Comparative Effectiveness of the Homeopathic Preparation Traumeel S in Third Molar Extraction Surgery: A Preliminary Triple-Blind Clinical Trial.

Abstract

This preliminary study aimed to evaluate whether a homeopathic preparation (Traumeel S) might be a good option to control post-operative outcomes (pain, edema and trismus) associated with surgical removal of mandibular third molar teeth. The null hypothesis was that Traumeel S is not different from dexamethasone (gold standard) in controlling these post-operative inflammatory complications. A randomized, "split-mouth", triple-blind clinical trial was conducted. Seventeen healthy patients with a mean age of 20.94 ( ± 5.83) years had their lower asymptomatic bilateral third molars removed. Patients were randomized to receive Traumeel S or dexamethasone pre-operatively by injection into the masseter muscle; each patient acted as his/her own control. At 24, 48, 72 hours and 7 days after the surgery, the pain was evaluated according to a visual analog scale, edema through linear measurements of the face, and trismus through the maximum buccal opening. Wilcoxon statistics or paired t-test were used, and a significance level of 95% was adopted. For pain, the results for Traumeel S were not different (p > 0.05) from those of dexamethasone after 24 hours, 72 hours, and 7 days. For edema, the results for Traumeel S were not different (p > 0.05) from those of dexamethasone at all post-operative evaluations. For mouth opening, the results for Traumeel S were not different (p > 0.05) from those of dexamethasone at 72 hours and 7 days after third molar extraction. With the exception of some early post-operative findings, the null hypothesis is not rejected. Traumeel S might be a good alternative approach to dexamethasone for controlling pain, edema and trismus after third molar removal.