Effectiveness of Different Application Modalities of Dexamethasone on Clinical Parameters and Quality of Life After Lower Third Molar Surgery
Overview
- Phase
- Phase 4
- Intervention
- Intramuscular application
- Conditions
- Impacted Third Molar Tooth
- Sponsor
- University of Belgrade
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Facial swelling (using 3 facial measurements (in millimeters)
- Status
- Completed
- Last Updated
- 7 years ago
Overview
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.
Investigators
Miroslav Andric
Assistant Professor
University of Belgrade
Eligibility Criteria
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
Arms & Interventions
Intramuscular application
Intramuscular application of 4mg Dexamethasone
Intervention: Intramuscular application
Submucosal application
Submucosal application of 4mg Dexamethasone
Intervention: Submucosal application
4mg Dexamethasone submucosal
4mg Dexamethasone submucosal application
Intervention: 4mg Dexamethasone submucosal
8mg Dexamethasone submucosal
8mg Dexamethasone submucosal application
Intervention: 8mg Dexamethasone submucosal
4mg Dexamethasone postoperative
4mg Dexamethasone postoperative application
Intervention: 4mg Dexamethasone preoperative
4mg Dexamethasone preoperative
4mg Dexamethasone postoperative application
Intervention: 4mg Dexamethasone postoperative
Outcomes
Primary Outcomes
Facial swelling (using 3 facial measurements (in millimeters)
Time Frame: 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 Outcomes
- Postoperative pain (visual analog scale)(1 day, 3 day, 7 day)
- Postoperative trismus (difference in interincisal distance at the maximal mouth opening (in millimeters) before and after surgery)(1 day, 3 day, 7 day)
- Postoperative discomfort (25-items custom made questionnaire)(4 day, 7 day)