Dexamethasone in Lower Third Molar Surgery

Phase 4

Completed

• Conditions: Impacted Third Molar Tooth
• Interventions: Drug: 8mg Dexamethasone submucosal; Procedure: 4mg Dexamethasone preoperative; Procedure: 4mg Dexamethasone postoperative; Procedure: Intramuscular application; Procedure: Submucosal application; Drug: 4mg Dexamethasone submucosal

• Registration Number: NCT02416869
• Lead Sponsor: University of Belgrade

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-01
• Study First Submitted: 2015-04-02
• Study First Submitted QC: 2015-04-14
• Study First Posted: 2015-04-15
• Status Verified: 2019-04
• Primary Completion: 2019-04
• Study Completion: 2019-04
• Last Update Submitted: 2019-04-19
• Last Update Posted: 2019-04-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Healthy patients (ASA I)
• Bilateral symmetrically impacted lower third molars according to Pel-Gregory's and Winter's classification

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Exclusion Criteria

• Heavy tobacco smokers
• Drug and / or alcohol abusers

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
8mg Dexamethasone submucosal	8mg Dexamethasone submucosal	8mg Dexamethasone submucosal application
4mg Dexamethasone postoperative	4mg Dexamethasone preoperative	4mg Dexamethasone postoperative application
4mg Dexamethasone preoperative	4mg Dexamethasone postoperative	4mg Dexamethasone postoperative application
Intramuscular application	Intramuscular application	Intramuscular application of 4mg Dexamethasone
Submucosal application	Submucosal application	Submucosal application of 4mg Dexamethasone
4mg Dexamethasone submucosal	4mg Dexamethasone submucosal	4mg Dexamethasone submucosal application

Primary Outcome Measures

Name	Time	Method
Facial swelling (using 3 facial measurements (in millimeters)	1 day, 3 day, 7 day	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.

Secondary Outcome Measures

Name	Time	Method
Postoperative pain (visual analog scale)	1 day, 3 day, 7 day	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".
Postoperative trismus (difference in interincisal distance at the maximal mouth opening (in millimeters) before and after surgery)	1 day, 3 day, 7 day	Postoperative trismus will be measured as the difference in interincisal distance at the maximal mouth opening (in millimeters) before and after surgery.
Postoperative discomfort (25-items custom made questionnaire)	4 day, 7 day	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.

Trial Locations

Locations (1)

School of Dental Medicine; 🇷🇸 Belgrade, Serbia