Clinical Trial
Journal Article
Multicenter Study
Research Support, Non-U.S. Gov't
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Evaluation of a variable-thread tapered implant in extraction sites with immediate temporization: a 3-year multicenter clinical study.

BACKGROUND: The purpose of this clinical study is to evaluate the radiographic bone remodeling, survival rate, and soft tissue health surrounding a variable-thread tapered implant immediately placed in extraction sites.

METHODS: Sixty implants were placed in 55 patients at six centers according to a predetermined protocol. All implants were placed in extraction sockets and were subjected to immediate temporization and function. Definitive prostheses (58 single crowns and one two-unit fixed bridge) were placed within the first year. Clinical and radiographic examinations were performed at implant placement and after 3, 6, 12, 24, and 36 months. Measurements of implant stability, papilla index, plaque, peri-implant mucosa, and marginal bone levels were recorded at each visit.

RESULTS: Thirty-five implants were evaluated at both implant insertion and 3-year follow-up. Bone levels were observed at 6 months after surgery and yearly intervals thereafter and remained stable throughout the study. There was a slight decrease in mean bone level from -0.68 mm at implant insertion to -0.93 mm at the 6-month recall and then an increase of bone to -0.53 mm from the reference point at the 2-year follow-up (an average increase of 0.15 mm from implant insertion). Bone levels remained steady between the 2-year recall and the 3-year recall. Papilla scores increased significantly (P <0.001; Wilcoxon signed-rank test) from insertion to the 3-year follow-up, with most of the increase occurring during the first year. Patient assessments of function, esthetics, feel of implant, speech, and self-esteem also showed significant improvement over the course of the study.

CONCLUSIONS: The results, over 36 months, indicate that the variable-thread tapered implant can be used safely and effectively under demanding conditions as an immediate postextraction tooth replacement. Bone remodeling remained stable with a slight increase, and patients expressed high levels of satisfaction with the restorative results over the course of the study.

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