Efficacy of Preoperative Long-acting Corticosteroids on Postoperative Pain, Swelling, and Trismus Following Impacted Mandibular Third Molar Surgery: A Randomized Controlled Clinical Trial.
Phase: NA
Conditions: Impacted Mandibular Third Molar, Postoperative Pain, Trismus, Facial Swelling
Sponsor: Al Salam University

 
 
 
Al Salam University 
Faculty of Dentistry 
Department of Oral and Maxillofacial Surgery 
 
Efficacy of Preoperative long-acting Corticosteroids on 
Postoperative Pain, Swelling, and Trismus Following Impacted 
Mandibular Third Molar Surgery: A Randomized Controlled 
Clinical Trial 
 
Research Proposal Prepared by: 
Omaima Mahmoud Sakr, BDS, MSc, PhD 
Ahmed Khalil Fawzi, BDS, MSc, PhD 
 
NCT Number: [To be added after PRS assigns it] 
Document Date: January 4, 2026 
  
 
 

Efficacy of Preoperative long-acting Corticosteroids on 
Postoperative Pain, Swelling, and Trismus Following Impacted 
Mandibular Third Molar Surgery: A Randomized Controlled 
Clinical Trial 
Abstract  
Background: Surgical removal of impacted mandibular third molars commonly results in 
postoperative pain, facial swelling, and trismus due to inflammatory mediator release 
.Corticosteroids suppress phospholipase A2 activity and reduce prostaglandin and leukotriene 
synthesis, thereby minimizing postoperative inflammation .Although corticosteroids are widely 
used in oral surgery, optimal timing, dosage, and clinical benefit of preoperative administration 
remain controversial, with conflicting evidence in the literature.  
Study objective: Evaluate the effectiveness of a single preoperative dose of long-acting 
corticosteroids in reducing postoperative pain, facial swelling, and trismus after impacted 
mandibular third molar surgery. 
 Methods: The study will be conducted as  prospective, randomized, double-blind, 
placebo-controlled clinical trial at the department of Oral & Maxillofacial Surgery 
Alsalam university on 60 patients (30 per group), individuals aging between 18 and 35 
years, which will be  randomized and submitted to two interventions, one with 8mg 
dexamethasone and the other with normal saline (placebo) will administered 
intramuscularly. The primary outcome variable is the postoperative pain level which will 
be measured with a Visual Analogue Scale (VAS) recorded at 6, 24, 48, and 72 hours 
postoperatively ,facial swelling  which will be measured using standardized facial 
landmarks (tragus–pogonion, gonion–lateral canthus)  preoperatively, day 2, and day 7 
and trismus will be measured by the  maximum interincisal mouth opening using calipers 
will recorded preoperatively, day 2, and day 7. The Secondary Outcome is analgesic 
consumption, number of rescue analgesic tablets taken postoperatively. 
 
Introduction 
The inflammatory process triggered by tissue trauma from third molar surgery commonly results 
in pain, swelling and trismus, and is responsible for significant functional and aesthetic 
discomfort during the postoperative period (1,2). In these cases, the preemptive use of anti-
inflammatory drugs has the potential to reduce the intensity and morbidity of these events by 
inhibiting the inflammatory response prior to surgical trauma (3-6).  
Corticosteroids are drugs capable of suppressing the inflammatory response and immune 
function at various stages (7,8). The perioperative use of systemic corticosteroids is a common 

approach to control inflammatory events after third molars removal, with potential to reduce 
early and late swelling and trismus, although its effects on pain control are controversial (5). 
Dexamethasone is a long-acting corticosteroid, a synthetic analogue of prednisolone, which has a 
potent anti-inflammatory effect, mainly by promoting the synthesis of regulatory proteins of the 
inflammatory process, such as lipocortin and vasocortin (9-12). Dexamethasone was used 
effectively in the field of oral surgery . (6,12,13-17). However optimal timing, dosage, and clinical 
benefit of preoperative administration remain controversial, with conflicting evidence in the 
literature.  
Objectives 
 To compare postoperative pain levels between corticosteroid and placebo groups 
 To assess facial swelling reduction postoperatively 
 To evaluate improvement in mouth opening (trismus) 
 To assess analgesic consumption post-surgery 
Hypothesis 
Null hypothesis (H₀): Preoperative corticosteroids have no significant effect on postoperative 
pain, swelling, or trismus following third molar surgery. 
Alternative hypothesis (H₁): Preoperative corticosteroids significantly reduce postoperative pain, 
swelling, and trismus compared to placebo. 
Study Design 
Design: Prospective, randomized, double-blind, placebo-controlled clinical trial 
Study Setting: Department of Oral & Maxillofacial Surgery Alsalam university  
Study Duration: 3 months 
Sample size: 60 patients (30 per group) 
Sample size calculation based on: 
Power: 80% 
Alpha: 0.05 
Effect size derived from previous similar studies 
Inclusion Criteria 
Patients aged 18–35 years Indicated for surgical removal of impacted mandibular third molars 
(Pell & Gregory Class II–III) NASA I or II. Willing to provide informed consent 
Exclusion Criteria 

 Known allergies 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 
Randomization & Blinding 
 Patients randomly will be assigned into two groups using computer-generated 
randomization 
 Double-blind: neither surgeon nor patient knows group allocation 
 Identical syringes will be prepared by an independent clinician 
Intervention 
Group A (Test Group) 
Dexamethasone 8 mg will administer intramuscularly 30 minutes preoperatively 
Group B (Control Group) 
Normal saline (placebo) will be administered intramuscularly 
Surgical Procedure 
Standardized surgical protocol: 
 Local anesthesia with 2% lidocaine + epinephrine 
 Mucoperiosteal flap elevation 
 Bone removal and tooth sectioning if required 
 Primary closure using 3-0 silk sutures 
 All surgeries performed by the same surgeon to reduce bias 
Outcome Measures 
Primary Outcomes 
Pain: Will be assessed using Visual Analog Scale (VAS) Recorded at 6, 24, 48, and 72 hours 
postoperatively 
Facial Swelling:  Will be measured using standardized facial landmarks (tragus–pogonion, 
gonion–lateral canthus) Recorded preoperatively, Day 2, and Day 7 
Trismus: Maximum interincisal mouth opening will be measured using calipers’ recorded 
preoperatively, Day 2, and Day 7 

Secondary Outcome: 
 Analgesic consumption 
 Number of rescue analgesic tablets taken postoperatively 
Postoperative Care 
All patients receive: 
 Standard antibiotics (if routinely prescribed) 
 Ibuprofen 400 mg as rescue analgesic 
 No additional steroids allowed 
Statistical Analysis 
 Data will be analyzed using SPSS 
 Continuous variables expressed as mean ± SD 
 Independent T-test for intergroup comparison 
 Repeated measures ANOVA for intra-group comparison 
 Significance level set at p < 0.05 
Ethical Considerations 
 Ethical approval will be obtained from Institutional Review Board 
 Written will be informed consent obtained from all participants 
 Study will be  conducted according to the Declaration of Helsinki 
Expected Outcomes 
 Reduced postoperative pain scores 
 Decreased facial swelling 
 Improved mouth opening 
 Lower analgesic consumption in corticosteroid group 
Clinical Significance 
This study may establish preoperative corticosteroid administration as a simple, safe, and 
effective protocol to reduce postoperative morbidity following third molar surgery. 
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