BACKGROUND: Comparatively few studies with at least 5 years of follow-up are available that describe the use of implants in prosthetic rehabilitation of partially edentulous patients. Randomized, controlled clinical studies that evaluated the effect of different surface designs of screw-shaped implants on the outcome of treatment are also sparse. OBJECTIVE: To determine, in a prospective randomized, controlled clinical trial, the outcome of restorative therapy in periodontitis-susceptible patients who, following basic periodontal therapy, had been restored with implants with either a machined- or a rough-surface topography. MATERIAL AND METHODS:Fifty-one subjects (mean age, 59.5 years), 20 males and 31 females who, following treatment of moderate-to-advanced chronic periodontitis, required implant therapy for prosthetic rehabilitation were recruited. Seventeen of the patients were current smokers. Following the active treatment, all subjects were included in an individually designed maintenance program. A total of 56 fixed partial dentures (FPDs) and a total of 149 screw-shaped, and self-tapping implants (Astra Tech implants) -- 83 in the maxilla and 66 in the mandible -- were installed in a two-stage procedure. Each patient received a minimum of two implants and by randomization every second implant that was installed had been designed with a machined surface and the remaining with a roughened Tioblast surface. Abutment connection was performed 3-6 months after implant installation. Clinical and radiographical examinations were performed following FPD connection and once a year during a 5-year follow-up period. The analysis of peri-implant bone-level alterations was performed on subject, FPD and implant levels. RESULTS: Four patients and four FPDs were lost to the 5 years of monitoring. One implant (machined surface) did not properly integrate (early failure), and was removed at the time of abutment connection. Three implants were lost during function and a further eight implants could not be accounted for at the 5-year follow-up examination. The overall failure rate at 5 years was 5.9% (subject level), 5.3% (FPD level) and 2.7% (implant level). Radiographic signs of loss of osseointegration were not found at any of the implants during the 5-year observation period. During the first year in function there was on average 0.33 (SD, 0.61) mm loss of peri-implant marginal bone on the subject and FPD levels and 0.31 (0.81) mm on the implant level. During the subsequent 4 years, the peri-implant bone-level alterations were small. The calculated annual change in peri-implant bone level was -0.02 (0.15) on subject and FPD levels and -0.03 (0.20) on the implant level. Thus, the mean total bone-level change over the 5-year interval amounted to 0.41 mm on all three levels of analysis. In the interval between baseline and 5 years, the machined and the Tioblast implants lost on average 0.33 and 0.48 mm, respectively (p>0.05). CONCLUSION: The present randomized, controlled clinical trial that included partially edentulous periodontitis-susceptible subjects demonstrated that bone loss (i) during the first year of function as well as annually thereafter was small and (ii) did not vary between implants with machined- or rough-surface designs.
RCT Entities:
BACKGROUND: Comparatively few studies with at least 5 years of follow-up are available that describe the use of implants in prosthetic rehabilitation of partially edentulouspatients. Randomized, controlled clinical studies that evaluated the effect of different surface designs of screw-shaped implants on the outcome of treatment are also sparse. OBJECTIVE: To determine, in a prospective randomized, controlled clinical trial, the outcome of restorative therapy in periodontitis-susceptible patients who, following basic periodontal therapy, had been restored with implants with either a machined- or a rough-surface topography. MATERIAL AND METHODS: Fifty-one subjects (mean age, 59.5 years), 20 males and 31 females who, following treatment of moderate-to-advanced chronic periodontitis, required implant therapy for prosthetic rehabilitation were recruited. Seventeen of the patients were current smokers. Following the active treatment, all subjects were included in an individually designed maintenance program. A total of 56 fixed partial dentures (FPDs) and a total of 149 screw-shaped, and self-tapping implants (Astra Tech implants) -- 83 in the maxilla and 66 in the mandible -- were installed in a two-stage procedure. Each patient received a minimum of two implants and by randomization every second implant that was installed had been designed with a machined surface and the remaining with a roughened Tioblast surface. Abutment connection was performed 3-6 months after implant installation. Clinical and radiographical examinations were performed following FPD connection and once a year during a 5-year follow-up period. The analysis of peri-implant bone-level alterations was performed on subject, FPD and implant levels. RESULTS: Four patients and four FPDs were lost to the 5 years of monitoring. One implant (machined surface) did not properly integrate (early failure), and was removed at the time of abutment connection. Three implants were lost during function and a further eight implants could not be accounted for at the 5-year follow-up examination. The overall failure rate at 5 years was 5.9% (subject level), 5.3% (FPD level) and 2.7% (implant level). Radiographic signs of loss of osseointegration were not found at any of the implants during the 5-year observation period. During the first year in function there was on average 0.33 (SD, 0.61) mm loss of peri-implant marginal bone on the subject and FPD levels and 0.31 (0.81) mm on the implant level. During the subsequent 4 years, the peri-implant bone-level alterations were small. The calculated annual change in peri-implant bone level was -0.02 (0.15) on subject and FPD levels and -0.03 (0.20) on the implant level. Thus, the mean total bone-level change over the 5-year interval amounted to 0.41 mm on all three levels of analysis. In the interval between baseline and 5 years, the machined and the Tioblast implants lost on average 0.33 and 0.48 mm, respectively (p>0.05). CONCLUSION: The present randomized, controlled clinical trial that included partially edentulous periodontitis-susceptible subjects demonstrated that bone loss (i) during the first year of function as well as annually thereafter was small and (ii) did not vary between implants with machined- or rough-surface designs.