Bone-level Tapered Implants for Single Tooth Replacement. Immediate vs Delayed Placement: A Randomized, Controlled, Multi-center One-year No-inferiority Clinical Study.

MATERIALS AND METHODS: Post-market, prospective, randomized, controlled, multi-center study with a primary endpoint of one year. 53 subjects were randomized to receive either immediate implant placement (test group) or delayed implant placement (control group). The mean crestal bone-level changes from implant loading to 12 months post-implant loading were measured using standardized, digital periapical radiographs. Changes in facial plate thickness measured on cone-beam computed tomography (CBCT) images, implant success and survival, implant stability, soft tissue changes, patient-centered outcomes, and adverse effects were measured to assess outcomes between the test and control treatments at 12 months post-loading.

RESULTS: 46 subjects completed the study (23 in each group). Mean bone changes from loading to the 12 month follow-up were recorded with no statistically significant difference (p=0.950) between both groups. The hypothesis was confirmed that immediate implant placement (Test) in extraction sockets is similar to delayed placement (Control). The test group was found to be similar to the control group (P=0.022) in terms of mean changes in facial plate thickness. Implant survival and success were 95.8% in the test group and 92% in the control group. Stability in the control group was superior at the time of surgery, but there was no difference between both groups at implant loading, producing a non-significant p-value of (0.563).

CONCLUSION: This randomized, controlled, multi-center one-year study showed comparable outcomes 1-year after prosthetic loading in the immediate and delayed placement groups.