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

NCT05830747 | Completed Phase 4

• 1 other identifier: 465/2020
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Facial Swelling; Tooth Position Anomalies; Tooth, Impacted; Tooth Extraction Status Nos; Tooth Avulsion

Keywords

third molar surgery; facial swelling; 3D facial swelling evaluation; tooth impacted; prednisone drug administration; corticosteroids administration

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (2)

• Change in trismus

  Change from baseline (before surgery) at 2 day after surgery and at 7 days after surgery

• Change in pain with Visual analogue scale (VAS)

  Change from baseline (before surgery) at 2 day after surgery and at 7 days after surgery

Study Arms (2)

Prednisone group (PG)

EXPERIMENTAL

Patients receiving a preoperative administration of prednisone 25 mg/os.

Drug: Prednisone

Control group (CG)

PLACEBO COMPARATOR

Patients receiving a preoperative administration of Placebo.

Drug: Placebo

Interventions

Prednisone DRUG

Pre-operative drug administration before third molar surgery

Prednisone group (PG)

Placebo DRUG

Pre-operative Placebo administration before third molar surgery

Control group (CG)

Eligibility Criteria

• Age: 18 Years - 32 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Magna Graecia: lead

Study Sites (1)

Magna Graecia University of Catanzaro

Catanzaro, CZ, 88100, Italy

Location

Related Publications (13)

• 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.

  PMID: 30376855 RESULT

• 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.

  PMID: 34030996 RESULT

• 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.

  PMID: 30878593 RESULT

• 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.

  PMID: 17619915 RESULT

• 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.

  PMID: 33479379 RESULT

• 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.

  PMID: 23108628 RESULT

• 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.

  PMID: 22902498 RESULT

• 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.

  PMID: 27287853 RESULT

• 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.

  PMID: 20440092 RESULT

• 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.

  PMID: 31668666 RESULT

• 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.

  PMID: 24422029 RESULT

• 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.

  PMID: 33058774 RESULT

• 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.

  PMID: 37653378 DERIVED

MeSH Terms

Conditions

Tooth, Impacted; Tooth Avulsion

Interventions

Prednisone

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases; Tooth Injuries; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Alessandro Antonelli, PhDs, DDS

  Magna Graecia University of Catanzaro

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 27, 2023
• First Posted: April 26, 2023
• Study Start: February 1, 2022
• Primary Completion: October 25, 2022
• Study Completion: December 10, 2022
• Last Updated: April 26, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)