Submucosal Dexamethasone for Control of Post-operative Pain, Trismus, and Swelling After Mandibular Third Molar Surgery

Submucosal Injection of Dexamethasone for the Control of Post-operative Sequelae After Mandibular Third Molar Surgery

Purpose: The aim of this study is to determine the efficacy of submucosal injection of dexamethasone in reducing pain, swelling and trismus, thus to minimize patient's discomfort after surgery, so that the patients could pursue their daily activities without delay. Moreover, the submucosal injection is convenient to the patient and surgeon both, as it is injected after application of local anesthesia and easily administered. OBJECTIVES: To evaluate the outcome of submucosal injection of 4mg/ml dexamethasone in comparison with submucosal injection of normal saline (N/S) on mean post-operative pain, trismus and swelling following mandibular third molar surgery.

Study Overview

• Status: Completed
• Conditions: Impacted Mandibular Third Molar Extraction
• Intervention / Treatment: Drug: Dexamethasone; Drug: Normal Saline

Detailed Description

OPERATIONAL DEFINITIONS:

Pain: Post-operative pain outcome when measured using Visual Analogue Scale (VAS) would determine the subjective pain experience of patients. VAS is a straight, 10 cm long horizontal line. VAS represents continuous pain intensity, where the left end of the line indicates "no pain," while the right end denotes "worst pain imaginable." Patients indicate their level of pain (in cm) by marking a single point on the line.

Swelling: Post-operative facial swelling would be assessed by using Gabka and Matsumara technique. Linear distance between angle of the mandible to lateral corner of the eye (A), distance between tragus to corner of the mouth (B), and distance between tragus to soft tissue pogonion (C) would be quantified in millimeters using measuring tape. The sum of these measurements would be calculated as facial dimension and used to measure the level of swelling in millimeters.

Trismus: Trismus i.e., reduced mouth opening would be quantified in millimeters by measuring interincisal distance at maximum mouth opening using a vernier caliper. Normal mouth opening ranges from 40 to 60 mm. Mouth opening less than 40 mm is considered trismus.

HYPOTHESIS:

Submucosal injection of 4mg/ml dexamethasone will result in lower mean postoperative pain, reduced trismus and less swelling after mandibular third molar surgery.

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Phase 4

Contacts and Locations

Study Locations

• Pakistan
  • Capital
    • Islamabad, Capital, Pakistan, 44000
      • PAEC General Hospital, Islamabad

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Cases of impacted mandibular third molar according to Pell and Gregory classification (class l, 2. 3 and A. B, C)
• Both genders (male and female)
• Age limit: 18 - 45 years

Exclusion Criteria:

• Patients with pericoronitis.
• Patients with known allergy to corticosteroids.
• Medically compromised patients.
• Current pregnancy.
• Lactating women.
• Use of medication by the patients that could interfere with the healing process.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dexamethasone; submucosal injection of dexamethasone would be used in this study to prevent post-operative pain , swelling and trismus in patient having surgical extraction of impacted mandibular third molars.	Drug: Dexamethasone; In this study submucosal injection of dexamethasone would be given to the patient 30 minutes before surgical extraction of impacted mandibular third molar surgery to reduce pain, swelling and trismus, thus to minimize patient's discomfort after surgery, so that the patients could pursue their daily activities without delay
Placebo Comparator: Normal saline (placebo); Out of 70 patients 35 patients would be given submucosal injection of normal saline as a placebo.	Drug: Normal Saline; submucosal injection of normal saline (N/S) would not reduce trismus, swelling, and pain

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
measurement of post-operative pain, in patients who have undergone surgery for impacted mandibular third molars.	Pain: Post-operative pain outcome when measured using Visual Analogue Scale (VAS) would determine the subjective pain experience of patients. VAS is a straight, 10 cm long horizontal line. VAS represents continuous pain intensity, where the left end of the line indicates "no pain," while the right end denotes "worst pain imaginable." Patients indicate their level of pain (in cm). by marking a single point on the line.	from enrolment to 7th post operative day
measurement of post-operative trismus in patients who have undergone surgery for impacted mandibular third molars.	Trismus i.e., reduced mouth opening would be quantified in millimeters by measuring interincisal distance at maximum mouth opening using a vernier caliper. Normal mouth opening ranges from 40 to 60 mm. Mouth opening less than 40 mm is considered trismus.	From enrollment to the 7th Postoperative day
measurement of post-operative swelling in patients who have undergone surgery for impacted mandibular third molars.	Swelling: Post-operative facial swelling would be assessed by using Gabka and Matsumara technique. Linear distance between angle of the mandible to lateral corner of the eye (A), distance between tragus to corner of the mouth (B), and distance between tragus to soft tissue pogonion (C) would be quantified in millimeters using measuring tape. The sum of these measurements would be calculated as facial dimension and used to measure the level of swelling in millimeters.	from enrolment to 7th post operative day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
demographic data (name, age, gender)	name, age, gender would be used to assess the effects of demographic data on post operative sequelae	from enrolment to 7th post operative day
tooth number of impacted tooth according to FDI tooth numbering system, type of impaction	tooth number of impacted tooth according to FDI tooth numbering system, type of impaction according to pell and gregory classification would be used to assess any effect of these outcomes on post-operative sequelae after mandibular third molar surgery.	from enrolment to 7th post operative day
No. of Paracetamol 500 mg tablets taken orally postoperatively	No. of Paracetamol 500 mg tablets taken orally postoperatively would be used to assess if patient was pain free or had pain post-operatively following impacted mandibular third molar surgery.	from enrolment to 7th post operative day

Collaborators and Investigators

• Sponsor: PAEC General Hospital, Islamabad
• Investigators: Principal Investigator: Dr Kanza Ateeque, BDS, PAEC General Hospital, Islamabad

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2024
• Primary Completion (Actual): September 30, 2025
• Study Completion (Actual): September 30, 2025

Study Registration Dates

• First Submitted: November 16, 2025
• First Submitted That Met QC Criteria: November 20, 2025
• First Posted (Actual): December 2, 2025

Study Record Updates

• Last Update Posted (Actual): December 2, 2025
• Last Update Submitted That Met QC Criteria: November 20, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: pain; trismus; swelling; submucosal dexamethasone; impacted mandibular third molar; surgical extraction
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Neuromuscular Manifestations; Spasm; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain; Trismus; Pharmaceutical Preparations; Polycyclic Compounds; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Steroids, Fluorinated; Crystalloid Solutions; Isotonic Solutions; Solutions; Pregnadienetriols; Dexamethasone; Saline Solution
• Other Study ID Numbers: PGHI-IRB (DMe)-RCD-06-068

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: As the hospital where this study is being conducted does allow to share any collected data with other researchers due to patient confidentiality

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No