Dexamethasone in Lower Third Molar Surgery

University of Belgrade60 enrolled

Overview

The aim of this randomized double-blind cross over clinical trial is to investigate effectiveness of different routes of applications (intramuscular and submucous at the site of surgery) and doses (4 mg and 8 mg) of Dexamethasone on swelling, trismus, pain and quality of life after lower third molar surgery.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Impacted Third Molar Tooth

Interventions

Intramuscular applicationPROCEDURE

Patient receive 4mg of Dexamethasone by intramuscular application

Submucosal applicationPROCEDURE

Patients receive 4mg of Dexamethasone by submucosal application

4mg Dexamethasone submucosalDRUG

Patients receive 4mg of submucosal Dexamethasone

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Healthy patients (ASA I) * Bilateral symmetrically impacted lower third molars according to Pel-Gregory's and Winter's classification Exclusion Criteria: * Heavy tobacco smokers * Drug and / or alcohol abusers

Locations (1)

School of Dental Medicine

Belgrade, Serbia

Outcomes

Primary Outcomes

Facial swelling (using 3 facial measurements (in millimeters)

We followed facial swelling 1, 3 and 7 days after intervention. Swelling in the operation site will be evaluated using 3 facial measurements (in millimeters): 1. Tragus - Midline. 2. Tragus - Corner of the mouth 3. Gonion - Lateral canthus.

Time frame: 1 day, 3 day, 7 day

Secondary Outcomes

Postoperative pain (visual analog scale)

Postoperative pain will be evaluated using a visual analog scale, 100 mm in length ranging from 0 for " no pain" to 100 for "the worse imaginable pain".

Time frame: 1 day, 3 day, 7 day

Postoperative trismus (difference in interincisal distance at the maximal mouth opening (in millimeters) before and after surgery)

Postoperative trismus will be measured as the difference in interincisal distance at the maximal mouth opening (in millimeters) before and after surgery.

Time frame: 1 day, 3 day, 7 day

Postoperative discomfort (25-items custom made questionnaire)

Postoperative discomfort will be evaluated by filling out the 25-items custom made questionnaire that was designed to asses the patient's perception of adverse effects.

Time frame: 4 day, 7 day

Data from ClinicalTrials.gov

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