Use of Corticosteroids in Third Molar Surgery

University of Granada (UGR)

Status and phase: Completed; Phase 3; Phase 2

Conditions: Inflammation; Pain, Postoperative; Trismus

Treatments: Drug: Dexamethasone 4 Mg/mL Injectable Solution; Drug: MethylPREDNISolone 40 Mg/mL Injectable Suspension

Study type: Interventional

Funder types: Other

Identifiers

NCT05752305

3180/CEIH/2023

Details and patient eligibility

About

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.

Full 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.

Enrollment: 84 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

84 participants in 2 patient groups

Methylprednisolone group

Experimental group

Description:

Preoperative administration of 40mg of methylprednisolone via submucosa

Treatment:

Drug: MethylPREDNISolone 40 Mg/mL Injectable Suspension

Dexamethasone group

Experimental group

Description:

Preoperative administration of 8mg of dexamethasone via submucosa

Treatment:

Drug: Dexamethasone 4 Mg/mL Injectable Solution