Purpose <p>To evaluate the effect of simvastatin gel–infused collagen-calcium phosphate bone graft on soft tissue healing and bone regeneration following mandibular third molar extraction.</p> Materials and methods <p>A prospective, randomized split-mouth clinical trial was conducted on 20 patients undergoing bilateral mandibular third molar extraction. One site received simvastatin gel–infused graft (test), while the contralateral site received saline-infused graft (control). Soft tissue healing was assessed on postoperative day 7 using the Landry, Turnbull, and Howley index. Bone regeneration was evaluated using radiographic grayscale analysis at 3 and 6 months. Paired t-tests were used for intergroup comparison, with <i>p</i> &lt; 0.05 considered statistically significant.</p> Results <p>The test group demonstrated significantly better soft tissue healing compared to control (<i>p</i> &lt; 0.001). Bone density was significantly higher in the test group at 3 months (<i>p</i> = 0.039), whereas no significant difference was observed at 6 months (<i>p</i> = 0.562). No serious adverse effects were reported. Mild postoperative pain, swelling, and trismus were observed in some patients, which were transient and resolved with routine care.</p> Conclusion <p>Simvastatin gel–infused graft significantly enhances early soft tissue healing and bone regeneration following mandibular third molar extraction. However, long-term bone density outcomes are comparable between groups.</p> Clinical trial registration <p>This trial was registered with the Clinical Trials Registry of India (CTRI/2024/03/064054).</p>