OBJECTIVES: To conduct a randomised controlled trial to evaluate the short-term clinical and radiographic efficacy of the NobelActive™ system and to evaluate the relative importance of achieving primary stability at placement. MATERIALS AND METHODS:A total of 32 subjects were recruited and, using a split-mouth design, the NobelActive(TM) implant was compared with a contralaterally matched Brånemark implant. Both implants were placed in a single surgical procedure into healed sites using a one-stage protocol and reviewed at monthly intervals. NobelActive(TM) implants were functionally loaded with provisional restorations at 1 month and all implants were restored with final crowns 3 months post-implant placement. The implant was assessed using peak insertion torque values, resonance frequency analysis (RFA), clinical parameters, digital subtraction radiography, and cone beam computed tomography. RESULTS: The insertion torque was significantly greater for the NobelActive(TM) implant group (P = 0.02), although no observable difference in RFA values were found. Preliminary results of 6 months follow-up suggest comparable clinical and radiographic healing responses between the test and control implants. Within the limits of the sample population, the survival rates were lower with the test implants, although this difference was not statistically significant. CONCLUSIONS: The NobelActive(TM) implant system requires higher insertion torques and can also achieve greater primary stability compared with a control implant system. Short-term survival and marginal bone levels of NobelActive(TM) and control implants are comparable, although the NobelActive(TM) implant system appeared to be more technique-sensitive.
RCT Entities:
OBJECTIVES: To conduct a randomised controlled trial to evaluate the short-term clinical and radiographic efficacy of the NobelActive™ system and to evaluate the relative importance of achieving primary stability at placement. MATERIALS AND METHODS: A total of 32 subjects were recruited and, using a split-mouth design, the NobelActive(TM) implant was compared with a contralaterally matched Brånemark implant. Both implants were placed in a single surgical procedure into healed sites using a one-stage protocol and reviewed at monthly intervals. NobelActive(TM) implants were functionally loaded with provisional restorations at 1 month and all implants were restored with final crowns 3 months post-implant placement. The implant was assessed using peak insertion torque values, resonance frequency analysis (RFA), clinical parameters, digital subtraction radiography, and cone beam computed tomography. RESULTS: The insertion torque was significantly greater for the NobelActive(TM) implant group (P = 0.02), although no observable difference in RFA values were found. Preliminary results of 6 months follow-up suggest comparable clinical and radiographic healing responses between the test and control implants. Within the limits of the sample population, the survival rates were lower with the test implants, although this difference was not statistically significant. CONCLUSIONS: The NobelActive(TM) implant system requires higher insertion torques and can also achieve greater primary stability compared with a control implant system. Short-term survival and marginal bone levels of NobelActive(TM) and control implants are comparable, although the NobelActive(TM) implant system appeared to be more technique-sensitive.
Authors: M Herrero-Climent; P López-Jarana; B F Lemos; F J Gil; C Falcão; J V Ríos-Santos; B Ríos-Carrasco Journal: Materials (Basel) Date: 2020-04-18 Impact factor: 3.623
Authors: Oliver Blume; Eva Maria Schnödt; Michael Back; Jan Ir Wildenhof; Florian A Probst; Sven Otto Journal: Medicina (Kaunas) Date: 2020-10-27 Impact factor: 2.430