An Assessment of the Risk of Bias in Randomized Controlled Trial Reports Published in Prosthodontic and Implant Dentistry Journals

PURPOSE The objective of this study was to assess the risk of bias of randomized controlled trials (RCTs) published in prosthodontic and implant dentistry journals. MATERIALS AND METHODS The last 30 issues of 9 journals in the field of prosthodontic and implant dentistry (Clinical Implant Dentistry and Related Research, Clinical Oral Implants Research, Implant Dentistry, International Journal of Oral & Maxillofacial Implants, International Journal of Periodontics and Restorative Dentistry, International Journal of Prosthodontics, Journal of Dentistry, Journal of Oral Rehabilitation, and Journal of Prosthetic Dentistry) were hand-searched for RCTs. Risk of bias was assessed using the Cochrane Collaboration's risk of bias tool and analyzed descriptively. RESULTS From the 3,667 articles screened, a total of 147 RCTs were identified and included. The number of published RCTs increased with time. The overall distribution of a high risk of bias assessment varied across the domains of the Cochrane risk of bias tool: 8% for random sequence generation, 18% for allocation concealment, 41% for masking, 47% for blinding of outcome assessment, 7% for incomplete outcome data, 12% for selective reporting, and 41% for other biases. CONCLUSION The distribution of high risk of bias for RCTs published in the selected prosthodontic and implant dentistry journals varied among journals and ranged from 8% to 47%, which can be considered as substantial.

Publication of statistically significant research findings in prosthodontics & implant dentistry in the context of other dental specialties

OBJECTIVES To assess the hypothesis that there is excessive reporting of statistically significant studies published in prosthodontic and implantology journals, which could indicate selective publication. METHODS The last 30 issues of 9 journals in prosthodontics and implant dentistry were hand-searched for articles with statistical analyses. The percentages of significant and non-significant results were tabulated by parameter of interest. Univariable/multivariable logistic regression analyses were applied to identify possible predictors of reporting statistically significance findings. The results of this study were compared with similar studies in dentistry with random-effects meta-analyses. RESULTS From the 2323 included studies 71% of them reported statistically significant results, with the significant results ranging from 47% to 86%. Multivariable modeling identified that geographical area and involvement of statistician were predictors of statistically significant results. Compared to interventional studies, the odds that in vitro and observational studies would report statistically significant results was increased by 1.20 times (OR: 2.20, 95% CI: 1.66-2.92) and 0.35 times (OR: 1.35, 95% CI: 1.05-1.73), respectively. The probability of statistically significant results from randomized controlled trials was significantly lower compared to various study designs (difference: 30%, 95% CI: 11-49%). Likewise the probability of statistically significant results in prosthodontics and implant dentistry was lower compared to other dental specialties, but this result did not reach statistical significant (P>0.05). CONCLUSIONS The majority of studies identified in the fields of prosthodontics and implant dentistry presented statistically significant results. The same trend existed in publications of other specialties in dentistry.

Modifying Post-Operative Medical Care after EBV Implant May Reduce Pneumothorax Incidence.

OBJECTIVE Endoscopic lung volume reduction (ELVR) with valves has been shown to improve COPD patients with severe emphysema. However, a major complication is pneumothoraces, occurring typically soon after valve implantation, with severe consequences if not managed promptly. Based on the knowledge that strain activity is related to a higher risk of pneumothoraces, we asked whether modifying post-operative medical care with the inclusion of strict short-term limitation of strain activity is associated with a lower incidence of pneumothorax. METHODS Seventy-two (72) emphysematous patients without collateral ventilation were treated with bronchial valves and included in the study. Thirty-two (32) patients received standard post-implantation medical management (Standard Medical Care (SMC)), and 40 patients received a modified medical care that included an additional bed rest for 48 hours and cough suppression, as needed (Modified Medical Care (MMC)). RESULTS The baseline characteristics were similar for the two groups, except there were more males in the SMC cohort. Overall, ten pneumothoraces occurred up to four days after ELVR, eight pneumothoraces in the SMC, and only two in the MMC cohorts (p=0.02). Complicated pneumothoraces and pneumothoraces after upper lobe treatment were significantly lower in MMC (p=0.02). Major clinical outcomes showed no significant differences between the two cohorts. CONCLUSIONS In conclusion, modifying post-operative medical care to include bed rest for 48 hours after ELVR and cough suppression, if needed, might reduce the incidence of pneumothoraces. Prospective randomized studies with larger numbers of well-matched patients are needed to confirm the data.

