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Use of Corticosteroids in Third Molar Surgery

Primary Purpose

Inflammation, Pain, Postoperative, Trismus

Status
Recruiting
Phase
Phase 2
Locations
Spain
Study Type
Interventional
Intervention
Dexamethasone 4 Mg/mL Injectable Solution
MethylPREDNISolone 40 Mg/mL Injectable Suspension
Sponsored by
Universidad de Granada
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Inflammation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

  • Unai Fernández MartínRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Methylprednisolone group

Dexamethasone group

Arm Description

Preoperative administration of 40mg of methylprednisolone via submucosa

Preoperative administration of 8mg of dexamethasone via submucosa

Outcomes

Primary Outcome Measures

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.
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.
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).

Secondary Outcome Measures

Full Information

First Posted
February 9, 2023
Last Updated
February 28, 2023
Sponsor
Universidad de Granada
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1. Study Identification

Unique Protocol Identification Number
NCT05752305
Brief Title
Use of Corticosteroids in Third Molar Surgery
Official Title
Effect of Preoperative Administration of Dexamethasone Versus Methylprednisolone in Surgical Extraction of Retained Lower Third Molars
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 15, 2022 (Actual)
Primary Completion Date
April 1, 2023 (Anticipated)
Study Completion Date
June 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad de Granada

4. Oversight

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
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inflammation, Pain, Postoperative, Trismus

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
84 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Methylprednisolone group
Arm Type
Experimental
Arm Description
Preoperative administration of 40mg of methylprednisolone via submucosa
Arm Title
Dexamethasone group
Arm Type
Experimental
Arm Description
Preoperative administration of 8mg of dexamethasone via submucosa
Intervention Type
Drug
Intervention Name(s)
Dexamethasone 4 Mg/mL Injectable Solution
Intervention Description
Preoperative submucosal administration of 8mg of dexamethasone or 40mg of methylprednisolone.
Intervention Type
Drug
Intervention Name(s)
MethylPREDNISolone 40 Mg/mL Injectable Suspension
Intervention Description
Preoperative submucosal administration of 8mg of dexamethasone or 40mg of methylprednisolone.
Primary Outcome Measure Information:
Title
Postoperative inflammation following third molar surgical extraction
Description
Postoperative swelling was determined by measuring tragus-chin distance, tragus-labial cleft distance and eye angle-jaw angle distance, using a millimeter ruler.
Time Frame
7 days
Title
Postoperative trismus following third molar surgical extraction
Description
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.
Time Frame
7 days
Title
Postoperative pain following third molar surgical extraction
Description
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).
Time Frame
7 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Unai Fernández
Phone
639428296
Ext
+34
Email
unaifmfl@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Unai Fernández
Organizational Affiliation
Universidad de Granada
Official's Role
Principal Investigator
Facility Information:
Facility Name
Unai Fernández Martín
City
Granada
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Unai Fernández Martín
Phone
639428296
Email
unaifmfl@correo.ugr.es

12. IPD Sharing Statement

Plan to Share IPD
No

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Use of Corticosteroids in Third Molar Surgery

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