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

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Multicenter Clinical Evaluation (FOCUS) of a Fluoride Modified Dental Implant
C.M. STANFORD1, W. WAGNER2, R.R.Y. BAENA3, M. NORTON4, E. MCGLUMPHY5, T. BERGLUNDH6, J. SCHMIDT7, B. DELIN8, and P. ASPLUND8, 1 University of Iowa, Iowa City, USA, 2 Universitats-zahnklinik Mainz, Germany, 3 University of Pavia, Italy, 4 Marquette University, London, United Kingdom, 5 Ohio State University, Columbus, USA, 6 Goteborgs Universitet, Sweden, 7 private practice, Waukesha, WI, USA, 8 Astra Tech AB, Goteborg, Sweden
2005
IADR
Evaluation of routine clinical effectiveness of dental implant procedures and devices is critical to understanding their performance in general practice. Objective: Multicenter clinical outcomes evaluation of a fluoride modified dental implant system (fixture Microthread; OsseoSpeedĒ—¢ Astra Tech AB,) in clinical practice. Methods: 80 international clinics are recruiting 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 60 month period. A steering committee was developed to monitor and evaluate the study. Results: Data is reported for the initial 12 month outcomes. 367 patients were recruited with a uniform gender distribution (170 male, 197 female). 18% reported smoking > 1 pack/day. 1354 implants 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. 50% of the sites (688/1354) were edentulous < 20 months. 88% of the implants were 11-15 mm in length placed in bone Quantity of A-C (87%), bone Quality 2-3 (81%). Recall examination indicated 5% surfaces had signs of inflammation (BOP) with plaque present on 13% of sites. One implant failure has been reported (99.9% CSR). Non-implant related complications (4%) were associated with prosthetic issues. Conclusions: In an ongoing 80 site multicenter evaluation of clinical effectiveness of a fluoride modified dental implant, fixture Microthread Ē—¢ OsseoSpeedĒ—¢, outcome results suggest favorable outcomes in routine practice. Supported by Astra Tech AB, M??lndal Sweden.