Accuracy of conventional radiography and computed tomography in predicting implant position in relation to the vertebral canal in dogs.

OBJECTIVE To compare the accuracy of radiography and computed tomography (CT) in predicting implant position in relation to the vertebral canal in the cervical and thoracolumbar vertebral column. STUDY DESIGN In vitro imaging and anatomic study. ANIMALS Medium-sized canine cadaver vertebral columns (n=12). METHODS Steinmann pins were inserted into cervical and thoracolumbar vertebrae based on established landmarks but without predetermination of vertebral canal violation. Radiographs and CT images were obtained and evaluated by 6 individuals. A random subset of pins was evaluated for ability to distinguish left from right pins on radiographs. The ability to correctly identify vertebral canal penetration for all pins was assessed both on radiographs and CT. Spines were then anatomically prepared and visual examination of pin penetration into the canal served as the gold standard. RESULTS Left/right accuracy was 93.1%. Overall sensitivity of radiographs and CT to detect vertebral canal penetration by an implant were significantly different and estimated as 50.7% and 93.4%, respectively (P<.0001). Sensitivity was significantly higher for complete versus partial penetration and for radiologists compared with nonradiologists for both imaging modalities. Overall specificity of radiographs and CT to detect vertebral canal penetration was 82.9% and 86.4%, respectively (P=.049). CONCLUSIONS CT was superior to radiographic assessment and is the recommended imaging modality to assess penetration into the vertebral canal. CLINICAL RELEVANCE CT is significantly more accurate in identifying vertebral canal violation by Steinmann pins and should be performed postoperatively to assess implant position.

Influence of prosthesis type and retention mechanism on complications with fixed implant-supported prostheses: a systematic review applying multivariate analyses

PURPOSE To identify the influence of fixed prosthesis type on biologic and technical complication rates in the context of screw versus cement retention. Furthermore, a multivariate analysis was conducted to determine which factors, when considered together, influence the complication and failure rates of fixed implant-supported prostheses. MATERIALS AND METHODS Electronic searches of MEDLINE (PubMed), EMBASE, and the Cochrane Library were conducted. Selected inclusion and exclusion criteria were used to limit the search. Data were analyzed statistically with simple and multivariate random-effects Poisson regressions. RESULTS Seventy-three articles qualified for inclusion in the study. Screw-retained prostheses showed a tendency toward and significantly more technical complications than cemented prostheses with single crowns and fixed partial prostheses, respectively. Resin chipping and ceramic veneer chipping had high mean event rates, at 10.04 and 8.95 per 100 years, respectively, for full-arch screwed prostheses. For "all fixed prostheses" (prosthesis type not reported or not known), significantly fewer biologic and technical complications were seen with screw retention. Multivariate analysis revealed a significantly greater incidence of technical complications with cemented prostheses. Full-arch prostheses, cantilevered prostheses, and "all fixed prostheses" had significantly higher complication rates than single crowns. A significantly greater incidence of technical and biologic complications was seen with cemented prostheses. CONCLUSION Screw-retained fixed partial prostheses demonstrated a significantly higher rate of technical complications and screw-retained full-arch prostheses demonstrated a notably high rate of veneer chipping. When "all fixed prostheses" were considered, significantly higher rates of technical and biologic complications were seen for cement-retained prostheses. Multivariate Poisson regression analysis failed to show a significant difference between screw- and cement-retained prostheses with respect to the incidence of failure but demonstrated a higher rate of technical and biologic complications for cement-retained prostheses. The incidence of technical complications was more dependent upon prosthesis and retention type than prosthesis or abutment material.

