Dexamethasone in Lower Third Molar Surgery
Effectiveness of Different Application Modalities of Dexamethasone on Clinical Parameters and Quality of Life After Lower Third Molar Surgery
1 other identifier
interventional
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Jan 2014
Longer than P75 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2014
CompletedFirst Submitted
Initial submission to the registry
April 2, 2015
CompletedFirst Posted
Study publicly available on registry
April 15, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2019
CompletedApril 22, 2019
April 1, 2019
5.2 years
April 2, 2015
April 19, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
1 day, 3 day, 7 day
Secondary Outcomes (3)
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
Study Arms (6)
Intramuscular application
ACTIVE COMPARATORIntramuscular application of 4mg Dexamethasone
Submucosal application
EXPERIMENTALSubmucosal application of 4mg Dexamethasone
4mg Dexamethasone submucosal
ACTIVE COMPARATOR4mg Dexamethasone submucosal application
8mg Dexamethasone submucosal
EXPERIMENTAL8mg Dexamethasone submucosal application
4mg Dexamethasone postoperative
ACTIVE COMPARATOR4mg Dexamethasone postoperative application
4mg Dexamethasone preoperative
EXPERIMENTAL4mg Dexamethasone postoperative application
Interventions
Patient receive 4mg of Dexamethasone by intramuscular application
Patients receive 4mg of Dexamethasone by submucosal application
Patients receive 4mg of submucosal Dexamethasone
Patients receive 8mg of submucosal Dexamethasone
Patients receive 4mg of Dexamethasone preoperatively
Patients receive 4mg of Dexamethasone postoperatively
Eligibility Criteria
You may qualify if:
- Healthy patients (ASA I)
- Bilateral symmetrically impacted lower third molars according to Pel-Gregory's and Winter's classification
You may not qualify if:
- Heavy tobacco smokers
- Drug and / or alcohol abusers
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
School of Dental Medicine
Belgrade, 11000, Serbia
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Miroslav M Andric, DDS, PhD
University of Zagreb
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
April 2, 2015
First Posted
April 15, 2015
Study Start
January 1, 2014
Primary Completion
April 1, 2019
Study Completion
April 1, 2019
Last Updated
April 22, 2019
Record last verified: 2019-04