"Effect of Preoperative Submucosal Dexamethasone on Postoperative Discomfort After Mandibular Third Molar Surgery" (DEXA-M3M)

Effect of Preoperative 4 mg Submucosal Dexamethasone on Postoperative Discomfort After Impacted Mandibular Third Molar Surgery: A Randomized Controlled Trial

This study aims to determine whether giving a single dose of dexamethasone before surgery can reduce pain and difficulty in opening the mouth after removal of an impacted lower wisdom tooth. Pain and limited mouth opening are common problems after this procedure and can affect eating, speaking, and daily activities.

A total of 268 patients aged 18 to 55 years who require surgical removal of an impacted mandibular third molar will be included. Participants will be randomly assigned to one of two groups. One group will receive a 4 mg dexamethasone injection under the gum before surgery, while the other group will not receive this medication. All patients will undergo the same surgical procedure and receive standard postoperative care.

Pain will be measured using a visual analogue scale, and mouth opening will be assessed using a standard measuring method. These outcomes will be recorded on the second and seventh days after surgery.

The results of this study will help determine whether preoperative dexamethasone is an effective and simple method to reduce postoperative discomfort and improve recovery after third molar surgery.

Study Overview

• Status: Not yet recruiting
• Conditions: Postoperative Pain; Trismus; Impacted Mandibular Third Molar
• Intervention / Treatment: Drug: Dexamethasone; Other: No intervention

Detailed Description

This randomized controlled trial is designed to evaluate the efficacy of a single preoperative 4 mg submucosal dexamethasone injection in reducing postoperative discomfort following surgical removal of impacted mandibular third molars. Postoperative discomfort is defined by two primary components: pain intensity and degree of trismus.

The study will be conducted at the Department of Oral and Maxillofacial Surgery, MTI-Hayatabad Medical Complex, Peshawar, Pakistan. A total of 268 participants aged 18-55 years requiring surgical extraction of impacted mandibular third molars will be enrolled using non-probability consecutive sampling. Participants with systemic disease, pregnancy, lactation, recent use of antibiotics or anti-inflammatory drugs, or periodontal disease will be excluded.

Eligible participants will be randomly allocated into two equal groups (n=134 each) using a computer-generated randomization method. The intervention group will receive a single 4 mg submucosal injection of dexamethasone at the surgical site following administration of local anesthesia. The control group will undergo the same surgical procedure without administration of dexamethasone.

All procedures will be standardized, including surgical technique (Ward's incision, bone removal, and suturing) and postoperative analgesia (diclofenac 50 mg). No blinding will be performed due to the nature of the intervention.

Pain intensity will be assessed using a 10-cm visual analogue scale (VAS), while trismus will be evaluated by measuring maximum inter-incisal distance (in millimeters) using a vernier caliper. Measurements will be recorded preoperatively and on postoperative days 2 and 7.

Data will be analyzed using SPSS. Continuous variables will be assessed for normality using the Shapiro-Wilk test and expressed as mean ± standard deviation. Between-group comparisons will be performed using independent samples t-test or Mann-Whitney U test, as appropriate. Categorical variables will be expressed as frequencies and percentages and analyzed using chi-square or Fisher's exact test. A p-value ≤0.05 will be considered statistically significant.

This study is expected to provide evidence on the effectiveness of submucosal dexamethasone as a simple, cost-effective intervention to reduce postoperative morbidity following third molar surgery.

