. For each outcome measure, a short summary is finally provided including concluding remarks. Survival of suprastructures and technical complications were not reported in any of the included studies. Moreover, PIMBL was not reported following TSMEOD compared with MSFA. These outcomes are, therefore, not presented in the following section or outlined in Table 3 and 4.

Survival of implants

TSMEOD versus OMSFE

Implant survival was 100% following TSMEOD and OMSFE, six months after implant placement (abutment connection) [20,21], and 12 months after implant placement, including six months of functional implant loading [23].

TSMEOD versus MSFA applying the lateral window technique

Implant survival rate was 100% following TSMEOD and MSFA, six months after implant placement (abutment connection) [24], and 12 months after implant placement, including six months of functional implant loading [25].

Summary

No implant loss or failures were reported following TSMEOD as compared with OMSFE or MSFA applying the lateral window technique, in short-term studies.

Duration of surgery

TSMEOD versus OMSFE

Duration of surgery was 7.3 minutes (SD 2.2) following TSMEOD [21]. Corresponding time was 14.5 minutes (SD 1.5) following OMSFE. The difference was statistically significant (P = 0.002) (Table 3) [21].

TSMEOD versus MSFA applying the lateral window technique

Duration of surgery was 30.9 minutes (SD 4.1) following TSMEOD [24]. Corresponding time was 83 minutes (SD 12) following MSFA. The difference was statistically significant (P < 0.05) (Table 4) [24].

Duration of surgery was 32.9 minutes (SD 5.3) following TSMEOD [25]. Corresponding time was 71.1 minutes (SD 10.4) following MSFA. The difference was statistically significant (P < 0.001) (Table 4) [25].

Meta-analysis

Duration of surgery was measured at different time point within the included studies. A meta-analysis was, therefore, not applicable for assessment of duration of surgery.

Summary

Duration of surgery was statistically significant shorter following TSMEOD as compared with OMSFE or MSFA applying the lateral window technique.

Implant stability quotient

TSMEOD versus OMSFE

ISQ at implant placement was 74.2 (SD 3.9), 66.2 (SD 9.6), and 65.2 (SD 4.4) following TSMEOD [20,21,23]. Corresponding ISQ following OMSFE was 68.5 (SD 2.2), 54.8 (SD 7.2), and 52.8 (SD 6.3). The difference was statistically significant (P < 0.001; P = 0.043; P ≤ 0.001) (Table 3) [20,21,23].

ISQ at abutment connection was 87.1 (SD 3.3), 77 (SD 3.5), and 75.9 (SD 2.9) following TSMEOD [20,21,23]. Corresponding ISQ following OMSFE was 80.2 (SD 1.6), 65.2 (SD 3.1), and 67.8 (SD 4.8), respectively. The difference was statistically significant (P < 0.001; P < 0.0001; P ≤ 0.001) (Table 3) [20,21,23].

TSMEOD versus MSFA applying the lateral window technique

ISQ at implant placement was 61.4 (SD 2) and 65.5 (SD 11.1) following TSMEOD [24,25]. Corresponding ISQ following MSFA was 56.9 (SD 2.9) and 61.5 (SD 10.9). The difference was not statistically significant (P > 0.05; P = 0.184) (Table 4) [24,25].

ISQ at abutment connection were 80 (SD 3.1) and 74.4 (SD 4) following TSMEOD [24,25]. Corresponding ISQ following MSFA were 75.9 (SD 2.9) and 69.8 (SD 5.1). The difference was statistically significant in one study (P = 0.046) [25], and not statistically significant in the other (P > 0.05) (Table 4) [24].

Meta-analysis

Meta-analysis revealed an overall mean difference of 9.17 (95% CI = 4.7 to 13.65) and 8.68 (95% CI = 5.8 to 11.56) between TSMEOD and OMSFE. The ISQ value was statistically significant higher at implant placement and abutment connection following TSMEOD compared with OMSFE (Figure 3). Moderate heterogeneity between the studies was found at implant placement (I² = 57.1%, P [Q] = 0.05). Moderate to high heterogeneity was found abutment connection (I² = 58.1%, P [Q] = 0.13) [20,21,23]. Funnel plot did not indicate small-study effects (P-value of Egger’s test = 0.28) (Figure 4).

