Comparative Effectiveness of the Homeopathic Preparation Traumeel S in Third Molar Extraction Surgery: A Preliminary Triple-Blind Clinical TrialFunding None.
Background and Aim 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.
Methods 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.
Results 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.
Conclusion 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.
• The potential of the homeopathic preparation Traumeel S as anti-inflammatory in lower third molar surgery was tested in a preliminary triple-blind clinical trial.
• The effects of Traumeel S were not significantly different from those of dexamethasone for pain after 24 hours, 72 hours, and 7 days; for mouth opening after 72 hours and 7 days; and for edema at all post-operative evaluations.
• Traumeel S might be a good alternative to dexamethasone as an anti-inflammatory medication following lower third molar extraction.
Received: 16 September 2020
Accepted: 23 December 2020
25 March 2021 (online)
© 2021. Faculty of Homeopathy. This article is published by Thieme.
Georg Thieme Verlag KG
Rüdigerstraße 14, 70469 Stuttgart, Germany
- 1 Zupelari-Gonçalves P, Weckwerth GM, Calvo AM. et al. Efficacy of oral diclofenac with or without codeine for pain control after invasive bilateral third molar extractions. Int J Oral Maxillofac Surg 2017; 46: 621-627
- 2 Vicente A, Loffi AOB, Nesi H. Uso de corticosteroide no pré-operatório em cirurgia de terceiros molares. Rev Bras Odontol 2013; 70: 22-27
- 3 Martin MV, Kanatas AN, Hardy P. Antibiotic prophylaxis and third molar surgery. Br Dent J 2005; 198: 327-330
- 4 Laureano Filho JR, Maurette PE, Allais M, Cotinho M, Fernandes C. Clinical comparative study of the effectiveness of two dosages of Dexamethasone to control postoperative swelling, trismus and pain after the surgical extraction of mandibular impacted third molars. Med Oral Patol Oral Cir Bucal 2008; 13: E129-E132
- 5 Braga AFA, D'Ottaviano LH, Braga FSS. et al. Extraction of retained third molar teeth under local anesthesia. Evaluation of anxiety, pain, hemodynamic and respiratory alterations. Rev Fac Odontol Univ Nac (Cordoba) 2010; 51: 9-14
- 6 Lima CAA, Favarini VT, Torres AM, da Silva RA, Sato FRL. Oral dexamethasone decreases postoperative pain, swelling, and trismus more than diclofenac following third molar removal: a randomized controlled clinical trial. Oral Maxillofac Surg 2017; 21: 321-326
- 7 Montgomery MT, Hogg JP, Roberts DL, Redding SW. The use of glucocorticosteroids to lessen the inflammatory sequelae following third molar surgery. J Oral Maxillofac Surg 1990; 48: 179-187
- 8 Chappi D M, Suresh KV, Patil MR. et al. Comparison of clinical efficacy of methylprednisolone and serratiopeptidase for reduction of postoperative sequelae after lower third molar surgery. J Clin Exp Dent 2015; 7: e197-e202
- 9 Al-Dajani M. Can preoperative intramuscular single-dose dexamethasone improve patient-centered outcomes following third molar surgery?. J Oral Maxillofac Surg 2017; 75: 1616-1626
- 10 Dereci O, Tüzüner-Öncül AM, Kocer G, Yuce E, Askar M, Ozturk A. Efficacy of immediate postoperative intramasseteric dexamethasone injection on postoperative swelling after mandibular impacted third molar surgery: a preliminary split-mouth study. J Pak Med Assoc 2016; 66: 320-323
- 11 Alcântara CEP, Falci SGM, Oliveira-Ferreira F, Santos CR, Pinheiro ML. Pre-emptive effect of dexamethasone and methylprednisolone on pain, swelling, and trismus after third molar surgery: a split-mouth randomized triple-blind clinical trial. Int J Oral Maxillofac Surg 2014; 43: 93-98
