To compare the clinical performance of two sandblasted, large-grit, acid-etched implant surfaces regarding changes in radiographic marginal bone level (MBL) 12 months after loading.
In this randomized, split-mouth, dual-center clinical trial, each patient received one test (modified hydrophilic surface) implant and one control (conventional surface) implant. The primary endpoint was the change in MBL measured 12 months after loading. Secondary outcomes included the assessment of soft tissue wound healing index (WHI), adverse events, implant stability quotient (ISQ), peri-implant soft tissue parameters (probing pocket depth, bleeding on probing, keratinized mucosa width), and oral health–related quality of life (OHRQoL) measured with the Oral Health Impact Profile-14 (OHIP-14). Generalized linear models, paired Student's t-tests, and Wilcoxon tests were employed for data analysis.
The study included 68 subjects (136 implants). No statistically significant differences were found between groups for any of the clinical outcomes measured. The mean change in MBL from loading to 12 months was 0.04 mm (SD = 0.39) for the modified hydrophilic implants and 0.07 mm (SD = 0.22) for the conventional implants (p = 0.658), with no significant differences between the groups.
Over a 12-month period of functional loading, both implant surfaces demonstrated comparable performance regarding peri-implant bone stability, safety, and clinical outcomes. Although a small but statistically significant difference between groups was observed in MBL changes from baseline to 12 months (MD = 0.15 mm), no significant differences were found in MBL changes from loading to 12 months (primary outcome), ISQ, soft tissue healing, or peri-implant health.
The study aims to investigate the effect of using the collagen membrane with symphyseal onlay blocks for horizontal augmentation of atrophic maxillary alveolar ridges versus uncovered symphyseal onlay blocks.
30 patients were randomly and equally allocated into test and control groups. The cortical block was fixed, and an equal mixture of xenograft and autograft particulates was placed to obliterate the gaps. Collagen membranes were used to cover the augmented sites in the test group, whereas they were not used in the control group. Bone thickness was measured at 2 and 5 mm from the crest at 6 months postoperative; bone biopsies were harvested for histomorphometric analysis.
The mean horizontal bone gain for the test group at 2 and 5 mm (5.18 ± 0.87 and 5.51 ± 0.83 mm, respectively) was significantly higher than the control group (4.05 ± 0.50 and 4.60 ± 0.69 mm, respectively). The mean graft resorption in the control group was (2.06 ± 0.43 and 1.03 ± 0.50) at 2 and 5 mm, respectively, and both were significantly higher than the test group (1.23 ± 0.46 and 0.74 ± 0.33). The mean bone area percent and the residual graft percent were higher in the test group (58.94% and 14.18%, respectively) than in the control group (43.18% and 3.97%, respectively), p < 0.001. Also, the mature bone percent in the test group (70.85%) was higher than the control group (48.37%), p < 0.001; both differences were statistically significant.
Collagen membranes' coverage of symphyseal onlay bone blocks resulted in superior bone quality and quantity for the augmented sites.
ClinicalTrials.gov identifier: NCT04462575
To compare the clinical and radiographic outcomes of crestal sinus floor elevation (SFE) using a digital surgical guide (DSG) and hydraulic sinus lift technique versus the conventional osteotome technique.
Patients requiring crestal SFE and single-implant placement in the posterior maxilla with a minimum of 5 mm of residual bone height were included and randomly assigned to two groups of crestal SFE with (i) the conventional technique (elevation of a mucoperiosteal flap and SFE by the osteotome technique, control group) and (ii) by using a DSG (without flap elevation, by using the sinus lift hydraulic system in the presence of a DSG, test group). Frequency of intraoperative membrane perforation, surgical time, and patient-reported outcomes were collected. Crestal bone loss at 6 months, new bone formation in the sinus, and implant position were assessed.
Twenty-three patients (24 implants, 12 in each group) were included. The DSG group experienced significantly lower postoperative pain (measured by the number of analgesics taken, 1.67 ± 0.77 vs. 2.75 ± 1.21, p = 0.028), shorter surgical time (22.3 ± 2.4 vs. 33.1 ± 4.1 min, p < 0.001), and smaller deviation of implant angulation from the ideal position (2.9° ± 0.6° vs. 8.6° ± 1.3°, p < 0.001) compared to the conventional group. The difference in other parameters was not significant.
Considering the study limitations, using a DSG with a hydraulic system for crestal SFE was superior to the conventional technique regarding pain score, surgical time, and implant angulation. Due to the relatively small sample size and lack of statistically significant differences in some parameters, these findings should be interpreted with caution.
