ClinicalTrials.gg
Active, not recruitingNCT07450638Updated Mar 5, 2026

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

An interventional study of Dexamethasone 8 mg IM and Normal Saline IM in Impacted Mandibular Third Molar, Postoperative Pain and Trismus, sponsored by Al Salam University. Active, not recruiting at 1 site in Egypt. Open to participants aged 18 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-03-05.

Sponsored by Al Salam University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Apr 2026, 7 months ago, but the record still lists the study as active, not recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years to 35 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • 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
03

In context

Pain, Postoperative

5,640 studies on the registry are indexed under Pain, Postoperative; 1,230 are open to participants now.

This study's planned enrollment of 60 is below the median of 75 across 4,821 interventional studies indexed under Pain, Postoperative.

Browse Pain, Postoperative studies →

Lead sponsor

Al Salam University is the lead sponsor of 2 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 35 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Known allergy to
  • Systemic diseases contraindicating steroid use (e.g., uncontrolled diabetes, )
  • Pregnancy or lactation
  • Acute pericoronitis or local infection
  • Current use of steroids or NSAIDs
Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

ASA physical status

The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
60 participants (estimated)

Study arms

  • Experimental
    Dexamethasone Group (Treatment)

    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 comparator
    Placebo Group (Control)

    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

  • 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.

06

What researchers measure

Primary outcomes

  1. 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.

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

  2. 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.

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

  3. Trismus (Maximum interincisal opening)

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

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

Secondary outcomes

  1. Analgesic consumption

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

    Time frame: Postoperative days 1-7

  2. Number of rescue analgesic tablets taken

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

    Time frame: Postoperative days 1-7

07

Study locations

1 site
08

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No — The individual participant data (IPD) will not be shared outside the study team due to privacy and confidentiality considerations.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 5, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07450638
Lead sponsor
Al Salam University
Responsible party
Sponsor
First posted
Mar 5, 2026
Start date
Jan 4, 2026
Primary completion
Apr 4, 2026 (estimated)
Completion
Apr 15, 2026 (estimated)
Last update
Mar 5, 2026

Study contacts

Omaima M Sakr, BDS, MSc, PhD
principal investigator · Al Salam University, Faculty of Oral & Dental Medicine, Egypt
Ahmed K Fawzi, BDS, MSc, PhD
study director · Al Salam University, Faculty of Oral & Dental Medicine, Egypt

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: Dexamethasone

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