The Effectiveness of Using a Single Post-operative Intramuscular Dexamethasone Injection on Patients with Surgical Extraction of Lower Third Molar

NCT06809855 | Completed Phase 1

• 1 other identifier: 997124
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

Evaluating the effectiveness of using a single immediate postoperative intramuscular Dexamethasone injection on pain, swelling, trismus and tissue healing in the first seven days. Methods: A split mouth technique on 16 patients with bilateral similar impacted mandibular third molar were extracted; one side was given 8mg intramuscular injection of dexamethasone (study group) and the other side wasn't given injection (control group) and compare of the two sides were done in the following seven days.

Conditions

Dexamethasone Administration; Post Extraction Complication

Outcome Measures

Primary Outcomes (3)

• post operative pain changes

  measurement of change in pain on visual scale analog from 10 to 1 , 10 mean the worst pain and 1 is least pain

  each participant was seen at 1st, 3rd and 7th post-operative days

• Change in post operative swelling

  The swelling was measured between two points marked on skin in millimeters using ruler

  each participant was seen at 1st, 3rd and 7th post-operative days

• Post operative Change in mouth opening

  The distance between upper and lower incisors was measured in millimeters using ruler

  each participant was seen at 1st, 3rd and 7th post-operative days

Secondary Outcomes (1)

• Tissue healing

  Healing was assessed on the 7th postoperative day

Study Arms (2)

dexamethasone immediate injection postoperatively

ACTIVE COMPARATOR

intramuscular injection of a single dose 8mg dexamethasone immediate postoperatively after removal of impacted mandibular third molar

Drug: Dexamethasone

no intervention

NO INTERVENTION

Interventions

Dexamethasone DRUG

single 8mg post-operative intramuscular injection

dexamethasone immediate injection postoperatively

Eligibility Criteria

• Age: 15 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• bilateral similar impacted lower third molar
• willing to do surgical extraction

You may not qualify if:

• allergic to dexamethasone
• who has medical diseases
• taking any medications
• pregnant or lactating women

Sponsors & Collaborators

• Yassir R. Al-khannaq: lead

Study Sites (1)

Department of Oral and Maxillofacial Surgery, College of Dentistry, University of Baghdad

Baghdad, Iraq

Location

MeSH Terms

Interventions

Dexamethasone

Intervention Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: lecturer Dr.

Model Details: Each patient resembles the study group in which the patient is injected intramuscularly by a single dose 8mg dexamethasone immediate postoperatively after removal of impacted mandibular third molar on one side and control group on which the impacted mandibular third molar on the other side is removed without usage of 8mg dexamethasone.

Study Record Dates

• First Submitted: January 30, 2025
• First Posted: February 5, 2025
• Study Start: April 20, 2024
• Primary Completion: September 15, 2024
• Study Completion: October 16, 2024
• Last Updated: February 25, 2025

Record last verified: 2025-02

Locations

IR (1)