Iranian Registry of Clinical Trials: IRCT20230529058333N1
To compare microbiological and immunological parameters of two sandblasted, large-grit, acid-etched implant surfaces during the first 8 weeks of healing following implant placement.
A dual-center, split-mouth, randomized controlled clinical trial was conducted on patients receiving one test (modified hydrophilic surface) and one control (conventional surface) implant in different quadrants. Peri-implant crevicular fluid samples were collected at implant placement and at 1, 2, 4, and 8 weeks to assess biomarkers of inflammation (Interleukin [IL]-1β, IL-6, Tumor Necrosis Factor-α, IL-2), biomarkers of anti-inflammation (IL-4, IL-10), and biomarkers of bone metabolism (osteocalcin, osteopontin [OPN], and vascular endothelial growth factor-α [VEGF-α]). Additionally, submucosal samples were obtained at implant placement and at 1, 2, and 4 weeks and analyzed using quantitative polymerase chain reaction (qPCR) and 16S rRNA sequencing. Biomarkers and qPCR data were analyzed with a general linear model using log10-transformed values. Microbiome data were analyzed via Wilcoxon tests and PERMANOVA.
Sixty patients were included in the 8-week analysis. VEGF-α levels were significantly higher at 1 week for the conventional surface (p = 0.018). OPN and IL-10 significantly increased from baseline to 4 weeks in both groups. Porphyromonas gingivalis and Fusobacterium species were the most prevalent bacteria; however, no significant differences were found between the surfaces in bacterial load analysis by qPCR. Additionally, no significant differences were observed between groups for microbiome diversity.
No differences were detected between the conventional and the modified hydrophilic surfaces in the immunological and microbiological parameters assessed during early implant healing.
With the global increase in the volume of digital health data recorded and accessible through national and institutional databases, such as clinical registries and evidence-based registries, new strategic approaches are now feasible in medical research. These approaches include the registry-based clinical trial (RBCT) design, where large-scale datasets—which grow exponentially over time (referred to as big data)—can be used to identify eligible study participants from a medical registry containing trial-specific inclusion criteria. The RBCT approach may also be used to establish historical control groups for prospective interventional studies that enable rapid recruitment with a lower study budget, while providing high statistical power. Hence, obstacles frequently encountered when conducting randomized controlled trials, such as difficulties in recruiting a sufficient sample size in a reasonable time period, may be overcome for specific research questions. This innovative study design of an RBCT aims to combine the external validity of medical registries with the internal validity of the traditional study designs, and has the potential to influence clinical decision making and healthcare policy. The aim of this perspective article is to describe this new methodological approach and to critically analyze the future possibilities and challenges of RBCTs in dental and implant research.
This study aimed to evaluate the long-term outcomes of two prospective cohorts of edentulous individuals treated with single implant mandibular overdentures (SIMO) opposed by a conventional maxillary complete denture.
A total of 74 participants, treated between 2013 and 2016 at the School of Dentistry of the Federal University of Goiás, Brazil, were included. A single midline implant was placed in the edentulous mandible; 93.2% of implants were immediately loaded, and outcomes were followed for 8–10 years. Data collected included dental patient-reported outcomes (dPROs), implant survival, implant stability, peri-implant health, and incidence of prosthodontic events. The frequency of the prosthetic maintenance and complication events was reported in terms of cumulative incidence. Within-group longitudinal changes were tested using paired comparison tests. A significance level of p < 0.05 was used for statistical inferences.
Significant improvements in OHIP-Edent and satisfaction scores were observed immediately post-treatment and maintained throughout the follow-up period, confirming a significant positive effect of SIMO on these outcomes (p < 0.001). The overall implant survival rate was 95.6%. Peri-implant outcomes showed favorable health status, with mild bone loss observed (−1.55 ± 1.09 mm at the 8–10-year follow-up). Prosthetic complications and the need for recall visits for maintenance were common. The most frequent prosthetic complications were matrix replacement (43.3%) and overdenture fracture (12.4%).
SIMO demonstrated sustained long-term effectiveness with regular clinical monitoring and frequent maintenance. For most patients, the positive initial outcomes continued for up to 10 years, suggesting SIMO particularly benefits older patients with financial constraints.
To evaluate the effect of lipid nanoparticle (LNP)-encapsulated N1-methylpseudouridine-modified mRNA encoding BMP-2 (BMP-2 mRNA-LNP) on enhancing osseointegration and bone regeneration around titanium implants in rat femur defects.
