Immediate loading of post-extractive versus delayed placed single implants in the anterior maxilla: outcome of a pragmatic multicenter randomised controlled trial 1-year after loading.

PURPOSE: To compare the effectiveness of immediate post-extractive single implants with delayed implants, placed in preserved sockets after 4 months of healing. Implants that achieved an insertion torque of at least 35 Ncm were immediately non-occlusally loaded. MATERIALS AND METHODS: Just after tooth extraction, and in the presence of less than 4 mm of vertical loss of the buccal bone in relation to the palatal wall, 106 patients requiring a single immediate post-extractive implant in the maxilla from second to second premolar were randomly allocated to immediate implant placement (immediate group; 54 patients) or to socket preservation using anorganic bovine bone covered by a resorbable collagen barrier (delayed group; 52 patients), according to a parallel group design at three different centres. Bone-to-implant gaps were to be filled with anorganic bovine bone, however this was not carried out in 17 patients (corresponding to 40% of those who should have been grafted). Four months after socket preservation, delayed implants were placed. Implants inserted with an insertion torque of at least 35 Ncm were immediately loaded with non-occluding provisional single crowns, then replaced after 4 months by definitive crowns. Patients were followed up to 1 year after loading. Outcome measures were implant failures, complications, aesthetics assessed using the pink esthetic score (PES), peri-implant marginal bone level changes and patient satisfaction recorded by blinded assessors. RESULTS: Nineteen (35%) implants were not immediately loaded in the immediate group versus 39 (75%) implants in the delayed placement group because an insertion torque superior to 35 Ncm could not be obtained. Six patients dropped out 4 months after loading from the delayed group versus none in the immediate group. Two implants failed in the immediate group (6%) versus none in the delayed group, with the difference showing no statistical significance (difference in proportions = 0.04; 95% CI: -0.03 to 0.11; P = 0.187). Eight minor complications occurred in the immediate group and one in the delayed group, and this was statistically significant (difference in proportions = 0.13; 95% CI: 0.03 to 0.23; P = 0.028). At delivery of definitive crowns, 4 months after loading, the mean aesthetic score was 12.8 and 12.6 in the immediate and delayed groups, respectively. At 1 year after loading, the mean aesthetic score was 13.0 and 12.8 in the immediate and delayed groups, respectively. There was no statistically significant difference at 4 months (P = 0.500) and at 1 year (P = 0.615). Marginal bone levels at implant insertion (after bone grafting) were 0.10 mm for immediate implants and 0.02 mm for delayed implants, which did not have a statistically significantly difference (mean difference = 0.08; 95% CI: 0.04 to 0.12; P < 0.001). One year after loading, patients of the immediate group lost on average 0.23 mm and those in the delayed group lost 0.29 mm, the difference being statistically significant (mean difference = -0.06; 95% CI: -0.11 to -0.01; P = 0.036). Patients of both groups were equally satisfied at 4 months as well as at 1 year after loading. CONCLUSIONS: There are more complications with immediate post-extractive implants in comparison to delayed implants. It seems more difficult to obtain an implant insertion torque superior to 35 Ncm in sockets preserved with anorganic bovine bone after a 4-month healing period than with postextractive sites. The aesthetic outcome appears to be similar for both groups.