Meta-analysis revealed an overall mean difference of 4.47 (95% CI = 1.95 to 6.99) and 4.29 (95% CI = 1.81 to 6.77) between TSMEOD and MSFA. The ISQ value was statistically significant higher at implant placement and abutment connection following TSMEOD compared with MSFA applying the lateral window technique (Figure 5). No statistically significant difference in heterogeneity between the included studies was found at implant placement (I² = 0.0%, P [Q] = 0.92), or abutment connection (I² = 0.1%, P [Q] = 0.85) [24,25]. Funnel plot did not indicate small-study effects (P-value of Egger’s test = 0.95) (Figure 6).

Summary

The ISQ value was significant higher at implant placement and at abutment connection following TSMEOD as compared with OMSFE or MSFA applying the lateral window technique.

Peri-implant marginal bone loss

TSMEOD versus OMSFE

The median radiographic PIMBL following TSMEOD was 0.2 mm (range 0 to 0.73), six months after implant placement (abutment connection) [20]. Corresponding PIMBL was 0.4 mm (range 0 to 0.97) following OMSFE. The difference was not statistically significant (P = 0.073) (Table 3) [20].

Radiographic PIMBL following TSMEOD was 0.9 (SD 0.2) mm, 12 months after implant placement including six months of functional implant loading [23]. Corresponding PIMBL was 1 mm (SD 0.2) following OMSFE. The difference was not statistically significant (P = 0.501) (Table 3) [23].

Summary

Comparable PIMBL was reported following TSMEOD compared with OMSFE, in short-term studies.

Surgical and biologic complications

TSMEOD versus OMSFE

Benign paroxysmal positional vertigo was reported in one patient following OMSFE [20].

Edema score using finger pitting was 1.3 (SD 0.5) following TSMEOD [21]. Corresponding score was 2.2 (SD 1) following OMSFE. The difference was not statistically significant (P = 0.118) (Table 3) [21].

Headache and vertigo were reported by none of the patients following TSMEOD, while all patients reported headache and vertigo following OMSFE [22]. The difference was statistically significant (P = 0.002) [22].

Swelling was reported by 40% of the patients following TSMEOD, while 80% reported swelling following OMSFE [22]. The difference was not statistically significant (P = 0.22) [22].

TSMEOD versus MSFA applying the lateral window technique

Schneiderian membrane perforation occurred in 10% of the patients following TSMEOD [25]. Corresponding incidence was 40% following MSFA. The difference was statistically significant (P < 0.001) [25].

Number of days with edema was 0.5 (SD 2.8) following TSMEOD [25]. Corresponding numbers were 7 (SD 2) following MSFA. The difference was statistically significant (P < 0.001) (Table 4) [25].

Epistaxis was reported by none of the patients following TSMEOD, while 40% of the patients reported epistaxis following MSFA [25]. The difference was statistically significant (P < 0.001) [25].

Hematoma was reported by 10% of the patients following TSMEOD, while 30% reported hematoma following MSFA [25]. The difference was statistically significant (P < 0.001) [25].

Summary

Frequency and severity of surgical and biologic complications are diminished following TSMEOD as compared with OMSFE or MSFA applying the lateral window technique.

Endo-sinus bone gain

TSMEOD versus OMSFE

Radiographic endo-sinus bone gain following TSMEOD was 5.8 (SD 0.5) mm, 1.8 (SD 0.4) mm, and 3.3 (SD 0.3) mm, six months after implant placement (abutment connection) [20,22,23]. Corresponding values was 6.9 (SD 0.5) mm, 1.4 (SD 0.5) mm, and 2.8 (SD 0.3) mm following OMSFE. Statistical analysis revealed opposite results between the included studies (P < 0.001, P = 0.21, P ≤ 0.001) (Table 3) [20,22,23].

TSMEOD versus MSFA applying the lateral window technique

Radiographic endo-sinus bone gain following TSMEOD was 5.3 mm (SD 0.8), six months after implant placement (abutment connection) [24]. Corresponding values was 10 mm (SD 1.8) following MSFA. The difference was statistically significant (P < 0.05) (Table 4) [24].

