Use of Corticosteroids in Third Molar Surgery

NCT05752305 | Completed Phase 2 DMC

• 1 other identifier: 3180/CEIH/2023
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

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.

Conditions

Inflammation; Pain, Postoperative; Trismus

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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

Study Arms (2)

Methylprednisolone group

EXPERIMENTAL

Preoperative administration of 40mg of methylprednisolone via submucosa

Drug: MethylPREDNISolone 40 Mg/mL Injectable Suspension

Dexamethasone group

EXPERIMENTAL

Preoperative administration of 8mg of dexamethasone via submucosa

Drug: Dexamethasone 4 Mg/mL Injectable Solution

Interventions

Dexamethasone 4 Mg/mL Injectable Solution DRUG

Preoperative submucosal administration of 8mg of dexamethasone or 40mg of methylprednisolone.

Dexamethasone group

MethylPREDNISolone 40 Mg/mL Injectable Suspension DRUG

Preoperative submucosal administration of 8mg of dexamethasone or 40mg of methylprednisolone.

Methylprednisolone group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universidad de Granada: lead

Study Sites (1)

Unai Fernández Martín

Granada, Spain

Location

MeSH Terms

Conditions

Inflammation; Pain, Postoperative; Trismus

Interventions

Dexamethasone; Methylprednisolone

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pain; Neurologic Manifestations; Signs and Symptoms; Spasm; Neuromuscular Manifestations; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Prednisolone

Study Officials

• Unai Fernández

  Universidad de Granada

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 9, 2023
• First Posted: March 2, 2023
• Study Start: January 15, 2022
• Primary Completion: July 1, 2023
• Study Completion: July 15, 2023
• Last Updated: December 6, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)