Evaluation of the Effectiveness of Dental Implant Therapy in a Practice-Based Network (FOCUS)

Purpose: Evaluations of multicenter clinical trials are needed to determine the effectiveness of care in routine implant therapy in clinical practice. Materials and Methods: Ninety-two clinicians in 75 clinics in 13 countries recruited five subjects per clinic who were in need of a minimum of two dental implants to restore a partially edentulous quadrant and were followed for a minimum of 1 year after loading. A centralized Internet-based case report form was developed to coordinate data recording. Data entry was done by each clinic, with follow-up source verification. Results: The study recruited 549 subjects in 101 clinics with 1,893 implants placed. Three hundred forty subjects completed the 1-year recall (gender distribution of 56% female, 44% male; mean age of 57 years with a range of 18 to 84 years). In all, 1,246 dental implants were followed; a majority of subjects had two to four implants. Twenty-eight percent of subjects received osseous grafting prior to or coincident with implant placement. In the maxilla, 779 (63%) implants were placed, 256 in the anterior and 523 in the posterior; in the mandible, 467 implants were placed, 85 in the anterior and 382 in the posterior arch. The median edentulous period prior to implant placement was 24 months (range, 0 to 480 months); 46% of all patients received implants within 12 months of tooth loss. At 1 year after prosthesis insertion, 15 subjects had lost a total of 17 implants, for a cumulative implant survival rate of 98.6%. Chi-square and Fisher exact tests indicated a higher risk of implant loss at sites with advanced resorption and for wider-diameter implants (5-mm tapered body). There was no statistical relationship with implant loss relative to implant length or anatomic location within the oral cavity. Conclusions: The outcomes support the need for ongoing involvement of clinicians in routine practice assessments of patient-based outcomes of implant therapy. Palabras clave: clinical trial, effectiveness trial, outcomes, risk factors, trial design