Multicenter Clinical Evaluation (FOCUS) of a Fluoride Modified Dental Implant

Evaluation of routine clinical effectiveness of dental implant procedures and devices is critical to understanding their clinical performance. Objective: Multicenter clinical outcomes evaluations are needed to measure effectiveness of care in clinical practice. Methods: 104 international clinics in 14 countries were recruited to enroll a minimum of 5 subjects needing a minimum of two dental implants to restore a partially edentulous quadrant with an early load one-stage approach. A centralized web-based data management system was developed to coordinate recording of outcomes over a 36 month period. Results: 634 patients have been recruited with a uniform gender distribution (55% female), median age 57 (range 18-88), 20% reported smoking > 1 pk/day. 1860 implants (Microthread OsseoSpeed™ Astra Tech AB) were placed with majority having 2-4 implants (range 1-8 implants/patient), 80% placed with a one-stage approach, 20% having osseous grafting prior to or coincident with implant placement. 95% were reported to have primary stability, distribution of implants in maxilla (1171 or 63%) was 377 anterior and 794 posterior with mandible (689) having 120 in anterior and 569 posterior. Median edentulous period was 24 months (range 0-480mo). 84% of the implants were 11-15 mm in length placed in bone Quantity of A-C (88%), bone Quality 2-3 (79%). Recall examination indicated 4% surfaces had signs of inflammation (BOP) with plaque present on 12% of sites. 21 patients have lost a total of 25 implants (15 maxilla and 10 in mandible) for a CISR of 98.7% from placement. Non-implant related complications (4%) were associated with prosthetic issues. Conclusions: In an ongoing 104 site multicenter evaluation of clinical effectiveness of a fluoride modified dental implant, fixture OsseoSpeed™, outcome results suggest favorable outcomes in routine practice. Supported by Astra Tech AB, Mölndal Sweden.