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

PAEC General Hospital, Islamabad

Status and phase: Completed; Phase 4

Conditions: Impacted Mandibular Third Molar Extraction

Treatments: Drug: Normal Saline; Drug: Dexamethasone

Study type: Interventional

Funder types: Other

Identifiers

NCT07258498

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

Details and patient eligibility

About

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.

Full 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.

Enrollment: 70 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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70 participants in 2 patient groups, including a placebo group

Dexamethasone

Experimental group

Description:

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.

Treatment:

Drug: Dexamethasone

Normal saline (placebo)

Placebo Comparator group

Description:

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

Treatment:

Drug: Normal Saline