Objectives: To obtain objective data of bone conduction implant stability and osseointegration in children; to compare in pediatric subjects the stability and osseointegration of the novel TiOblast-coated implant system (BI300) to the previous generation, as-machined model.
Study design: Multicenter, controlled, nonrandomized, longitudinal, prospective study.
Setting: Tertiary referral center.
Level of evidence: IIIb
Patients: Ten subjects were enrolled, aged younger than 16 years and without comorbidities that negatively affect osseointegration. All patients were implanted "single stage": 5 received the previous generation, pure titanium fixture (control group), and 5 were implanted the BI300, TiOblast-coated fixture (test group).
Interventions: Measurement of implant stability and osseointegration.
Main outcome measure(s): Implant stability and osseointegration as measured by means of resonance frequency analysis intraoperatively, at 1 week, 2 weeks, 1 month, and every month till processor loading 6 months after surgery.
Results: BI300 is, on average, more stable than the control fixture, both intraoperatively and over time till processor loading. Over the 6 months' follow-up, a stability increase was observed with both models, although it resulted statistically not significant.
Conclusion: The BI300 implant system has a greater primary stability as compared with the previous generation model, but its faster osseointegration could not be definitely verified. It is reasonable to assume that the BI300 fixture will enable surgeons to perform single-stage surgery more safely and with a lower failure rate. The possibility of an earlier processor loading remains to be confirmed in a greater sample.