Use of Corticosteroids in Third Molar Surgery

Pain, Postoperative Clinical Trial

Official title:

Effect of Preoperative Administration of Dexamethasone Versus Methylprednisolone in Surgical Extraction of Retained Lower Third Molars

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05752305
• Other study ID #: 3180/CEIH/2023
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: January 15, 2022
• Est. completion date: July 15, 2023

Study information

• Verified date: November 2023
• Source: Universidad de Granada
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Surgical extraction of retained lower third molars is associated with the development of postoperative complications, including inflammation, trismus and postoperative pain, that lead to a decrease in patients' quality of life. Therefore, the use of drugs is essential to reduce the morbidity associated with surgery, with NSAIDs and corticosteroids being the most commonly used drugs.

Description:

Surgical extraction of retained lower third molars is associated with the development of postoperative complications, including inflammation, trismus and postoperative pain. Traditionally, NSAIDs have been used for the treatment of postoperative pain and inflammation, although corticosteroids are increasingly used in oral surgery, as they have proven to be clinically effective in reducing postoperative complications without causing serious adverse effects. Although numerous studies have been carried out comparing different corticosteroids in order to determine which of them is the most effective, there is still no clinical protocol regulating the use of these drugs in oral surgery. Therefore, this clinical trial is based on comparing two of the most studied corticosteroids used in oral surgery to date: dexamethasone and methylprednisolone. This study is based on the preoperative administration of 8mg of dexamethasone or 40mg of methylprednisolone via submucosa, randomly, in patients undergoing surgical extraction of a retained lower third molar, to determine which of these two drugs is more effective in the prevention of inflammation, trismus and postoperative pain.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 84
• Est. completion date: July 15, 2023
• Est. primary completion date: July 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients over 18 years of age
• Indication for surgical extraction of a retained lower third molar

Exclusion Criteria:

• Patients treated with corticosteroids in the last 3 months
• Patients treated with NSAIDs in the last 7 days
• Patients with hypersensitivity to the drug
• Patients with a medical condition that contraindicates the administration of the drug

Related Conditions & MeSH terms

• Inflammation
• Pain, Postoperative
• Trismus

Intervention

Drug:
• Dexamethasone 4 Mg/mL Injectable Solution
Preoperative submucosal administration of 8mg of dexamethasone or 40mg of methylprednisolone.
• MethylPREDNISolone 40 Mg/mL Injectable Suspension
Preoperative submucosal administration of 8mg of dexamethasone or 40mg of methylprednisolone.

Locations

Country	Name	City	State
Spain	Unai Fernández Martín	Granada

Sponsors (1)

Lead Sponsor	Collaborator
Universidad de Granada

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative inflammation following third molar surgical extraction	Postoperative swelling was determined by measuring tragus-chin distance, tragus-labial cleft distance and eye angle-jaw angle distance, using a millimeter ruler.	7 days
Primary	Postoperative trismus following third molar surgical extraction	Postoperative trismus was assessed by measuring the patient's maximum mouth opening (measuring the distance between the incisal edge of the upper central incisor and the lower central incisor) using a millimeter ruler.	7 days
Primary	Postoperative pain following third molar surgical extraction	Postoperative pain was measured using the Visual Analogue Scale (VAS): patients were asked to assign a numerical value from 0-100 (0 being no pain and 100 the maximum pain).	7 days