RESUMO
PURPOSE: Clinicians often do not have the benefit of adequate safety or clinical data when evaluating the merit of either newly marketed implant devices or novel clinical procedures. This has been the case for dental implants following the initial documentation of their safety and efficacy and is demonstrated in the evolution of immediate load application. Following demonstration of safety and successful application of an implant in an animal study prior to its market release, this report provides the clinical outcomes for the first 100 Ti-Unite implants provided to 24 patients in a clinical practice over 9 years. MATERIALS AND METHODS: An electronic record/clinical database review of consecutive early loaded implants from a multiple surgeon/single prosthodontist practice was conducted for quality assurance. Data extraction of standard exposure and outcome variables was accomplished by a trained individual not affiliated with the clinical practice. RESULTS: The results revealed one failure before and none following definitive restoration with a variety of prostheses. The mean length of time from immediate to definitive restorations was 5.3 ± 1.1 months for crowns, 3.9 ± 1.3 months for fixed partial dentures, and 7.8 ± 4.1 months for mandibular "hybrid" prostheses. The most common unexpected findings during the initial three postinsertion visits were lost access restoration and cement failure. CONCLUSIONS: Pre-market animal data regarding the safety and success of a new implant used with an early loading protocol was replicated in the clinical results of the first 100 implants used in practice. Additionally, the clinical results are favorable when compared to conventional loading protocols from this same practice and provide helpful comparative metrics (delayed vs immediate loading) to use when discussing implant treatment with patients.