A Randomized Controlled Trial on the Timing of Soft-Tissue Augmentation in Immediate Implant Placement: Hard-Tissue Changes and Clinical Outcome.

Abstract

To assess the impact of the timing of soft-tissue augmentation (STA) on mean buccal bone changes following immediate implant placement (IPP) in the anterior maxilla. Patients with a failing tooth and intact buccal bone wall in the anterior maxilla (15-25) were enrolled in this randomized controlled trial. Following single IIP and socket grafting, they were randomly allocated to the control group (immediate STA performed during the same surgical procedure) or the test group (delayed STA performed 3 months later). Implants were placed with a surgical guide and immediately restored with an implant-supported provisional crown. Changes in bone dimensions were assessed using superimposed CBCT images taken prior to surgery and at 1-year follow-up. Clinical outcomes were registered at 1-year follow-up. Twenty patients were randomized to each group (control: 16 females, 4 males, mean age 57.6; test: 9 females, 11 males, mean age 54.2). Ten patients in the control group and 13 patients in the test group had a thick bone wall phenotype. Estimated marginal mean horizontal buccal bone loss at 1 mm below the implant shoulder was -0.553 and -0.898 mm for the control and test group, respectively. The estimated mean difference of 0.344 mm in favour of the control group was not significant (95% CI: -0.415 to 1.104; p = 0.363). Also at all other horizontal and vertical levels, no significant differences could be observed between the groups. The combination of socket grafting and STA enabled counteraction of any buccal soft-tissue loss (≥ 0 mm) at 1 mm below the implant shoulder in 82% of the patients in the control group and in 75% of the patients in the test group (p = 1.000). The clinical outcome was favourable in both groups, yet implants in the control group demonstrated slightly less marginal bone loss (median difference 0.20 mm; 95% CI: 0.00-0.44; p = 0.028). In patients with an intact and mainly thick buccal bone wall in the anterior maxilla, the timing of STA following IIP had no significant impact on mean buccal bone loss. ClinicalTrials.gov identifier: NCT05537545.