RESUMO
OBJECTIVES: To compare the 1-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 (CTG). MATERIAL AND METHODS: The present study proposes a partially blinded multicentre parallel randomized controlled trial, where computer-generated tables were used for central randomization to allocate treatments. A total of 59 of the 60 patients screened by eight private practices in Northern Italy fulfilled the inclusion criteria. Immediate implants were placed in a fresh extraction socket with a non-functional immediate provisional restoration with (Test group) or without (Control group) a CTG. The primary outcome variable was the implant Crown Aesthetic Index (ICAI) at the 1-year follow-up. RESULTS: ICAI 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 = .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. CONCLUSIONS: Within 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.