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

NCT ID: NCT07258498

Last Updated: 2025-12-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-01
• Study Completion Date: 2025-09-30

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.

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.

Conditions

Impacted Mandibular Third Molar Extraction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Dexamethasone

Intervention Type: 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 (placebo)

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

Group Type: PLACEBO_COMPARATOR

Normal Saline

Intervention Type: DRUG

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

Interventions

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

Intervention Type: DRUG

Normal Saline

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

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

PAEC General Hospital, Islamabad

OTHER

Sponsor Role: lead

Responsible Party

Kanza Ateeque

Postgraduate Trainee Dr Kanza Ateeque

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Dr Kanza Ateeque, BDS

Role: PRINCIPAL_INVESTIGATOR

PAEC General Hospital, Islamabad

Locations

PAEC General Hospital, Islamabad

Islamabad, Capital, Pakistan

Countries

Pakistan

Other Identifiers

PGHI-IRB (DMe)-RCD-06-068

Identifier Type: -

Identifier Source: org_study_id