Effect of Pre-emptive Dose of Prednisone Versus Placebo in Impacted Third Molar Surgery

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05830747
• Other study ID #: 465/2020
• Status: Completed
• Phase: Phase 4
• Start date: February 1, 2022
• Est. completion date: December 10, 2022

Study information

• Verified date: April 2023
• Source: University Magna Graecia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

This study aims 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 M3M in a split-mouth randomized controlled clinical trial. Facial swelling will be evaluated using an innovative three-dimensional digital technique.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Facial Swelling
• Facies
• Tooth Avulsion
• Tooth Extraction Status Nos
• Tooth Position Anomalies
• Tooth, Impacted

Intervention

Drug:
• Prednisone
Pre-operative drug administration before third molar surgery
• Placebo
Pre-operative Placebo administration before third molar surgery

Locations

Country	Name	City	State
Italy	Magna Graecia University of Catanzaro	Catanzaro	CZ

Sponsors (1)

Lead Sponsor	Collaborator
University Magna Graecia

Country where clinical trial is conducted

Italy, 

References & Publications (12)

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

Outcome

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