A Comparison of Recovery After Impacted Wisdom Tooth Removal
Summary
Justification of the Study There is a high prevalence of impacted third molars, often accompanied by a range of postoperative complications. To the best of the researcher's knowledge, no clinical study to date has directly compared the efficacy of serratiopeptidase and escin in minimizing the most commonly observed postoperative complications following impacted mandibular third molar surgery. This study seeks to address this gap by providing empirical evidence that could contribute to optimizing postoperative care. Objectives of the Study Drawing from the background and research questions outlined above, the objectives of this study are divided into general and specific ones, outlined as follows: General Objective To compare the efficacy of serratiopeptidase and escin, when used as adjuncts to conventional drugs, in reducing postoperative complications (i.e., trismus, facial edema, and pain) following impacted mandibular third molar surgery. Specific Objectives The study set the following specific objectives: 1. To evaluate the efficacy of serratiopeptidase, as an adjunct to conventional drugs, in reducing postoperative complications (i.e., trismus, facial edema, and pain) following impacted mandibular third molar surgery. 2. To evaluate the efficacy of escin, as an adjunct to conventional drugs, in reducing postoperative complications (i.e., trismus, facial edema, and pain) following impacted mandibular third molar surgery. Study Hypotheses The study formulated the following hypotheses 1. Serratiopeptidase, as an adjunct to conventional drugs, provides significantly greater efficacy than conventional drugs alone in reducing postoperative complications (i.e., trismus, facial edema, and pain) following impacted mandibular third molar surgery. 2. Escin, as an adjunct to conventional drugs, provides significantly greater efficacy than conventional drugs alone in reducing postoperative complications (i.e., trismus, facial edema, and pain) following impacted mandibular third molar surgery. 3. There is a statistically significant difference in the efficacy of serratiopeptidase compared to escin in reducing postoperative complications (i.e., trismus, facial edema, and pain) when both are used as adjuncts to conventional drugs following impacted mandibular third molar surgery.
Timeline
- Start
- 2023-11-30
- Primary completion
- 2025-01-04
- Completion
- 2025-01-04
Publications
- Background Chopra D, Rehan HS, Mehra P, Kakkar AK. A randomized, double-blind, placebo-controlled study comparing the efficacy and safety of paracetamol, serratiopeptidase, ibuprofen and betamethasone using the dental impaction pain model. Int J Oral Maxillofac Surg. 2009 Apr;38(4):350-5. doi: 10.1016/j.ijom.2008.12.013. Epub 2009 Jan 24.
- Background Chappi D M, Suresh KV, Patil MR, Desai R, Tauro DP, Bharani K N S S, Parkar MI, Babaji HV. Comparison of clinical efficacy of methylprednisolone and serratiopeptidase for reduction of postoperative sequelae after lower third molar surgery. J Clin Exp Dent. 2015 Apr 1;7(2):e197-202. doi: 10.4317/jced.51868. eCollection 2015 Apr.
- Background Sannino G, Gigola P, Puttini M, Pera F, Passariello C. Combination therapy including serratiopeptidase improves outcomes of mechanical-antibiotic treatment of periimplantitis. Int J Immunopathol Pharmacol. 2013 Jul-Sep;26(3):825-31. doi: 10.1177/039463201302600332.
- Background Bataineh AB, Batarseh RA. The effect of modified surgical flap design for removal of lower third molars on lingual nerve injury. Clin Oral Investig. 2017 Jul;21(6):2091-2099. doi: 10.1007/s00784-016-1999-5. Epub 2016 Nov 12.
- Background Wang T, Fu F, Zhang L, Han B, Zhu M, Zhang X. Effects of escin on acute inflammation and the immune system in mice. Pharmacol Rep. 2009 Jul-Aug;61(4):697-704. doi: 10.1016/s1734-1140(09)70122-7.
- Background Isola G, Matarese M, Ramaglia L, Iorio-Siciliano V, Cordasco G, Matarese G. 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 Investig. 2019 May;23(5):2443-2453. doi: 10.1007/s00784-018-2690-9. Epub 2018 Oct 11.
- Background Pavan R, Jain S, Shraddha, Kumar A. Properties and therapeutic application of bromelain: a review. Biotechnol Res Int. 2012;2012:976203. doi: 10.1155/2012/976203. Epub 2012 Dec 10.
- Background Olmedo-Gaya MV, Manzano-Moreno FJ, Galvez-Mateos R, Gonzalez-Rodriguez MP, Talero-Sevilla C, Vallecillo-Capilla M. Oral pregabalin for postoperative pain relief after third molar extraction: a randomized controlled clinical trial. Clin Oral Investig. 2016 Sep;20(7):1819-26. doi: 10.1007/s00784-015-1657-3. Epub 2015 Nov 18.
- Background Villafuerte-Nuñez AE, Téllez-Anguiano AC, Hernández-Díaz O, Rodríguez-Vera R, Gutiérrez-Gnecchi JA, Salazar-Martínez JL. Facial edema evaluation using digital image processing. Discrete Dynamics in Nature and Society. 2013;2013(1):927843. https://doi.org/10.1155/2013/927843
- Background Piecuch JF. What strategies are helpful in the operative management of third molars? J Oral Maxillofac Surg. 2012 Sep;70(9 Suppl 1):S25-32. doi: 10.1016/j.joms.2012.04.027.
- Background Kaplan V, Eroglu CN. Comparison of the Effects of Daily Single-Dose Use of Flurbiprofen, Diclofenac Sodium, and Tenoxicam on Postoperative Pain, Swelling, and Trismus: A Randomized Double-Blind Study. J Oral Maxillofac Surg. 2016 Oct;74(10):1946.e1-6. doi: 10.1016/j.joms.2016.05.015. Epub 2016 May 24.
- Background Brkovic B, Andric M, Calasan D, Milic M, Stepic J, Vucetic M, Brajkovic D, Todorovic L. Efficacy and safety of 1% ropivacaine for postoperative analgesia after lower third molar surgery: a prospective, randomized, double-blinded clinical study. Clin Oral Investig. 2017 Apr;21(3):779-785. doi: 10.1007/s00784-016-1831-2. Epub 2016 Apr 25.
- Background Al-Khateeb TH, Nusair Y. Effect of the proteolytic enzyme serrapeptase on swelling, pain and trismus after surgical extraction of mandibular third molars. Int J Oral Maxillofac Surg. 2008 Mar;37(3):264-8. doi: 10.1016/j.ijom.2007.11.011. Epub 2008 Feb 12.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Escin | Unknown | 20 mg | Oral |
| Subject | serrapeptase | Protein / enzyme biologic | 10 mg | Oral |
| Background | Amoxicillin | Other / unclassified | 500 mg | — |
| Background | Diclofenac | Other / unclassified | 50 mg | — |
| Background | Metronidazole | Small molecule | 500 mg | — |