A total of 48 rat femurs were examined in this study. BMP-2 mRNA-LNP (5 μg and 15 μg), recombinant human BMP-2 protein (4 μg), or dPBS (control) were randomly injected in a single dose into distal rat femurs (n = 6). Titanium wires were implanted, and bone formation was evaluated at 3 and 6 weeks post treatment using micro-computed tomography, histology, and immunohistochemistry analysis. Data were analyzed using the Kruskal-Wallis test, followed by the Dunn-Bonferroni test and the Wilcoxon signed-rank test with 95% confidence intervals (CIs). p-values < 0.05 were considered statistically significant.
Micro-computed tomography analysis of bone volume, bone volume fraction, trabecular number, trabecular thickness, and bone-to-implant contact at both time points indicated a trend toward greater bone formation in the mRNA groups compared to the other groups. Significant differences were observed between the 15 μg BMP-2 mRNA-LNP group and the dPBS group at 6 weeks (p < 0.05). The 15 μg BMP-2 mRNA-LNP group also exhibited the most intense positive bone sialoprotein and osteocalcin staining compared to the other groups at 3 weeks and 6 weeks, respectively. Interestingly, histomorphometry at 6 weeks revealed a significantly higher bone area around the implants in both 5 μg and 15 μg BMP-2 mRNA-LNP groups compared to the rhBMP-2 and dPBS groups.
This preclinical study highlights the potential of BMP-2 mRNA-LNP for promoting bone regeneration around dental implants.
To evaluate the use and osseointegration of dental implants in combination with 3D-printed hydroxyapatite (3DHA) blocks featuring gyroid porosity for large mandibular bone augmentation.
Mandibular lateral bone augmentation with gyroid-3DHA blocks was performed bilaterally on four female Göttingen minipigs. After 8 or 12 weeks of healing, a dental implant was placed into each 3DHA block. Following an additional 12-week healing period, the augmented sites (including 3DHA blocks and dental implants) were harvested for histological and histomorphometric analysis, assessing new bone formation, 3DHA integration, total bone gain, and bone-to-implant contact (BIC).
Gyroid-3DHA blocks were easily fixated with screws. Dental implants were placed through the 3DHA blocks with a standard drilling procedure, and good primary stability was achieved. 3DHA blocks demonstrated good osseointegration with 39.17% of new bone and a significant bone gain of 4.73 mm on average. Dental implants showed comparable BIC within the 3DHA and into the native bone (42.79% vs. 34.17%). No significant difference was found between the healing periods.
This is the first study to evaluate a 3D-printed bone substitute in combination with a dental implant in an animal study. Gyroid-3DHA blocks and dental implants demonstrated good osseointegration, and the bone augmentation was significant, making it a promising material for large and complex alveolar ridge augmentations.
This randomized clinical trial aimed to evaluate implant stability following graftless lateral window and crestal implant approaches for maxillary sinus floor elevation (MSFE) 1 year after implant placement.
Twenty-six single missing posterior maxillary teeth indicated for delayed implant placement, with a residual ridge height of 4–6 mm, were randomly assigned to perform either graftless lateral window (control) or crestal implant (test) approaches for MSFE. Implant stability was assessed using resonance frequency analysis; intra-sinus vertical bone gain and marginal bone loss were measured via CBCT 1 year after implant placement. Clinical parameters and patient-reported outcomes were also measured.
The reported implant stability quotient (ISQ) values were not significantly different between the lateral window and the crestal implant approaches (80.92 ± 4.57 and 80.19 ± 7.28, respectively) 12 months after implant placement. However, the lateral window approach revealed a significant increase (p < 0.001) in the mean ± SD intra-sinus vertical bone gain at 6 and 12 months (3.64 ± 0.84 mm and 3.82 ± 0.84 mm, respectively) compared to the crestal implant approach (1.66 ± 1.27 mm and 2.42 ± 1.39 mm, respectively). However, no intergroup significant difference was noticed concerning average marginal bone loss (p = 0.31) after 12 months. Postoperative complications and patient discomfort were more evident in the lateral window approach group.
In patients with a residual ridge height of 4–6 mm receiving implant therapy in conjunction with maxillary sinus elevation without graft material, there was no statistically significant difference in implant stability at 12 months between a lateral window and transcrestal sinus approach. Greater vertical bone gain was achieved following the lateral window approach.
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