Stiffness, Strength, and Failure Modes of Implant-Supported Monolithic Lithium Disilicate Crowns: Influence of Titanium and Zirconia Abutments

PURPOSE The objective of this study was to evaluate stiffness, strength, and failure modes of monolithic crowns produced using computer-aided design/computer-assisted manufacture, which are connected to diverse titanium and zirconia abutments on an implant system with tapered, internal connections. MATERIALS AND METHODS Twenty monolithic lithium disilicate (LS2) crowns were constructed and loaded on bone level-type implants in a universal testing machine under quasistatic conditions according to DIN ISO 14801. Comparative analysis included a 2 × 2 format: prefabricated titanium abutments using proprietary bonding bases (group A) vs nonproprietary bonding bases (group B), and customized zirconia abutments using proprietary Straumann CARES (group C) vs nonproprietary Astra Atlantis (group D) material. Stiffness and strength were assessed and calculated statistically with the Wilcoxon rank sum test. Cross-sections of each tested group were inspected microscopically. RESULTS Loaded LS2 crowns, implants, and abutment screws in all tested specimens (groups A, B, C, and D) did not show any visible fractures. For an analysis of titanium abutments (groups A and B), stiffness and strength showed equally high stability. In contrast, proprietary and nonproprietary customized zirconia abutments exhibited statistically significant differences with a mean strength of 366 N (Astra) and 541 N (CARES) (P < .05); as well as a mean stiffness of 884 N/mm (Astra) and 1,751 N/mm (CARES) (P < .05), respectively. Microscopic cross-sections revealed cracks in all zirconia abutments (groups C and D) below the implant shoulder. CONCLUSION Depending on the abutment design, prefabricated titanium abutment and proprietary customized zirconia implant-abutment connections in conjunction with monolithic LS2 crowns had the best results in this laboratory investigation.

Time-Efficiency Analysis Comparing Digital and Conventional Workflows for Implant Crowns: A Prospective Clinical Crossover Trial

PURPOSE To compare time-efficiency in the production of implant crowns using a digital workflow versus the conventional pathway. MATERIALS AND METHODS This prospective clinical study used a crossover design that included 20 study participants receiving single-tooth replacements in posterior sites. Each patient received a customized titanium abutment plus a computer-aided design/computer-assisted manufacture (CAD/CAM) zirconia suprastructure (for those in the test group, using digital workflow) and a standardized titanium abutment plus a porcelain-fused-to-metal crown (for those in the control group, using a conventional pathway). The start of the implant prosthetic treatment was established as the baseline. Time-efficiency analysis was defined as the primary outcome, and was measured for every single clinical and laboratory work step in minutes. Statistical analysis was calculated with the Wilcoxon rank sum test. RESULTS All crowns could be provided within two clinical appointments, independent of the manufacturing process. The mean total production time, as the sum of clinical plus laboratory work steps, was significantly different. The mean ± standard deviation (SD) time was 185.4 ± 17.9 minutes for the digital workflow process and 223.0 ± 26.2 minutes for the conventional pathway (P = .0001). Therefore, digital processing for overall treatment was 16% faster. Detailed analysis for the clinical treatment revealed a significantly reduced mean ± SD chair time of 27.3 ± 3.4 minutes for the test group compared with 33.2 ± 4.9 minutes for the control group (P = .0001). Similar results were found for the mean laboratory work time, with a significant decrease of 158.1 ± 17.2 minutes for the test group vs 189.8 ± 25.3 minutes for the control group (P = .0001). CONCLUSION Only a few studies have investigated efficiency parameters of digital workflows compared with conventional pathways in implant dental medicine. This investigation shows that the digital workflow seems to be more time-efficient than the established conventional production pathway for fixed implant-supported crowns. Both clinical chair time and laboratory manufacturing steps could be effectively shortened with the digital process of intraoral scanning plus CAD/CAM technology.

Digital vs. conventional implant prosthetic workflows: a cost/time analysis.

