TY - JOUR
T1 - Randomized controlled trial comparing a variable-thread novel tapered and a standard tapered implant
T2 - Interim one-year results
AU - Kielbassa, Andrej M.
AU - Fuentes, Rafael Martinez de
AU - Goldstein, Moshe
AU - Arnhart, Christoph
AU - Barlattani, Alberto
AU - Jackowski, Jochen
AU - Knauf, Marko
AU - Lorenzoni, Martin
AU - Maiorana, Carlo
AU - Mericske-Stern, Regina
AU - Rompen, Eric
AU - Sanz, Mariano
PY - 2009/5
Y1 - 2009/5
N2 - Statement of problem: A tapered implant with continuously changing threads purported to provide stable tissue support and allow immediate function has been developed. Treatment success and stabilization of supporting tissues over time require documentation. Purpose: The purpose of this prospective, randomized, controlled, multicenter study was to evaluate changes in bone level and soft tissue behavior between the novel implant (NobelActive/NA) and a standard tapered implant (NobelReplace Tapered Groovy/NR) with regard to immediate function. Material and Methods: A total of 177 patients randomly allocated to 3 treatment groups (2 different test implant groups: NA Internal (n=117; internal connection) and External (n=82), and 1 standard treatment group, NR (n=126)) received 325 implants. Implants were placed into healed sites, and all but 6 implants were immediately nonocclusally loaded. Clinical and radiographic evaluations of treatment success, crestal bone levels, and soft tissue changes were performed at the time of placement and after 3, 6, and 12 months. Log-Rank test was used to analyze the differences in survival rate. Marginal bone level was compared using the Kruskal-Wallis test and Mann-Whitney U-test (α=.05). Results: One-year cumulative survival rates were comparable (96.6% for NA Internal; 96.3% for NA External; 97.6% for NR; P=.852; Log-Rank). Mean (SD) change in bone level was -0.95 mm (1.37) for NA Internal, -0.64 mm (0.97) for NA External, and -0.63 mm (1.18) for NR (P=.589; Kruskal-Wallis). Stable soft tissues and significantly increased papilla scores (P
AB - Statement of problem: A tapered implant with continuously changing threads purported to provide stable tissue support and allow immediate function has been developed. Treatment success and stabilization of supporting tissues over time require documentation. Purpose: The purpose of this prospective, randomized, controlled, multicenter study was to evaluate changes in bone level and soft tissue behavior between the novel implant (NobelActive/NA) and a standard tapered implant (NobelReplace Tapered Groovy/NR) with regard to immediate function. Material and Methods: A total of 177 patients randomly allocated to 3 treatment groups (2 different test implant groups: NA Internal (n=117; internal connection) and External (n=82), and 1 standard treatment group, NR (n=126)) received 325 implants. Implants were placed into healed sites, and all but 6 implants were immediately nonocclusally loaded. Clinical and radiographic evaluations of treatment success, crestal bone levels, and soft tissue changes were performed at the time of placement and after 3, 6, and 12 months. Log-Rank test was used to analyze the differences in survival rate. Marginal bone level was compared using the Kruskal-Wallis test and Mann-Whitney U-test (α=.05). Results: One-year cumulative survival rates were comparable (96.6% for NA Internal; 96.3% for NA External; 97.6% for NR; P=.852; Log-Rank). Mean (SD) change in bone level was -0.95 mm (1.37) for NA Internal, -0.64 mm (0.97) for NA External, and -0.63 mm (1.18) for NR (P=.589; Kruskal-Wallis). Stable soft tissues and significantly increased papilla scores (P
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U2 - 10.1016/S0022-3913(09)60060-3
DO - 10.1016/S0022-3913(09)60060-3
M3 - Article
C2 - 19410064
AN - SCOPUS:65449157280
VL - 101
SP - 293
EP - 305
JO - Journal of Prosthetic Dentistry
JF - Journal of Prosthetic Dentistry
SN - 0022-3913
IS - 5
ER -