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

Abstract

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.

Keywords: Alveolar ridge augmentation; Bone regeneration; Cone-beam computed tomography; Molar, third; Simvastatin; Tooth socket.