OBJECTIVES The aim of this prospective cohort trial was to perform a cost/time analysis for implant-supported single-unit reconstructions in the digital workflow compared to the conventional pathway. MATERIALS AND METHODS A total of 20 patients were included for rehabilitation with 2 × 20 implant crowns in a crossover study design and treated consecutively each with customized titanium abutments plus CAD/CAM-zirconia-suprastructures (test: digital) and with standardized titanium abutments plus PFM-crowns (control conventional). Starting with prosthetic treatment, analysis was estimated for clinical and laboratory work steps including measure of costs in Swiss Francs (CHF), productivity rates and cost minimization for first-line therapy. Statistical calculations were performed with Wilcoxon signed-rank test. RESULTS Both protocols worked successfully for all test and control reconstructions. Direct treatment costs were significantly lower for the digital workflow 1815.35 CHF compared to the conventional pathway 2119.65 CHF [P = 0.0004]. For subprocess evaluation, total laboratory costs were calculated as 941.95 CHF for the test group and 1245.65 CHF for the control group, respectively [P = 0.003]. The clinical dental productivity rate amounted to 29.64 CHF/min (digital) and 24.37 CHF/min (conventional) [P = 0.002]. Overall, cost minimization analysis exhibited an 18% cost reduction within the digital process. CONCLUSION The digital workflow was more efficient than the established conventional pathway for implant-supported crowns in this investigation.

Influence of Abutment Design on Stiffness, Strength, and Failure of Implant-Supported Monolithic Resin Nano Ceramic (RNC) Crowns

BACKGROUND Recent technical development allows the digital manufacturing of monolithic reconstructions with high-performance materials. For implant-supported crowns, the fixation requires an abutment design onto which the reconstruction can be bonded. PURPOSE The aim of this laboratory investigation was to analyze stiffness, strength, and failure modes of implant-supported, computer-assisted design and computer-aided manufacturing (CAD/CAM)-generated resin nano ceramic (RNC) crowns bonded to three different titanium abutments. MATERIALS AND METHODS Eighteen monolithic RNC crowns were produced and loaded in a universal testing machine under quasi-static condition according to DIN ISO 14801. With regard to the type of titanium abutment, three groups were defined: (1) prefabricated cementable standard; (2) CAD/CAM-constructed individualized; and (3) novel prefabricated bonding base. Stiffness and strength were measured and analyzed statistically with Wilcoxon rank sum test. Sections of the specimens were examined microscopically. RESULTS Stiffness demonstrated high stability for all specimens loaded in the physiological loading range with means and standard deviations of 1,579 ± 120 N/mm (group A), 1,733 ± 89 N/mm (group B), and 1,704 ± 162 N/mm (group C). Mean strength of the novel prefabricated bonding base (group C) was 17% lower than of the two other groups. Plastic deformations were detectable for all implant-abutment crown connections. CONCLUSIONS Monolithic implant crowns made of RNC seem to represent a feasible and stable prosthetic construction under laboratory testing conditions with strength higher than the average occlusal force, independent of the different abutment designs used in this investigation.

Retrievability of implant-supported crowns when using three different cements: a controlled clinical trial

PURPOSE The purpose of this study was to analyze the removal of implant-supported crowns retained by three different cements using an air-accelerated crown remover and to evaluate the patients' response to the procedure. MATERIALS AND METHODS This controlled clinical trial was conducted with 21 patients (10 women, 11 men; mean age: 51 ± 10.2 years) who had received a total of 74 implants (all placed in the posterior zone of the mandible). Four months after implant surgery, the crowns were cemented on standard titanium abutments of different heights. Three different cements (two temporary: Harvard TEMP and Improv; and one definitive: Durelon) were used and randomly assigned to the patients. Eight months later, one blinded investigator removed all crowns. The number of activations of the instrument (CORONAflex, KaVo) required for crown removal was recorded. The patients completed a questionnaire retrospectively to determine the impact of the procedure and to gauge their subjective perception. A linear regression model and descriptive statistics were used for data analysis. RESULTS All crowns could be retrieved without any technical complications or damage. Both abutment height (P = .019) and cement type (P = .004) had a significant effect on the number of activations, but the type of cement was more important. An increased total number of activations had no or only a weak correlation to the patients' perception of concussion, noise, pain, and unwillingness to use the device. CONCLUSIONS Cemented implant crowns can be removed, and the application of an air-accelerated device is a practicable method. A type of cement with appropriate retention force has to be selected. The impact on the patients' subjective perception should be taken into account.

