Tomographic evaluation of the effect of simvastatin topical use on alveolar bone microarchitecture, pain and swelling after mandibular third molar extraction: a randomized controlled trial

Objectives To evaluate the effect of a collagen sponge containing simvastatin on socket healing in terms of bone microarchitecture through tomographic analysis, pain, and swelling after impacted third molar extraction. Materials and methods In this single-blind, split-mouth, randomized clinical trial, 29 patients undergoing impacted third molar extraction were allocated into two groups: (i) test group, a collagen sponge containing simvastatin was inserted within the sockets; and (ii) control group, in which sockets retained the clot. Bone volume (BV), bone volume fraction (BV/TV), trabecular thickness (Tb.Th), trabecular spacing (Tb.Sp), and gray scale were evaluated using cone beam computed tomography (CBCT) acquired immediately postoperative and 3 months after surgery. Pain, swelling, and wound healing were evaluated using the 10-point visual analogue scale, three extra-oral reference measurements, and the Landry index. Results In total, 22 participants remained in the study; no loss-to-follow-up was related to the intervention. BV and BV/TV were significantly higher at 3 months postoperatively in the test group compared with the control group and were correlated with greater bone trabeculation. Pain, edema, and the Landry index revealed a greater inflammatory response in the test group during early repair. Simvastatin contributed to bone healing, with no adverse effects or postoperative complications. Conclusions The absorbable collagen sponge containing simvastatin improved BV, BV/TV, and trabecular bone, indicating the potential of this drug to induce the formation of autogenous bone. Clinical relevance Intraosseous statins represent a promising, low-cost, and easy-to-use alternative for alveolar ridge preservation and bone regeneration. Trial registration Brazilian Registry of Clinical Trials (REBEC), No. RBR-523N7R.