Use of Corticosteroids in Third Molar Surgery

Phase 2

Completed

• Conditions: Pain, Postoperative; Trismus; Inflammation
• Interventions: Drug: Dexamethasone 4 Mg/mL Injectable Solution; Drug: MethylPREDNISolone 40 Mg/mL Injectable Suspension

• Registration Number: NCT05752305
• Lead Sponsor: Universidad de Granada

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2022-01-15
• Study First Submitted: 2023-02-09
• Study First Submitted QC: 2023-02-28
• Study First Posted: 2023-03-02
• Primary Completion: 2023-07-01
• Study Completion: 2023-07-15
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-29
• Last Update Posted: 2023-12-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 84

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dexamethasone group	Dexamethasone 4 Mg/mL Injectable Solution	Preoperative administration of 8mg of dexamethasone via submucosa
Methylprednisolone group	MethylPREDNISolone 40 Mg/mL Injectable Suspension	Preoperative administration of 40mg of methylprednisolone via submucosa

Primary Outcome Measures

Name	Time	Method
Postoperative inflammation following third molar surgical extraction	7 days	Postoperative swelling was determined by measuring tragus-chin distance, tragus-labial cleft distance and eye angle-jaw angle distance, using a millimeter ruler.
Postoperative trismus following third molar surgical extraction	7 days	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.
Postoperative pain following third molar surgical extraction	7 days	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).

Trial Locations

Locations (1)

Unai Fernández Martín; 🇪🇸 Granada, Spain