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

NCT07258498 | Completed Phase 4 DMC

• 1 other identifier: PGHI-IRB (DMe)-RCD-06-068
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Impacted Mandibular Third Molar Extraction

Keywords

submucosal dexamethasone; impacted mandibular third molar; surgical extraction; pain; swelling; trismus

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• demographic data (name, age, gender)

  from enrolment to 7th post operative day

• tooth number of impacted tooth according to FDI tooth numbering system, type of impaction

  from enrolment to 7th post operative day

• No. of Paracetamol 500 mg tablets taken orally postoperatively

  from enrolment to 7th post operative day

Study Arms (2)

Dexamethasone

EXPERIMENTAL

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

Normal saline (placebo)

PLACEBO COMPARATOR

Out of 70 patients 35 patients would be given submucosal injection of normal saline as a placebo.

Drug: Normal Saline

Interventions

Dexamethasone DRUG

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

Dexamethasone

Normal Saline DRUG

submucosal injection of normal saline (N/S) would not reduce trismus, swelling, and pain

Normal saline (placebo)

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• PAEC General Hospital, Islamabad: lead

Study Sites (1)

PAEC General Hospital, Islamabad

Islamabad, Capital, 44000, Pakistan

Location

MeSH Terms

Conditions

Pain; Trismus

Interventions

Dexamethasone; Saline Solution

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Spasm; Neuromuscular Manifestations; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Dr Kanza Ateeque, BDS

  PAEC General Hospital, Islamabad

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Postgraduate Trainee Dr Kanza Ateeque

Model Details: Study design: Randomized controlled trial (RCT). Setting: Department of Oral \& Maxillofacial Surgery, Pakistan Atomic Energy Commission General Hospital, Islamabad. Duration: 12 months (after approval of synopsis from CPSP)

Study Record Dates

• First Submitted: November 16, 2025
• First Posted: December 2, 2025
• Study Start: October 1, 2024
• Primary Completion: September 30, 2025
• Study Completion: September 30, 2025
• Last Updated: December 2, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)