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NCT Number: NCT07450638

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

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.

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Key information

Conditions

Impacted Mandibular Third Molar Facial Swelling Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Postoperative Pain Signs and Symptoms Spasm Trismus

Age range

18 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Oral & Maxillofacial Surgery, Al Salam University

Tanta, Gharbia Governorate, Egypt

About this study

Surgical removal of impacted lower wisdom teeth often causes pain, swelling, and reduced jaw opening (trismus) due to tissue inflammation. This study examined whether giving a single dose of long-acting corticosteroids before surgery could reduce these postoperative problems.

Adult patients aged 18-35 years who required surgical extraction of impacted mandibular third molars were randomly assigned to receive either 8 mg dexamethasone (treatment group) or a placebo (control group) 30 minutes before surgery. The study measured pain using a visual analog scale, facial swelling with standard facial landmarks, and jaw opening with calipers at multiple time points after surgery. Analgesic consumption was also recorded.

The goal was to determine whether preoperative corticosteroid administration could improve recovery, reduce discomfort, and enhance patient comfort after third molar surgery. This information may help guide oral surgeons in postoperative care and improve outcomes for patients undergoing similar procedures.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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.

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.

Primary outcomes

  1. Postoperative pain

    Time frame: 6, 24, 48, and 72 hours postoperatively.

    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.

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

    Time frame: Preoperatively, Day 2, and Day 7 postoperatively

    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.

  3. Trismus (Maximum interincisal opening)

    Time frame: Preoperatively, Day 2, and Day 7 postoperatively

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

Secondary outcomes

  1. Analgesic consumption

    Time frame: Postoperative days 1-7

    Total number of rescue analgesic tablets (ibuprofen 400 mg) taken postoperatively.

  2. Number of rescue analgesic tablets taken

    Time frame: Postoperative days 1-7

    Number of additional analgesic tablets consumed by each participant after surgery.

Sponsors and collaborators

Lead sponsor

Al Salam University

Other

Registry information

Official study title

Efficacy of Preoperative Long-acting Corticosteroids on Postoperative Pain, Swelling, and Trismus Following Impacted Mandibular Third Molar Surgery: A Randomized Controlled Clinical Trial.

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Mar 5, 2026
Registry last updated
Mar 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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