Tooth Extraction Status Nos Clinical Trial
Official title:
Three-dimensional Facial Swelling Evaluation of Pre-operative Single-dose of Prednisone in Third Molar Surgery: a Split-mouth Randomized Controlled Trial
Verified date | April 2023 |
Source | University Magna Graecia |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The present study proposes to compare the effect of a single preoperative dose of prednisone versus placebo in terms of facial swelling, trismus and pain after surgical removal of the mandibular third molar (M3M) in a split-mouth randomized controlled clinical trial.
Status | Completed |
Enrollment | 34 |
Est. completion date | December 10, 2022 |
Est. primary completion date | October 25, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 32 Years |
Eligibility | Inclusion Criteria: - Patients aged 18 to 32 years who required both M3M extractions were recruited - 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: - Person under the age of 18 or over 32 - 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 |
Country | Name | City | State |
---|---|---|---|
Italy | Magna Graecia University of Catanzaro | Catanzaro | CZ |
Lead Sponsor | Collaborator |
---|---|
University Magna Graecia |
Italy,
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):1 — View Citation
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. — View Citation
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: 10.101 — View Citation
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. — View Citation
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 tria — View Citation
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 S — View Citation
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. — View Citation
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):1337-1 — View Citation
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 — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
* Note: There are 12 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in facial swelling | To compare the effectiveness of prednisone/os versus placebo in reducing facial swelling using qualitative three-dimensional analysis (measured by colorimetric variation given by the overlapping volumes) . | Change from baseline (before surgery) at 2 day after surgery and at 7 days after surgery | |
Primary | Change in facial swelling | To compare the effectiveness of prednisone/os versus placebo in reducing facial swelling using quantitative three-dimensional analysis (differences are measured in cm3). | Change from baseline (before surgery) at 2 day after surgery and at 7 days after surgery | |
Secondary | Change in trismus | To assess the effects of prednisone/os administration on trismus (measured in cm) | Change from baseline (before surgery) at 2 day after surgery and at 7 days after surgery | |
Secondary | Change in pain with Visual analogue scale (VAS) | To assess the effects of prednisone/os administration on pain (measured by VAS-score from 0 to 10 point, with 10 as the worst outcome) | Change from baseline (before surgery) at 2 day after surgery and at 7 days after surgery |
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