Abstract
Background The objective of this retrospective descriptive study was to analyze the characteristics of incident reports provided by dentists while using a specific brand of dental implants. Material and Methods The study was carried out in collaboration with Oxtein Iberia S.L.®, with the company providing access to the incident database in order to evaluate the characteristics of incidents from January 2014 to December 2017 (a total of 917 over four years). The data sheet recorded different variables during each of the stages of implant treatment, from initial implant placement to subsequent prosthetic rehabilitation. These variables included age, sex, systemic pathologies, smoking habits, bone quality, implant type, prosthesis type, and type of load applied, among others. SPSS Statistics was used to perform statistical analysis of the qualitative variables (univariate logistic regressions, χ2 test, Haberman's adjusted standardized residuals). Results The total study sample consisted of 44,415 implants shipped from Oxtein® warehouses on the dates indicated, of which 917 implants (2.1%) were flagged due to reports of lack of primary stability, failed osseointegration, or implant failure within one year of placement. When analyzing incident reports, it was observed that 61.6% of incidents occurred in male patients, compared to 38.4% in female patients. The average age of patients in the reported cases was 56.12 ± 12.15 years. A statistically significant correlation was discovered between incidents of implant failure and tobacco use, diabetes, heart disease, poor oral hygiene, previous infection, poor bone quality, and bruxism (p < 0.05). A (statistically significant) higher rate of incidents was also observed in tapered, internal connection, Grade IV titanium, narrow, and short implants. Conclusions Analysis of these implants reveals a higher rate of complication in short, tapered, internal connection and narrow-diameter implants. These data can help and encourage clinicians to use the utmost surgical precautions when placing these implants. Key words:Pharmacovigilance, Dental implant, Dental implant failure.
Highlights
Oral rehabilitation with dental implants has been described as a predictable alternative treatment with a success rate higher than 90% [1] to other alternatives for prosthetic treatment
Incident reports of implant failure can be considered as a powerful tool for descriptive analysis of the factors that most frequently appear in cases of implant treatment failure
The present study observed the highest percentage of implant failure incident reports in the age range of 51–60 (30.1%) and 60–70 (29.7%)
Summary
Oral rehabilitation with dental implants has been described as a predictable alternative treatment with a success rate higher than 90% [1] to other alternatives for prosthetic treatment (fixed dental prosthesis, removable prosthesis). The recent Regulation [4] 2017/745 has increased product safety through a new post-marketing oversight scheme that requires manufacturers to document and maintain a monitoring system of products after placing them on the market, using a plan that reflects risk level and product type This obliges manufacturers to periodically report the results and conclusions of their analyses throughout the lifetime of the product. The data sheet recorded different variables during each of the stages of implant treatment, from initial implant placement to subsequent prosthetic rehabilitation These variables included age, sex, systemic pathologies, smoking habits, bone quality, implant type, prosthesis type, and type of load applied, among others. Conclusions: Analysis of these implants reveals a higher rate of complication in short, tapered, internal connection and narrow-diameter implants These data can help and encourage clinicians to use the utmost surgical precautions when placing these implants
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