- 12 Sanadhya YK, Sanadhya S, Sharma N. et al. Homeopathy a compliment to dentistry—a review. IJOCR 2013; 1: 31-38
- 13 Ho D, Jagdeo J, Waldorf HA. Is there a role for Arnica and Bromelain in prevention of post-procedure ecchymosis or edema? A systematic review of the literature. Dermatol Surg 2016; 42: 445-463
- 14 Scientific Bio-Logics—Heel. Traumeel®. Accessed December 14, 2020 at: http://www.healingedge.net/pdf/traumeel.pdf
- 15 Vanden Bossche L, Vanderstraeten G. A multi-center, double-blind, randomized, placebo-controlled trial protocol to assess Traumeel injection vs dexamethasone injection in rotator cuff syndrome: the TRAumeel in ROtator cuff syndrome (TRARO) study protocol. BMC Musculoskelet Disord 2015; 16: 8
- 16 González de Vega C, Speed C, Wolfarth B, González J. Traumeel vs. diclofenac for reducing pain and improving ankle mobility after acute ankle sprain: a multicentre, randomised, blinded, controlled and non-inferiority trial. Int J Clin Pract 2013; 67: 979-989
- 17 Sencer SF, Zhou T, Freedman LS. et al. Traumeel S in preventing and treating mucositis in young patients undergoing SCT: a report of the Children's Oncology Group. Bone Marrow Transplant 2012; 47: 1409-1414
- 18 Muders K, Pilat C, Deuster V. et al. Effects of Traumeel (Tr14) on recovery and inflammatory immune response after repeated bouts of exercise: a double-blind RCT. Eur J Appl Physiol 2017; 117: 591-605
- 19 Moher D, Hopewell S, Schulz KF. et al. CONSORT 2010 explanation and elaboration: updated guidelines for reporting parallel group randomised trials. BMJ 2010; 340: c869
- 20 Messer EJ, Keller JJ. The use of intraoral dexamethasone after extraction of mandibular third molars. Oral Surg Oral Med Oral Pathol 1975; 40: 594-598
- 21 Antunes AA, Avelar RL, Martins Neto EC, Frota R, Dias E. Effect of two routes of administration of dexamethasone on pain, edema, and trismus in impacted lower third molar surgery. Oral Maxillofac Surg 2011; 15: 217-223
- 22 Rocha-Neto AM, Nogueira EFC, Borba PM, Laureano-Filho JR, Vasconcelos BC. Application of dexamethasone in the masseter muscle during the surgical removal of lower third molars. J Craniofac Surg 2017; 28: e43-e47
- 23 Singer SR, Amit-Kohn M, Weiss S. et al. Efficacy of a homeopathic preparation in control of post-operative pain—a pilot clinical trial. Acute Pain 2007; 9: 7-12
- 24 Finsterbusch RM, Urrutia AMR. Comparación del control del dolor postoperatorio en la cirurgía de implantes entre ketoprofeno y traumeel s [Online dissertation]. Chile: Universidad Nacional Andres Bello; 2013
- 25 Nandini GD. Eventuality of dexamethasone injected intra-massetrically on post operative sequel following the surgical extraction of impacted mandibular third molars: a prospective study. J Maxillofac Oral Surg 2016; 15: 456-460
- 26 Zurita P, Vallejo-rosero KA. Valoración del medicamento homeopático, como terapia post extracción del tercer molar inferior incluído. Dom. Cien. 2017; 3: 147-167
- 27 Niño SLP, Díaz ACM, Mosquera MCS. Medicamentos Homeopáticos Útiles en el Tratamiento de Afecciones Presentes en el Sistema Estomatognático. Revisión de la Literatura. Acta Odontol. 2011; 1: 39-52
- 28 Sales KCC, Sánchez EZ, Iglesias RA. et al. Effectiveness of homeopathy in the treatment of traumatic tooth extractions. Revista Electrónica Dr. Zoilo E. Marinello Vidaurreta. 2014; 39: 1-6
- 29 Das R, Deshmukh J, Asif K, Sindhura H, Devarathanamma MV, Jyothi L. Comparative evaluation of analgesic and anti-inflammatory efficacy of ibuprofen and traumeel after periodontal flap surgery: a randomized triple-blind clinical trial. J Indian Soc Periodontol 2019; 23: 549-553