PURPOSE: To test the hypothesis that there is no difference in clinical, radiographic and aesthetic outcomes positioning single post-extractive ultra-wide 7 mm-diameter implants or waiting 4 months to place implant, after molar extraction and the socket preservation procedure. MATERIAL AND METHODS:Patients requiring one implant-supported single restoration to replace a failed tooth in the molar region of both maxilla and mandible were selected. Patients were randomised according to a parallel group design into two arms: implant installation in fresh extraction sockets augmented with corticocancellous heterologous bone and porcine derma (group A) or delayed implant installation 4 months after tooth extraction and socket preservation using the same materials (group B). Ultra-wide 7 mm-diameter implants were submerged for 4 months. Outcome measures were implant success and survival; complications; horizontal dimensional changes measured on cone beam computed tomography (CBCT) scans at three levels, localised 1, 2 and 3 mm below the most coronal aspect of the bone crest (level A, B and C); peri-implant marginal bone level changes; implant stability quotient (ISQ); and pink esthetic score (PES). RESULTS: Twelve patients were randomised to group A and 12 to group B. No patients dropped out. No implant failed or complications occurred up to 6-months post-loading. Six months after loading there was more horizontal alveolar bone reduction at immediate post-extractive implants, which was statistically significant. At level A was 1.78 mm ± 1.30 in group A, 0.45 mm ± 0.42 in group B, (difference 1.33 mm ± 1.39; 95% CI: 0.38 to 1.95; P = 0.003); at level B was 0.98 mm ± 1.13 in group A, 0.14 mm ± 0.22 in group B, (difference 0.84 mm ± 1.16; 95% CI: 0.24 to 1.07; P = 0.019); at level C was 0.55 mm ± 0.74 in group A, 0.03 mm ± 0.24 in group B, (difference 0.51 mm ± 0.76, 95% CI: 0.01 to 0.87; P = 0.032). One year after implant placement, mean peri-implant marginal bone loss was 0.43 mm ± 0.37 for group A and 0.10 mm ± 0.10 for group B, showing a statistically significant difference between groups (difference 0.33 mm ± 0.30; 95% CI: 18 to 0.52; P = 0.010). Mean ISQ value was 78.8 ± 2.8 for group A and 79.9 ± 3.6 for group B, showing no statistically significant differences between groups (difference 1.1 ± 2.6; 95% CI: 0.04 to 2.96; P = 0.422). Mean PES was similar in both groups (10.7 ± 1.5 [range: 8 to 13] in group A and 11.7 ± 1.2 [range: 10 to 13] in group B; difference 1.0 ± 2.2; 95% CI: -0.23 to 2.23; P = 0.081). CONCLUSIONS:Single post-extractive ultra-wide 7 mm-diameter implants, in combination with socket preservation, might be a possible strategy in the replacement of hopeless molars in both jaws, with high implant and prosthetic survival and success rates, and good aesthetic outcomes. Longer follow-ups are needed to properly evaluate this therapeutic option. Conflict-of-interest statement: Dr Marco Tallarico is Research and Scientific Project Manager of Osstem AIC Italy. However, this study was not supported by any company and all authors declare no conflicts of interest.
RCT Entities:
PURPOSE: To test the hypothesis that there is no difference in clinical, radiographic and aesthetic outcomes positioning single post-extractive ultra-wide 7 mm-diameter implants or waiting 4 months to place implant, after molar extraction and the socket preservation procedure. MATERIAL AND METHODS:Patients requiring one implant-supported single restoration to replace a failed tooth in the molar region of both maxilla and mandible were selected. Patients were randomised according to a parallel group design into two arms: implant installation in fresh extraction sockets augmented with corticocancellous heterologous bone and porcine derma (group A) or delayed implant installation 4 months after tooth extraction and socket preservation using the same materials (group B). Ultra-wide 7 mm-diameter implants were submerged for 4 months. Outcome measures were implant success and survival; complications; horizontal dimensional changes measured on cone beam computed tomography (CBCT) scans at three levels, localised 1, 2 and 3 mm below the most coronal aspect of the bone crest (level A, B and C); peri-implant marginal bone level changes; implant stability quotient (ISQ); and pink esthetic score (PES). RESULTS: Twelve patients were randomised to group A and 12 to group B. No patients dropped out. No implant failed or complications occurred up to 6-months post-loading. Six months after loading there was more horizontal alveolar bone reduction at immediate post-extractive implants, which was statistically significant. At level A was 1.78 mm ± 1.30 in group A, 0.45 mm ± 0.42 in group B, (difference 1.33 mm ± 1.39; 95% CI: 0.38 to 1.95; P = 0.003); at level B was 0.98 mm ± 1.13 in group A, 0.14 mm ± 0.22 in group B, (difference 0.84 mm ± 1.16; 95% CI: 0.24 to 1.07; P = 0.019); at level C was 0.55 mm ± 0.74 in group A, 0.03 mm ± 0.24 in group B, (difference 0.51 mm ± 0.76, 95% CI: 0.01 to 0.87; P = 0.032). One year after implant placement, mean peri-implant marginal bone loss was 0.43 mm ± 0.37 for group A and 0.10 mm ± 0.10 for group B, showing a statistically significant difference between groups (difference 0.33 mm ± 0.30; 95% CI: 18 to 0.52; P = 0.010). Mean ISQ value was 78.8 ± 2.8 for group A and 79.9 ± 3.6 for group B, showing no statistically significant differences between groups (difference 1.1 ± 2.6; 95% CI: 0.04 to 2.96; P = 0.422). Mean PES was similar in both groups (10.7 ± 1.5 [range: 8 to 13] in group A and 11.7 ± 1.2 [range: 10 to 13] in group B; difference 1.0 ± 2.2; 95% CI: -0.23 to 2.23; P = 0.081). CONCLUSIONS: Single post-extractive ultra-wide 7 mm-diameter implants, in combination with socket preservation, might be a possible strategy in the replacement of hopeless molars in both jaws, with high implant and prosthetic survival and success rates, and good aesthetic outcomes. Longer follow-ups are needed to properly evaluate this therapeutic option. Conflict-of-interest statement: Dr Marco Tallarico is Research and Scientific Project Manager of Osstem AIC Italy. However, this study was not supported by any company and all authors declare no conflicts of interest.