SOFT TISSUE SUBSTITUTES AT IMMEDIATE POSTEXTRACTIVE IMPLANTS TO REDUCE TISSUE SHRINKAGE – 3-YEAR RESULTS FROM A RANDOMIZED CONTROLLED TRIAL

PURPOSE. The aim of this parallel randomized controlled trial (RCT) was to evaluate whether placement of a soft tissue graft substitute (STGS) could decrease peri-implant tissue shrinkage at immediate post-extractive implants.

MATERIALS AND METHODS. Twenty patients with one missing tooth between two adjacent healthy teeth in aesthetic areas and at least 4 mm of bone apically to the tooth apex were randomly allocated after tooth extraction to receive or not a subepithelial buccal STGS. Implants were inserted with a torque of at least 30 Ncm and sites were grafted with a cancellous particulate allograft. Ten patients received a buccal STGS and 10 patients did not (control group). All patients were restored with non-occluding immediate provisional screw-retained crowns, replaced after 6 months by definitive metal-ceramic crowns, and were followed to 3-year after grafting/loading.

RESULTS. Three-year after loading, no drop-out, crown or implant failure or complication occurred. No statistically significant difference or trends in aesthetics (difference = 0.2, 95% CI: -0.81 to 1.21; P = 0.97), peri-implant marginal bone loss (difference = 0.14 mm; 95% CI: -0.27 to 0.57; P = 0.58) and keratinized mucosa heights (difference = 0.8 mm; 95% CI: -1.79 to 3.39; P = 0.57) between the two groups were observed.

CONCLUSIONS. Acknowledging that the sample size was small, no clinical benefits could be observed using a soft tissue graft substitute at immediate post-extractive implants up to 3-year after grafting.