Effect of Pre-emptive Dose of Prednisone Versus Placebo in Impacted Third Molar Surgery
NCT ID: NCT05830747
Last Updated: 2023-04-26
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
PHASE4
34 participants
INTERVENTIONAL
2022-02-01
2022-12-10
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
TRIPLE
Study Groups
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Prednisone group (PG)
Patients receiving a preoperative administration of prednisone 25 mg/os.
Prednisone
Pre-operative drug administration before third molar surgery
Control group (CG)
Patients receiving a preoperative administration of Placebo.
Placebo
Pre-operative Placebo administration before third molar surgery
Interventions
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Prednisone
Pre-operative drug administration before third molar surgery
Placebo
Pre-operative Placebo administration before third molar surgery
Eligibility Criteria
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Inclusion Criteria
* Good health status
* Indication to surgical extraction of both M3M
* Complete root formation
* Surgical risk level classified as "Conventional" or "Moderate" according to Daugela et al. classification
Exclusion Criteria
* Allergy or contraindications to administration of corticosteroids
* Acute infection in any of the teeth to be extracted
* Patients with chronic liver disease, diabetes, immune system dysfunction, or haematological disease
* Pregnancy or breastfeeding
* History of treatment with antiresorptive drugs
* Chronic kidney disease
* History of systemic corticosteroid therapy in the past 4 weeks
18 Years
32 Years
ALL
Yes
Sponsors
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University Magna Graecia
OTHER
Responsible Party
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Amerigo Giudice
Professor
Principal Investigators
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Alessandro Antonelli, PhDs, DDS
Role: PRINCIPAL_INVESTIGATOR
Magna Graecia University of Catanzaro
Locations
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Magna Graecia University of Catanzaro
Catanzaro, CZ, Italy
Countries
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References
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Cankaya AB, Akcay C, Kahraman N, Koseoglu BG. Oral surgical procedures under local anaesthesia in day surgery. BMC Oral Health. 2018 Oct 30;18(1):179. doi: 10.1186/s12903-018-0648-6.
Sifuentes-Cervantes JS, Carrillo-Morales F, Castro-Nunez J, Cunningham LL, Van Sickels JE. Third molar surgery: Past, present, and the future. Oral Surg Oral Med Oral Pathol Oral Radiol. 2021 Nov;132(5):523-531. doi: 10.1016/j.oooo.2021.03.004. Epub 2021 Mar 14.
Sainz de Baranda B, Silvestre FJ, Silvestre-Rangil J. Relationship Between Surgical Difficulty of Third Molar Extraction Under Local Anesthesia and the Postoperative Evolution of Clinical and Blood Parameters. J Oral Maxillofac Surg. 2019 Jul;77(7):1337-1345. doi: 10.1016/j.joms.2019.02.020. Epub 2019 Feb 20.
Yamalik K, Bozkaya S. The predictivity of mandibular third molar position as a risk indicator for pericoronitis. Clin Oral Investig. 2008 Mar;12(1):9-14. doi: 10.1007/s00784-007-0131-2. Epub 2007 Jul 10.
Yoo JH, Yeom HG, Shin W, Yun JP, Lee JH, Jeong SH, Lim HJ, Lee J, Kim BC. Deep learning based prediction of extraction difficulty for mandibular third molars. Sci Rep. 2021 Jan 21;11(1):1954. doi: 10.1038/s41598-021-81449-4.
Acham S, Klampfl A, Truschnegg A, Kirmeier R, Sandner-Kiesling A, Jakse N. Beneficial effect of methylprednisolone after mandibular third molar surgery: a randomized, double-blind, placebo-controlled split-mouth trial. Clin Oral Investig. 2013 Sep;17(7):1693-700. doi: 10.1007/s00784-012-0867-1. Epub 2012 Oct 30.
Herrera-Briones FJ, Prados Sanchez E, Reyes Botella C, Vallecillo Capilla M. Update on the use of corticosteroids in third molar surgery: systematic review of the literature. Oral Surg Oral Med Oral Pathol Oral Radiol. 2013 Nov;116(5):e342-51. doi: 10.1016/j.oooo.2012.02.027. Epub 2012 Aug 17.
Ngeow WC, Lim D. Do Corticosteroids Still Have a Role in the Management of Third Molar Surgery? Adv Ther. 2016 Jul;33(7):1105-39. doi: 10.1007/s12325-016-0357-y. Epub 2016 Jun 10.
Tiigimae-Saar J, Leibur E, Tamme T. The effect of prednisolone on reduction of complaints after impacted third molar removal. Stomatologija. 2010;12(1):17-22.
Kaewkumnert S, Phithaksinsuk K, Changpoo C, Nochit N, Muensaiyat Y, Wilaipornsawai S, Piriyaphokai U, Powcharoen W. Comparison of intraosseous and submucosal dexamethasone injection in mandibular third molar surgery: a split-mouth randomized clinical trial. Int J Oral Maxillofac Surg. 2020 Apr;49(4):529-535. doi: 10.1016/j.ijom.2019.10.006. Epub 2019 Oct 25.
Juodzbalys G, Daugela P. Mandibular third molar impaction: review of literature and a proposal of a classification. J Oral Maxillofac Res. 2013 Jul 1;4(2):e1. doi: 10.5037/jomr.2013.4201.
Lau AAL, De Silva RK, Thomson M, De Silva H, Tong D. Third Molar Surgery Outcomes: A Randomized Clinical Trial Comparing Submucosal and Intravenous Dexamethasone. J Oral Maxillofac Surg. 2021 Feb;79(2):295-304. doi: 10.1016/j.joms.2020.09.020. Epub 2020 Sep 17.
Antonelli A, Barone S, Bennardo F, Giudice A. Three-dimensional facial swelling evaluation of pre-operative single-dose of prednisone in third molar surgery: a split-mouth randomized controlled trial. BMC Oral Health. 2023 Aug 31;23(1):614. doi: 10.1186/s12903-023-03334-y.
Other Identifiers
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465/2020
Identifier Type: -
Identifier Source: org_study_id
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