Use of Corticosteroids in Third Molar Surgery

Sponsor
Universidad de Granada (Other)
Overall Status
Recruiting
CT.gov ID
NCT05752305
Collaborator
(none)
84
1
2
16.5
5.1

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Dexamethasone 4 Mg/mL Injectable Solution
  • Drug: MethylPREDNISolone 40 Mg/mL Injectable Suspension
Phase 2/Phase 3

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 Design

Study Type:
Interventional
Anticipated Enrollment :
84 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
Effect of Preoperative Administration of Dexamethasone Versus Methylprednisolone in Surgical Extraction of Retained Lower Third Molars
Actual Study Start Date :
Jan 15, 2022
Anticipated Primary Completion Date :
Apr 1, 2023
Anticipated Study Completion Date :
Jun 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Methylprednisolone group

Preoperative administration of 40mg of methylprednisolone via submucosa

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

Experimental: Dexamethasone group

Preoperative administration of 8mg of dexamethasone via submucosa

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

Outcome Measures

Primary Outcome Measures

  1. 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.

  2. 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.

  3. 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).

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Unai Fernández Martín Granada Spain

Sponsors and Collaborators

  • Universidad de Granada

Investigators

  • Principal Investigator: Unai Fernández, Universidad de Granada

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Unai Fernández Martín, Principal Investigator, Universidad de Granada
ClinicalTrials.gov Identifier:
NCT05752305
Other Study ID Numbers:
  • 3180/CEIH/2023
First Posted:
Mar 2, 2023
Last Update Posted:
Mar 2, 2023
Last Verified:
Feb 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 2, 2023