Effect of Preoperative Long-Acting Corticosteroids on Pain, Swelling, and Trismus After Impacted Lower Third Molar Surgery

NCT07450638 | Active Not Recruiting DMC

• 1 other identifier: Sue010401262
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This study evaluated whether giving a single dose of long-acting corticosteroids before wisdom tooth surgery reduces pain, facial swelling, and limited jaw opening (trismus) after surgery. Adult patients aged 18-35 undergoing impacted lower wisdom tooth removal were randomly assigned to receive either 8 mg dexamethasone or a placebo before surgery. Pain, swelling, and jaw mobility were measured at several time points after surgery. The study aimed to determine if preoperative corticosteroids improve recovery and reduce discomfort following surgery.

Conditions

Impacted Mandibular Third Molar; Postoperative Pain; Trismus; Facial Swelling

Keywords

Impacted third molar; Dexamethasone; Postoperative pain; Facial swelling; Trismus; Third molar surgery; Oral surgery; Randomized clinical trial

Outcome Measures

Primary Outcomes (3)

• Postoperative pain

  Postoperative pain will be assessed using the Visual Analog Scale (VAS), a 10-cm horizontal line ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst pain imaginable. Higher scores indicate greater pain intensity.

  6, 24, 48, and 72 hours postoperatively.

• Facial Swelling Measured by Linear Facial Measurements (Tragus-Pogonion and Gonion-Lateral Canthus Distances)

  Facial swelling will be assessed using standardized linear facial measurements between anatomical landmarks (tragus to pogonion and gonion to lateral canthus) using a flexible measuring tape. Measurements will be recorded in millimeters (mm). An increase in distance compared to preoperative values indicates greater facial swelling.

  Preoperatively, Day 2, and Day 7 postoperatively

• Trismus (Maximum interincisal opening)

  Trismus will be measured by maximum interincisal mouth opening using calipers.

  Preoperatively, Day 2, and Day 7 postoperatively

Secondary Outcomes (2)

• Analgesic consumption

  Postoperative days 1-7

• Number of rescue analgesic tablets taken

  Postoperative days 1-7

Study Arms (2)

Dexamethasone Group (Treatment)

EXPERIMENTAL

Participants receive a single dose of 8 mg dexamethasone administered intramuscularly 30 minutes before impacted mandibular third molar surgery. This intervention is intended to reduce postoperative pain, facial swelling, and limited jaw opening (trismus). Participants, care providers, investigators, and outcome assessors are blinded to group allocation.

Drug: Dexamethasone 8 mg IM

Placebo Group (Control)

PLACEBO COMPARATOR

Participants receive a single dose of normal saline (placebo) administered intramuscularly 30 minutes before impacted mandibular third molar surgery. This arm serves as the control group for comparison with the dexamethasone group. Blinding is maintained for participants, care providers, investigators, and outcome assessors.

Drug: Normal Saline IM

Interventions

Dexamethasone 8 mg IM DRUG

Patients receive a single intramuscular injection of 8 mg dexamethasone 30 minutes before surgical removal of impacted mandibular third molars. This intervention is intended to reduce postoperative pain, facial swelling, and trismus. No additional steroids are allowed postoperatively.

Dexamethasone Group (Treatment)

Normal Saline IM DRUG

Patients receive a single intramuscular injection of 2 mL normal saline 30 minutes before surgical removal of impacted mandibular third molars. This placebo control is used to compare the effect of preoperative dexamethasone on postoperative pain, facial swelling, and trismus.

Placebo Group (Control)

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Adults aged 18-35 years
• Indicated for surgical removal of impacted mandibular third molars (Pell \& Gregory Class II-III)
• ASA I or II (healthy or mild systemic disease)
• Willing to provide informed consent

You may not qualify if:

• Known allergy to corticosteroids
• Systemic diseases contraindicating steroid use (e.g., uncontrolled diabetes, immunosuppression)
• Pregnancy or lactation
• Acute pericoronitis or local infection
• Current use of steroids or NSAIDs

Sponsors & Collaborators

• Al Salam University: lead

Study Sites (1)

Department of Oral & Maxillofacial Surgery, Al Salam University

Tanta, Gharbia Governorate, Egypt

Location

MeSH Terms

Conditions

Pain, Postoperative; Trismus

Interventions

Dexamethasone

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; 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

Study Officials

• Omaima M Sakr, BDS, MSc, PhD

  Al Salam University, Faculty of Oral & Dental Medicine, Egypt

  PRINCIPAL INVESTIGATOR

• Ahmed K Fawzi, BDS, MSc, PhD

  Al Salam University, Faculty of Oral & Dental Medicine, Egypt

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants, care providers, investigators, and outcome assessors were blinded to group allocation. Identical syringes were prepared by an independent clinician not involved in treatment or outcome assessment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants are randomly assigned to receive either preoperative intramuscular dexamethasone or placebo before impacted mandibular third molar surgery, and outcomes are compared between both groups.

Study Record Dates

• First Submitted: February 15, 2026
• First Posted: March 5, 2026
• Study Start: January 4, 2026
• Primary Completion: April 4, 2026
• Study Completion: April 15, 2026
• Last Updated: March 5, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)