Efficacy of a drug composed of herbal extracts on postoperative discomfort after surgical removal of impacted mandibular third molar: a randomized, triple-blind, controlled clinical trial
This study investigated and compared the effectiveness of a phytotherapeutic drug composed of herbal extracts on postsurgical discomfort after mandibular third molar surgery.
Materials and methods
Eighty-two patients requiring the surgical removal of a mandibular third molar were randomly assigned to receive placebo (group 1), ibuprofen (group 2), and a phytotherapeutic drug (composed of baicalin, 190 mg; bromelain, 50 mg; escin, 30 mg) (group 3). Drugs were administered after tooth extraction twice a day for 5 days. The primary outcome, pain, was evaluated using a visual analogue scale at 2 h, 6 h, 12 h, 24 h, 48 h, and 7 and 10 days after surgery. The secondary outcomes were the changes in maximum mouth opening and facial contours (mm) between baseline and at 24 h, 72 h, and 7 and 10 days after surgery.
Compared to the baseline, all treatments demonstrated an improvement in the primary and secondary outcomes. Moreover, compared to groups 1 and 2, patients in group 3 yielded a significant reduction of the postoperative pain score at 12 h (p < 0.001), 24 h (p = 0.010), and 48 h (p = 0.048) after surgery. The mean reduction of the swelling and trismus was similar between groups.
The results of this study suggest that a postoperative administration of a phytotherapeutic drug was found to be effective in postoperative pain management after the surgical removal of impacted mandibular third molars.
The phytotherapeutic drug composed of herbal extract determined a decrease in the severity of postoperative pain compared to ibuprofen and placebo.
KeywordsThird molar surgery Phytotherapeutic drug Ibuprofen Pain Swelling Trismus
All authors were involved in drafting the manuscript and took responsibility for the integrity of the data that is present in this study.
This work was carried out with funding by the Department of Biomedical, Odontostomatological Sciences and of Morphological and Functional Images, University of Messina.
Compliance with ethical standards
Conflict of interest
The authors declare that they have no conflicts of interest.
This study followed the Declaration of Helsinki on medical protocol, and the institutional review board of the University of Messina, Messina, Italy, approved the study protocol (09/17).
Written informed consent was obtained from the patient for publication. A copy of the written consent may be requested for review from the corresponding author.
- 1.Brković B, Andrić M, Ćalasan D, Milić M, Stepić J, Vučetić M, Brajković D, Todorović L (2017) Efficacy and safety of 1% ropivacaine for postoperative analgesia after lower third molar surgery: a prospective, randomized, double-blinded clinical study. Clin Oral Investig 21:779–785CrossRefGoogle Scholar
- 8.Ghaeminia H, Hoppenreijs TJ, Xi T, Fennis JP, Maal TJ, Bergé SJ, Meijer GJ (2017) Postoperative socket irrigation with drinking tap water reduces the risk of inflammatory complications following surgical removal of third molars: a multicenter randomized trial. Clin Oral Investig 21:71–83CrossRefGoogle Scholar
- 12.Müller S, März R, Schmolz M, Drewelow B, Eschmann K, Meiser P (2012) Placebo-controlled randomised clinical trial on the immunomodulating activities of low and high dose bromelain after oral administration – new evidence on the anti-inflammatory mode of action of bromelain. Phytother Res 27:199–204CrossRefGoogle Scholar
- 19.de la Barrera-Núñez MC, Yáñez-Vico RM, Batista-Cruzado A, Heurtebise-Saavedra JM, Castillo-de Oyagüe R, Torres-Lagares D (2014) Prospective double-blind clinical trial evaluating the effectiveness of bromelain in the third molar extraction postoperative period. Med Oral Patol Oral Cir Bucal 19:e157–e162CrossRefGoogle Scholar
- 20.Li HY, Hu J, Zhao S, Yuan ZY, Wan HJ, Lei F, Ding Y, Xing DM, Du LJ (2012) Comparative study of the effect of baicalin and its natural analogs on neurons with oxygen and glucose deprivation involving innate immune reaction of TLR2/TNF alpha. J Biomed Biotechnol 2012:267890PubMedPubMedCentralGoogle Scholar
- 29.Pell GJ, Gregory BT (1933) Impacted mandibular third molars: classification and modified techniques for removal. Dent Dig 39:330–338Google Scholar
- 38.Henry D, Lim LL, Garcia Rodriguez LA, Perez Gutthann S, Carson JL, Griffin M, Savage R, Logan R, Moride Y, Hawkey C, Hill S, Fries JT (1996) Variability in risk of gastrointestinal complications with individual non-steroidal anti-inflammatory drugs: results of a collaborative meta-analysis. Br Med J 312:1563–1566CrossRefGoogle Scholar
- 39.Albuquerque AFM, Fonteles CSR, do Val DR, Chaves HV, Bezerra MM, Pereira KMA, de Barros Silva PG, de Lima BB, Soares ECS, Ribeiro TR, Costa FWG (2017) Effect of pre-emptive analgesia on clinical parameters and tissue levels of TNF-α and IL-1β in third molar surgery: a triple-blind, randomized, placebo-controlled study. Int J Oral Maxillofac Surg 46:1615–1625CrossRefGoogle Scholar
- 46.Meiser P, Xu Z, Kirsch G, Jacob C (2014) Chapter 18 – systemic enzyme therapy: fact or fiction? A review with focus on bromelains, proteolytic enzymes from the pineapple plant. In: Jacob C (ed) Recent advances in redox active plant and microbial products. Springer Science+Business Media, Dordrecht, pp 449–467Google Scholar
- 51.Barbalho JC, Vasconcellos RJ, de Morais HH, Santos LA, Almeida RA, Rêbelo HL, Lucena EE, de Araújo SQ (2017) Effects of co-administered dexamethasone and nimesulide on pain, swelling, and trismus following third molar surgery: a randomized, triple-blind, controlled clinical trial. Int J Oral Maxillofac Surg 46:236–242CrossRefGoogle Scholar
- 58.Costa FW, Soares EC, Esses DF, Silva PG, Bezerra TP, Scarparo HC, Ribeiro TR, Fonteles CS (2015) A split-mouth, randomized, triple-blind, placebo-controlled study to analyze the pre-emptive effect of etoricoxib 120 mg on inflammatory events following removal of unerupted mandibular third molars. Int J Oral Maxillofac Surg 44:1166–1174CrossRefGoogle Scholar
- 61.Martuscelli R, Toti P, Sbordone L, Guidetti F, Ramaglia L, Sbordone C (2014) Five-year outcome of bone remodelling around implants in the maxillary sinus: assessment of differences between implants placed in autogenous inlay bone blocks and in ungrafted maxilla. Int J Oral and Maxillofac Surg 43:1117–1126CrossRefGoogle Scholar