A Comparison of Recovery After Impacted Wisdom Tooth Removal
NCT ID: NCT07304882
Last Updated: 2025-12-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
24 participants
INTERVENTIONAL
2023-11-30
2025-01-04
Brief Summary
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Objectives of the Study
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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.
Detailed Description
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Participants were allocated into two groups, with each patient serving as their own control through the split-mouth approach. On one side, an impacted mandibular third molar was extracted and treated with conventional medications. After a washout period of three weeks, the contralateral molar was extracted and treated with an additional intervention alongside the conventional drugs-either an enzyme or a herbal agent. The groups were defined as follows:
* The first group received conventional medications combined with 10 mg oral serratiopeptidase, administered immediately postoperatively and then thrice daily for five days following the first surgical visit. During the second visit (after three weeks), only conventional drugs were given, or vice versa.
* The second group received conventional medications combined with 20 mg oral escin, administered immediately postoperatively and then thrice daily for five days following the first surgical visit. At the second visit (after three weeks), only conventional drugs were administered, or vice versa.
The conventional medication administered to both groups consisted of Amoxicillin 500 mg capsules twice daily, Metronidazole 500 mg tablets three times daily, and Diclofenac sodium 50 mg tablets twice daily.
Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
TRIPLE
Study Groups
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Serratiopeptidase (Test 1)
This group received conventional medications combined with 10 mg oral serratiopeptidase, administered immediately postoperatively and then thrice daily for five days following the first surgical visit.
serratiopeptidase
10 mg oral serratiopeptidase , Amoxicillin 500 mg, Metronidazole 500 mg, Diclofenac sodium 50 mg
Conventional medication (Control 1)
During the second visit (after three weeks), only conventional drugs were given. It was consisted of Amoxicillin 500 mg capsules twice daily, Metronidazole 500 mg tablets three times daily, and Diclofenac sodium 50 mg tablets twice daily.
Conventional drugs
Amoxicillin 500 mg, Metronidazole 500 mg, Diclofenac sodium 50 mg
Escin (Test 2)
This group received conventional medications combined with 20 mg oral escin, administered immediately postoperatively and then thrice daily for five days following the first surgical visit
Escin
20 mg oral escin , Amoxicillin 500 mg, Metronidazole 500 mg, Diclofenac sodium 50 mg
Conventional medication (Control 2)
During the second visit (after three weeks), only conventional drugs were given. It was consisted of Amoxicillin 500 mg capsules twice daily, Metronidazole 500 mg tablets three times daily, and Diclofenac sodium 50 mg tablets twice daily.
Conventional drugs
Amoxicillin 500 mg, Metronidazole 500 mg, Diclofenac sodium 50 mg
Interventions
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serratiopeptidase
10 mg oral serratiopeptidase , Amoxicillin 500 mg, Metronidazole 500 mg, Diclofenac sodium 50 mg
Escin
20 mg oral escin , Amoxicillin 500 mg, Metronidazole 500 mg, Diclofenac sodium 50 mg
Conventional drugs
Amoxicillin 500 mg, Metronidazole 500 mg, Diclofenac sodium 50 mg
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Presence of two mandibular third molars indicated for surgical extraction.
* No history of pericoronitis or other signs of inflammation within the past 30 days.
Exclusion Criteria
* Known allergy to any drugs administered in this study.
* Pregnancy or breastfeeding.
* History of diabetes or hypertension.
* Previous irradiation to the maxillofacial region.
* Intellectual disability or inability to attend follow-up visits.
* Presence of acute or subacute pericoronitis.
ALL
No
Sponsors
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University of Science and Technology, Yemen
OTHER
Responsible Party
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Arwa Mohammed Dahak
Principal Investigator
Locations
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University of Science and Technology
Sanaa, Sana'a, Yemen
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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
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.
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.
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.
Provided Documents
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Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form
Other Identifiers
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ISRCTN15432618
Identifier Type: REGISTRY
Identifier Source: secondary_id
1445/0012/UREC/UST
Identifier Type: -
Identifier Source: org_study_id