Meta-analysis

Meta-analysis revealed an overall mean difference of -0.31 mm (95% CI = -1.21 to 0.6) in endo-sinus bone gain between TSMEOD and OMSFE, six months after implant placement (abutment connection). The endo-sinus bone gain was comparable without statistically significant difference following TSMEOD compared with OMSFE (Figure 7). No statistically significant difference in heterogeneity between the included studies was found (I² = 92.4%, P [Q] < 0.01) [20,22,23]. Funnel plot did not indicate small-study effects (P-value of Egger’s test = 0.1) (Figure 8).

Summary

Comparable PIMBL was observed following TSMEOD compared with OMSFE, in short-term studies. However, statistically significant diminished endo-sinus bone gain was reported following TSMEOD compared with MSFA applying the lateral window technique.

Bone density

TSMEOD versus OMSFE

The median bone density following TSMEOD increased from 266.4 HU (range 106.6 to 464.4) at implant placement to 660.3 HU (range 350.9 to 740.2), six months after implant placement (abutment connection) [20]. Corresponding HU values were 248.8 HU (range 166.2 to 523.9) and 530.4 HU (444.8 to 890.7) following OMSFE. The difference was not statistically significant (P = 0.754; P = 0.58) (Table 3) [20].

TSMEOD versus MSFA applying the lateral window technique

The bone density following TSMEOD increased from 457.3 HU (SD 69.9) at implant placement to 818.4 HU (SD 109.6), six months after implant placement (abutment connection) [24]. Corresponding HU values were 505.9 (SD 50.4) and 827.1 (SD 109.7) following MSFA. The difference was not statistically significant (P > 0.05) (Table 4) [24].

Summary

Comparable bone density values at implant placement and abutment connection were reported following TSMEOD as compared with OMSFE and MSFA applying the lateral window technique, in short-term studies.

Patient-reported outcome measures

TSMEOD versus OMSFE

Pain intensity scale score was 3 (SD 2.3) following TSMEOD [21]. Corresponding scores was 4.2 (SD 2.3) following OMSFE. The difference was not statistically significant (P = 373) (Table 3) [21].

TSMEOD versus MSFA applying the lateral window technique

Pain experience was statistically significant lower until the third postoperative day following TSMEOD compared with MSFA (P < 0.05) [25]. Number of days with medication usage was 2 (SD 1) following TSMEOD. Corresponding numbers of days were 7.5 (SD 6.5) following MSFA. The difference was statistically significant (P < 0.001) [25].

Postoperative OHIP-14 scores were statistically significant lower, except for day five, following TSMEOD compared with MSFA (P < 0.05) [25]. (Table 3)

Summary

Comparable pain intensity scale score was reported following TSMEOD compared with OMSFE, while TSMEOD was associated with less pain, numbers of days with medication usage, and improved immediate oral-health related quality of life compared with MSFA applying the lateral window technique.

DISCUSSION

The objective of the present systematic review was to test the hypothesis of no difference in implant treatment outcome following TSMEOD compared with OMSFE or MSFA applying the lateral window technique. Six short-term RCTs characterized by high risk of bias and low grade fulfilled the inclusion criteria [20-25]. The primary outcome measure included survival of suprastructures and implants. Survival of suprastructures was not assessed in any of the included studies, and no implant losses were reported [20-25]. The hypothesis could, therefore, not be rejected. Secondary outcome measures were included as supplementary measurements. Meta-analyses disclosed a statistically significant higher ISQ, at implant placement and at abutment connection, following TSMEOD compared with OMSFE and MSFA [20,21,23-25], while no statistically significant difference in endo-sinus bone gain was revealed following TSMEOD compared with OMSFE [20,22,23]. Duration of surgery, frequency of surgical and biologic complications, and number of days using analgesics were diminished following TSMOD compared with OMSFE and MSFA [20-22,24,25]. However, lack of well-designed long-term RCTs related to the focus question posed serious restrictions to review the literature in a quantitative systematic manner. Conclusions provided from the results of this systematic review should, therefore, be interpreted with pronounced caution.

Survival of suprastructures and implants are generally considered as the most important criteria for a successful long-term implant treatment outcome [31]. Survival of suprastructure was not assessed in the included short-term studies of the present systematic review, and no implants were lost [20,21,23-25]. Long-term RCTs assessing survival of suprastructures and implants following TSMEOD compared with OMSFE or MSFA applying the lateral window technique are, therefore, needed before one treatment modality may be considered superior to another.

