Objectives: A randomized clinical trial was conducted to compare all three known static guided surgery protocols (pilot, partial, and full) with each other and with freehand surgery in terms of accuracy, under the same conditions.
Material and Methods:A total of 207 implants of the same brand and type were placed in 101 partially edentulous volunteers in need of implantation in the mandible or maxilla or both. All cases were digitally planned, and the comparison of the planned and actual implant positions was performed using a medical image analysis software with dedicated algorithms. The primary outcome variable was angular deviation (AD, degrees). The secondary outcome variables were coronal global deviation (CGD, mm), apical global deviation (AGD, mm), and voxel overlap (VO, %).Results: AD showed stepwise improvement in significant steps as the amount of guidance increased. The highest mean AD (7.03° ± 3.44) was obtained by freehand surgery and the lowest by fully guided surgery (3.04° ± 1.51). As for the secondary outcome variables, all guided protocols turned out to be significantly superior to freehand surgery, but they were not always significantly different from each other.
Conclusions:As for the comparison that this study sought to perform, it can be said that the static guided approach significantly improves the accuracy of dental implant surgery as compared to freehand surgery. Furthermore, the results suggest that any degree of guidance yields better results than freehand surgery and that increasing the level of guidance increases accuracy.
K E Y W O R D Scomputer-assisted surgery, dental implants, oral surgical procedures, prosthodontics, randomized controlled trial This is an open access article under the terms of the Creative Commons Attribution-NonCommercial License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited and is not used for commercial purposes.
BackgroundVerapamil is traditionally applied prophylactically in transradial procedures to prevent radial artery spasm. However, verapamil may have side effects and is contraindicated in some clinical settings.Methods and ResultsDuring an investigator‐initiated, randomized, double‐blind trial, we evaluated the need for preventive verapamil administration. After vascular access was established, patients received either 5 mg verapamil (n=297) or placebo (n=294). We compared the rate of access site conversions as primary end point using a superiority margin of 5%. Occurrence of code breaks (composite of conversions and unplanned use of verapamil), overall verapamil use, procedural and fluoroscopic times, contrast volume, and subjective pain were investigated as secondary end points. The rate of access site conversions was not different in the 2 arms (placebo 1.7% versus verapamil 0.7%, P=0.28, difference 1.0%, 95% CI for the difference −1.1% to 3.3%). Proportion of code breaks was similar in the 2 groups (3.4% versus 1.3%, P=0.11), whereas overall verapamil use was markedly lower in the placebo arm (2.0% versus 100%, P<0.0001). Procedural time (median [IQR] 16.0 minutes [9.0 to 30.0 minutes] versus 17.0 minutes [10.0 to 31.0 minutes], P=0.37), fluoroscopic time (4.4 minutes [2.1 to 9.6 minutes] versus 4.8 minutes [2.4 to 10.7 minutes], P=0.28), contrast volume (72.5 mL [48.0 to 146.0 mL] versus 75.5 mL [47.0 to 156.5 mL], P=0.74), and pain score (P for trend=0.12) were comparable in the 2 groups.ConclusionsThe preventive use of verapamil may be unnecessary for transradial procedures. The omission of prophylactic verapamil may not only reduce the rate of potential complications related to the drug but also allow the safe extension of the transradial method to those with contraindications to verapamil.Clinical Trial RegistrationURL: http://www.clinicaltrials.gov. Unique identifier: NCT01402427.
These data demonstrate the effectiveness of GPC therapies and provide indirect evidence that the anti-inflammatory effects of PC could be linked to a reaction involving the polar part of the molecule.
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