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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

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Abstract

Objectives

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.

Results

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.

Conclusions

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.

Clinical relevance

The phytotherapeutic drug composed of herbal extract determined a decrease in the severity of postoperative pain compared to ibuprofen and placebo.

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Funding

This work was carried out with funding by the Department of Biomedical, Odontostomatological Sciences and of Morphological and Functional Images, University of Messina.

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Authors and Affiliations

  1. Department of Biomedical, Odontostomatological Sciences and of Morphological and Functional Images, School of Dentistry, University of Messina, AOU Policlinico “G. Martino”, Via C. Valeria 1, 98125, Messina, Italy

    Gaetano Isola, Marco Matarese, Giancarlo Cordasco & Giovanni Matarese

  2. Department of Neurosciences, Reproductive and Odontostomatological Sciences, School of Medicine, University of Naples “Federico II”, Via G. Pansini 5, 80131, Naples, Italy

    Gaetano Isola, Luca Ramaglia & Vincenzo Iorio-Siciliano

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  1. Gaetano Isola
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  2. Marco Matarese
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  4. Vincenzo Iorio-Siciliano
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  5. Giancarlo Cordasco
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  6. Giovanni Matarese
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All authors were involved in drafting the manuscript and took responsibility for the integrity of the data that is present in this study.

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Correspondence to Gaetano Isola.

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The authors declare that they have no conflicts of interest.

Ethical approval

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).

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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.

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Isola, G., Matarese, M., Ramaglia, L. et al. 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. Clin Oral Invest 23, 2443–2453 (2019). https://doi.org/10.1007/s00784-018-2690-9

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