Complications with computer-aided designed/computer-assisted manufactured titanium and soldered gold bars for mandibular implant-overdentures: short-term observations

BACKGROUND Implant-overdentures supported by rigid bars provide stability in the edentulous atrophic mandible. However, fractures of solder joints and matrices, and loosening of screws and matrices were observed with soldered gold bars (G-bars). Computer-aided designed/computer-assisted manufactured (CAD/CAM) titanium bars (Ti-bars) may reduce technical complications due to enhanced material quality. PURPOSE To compare prosthetic-technical maintenance service of mandibular implant-overdentures supported by CAD/CAM Ti-bar and soldered G-bar. MATERIALS AND METHODS Edentulous patients were consecutively admitted for implant-prosthodontic treatment with a maxillary complete denture and a mandibular implant-overdenture connected to a rigid G-bar or Ti-bar. Maintenance service and problems with the implant-retention device complex and the prosthesis were recorded during minimally 3-4 years. Annual peri-implant crestal bone level changes (ΔBIC) were radiographically assessed. RESULTS Data of 213 edentulous patients (mean age 68 ± 10 years), who had received a total of 477 tapered implants, were available. Ti-bar and G-bar comprised 101 and 112 patients with 231 and 246 implants, respectively. Ti-bar mostly exhibited distal bar extensions (96%) compared to 34% of G-bar (p < .001). Fracture rate of bars extensions (4.7% vs 14.8%, p < .001) and matrices (1% vs 13%, p < .001) was lower for Ti-bar. Matrices activation was required 2.4× less often in Ti-bar. ΔBIC remained stable for both groups. CONCLUSIONS Implant overdentures supported by soldered gold bars or milled CAD/CAM Ti-bars are a successful treatment modality but require regular maintenance service. These short-term observations support the hypothesis that CAD/CAM Ti-bars reduce technical complications. Fracture location indicated that the titanium thickness around the screw-access hole should be increased.

Management of a complication with a fractured zirconia implant abutment in the esthetic zone

Technical complications in implant prosthetic cases represent a major challenge in dentistry. This case report describes minimally invasive management to recover an implant with a fractured remnant of a zirconia abutment, including provisional rehabilitation during a sequential treatment protocol in the esthetic zone. A patient was treated with a screw-retained one-piece implant-supported reconstruction made of a customized zirconia abutment with direct ceramic veneering in the maxillary right central incisor position. During the prosthetic try-in, a fracture in the apical portion of the abutment was evident. The first rescue attempt led to fracture of the retrieval instrument. Immediately, an individualized wired construction was applied to bond the existing fractured reconstruction to the neighboring teeth to maintain the peri-implant mucosal architecture. Because the implant screw canal was blocked, a customized round bur had to be manufactured and was placed in the implant axis with a specific bracket tool from the service set to protect the interior implant threads. Then, the drills of the service set were guided by the newly created access to remove the fractured remnants. The implant screw was retapped and the area rinsed with chlorhexidine solution. All remnants were removed without the need for surgical intervention. Neither the implant connection nor the bone-to-implant interface was damaged. The stepwise treatment approach with the customized round bur combined with the system-specific drills of the service set saved the blocked implant so that the patient could be successfully rehabilitated with a new implant reconstruction.