• Study Type: Interventional
• Enrollment (Estimated): 268
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Abdul Basit Khan, FCPS I; Phone Number: +92 318 6809664; Email: drbasitkhan7@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Adults aged 18 to 55 years
• Patients requiring surgical extraction of impacted mandibular third molars
• Patients willing to provide informed consent

Exclusion Criteria:

• Patients with systemic diseases
• Patients with periodontal disease
• Pregnant or lactating women
• Patients who have used antibiotics or anti-inflammatory drugs within the past 7 days
• Patients with known hypersensitivity to dexamethasone

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dexamethasone Group; Participants receive a single preoperative 4 mg submucosal injection of dexamethasone at the surgical site following administration of local anesthesia. All patients undergo standardized surgical extraction of impacted mandibular third molars and receive identical postoperative care.	Drug: Dexamethasone; A single 4 mg dose of dexamethasone is administered via submucosal injection at the surgical site following local anesthesia prior to extraction of the impacted mandibular third molar.; Other: No intervention; Participants do not receive dexamethasone or any study drug. Standard surgical extraction of impacted mandibular third molars is performed, followed by routine postoperative care including analgesia.
No Intervention: No Drug Control Group; Participants undergo standardized surgical extraction of impacted mandibular third molars without receiving dexamethasone or any study drug. All patients receive identical postoperative care, including analgesia, as per institutional protocol.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative Pain Assessed by Visual Analogue Scale (VAS)	Pain intensity will be measured using a 10-cm visual analogue scale (VAS), where 0 indicates no pain and 10 indicates worst possible pain. Scores will be recorded on postoperative day 2 and day 7.	Postoperative Days 2 and 7

Collaborators and Investigators

• Sponsor: Hayat Abad Medical Complex, Peshawar

Publications and helpful links

General Publications

• 6. Gaballah K, Tröller K, Kokemüller H, Arweiler N, Boehme A, Finzen FC. Comparing the effectiveness of submucosal and intramuscular dexamethasone in reducing postoperative discomfort following mandibular third molar surgery: a randomized trial. Sci Rep. 2025;15:11519. doi:10.1038/s41598-025-89744-0
• 5. Selvido D, Bhattarai BP, Rokaya D, Thapa SB, Tritila S, Joda T, et al. Review of dexamethasone administration for management of complications in postoperative third molar surgery. J Korean Assoc Oral Maxillofac Surg. 2021;47(5):341-350. doi:10.5125/jkaoms.2021.47.5.341
• 4. Hou Y, Huang J, Chen J, Yang H, Shen J. The efficacy of corticosteroids on postoperative complications following third molar surgery: a systematic review and meta-analysis. Front Surg. 2021;8:714950. doi:10.3389/fsurg.2021.714950
• 3. Gojayeva N, Pashtayeva N, Nagiyev N, Aliyev A, Özmeriç N, Gülşahı A, et al. Comparison of postoperative pain, swelling, and trismus after impacted mandibular third molar extraction using different cold applications: a randomized controlled clinical trial. BMC Oral Health. 2024;24:131. doi:10.1186/s12903-024-03877-8
• 2. Rizqiawan A, Tjokro S, Widodo A, Ervina E, Ferdiansyah F, Putri MM. Postoperative complications of impacted mandibular third molar extraction and dental anxiety: a cross-sectional study. Int J Dent. 2022;2022:7239339. doi:10.1155/2022/7239339
• 1. Synan W, Stein K. Management of impacted third molars. Oral Maxillofac Surg Clin North Am. 2020;32(4):519-559. doi:10.1016/j.coms.2020.07.002

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026

Study Registration Dates

• First Submitted: April 21, 2026
• First Submitted That Met QC Criteria: April 21, 2026
• First Posted (Actual): April 28, 2026

Study Record Updates

• Last Update Posted (Actual): May 1, 2026
• Last Update Submitted That Met QC Criteria: April 27, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Postoperative Pain; Dexamethasone; Impacted Tooth; Third Molar Surgery
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Stomatognathic Diseases; Nervous System Diseases; Neuromuscular Manifestations; Postoperative Complications; Pathologic Processes; Tooth Diseases; Spasm; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain, Postoperative; Trismus; Tooth, Impacted; Polycyclic Compounds; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Steroids, Fluorinated; Pregnadienetriols; Dexamethasone
• Other Study ID Numbers: HMC-OMFS-DEXA-2025

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: The plan to share individual participant data has not been finalized at this stage. Data sharing will be considered following study completion and publication, subject to institutional policies, ethical considerations, and participant confidentiality safeguards.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No