Assessment of a novel electrochemically deposited smart bioactive trabecular coating (SBTC®): a randomized controlled clinical trial.

OBJECTIVES: A randomized controlled clinical trial of dental implants was conducted to compare the clinical properties of a novel electrochemically deposited calcium phosphate coating to those of a common marketed surface treatment. MATERIAL AND METHODS: Forty implants of the same brand and type were placed in 20 fully edentulous participants requiring mandibular implantation. The two study groups were defined by the surface treatment of the implants. 20 implants in the control group were coated via a commercial electrochemical surface treatment that forms a mixture of brushite and hydroxyapatite, while the remaining 20 in the test group were coated with a novel electrochemical Smart Bioactive Trabecular Coating (SBTC®). A split-mouth design was employed, with each participants receiving one control implant in one mandibular side and a test implant in the other. To mitigate potential operator-handedness bias, control and test implants were randomly assigned to mandibular sides. All cases underwent digital planning, implant placement with a static surgical guide, and participants received locator-anchored full-arch dentures. The primary outcome was implant stability (measured using Osstell ISQ) assessed at insertion, loading, and then 3 months, 9 months, and 2 years post-insertion. The secondary outcome was bone level change (in millimeters) over the 2-year observation period. Oral health-related quality of life (OHRQL) was monitored using the OHIP-14 questionnaire. Complications and adverse events were recorded. RESULTS: Successful osseointegration and implant stability were achieved in all cases, allowing loading. ISQ values steadily increased throughout the observation period. While no significant differences were observed between the SBTC® and control coatings, the test group exhibited a higher ISQ gain. Bone resorption was somewhat lower in the SBTC® but not significantly so. Patients' OHRQL significantly improved after denture delivery and remained stable throughout the follow-up. No complications or adverse events were observed. CONCLUSIONS: Based on the study results, we conclude that the new surface treatment is a safe alternative to the widely used control surface, demonstrating similar osseointegrative properties and time-dependent bone level changes. Further research may explore the broader implications of these findings. TRIAL REGISTRATION: The study is registered on clinicaltrials.gov under the identifier ID: NCT06034171.

Guidance means accuracy: A randomized clinical trial on freehand versus guided dental implantation.

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.