Wide diameter immediate post-extractive implants vs delayed placement of normal-diameter implants in preserved sockets in the molar region: 1-year post-loading outcome of a randomised controlled trial

PURPOSE: To compare the effectiveness of 6.0 to 8.0 mm-wide diameter implants, placed immediately after tooth extraction, with conventional 4.0 or 5.0 mm diameter implants placed in a preserved socket after a 4-month period of healing in the molar region. MATERIALS AND METHODS: Just after extraction of one or two molar teeth, and with no vertical loss of the buccal bone in relation to the palatal wall, 100 patients requiring immediate post-extractive implants were randomly allocated to immediate placement of one or two 6.0 to 8.0 mm-wide diameter implants (immediate group; 50 patients) or for socket preservation using a porcine bone substitute covered by a resorbable collagen barrier (delayed group; 50 patients), according to a parallel group design in one centre. Bone-to-implant gaps were filled with autogenous bone retrieved with a trephine drill used to prepare the implant sites for the immediate wide diameter post-extractive implants. Four months after socket preservation, one to two 4.0 or 5.0 mm-wide delayed implants were placed. Implants were loaded 4 months after placement with fixed provisional restorations in acrylic, and replaced after 4 months by fixed, definitive, metal-ceramic restorations. Patients were followed 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, patient satisfaction, number of appointments and surgical interventions recorded, when possible, by blinded assessors. RESULTS: Three patients dropped out 1 year after loading from the immediate group vs six from the delayed group. Five implants out of 47 failed in the immediate group (10.6%) vs two out 44 (4.6%) in the delayed group, the difference being not statistically significant (difference in proportion = 6.0%, 95% CI: -8.8% to 20.8%, P = 0.436). In the immediate group 10 patients were affected by 10 complications, while in the delayed group four patients were affected by four complications. The difference was not statistically significant (difference in proportion = 12%, 95% CI: -2% to 26%, P = 0.084). At delivery of the definitive prostheses, 4 months after loading, the mean total PES score was 9.65 ± 1.62 and 10.44 ± 1.47 in the immediate and delayed groups, respectively. At 1 year after loading, the mean total PES score was 9.71 ± 2.71 and 10.86 ± 1.37 in the immediate and delayed groups, respectively. The Total PES score was statistically significantly better at delayed implants both at 4 months (mean difference = 0.79; 95% CI: 0.05 to 1.53; P = 0.03) and at 1 year (mean difference = 1.15; 95% CI: 0.13 to 2.17; P = 0.02). Marginal bone levels at implant insertion (after bone grafting) were 0.04 mm for immediate and 0.11 mm for delayed implants, which was statistically significantly different (mean difference = 0.07; 95% CI: 0.02 to 0.12; P < 0.0001). One year after loading, patients in the immediate group lost on average 1.06 mm and those from the delayed group 0.63 mm, the difference being statistically significant (mean difference = 0.43 mm; 95% CI: 0.15 to 0.61; P < 0.0001). All patients were fully or partially satisfied both for function and aesthetics, and would undergo the same procedure again both at 4 months and 1 year after loading. Patients from the immediate group required on average 7.48 ± 1.45 visits to the clinician and 2.14 ± 0.49 surgical interventions and to have their definitive prostheses delivered vs 10.30 ± 0.99 visits and 3.08 ± 0.40 surgical interventions for the delayed group, the difference being statistically significant (P < 0.001 for visits, and P < 0.001 for surgical interventions). CONCLUSIONS: Preliminary 1 year follow-up data suggest that immediate placement of 6.0 to 8.0 mm wide diameter implants in molar extraction sockets yielded inferior aesthetic outcomes than ridge preservation and delayed placement of conventional 4.0 to 5.0 mm diameter implants.