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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07450638
Enrollment
60
Registered
2026-03-05
Start date
2026-01-04
Completion date
2026-04-15
Last updated
2026-03-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

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

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.

Detailed description

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.

Interventions

DRUGDexamethasone 8 mg IM

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.

DRUGNormal Saline IM

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.

Sponsors

Al Salam University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Masking description

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.

Intervention model description

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.

Eligibility

Sex/Gender
ALL
Age
18 Years to 35 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Postoperative pain6, 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.
Facial Swelling Measured by Linear Facial Measurements (Tragus-Pogonion and Gonion-Lateral Canthus Distances)Preoperatively, Day 2, and Day 7 postoperativelyFacial 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.
Trismus (Maximum interincisal opening)Preoperatively, Day 2, and Day 7 postoperativelyTrismus will be measured by maximum interincisal mouth opening using calipers.

Secondary

MeasureTime frameDescription
Analgesic consumptionPostoperative days 1-7Total number of rescue analgesic tablets (ibuprofen 400 mg) taken postoperatively.
Number of rescue analgesic tablets takenPostoperative days 1-7Number of additional analgesic tablets consumed by each participant after surgery.

Countries

Egypt

Contacts

PRINCIPAL_INVESTIGATOROmaima M Sakr, BDS, MSc, PhD

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

STUDY_DIRECTORAhmed K Fawzi, BDS, MSc, PhD

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 6, 2026