Effect of Thermosetting Gel with Doxycycline Hyclate 3% + Ketorolac Tromethamine 0.5% on Postoperative Discomfort after Third Molar Surgery: A Prospective Randomized Study

Abstract

This study compared the analgesic and anti-inflammatory efficacy of intra-alveolar administration of a thermosetting gel containing Doxycycline Hyclate 3% + Ketorolac Tromethamine 0.5% (Tg-DHKT) (Thermosetting gel, Monteresearch, Bollate, Italy) on patient discomfort after third molar surgery. This study was a single-blind, randomized clinical trial, including two study groups of39 and 41 patients each, who required surgical removal of a single mandibular impacted third molar. After the extraction the test group received an intra-alveolar injection with Tg-DHKT and the second group a thermosetting gel containing only Doxycycline Hyclate 3% (Tg-DH). Each patient's symptoms (pain, swelling, reddening, bleeding and body temperature) was assessed with a follow-up questionnaire (PoSSe scale). Nimesulide 100 mg, a painkiller, every 8 hours was prescribed to the Control and Test groups if necessary (maximum 3 doses); if they needed to assume it they were asked to mark it on the questionnaire. Results showed that on the second day after surgery pain, oedema and reddening decreased faster in the Control group (Tg-DH). There was no difference between the two groups when postoperative bleeding was evaluated. In both groups bleeding decreased in the same way, probably due to the mechanical characteristics of the gel itself. 46% of patients of the Test group did not require to take any painkiller at home. Our data demonstrate that the use of Tg-DHKT is less effective in the prevention of postoperative symptoms after third molar extraction compared to Tg-DH. However, almost half of patients in the Test group did not need to take more pain medication at home, suggesting that a single postoperative local administration of Tg-DHKT is a safe and effective concept for controlling pain, oedema and inflammation after third molar extraction.The surgical removal of impacted third molars is one of the most frequently performed procedures in oral surgery and afterwards complications such as post-operative pain, swelling and trismus may occur, and in some cases fever, during the first few postoperative days. As prostaglandins are presumed to be a primary mediator of acute postsurgical inflammatory changes, these patients, are therefore ideal clinical subjects for studying the effect of antiinflammatory agents on sequelae ofteeth extractions.