RESUMO
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.
Assuntos
Implantes Dentários , Boca Edêntula , Humanos , Implantação Dentária Endóssea/métodos , Qualidade de Vida , Osseointegração , Resultado do Tratamento , Prótese Dentária Fixada por Implante/métodos , Planejamento de Prótese DentáriaRESUMO
Our objective was to assess the literature regarding the accuracy of the different static guided systems. After applying electronic literature search we found 661 articles. After reviewing 139 articles, the authors chose 52 articles for full-text evaluation. 24 studies involved accuracy measurements. Fourteen of our selected references were clinical and ten of them were in vitro (modell or cadaver). Variance-analysis (Tukey's post-hoc test; p < 0.05) was conducted to summarize the selected publications. Regarding 2819 results the average mean error at the entry point was 0.98 mm. At the level of the apex the average deviation was 1.29 mm while the mean of the angular deviation was 3,96 degrees. Significant difference could be observed between the two methods of implant placement (partially and fully guided sequence) in terms of deviation at the entry point, apex and angular deviation. Different levels of quality and quantity of evidence were available for assessing the accuracy of the different computer-assisted implant placement. The rapidly evolving field of digital dentistry and the new developments will further improve the accuracy of guided implant placement. In the interest of being able to draw dependable conclusions and for the further evaluation of the parameters used for accuracy measurements, randomized, controlled single or multi-centered clinical trials are necessary.