Aesthetic Outcomes of Non-functional Immediately Restored Single Post-extraction Implants with and without Connective Tissue Graft: A Multicenter Randomized Controlled Trial.

Abstract

OBJECTIVES\nTo compare the one-year aesthetic results of flapless single implants, placed in fresh extraction sockets with bone replacement and immediate provisional restoration with or without a connective tissue graft (CGT).\n\n\nMATERIAL AND METHODS\nThe present study proposes a partially blinded multicenter parallel randomized controlled trial, where computer-generated tables were used for central randomization to allocate treatments. 59 out of the 60 patients screened by eight private practices in Northern Italy fulfilled the inclusion criteria. Immediate implants was placed in a fresh extraction socket with a non-functional immediate provisional restoration with (Test group) or without (Control group) a CGT. The primary outcome variable was the implant Crown Aesthetic Index (ICAI) at the 1-year follow-up.\n\n\nRESULTS\nICAI for the 59 randomized patients (Test group = 31, Control group = 28) at the 1-year follow-up was 4.69 (95% CI = 3.16 - 6.22) for the Test group and 3.45 (95%CI = 1.83-5.08) for the Control group, without statistically significant difference between the two groups (p=0.086). One implant failure was recorded in each group, resulting in an implant survival rate of 96.8% [95%CI = 83.3 - 99.9] for the Test group and 96.4% [95%CI = 81.7 -99.9] for the Control group. Other secondary outcome variables and complication rates were comparable across the two groups.\n\n\nCONCLUSIONS\nWithin the limitations of the present clinical trial, the results suggested that the adjunct use of CTG is not mandatory to achieve successful aesthetic outcomes for a well-planned immediate implant placement with immediate non-functional provisional restoration in a fresh extraction socket.