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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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16 December 2017 |
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Main ID: |
NCT03130933 |
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Date of registration:
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17/04/2017 |
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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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Complications After Lower Third Molar Surgery
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Scientific title:
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Does a Single Dose of Systemic Antibiotics Prevent Postoperative Inflammatory Complications After Lower Third Molar Surgery? A Randomized Controlled Trial |
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Date of first enrolment:
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April 2010 |
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Target sample size:
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400 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT03130933 |
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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: Parallel Assignment. Primary purpose: Prevention. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
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Phase:
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Phase 1/Phase 2
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Countries of recruitment
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Croatia
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Contacts
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Name:
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Nino Grgic, DMD |
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Address:
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Telephone:
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Email:
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Affiliation:
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fifth author |
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Name:
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Marko Granic, DMD,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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Second author |
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Name:
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Dinko Kneževic, DMD |
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Address:
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Email:
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Affiliation:
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fourth author |
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Name:
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Tihomir Kuna, DMD, 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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Third author |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- systematically healthy subjects between 18 to 40 years (both gender) and having
semi-impacted lower third molars indicated for surgical removal
Exclusion Criteria:
- The exclusion criteria in this study were systematic diseases, with developing local
infections, current smokers, pregnant women, lactating females, patients using oral
contraceptive drugs and those under any antibiotic coverage.
Age minimum:
18 Years
Age maximum:
40 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Third Molar
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Postoperative Complications
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Intervention(s)
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Other: Placebo
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Drug: Amoxicillin 500 Mg
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Procedure: Lower third molar surgery
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Primary Outcome(s)
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Pain
[Time Frame: 1 day and 7 days after surgery]
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Secondary Outcome(s)
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Wound healing ( AO, SSI )
[Time Frame: 1 day and 7 days after surgery]
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Hemorrhage
[Time Frame: through 7 days]
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Swelling
[Time Frame: 1 day and 7 days after surgery]
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Increased body temperature
[Time Frame: through 7 days]
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Maximum inter-incisal opening of mouth
[Time Frame: 1 day and 7 days after surgery]
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Secondary ID(s)
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SCHOOL OF DENTAL MEDICINE
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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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