Single blind, randomized study comparing clinical equivalence of Trusilk® and Mersilk® silk sutures for mucosal closure following surgical removal of mesioangular impacted mandibular third molar

Abstract

Background: Mesioangular impacted mandibular third molar is a common dental anomaly, for which surgical extraction is required. Post-surgery closure of mucosa reduces the prevalence of pain and other surgery-associated complications. We compared tissue reaction/inflammation after 3 and 7 days of mucosal closure with Trusilk® and Mersilk® silk sutures, following impacted mandibular third molar removal. Methods: This multicenter, prospective, two-arm, parallel-group, randomized (1:1), single-blind study (July 2020-November 2021) included subjects (Trusilk®, n=65 and Mersilk®, n=64), requiring mucosal suturing following impacted mandibular third molar removal. The primary endpoint, incidence of pain, swelling and trismus at the extraction area on post-surgery day 3 and 7 was evaluated. The secondary endpoints, incidence of tissue reaction, wound infection, suture loosening, other complications, operative time, amount of anesthesia, intraoperative suture handling, time needed for complete wound healing and suture removal, and adverse events were also recorded. Results: Socio-demographic and intra-oral characteristics were comparable between the groups. In Trusilk® and Mersilk® groups, a gradually decreasing pain score, starting from day 0 post-surgery (42.17±22.38 vs. 45.97±22.20) to day 7 (8.40±11.93 vs. 8.28±12.13) to day 30 (1.98±0.89 vs. 1.75±0.76) was witnessed. After the surgery, 21.54% and 17.19% subjects in Trusilk® and Mersilk® groups, respectively, had no post-operative swelling, while at the last two visits none of the subjects had swelling. Non-significant difference in wound infection, suture loosening, wound healing, bleeding, taste changes, operative time, amount of anesthesia, intraoperative suture handling, and time needed for complete wound healing and suture removal was noted among the groups. No suture-related adverse events were recorded. Conclusions: The results indicated that the Trusilk® and Mersilk® silk sutures are clinically equivalent and can be used for mucosal closure after removal of an impacted mandibular third molar with a minimal rate of pain, swelling and trismus. Clinical Trial Registry of India Registration: CTRI/2020/03/024100 (20/03/2020)