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Completed

NCT Number: NCT07258498

Submucosal Dexamethasone for Control of Post-operative Pain, Trismus, and Swelling 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.

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Key information

Conditions

Impacted Mandibular Third Molar Extraction Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Spasm Trismus

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

PAEC General Hospital, Islamabad

Islamabad, Capital, 44000, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

normal saline

Drug

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

Primary outcomes

  1. measurement of post-operative pain, in patients who have undergone surgery for impacted mandibular third molars.

    Time frame: from enrolment to 7th post operative day

    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.

  2. measurement of post-operative trismus in patients who have undergone surgery for impacted mandibular third molars.

    Time frame: From enrollment to the 7th Postoperative day

    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.

  3. measurement of post-operative swelling in patients who have undergone surgery for impacted mandibular third molars.

    Time frame: from enrolment to 7th post operative day

    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.

Secondary outcomes

  1. demographic data (name, age, gender)

    Time frame: from enrolment to 7th post operative day

    name, age, gender would be used to assess the effects of demographic data on post operative sequelae

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

    Time frame: from enrolment to 7th post operative day

    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.

  3. No. of Paracetamol 500 mg tablets taken orally postoperatively

    Time frame: from enrolment to 7th post operative day

    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.

Sponsors and collaborators

Lead sponsor

PAEC General Hospital, Islamabad

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Dec 2, 2025
Registry last updated
Dec 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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