Peri-implant bone loss of dental implants with platform-switching design after 5 years of loading: a cross-sectional study

OBJECTIVE The aim of this cross-sectional study was to estimate bone loss of implants with platform-switching design and analyze possible risk indicators after 5 years of loading in a multi-centered private practice network. METHOD AND MATERIALS Peri-implant bone loss was measured radiographically as the distance from the implant shoulder to the mesial and distal alveolar crest, respectively. Risk factor analysis for marginal bone loss included type of implant prosthetic treatment concept and dental status of the opposite arch. RESULTS A total of 316 implants in 98 study patients after 5 years of loading were examined. The overall mean value for radiographic bone loss was 1.02 mm (SD ± 1.25 mm, 95% CI 0.90- 1.14). Correlation analyses indicated a strong association of peri-implant bone loss > 2 mm for removable implant-retained prostheses with an odds ratio of 53.8. CONCLUSION The 5-year-results of the study show clinically acceptable values of mean bone loss after 5 years of loading. Implant-supported removable prostheses seem to be a strong co-factor for extensive bone level changes compared to fixed reconstructions. However, these results have to be considered for evaluation of the included special cohort under private dental office conditions.

In Vitro Implant Impression Accuracy Using a New Photopolymerizing SDR Splinting Material

PURPOSE The study aims to evaluate three-dimensionally (3D) the accuracy of implant impressions using a new resin splinting material, "Smart Dentin Replacement" (SDR). MATERIALS AND METHODS A titanium model of an edentulous mandible with six implant analogues was used as a master model and its dimensions measured with a coordinate measuring machine. Before the total 60 impressions were taken (open tray, screw-retained abutments, vinyl polysiloxane), they were divided in four groups: A (test): copings pick-up splinted with dental floss and fotopolymerizing SDR; B (test): see A, additionally sectioned and splinted again with SDR; C (control): copings pick-up splinted with dental floss and autopolymerizing Duralay® (Reliance Dental Mfg. Co., Alsip, IL, USA) acrylic resin; and D (control): see C, additionally sectioned and splinted again with Duralay. The impressions were measured directly with an optomechanical coordinate measuring machine and analyzed with a computer-aided design (CAD) geometric modeling software. The Wilcoxon matched-pair signed-rank test was used to compare groups. RESULTS While there was no difference (p = .430) between the mean 3D deviations of the test groups A (17.5 μm) and B (17.4 μm), they both showed statistically significant differences (p < .003) compared with both control groups (C 25.0 μm, D 19.1 μm). CONCLUSIONS Conventional impression techniques for edentulous jaws with multiple implants are highly accurate using the new fotopolymerizing splinting material SDR. Sectioning and rejoining of the SDR splinting had no impact on the impression accuracy.

CAD/CAM fabrication accuracy of long- vs. short-span implant-supported FDPs

OBJECTIVE To compare the precision of fit of long-span vs. short-span implant-supported screw-retained fixed dental prostheses (FDPs) made from computer-aided-design/computer-aided-manufactured (CAD/CAM) titanium and veneered with ceramic. The null hypothesis was that there is no difference in the vertical microgap between long-span and short-span FDPs. MATERIALS AND METHODS CAD/CAM titanium frameworks for an implant-supported maxillary FDP on implants with a flat platform were fabricated on one single master cast. Group A consisted of six 10-unit FDPs connected to six implants (FDI positions 15, 13, 11, 21, 23, 25) and group B of six 5-unit FDPs (three implants, FDI positions 21, 23, 25). The CAD/CAM system from Biodenta Swiss AG (Berneck, Switzerland) was used for digitizing (laser scanner) the master cast and anatomical CAD of each framework separately. The frameworks were milled (CAM) from a titanium grade V monobloc and veneered with porcelain. Median vertical distance between implant and FDP platforms from the non-tightened implants (one-screw test on implant 25) was calculated from mesial, buccal, and distal scanning electron microscope measurements. RESULTS All measurements showed values <40 μm. Total median vertical microgaps were 23 μm (range 2-38 μm) for group A and 7 μm (4-24 μm) for group B. The difference between the groups was statistically significant at implant 21 (P = 0.002; 97.5% CI -27.3 to -4.9) and insignificant at implant 23 (P = 0.093; -3.9 to 1.0). CONCLUSIONS CAD/CAM fabrication including laboratory scanning and porcelain firing was highly precise and reproducible for all long- and short-span FDPs. While all FDPs showed clinically acceptable values, the short-span FDPs were statistically more precise at the 5-unit span distance.