Duration of surgery, ISQ, complications, PIMBL, endo-sinus bone gain, bone density, and PROMs were included in the present systematic review as secondary outcome measures, because these outcomes may influence the implant treatment outcome as well as patient’s treatment satisfaction.

Duration of surgery was statistically significant shorter following TSMEOD compared with OMSFE or MSFA [21,24,25]. A shorter duration of surgery does not necessarily reflect improved implant treatment outcome or diminish postoperative discomfort, but a shorter duration of surgery may have an impact on patient’s treatment selection if other primary or secondary outcomes are similar. However, prolonged duration of surgery is generally associated with an increased risk of complications and impaired convalescence, as reported in a systematic review [32].

ISQ indicates the level of mechanical stability and osseointegration of the inserted implants. The scale ranges from 1 to 100, with higher values representing greater implant stability. The average ISQ after osseointegration is generally 70 and the acceptable ISQ range lies between 55 and 85 [33]. The included studies of the present systematic review presented ISQ values higher than 55 at implant placement and at abutment connection, indicating sufficient mechanical stability and osseointegration of the inserted implants [20,21,23-25]. Meta-analyses disclosed a statistically significant higher ISQ values following TSMEOD compared with OMSFE or MSFA [20,21,23-25]. However, a higher ISQ value seems not to enhance the short-term implant survival following TSMEOD compared with OMSFE or MSFA. Consequently, a higher ISQ value is not necessarily correlated with a higher implant survival rate if the ISQ value is above 55 at implant placement. ISQ should, therefore, be considered as a supplementary instrument to the clinical and radiographic examination [34]. Thus, future RCTs assessing ISQ at different time points following TSMEOD compared with OMSFE or MSFA are needed to determine if a higher ISQ value at implant placement influences the long-term implant treatment outcome.

PIMBL is commonly used for defining a successful implant treatment outcome [35,36]. A clinical healthy peri-implant tissue is characterized by absence of erythema, bleeding on probing, swelling, and suppuration [37]. In the present systematic review, no statistically significant difference was reported in short-term radiographic PIMBL following TSMEOD compared with OMSFE [20,23]. Clinical and radiographic PIMBL measurements should, therefore, be included in future long-term RCTs assessing TSMEOD compared with OMSFE and MSFA applying the lateral window technique.

Surgical, biological, or technical complications may lead to loss of suprastructure or implant. Surgical complications include Schneiderian membrane perforation, intra- and postoperative bleeding, epistaxis, bruising, swelling, dehiscence, infection, benign paroxysmal positional vertigo, migration of the graft, and sinusitis, while PIMBL, implant loss, oroantral fistula are define as biological complications. Chipping of ceramic, loss of the mounted crown, or loosening of the abutment screw are considered technical complications [38]. The included studies of the present systematic review revealed a statistically significant lower frequency of surgical and biological complications following TSMEOD compared with OMSFE and MSFA [20-22,25]. Benign paroxysmal positional vertigo was reported following OMSFE [20], while no serious complications were reported following TSMEOD. Technical complications were not reported in any of the included studies of the present systematic review [20-25]. Hence, TSMEOD seems to be associated with less surgical and biological complications compared with OMSFE and MSFA applying the lateral window technique.

Endo-sinus bone gain is an important parameter for establishing adequate alveolar ridge height for placement of standard-length implant in the atrophic posterior maxilla. The included studies of the present systematic review reported opposing estimates of endo-sinus bone gain following TSMEOD compared with OMSFE [20,22,23]. However, the meta-analysis revealed no statistically significant difference in endo-sinus bone gain following TSMEOD compared with OMSFE [20,22,23]. The endo-sinus bone gain was statistically significant less following TSMEOD compared with MSFA [24]. Thus, TSMEOD seems to be associated with diminutive endo-sinus bone gain as evaluated in short-term studies.

