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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02416869 |
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Date of registration:
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02/04/2015 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Dexamethasone in Lower Third Molar Surgery
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Scientific title:
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Effectiveness of Different Application Modalities of Dexamethasone on Clinical Parameters and Quality of Life After Lower Third Molar Surgery |
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Date of first enrolment:
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January 2014 |
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Target sample size:
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60 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02416869 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
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Phase:
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Phase 4
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Countries of recruitment
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Serbia
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Contacts
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Name:
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Miroslav M Andric, DDS, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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School of Dental Medicine |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
65 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Impacted Third Molar Tooth
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Intervention(s)
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Drug: 4mg Dexamethasone submucosal
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Drug: 8mg Dexamethasone submucosal
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Procedure: 4mg Dexamethasone preoperative
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Procedure: Intramuscular application
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Procedure: Submucosal application
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Procedure: 4mg Dexamethasone postoperative
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Primary Outcome(s)
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Facial swelling (using 3 facial measurements (in millimeters)
[Time Frame: 1 day, 3 day, 7 day]
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Secondary Outcome(s)
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Postoperative discomfort (25-items custom made questionnaire)
[Time Frame: 4 day, 7 day]
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Postoperative pain (visual analog scale)
[Time Frame: 1 day, 3 day, 7 day]
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Postoperative trismus (difference in interincisal distance at the maximal mouth opening (in millimeters) before and after surgery)
[Time Frame: 1 day, 3 day, 7 day]
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Secondary ID(s)
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36/11-2013
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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