An Evaluation of the Effects of Pineapple-Extract and Bromelain-Based Treatment after Mandibular Third Molar Surgery: A Randomized Three-Arm Clinical Study.

Alma Martelli, Alessandro Colletti, Marzia Pellizzato, Giancarlo Cravotto, Chiara Procchio, Mariaelena Pisano

Journal: Nutrients 2024;16(6):

PMID: 38542694

Abstract

A three-arm, randomized, placebo-controlled clinical study was conducted to assess the impact of lyophilized pineapple extract with titrated bromelain (Brome-Inf) and purified bromelain on pain, swelling, trismus, and quality of life (QoL) following the surgical extraction of the mandibular third molars. Furthermore, this study examined the need for Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) by comparing their effects with a placebo group. This study enrolled 42 individuals requiring the extraction of a single mandibular third molar under local anesthesia. The patients were randomly assigned to receive Brome-Inf, purified bromelain, or a placebo orally, initiating treatment on the day of surgery and continuing for the next 7 days. The primary outcome measured was the requirement for NSAIDs in the three groups. Pain, swelling, and trismus were secondary outcome variables, evaluated postoperatively at 1, 3, and 7 days. This study also assessed the comparative efficacy of freeze-dried pineapple extract and single-component bromelain. Ultimately, the placebo group showed a statistically higher need for ibuprofen (from days 1 to 7) at the study's conclusion ( < 0.0001). In addition, reductions in pain and swelling were significantly higher in both the bromelain and pineapple groups ( < 0.0001 for almost all patients, at all intervals) than in the placebo group. The active groups also demonstrated a significant difference in QoL compared to the placebo group ( < 0.001). A non-significant reduction in trismus occurred in the treatment groups compared to the placebo group. Therefore, the administration of pineapple extract titrated in bromelain showed significant analgesic and anti-edema effects in addition to improving QoL in the postoperative period for patients who had undergone mandibular third molar surgery. Moreover, both bromelain and Brome-Inf supplementation reduced the need for ibuprofen to comparable extents, proving that they are good alternatives to NSAIDs in making the postoperative course more comfortable for these patients. A further investigation with larger samples is necessary to assess the pain-relieving and anti-inflammatory impacts of the entire pineapple phytocomplex in surgical procedures aside from mandibular third molar surgery.

Address: Department of Drug Science and Technology, University of Turin, 10125 Turin, Italy.; Italian Society of Nutraceutical Formulators (SIFNut), 31033 Treviso, Italy.; Studio Dentistico Pisano Procchio, 15121 Alessandria, Italy.; Italian Society of Nutraceutical Formulators (SIFNut), 31033 Treviso, Italy.; Department of Pharmacy, University of Pisa, 56126 Pisa, Italy.; Interdepartmental Research Centre "Nutraceuticals and Food for Health (NUTRAFOOD)", University of Pisa, 56120 Pisa, Italy.; Interdepartmental Research Centre of Ageing, Biology and Pathology, University of Pisa, 56120 Pisa, Italy.; Italian Society of Nutraceutical Formulators (SIFNut), 31033 Treviso, Italy.
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