"Effect of Preoperative Submucosal Dexamethasone on Postoperative Discomfort After Mandibular Third Molar Surgery"

NCT07554963 | Not Yet Recruiting Phase 4

• 1 other identifier: HMC-OMFS-DEXA-2025
• Study Type: interventional
• Target: 268
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Postoperative Pain; Trismus; Impacted Mandibular Third Molar

Keywords

Dexamethasone; Third Molar Surgery; Impacted Tooth; Postoperative Pain

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Dexamethasone Group

EXPERIMENTAL

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; Other: No intervention

No Drug Control Group

NO INTERVENTION

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.

Interventions

Dexamethasone DRUG

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.

Dexamethasone Group

No intervention OTHER

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.

Dexamethasone Group

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hayat Abad Medical Complex, Peshawar: lead

Related Publications (6)

• 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

  RESULT

• 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

  RESULT

• 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

  RESULT

• 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

  RESULT

• 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

  RESULT

• 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

  RESULT

MeSH Terms

Conditions

Pain, Postoperative; Trismus; Tooth, Impacted

Interventions

Dexamethasone

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Spasm; Neuromuscular Manifestations; Nervous System Diseases; Tooth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Central Study Contacts

Abdul Basit Khan, FCPS I

CONTACT

+92 318 6809664; drbasitkhan7@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: This study is conducted as an open-label trial. No blinding is applied to participants, care providers, investigators, or outcome assessors due to the nature of the intervention (submucosal injection versus no intervention).
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Postgraduate Resident

Model Details: Participants will be randomly assigned in a 1:1 ratio to either the intervention group (preoperative 4 mg submucosal dexamethasone) or the control group (no study drug). Allocation will be performed using a computer-generated randomization sequence. Both groups will undergo the same standardized surgical procedure and receive identical postoperative care. Outcomes will be assessed at predefined time points (postoperative days 2 and 7). The study follows a parallel design in which participants remain in their assigned groups throughout the study period.

Study Record Dates

• First Submitted: April 21, 2026
• First Posted: April 28, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: May 1, 2026

Record last verified: 2026-04