Bone density measurements represent the amount of inorganic bone mineral. Implant survival and ISQ are anticipated to be improved by higher BD values [39]. Radiographic methods are commonly used to measure bone density at the implant site, including CT-scan (HU) and CBCT-scan (grayscale density). HU is a quantitative scale measuring pixel values, which is proportional to radiodensity. HU values between 300 to 400 and 500 to 1900 represent cancellous and cortical bone, respectively. Grayscale density scale measure voxel values, which are proportional to radiodensity. Grayscale density values of 830 and 1068 in the posterior maxilla represent cancellous and cortical bone, respectively [40]. Although the scales are different, a strong correlation between HU and grayscale density has been reported [41,42]. Bone density was assessed in two studies of the present systematic review disclosing no statistically significant difference at implant placement or at abutment connection following TSMEOD compared with OMSFE and MSFA [20,24]. A higher bone density and ISQ value was reported at abutment connection compared with implant placement, indicating a strong association between bone density and ISQ values [20,24], which is in accordance with previous publications [43,44].

PROMs are valuable parameters to assess patient´s perception of recovery and improvement in oral health-related quality of life following an implant-supported prosthetic rehabilitation. No statistically significant difference in pain intensity scale score was reported following TSMEOD compared with OMSFE [21], while a statistically significant difference in fewer days using analgesics was reported following TSMEOD compared with MSFA [25]. Moreover, statistically significant lower OHIP-14 scores were reported following TSMEOD compared with MSFA, indicating improved oral health-related quality of life following TSMEOD [25]. Consequently, TSMEOD seems to be associated with limited postoperative discomfort and impact on oral health-related quality of life compared with MSFA.

Systematic reviews intend to minimize bias by using PICOS guidelines and reproducible methods to systematically identify, select, and critically appraise relevant research as well as collecting and synthesize data from the included studies. A systematic review combined with a meta-analysis of high-quality, long-term RCTs are considered as highest level of evidence. However, validity of the conclusions relies on the methodological quality and heterogeneity of the included studies. Quality and risk of bias assessment is, therefore, an integral element of the data extraction process. Moreover, studies with low methodological quality and inadequate allocation concealment are associated with increased benefit of the intervention [45]. Investigators, assessors, and participants should, therefore, be unaware of group assignment, as subjective outcomes may be influenced by knowledge of assignment. The strength of evidence from a systematic review and meta-analysis is, therefore, related to the scientific quality of the included studies and independence of various biases. In the present systematic review, quality and risk of bias assessment was conducted by Cochrane Handbook for Systematic of Interventions [17-19], identifying one study characterised by low risk of bias [21], two studies by moderate risk of bias [22], and three studies by high risk of bias [23,25].

The GRADE system is used to rate the certainty of evidence for a treatment efficacy from high to very low [19]. The included studies of the present systematic review were rated as low grade due to lack of allocation concealment and blinding [20-25]. Consequently, the conclusions provided from the results of the present systematic review seems to be inadequate to propose implications for evidence based clinical guidelines according to the focus question of the present systematic review.

CONCLUSIONS

Placement of standard-length implants in conjunction with transcrestal maxillary sinus membrane elevation using osseodensification are associated with equivalent high implant survival compared with osteotome-mediated sinus floor elevation and maxillary sinus floor augmentation, based on short-term randomized controlled trials. Implant stability quotient was statistically significant higher following transcrestal maxillary sinus membrane elevation using osseodensification compared with osteotome-mediated sinus floor elevation and maxillary sinus floor augmentation, at implant placement and abutment connection. Duration of surgery, surgical and biological complications, and numbers of days using analgesics were reduced following transcrestal maxillary sinus membrane elevation using osseodensification. Endo-sinus bone gain was statistically significant less following transcrestal maxillary sinus membrane elevation using osseodensification compared with maxillary sinus floor augmentation, while no statistically significant difference was revealed between transcrestal maxillary sinus membrane elevation using osseodensification and osteotome-mediated sinus floor elevation. However, absence of well-designed long-term randomized controlled trials related to the focus question of the present systematic review posed serious restrictions to review the literature in a quantitative systematic manner. Hence, conclusions drawn from results of this systematic review should be interpreted with pronounced caution and further long-term randomized controlled trials involving larger patient samples, peri-implant marginal bone loss, and endo-sinus bone gain are needed before definite conclusions can be provided.

APPENDIX 1 - 5

ACKNOWLEDGMENTS AND DISCLOSURE STATEMENTS

The authors declare that there are no financial or other conflicts of interest related to this publication. The authors would like to give a special thanks to Ms. Anja Gamskjær Hansen (Medical Library, Aalborg University Hospital, Aalborg, Denmark) for her assistance with the search strategy. There were no sources of funding for this systematic review.

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