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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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3 August 2015 |
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Main ID: |
NCT02440347 |
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Date of registration:
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23/04/2015 |
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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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Effects of Articaine Computer-controlled and Conventional Delivery for Anterior and Middle Superior Alveolar Nerve Block
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Scientific title:
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Efficacy and Safety of Pulpal Anesthesia After Anterior and Middle Superior Alveolar (AMSA) Nerve Block Obtained by Articaine Computer-controlled and Conventional Delivery |
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Date of first enrolment:
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June 2014 |
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Target sample size:
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30 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02440347 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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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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Bozidar M Brkovic, 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, University of Belgrade |
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Name:
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Marija S Milic, DDS |
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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, University of Belgrade |
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Name:
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Vladimir M Biocanin, 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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Faculty of Pharmacy and Health, University of Travnik, Bosnia and Herzegovina |
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Name:
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Dejan Cetkovic, DDS |
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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, University of Belgrade |
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Name:
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Ivana Brajic, DDS |
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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, University of Belgrade |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- ASA I
- full maxillary dental arch
- vital maxillary teeth without caries, restorations, periodontal disease or history of
trauma
Exclusion Criteria:
- allergies to local anesthetic solution ingredients, food and drugs
- alcohol and drugs abuse
- heavy tobacco smoking
Age minimum:
18 Years
Age maximum:
30 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Local Anesthesia
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Intervention(s)
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Device: Computer controlled anesthetic delivery by Anaeject
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Device: Conventional anesthetic delivery by carpule syringe
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Primary Outcome(s)
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Duration of pulpal anesthesia
[Time Frame: up to 64 minutes from baseline]
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Secondary Outcome(s)
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Duration of soft tissue anesthesia buccal
[Time Frame: Up to 120 min]
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Systolic blood pressure at 35 minutes
[Time Frame: 0, 35 minutes]
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Diastolic blood pressure at 15 minutes
[Time Frame: 0, 15 minutes]
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Heart rate at 5 minutes
[Time Frame: 0, 5 mninutes]
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Systolic blood pressure at 20 minutes
[Time Frame: 0, 20 minutes]
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Systolic blood pressure at 5 minutes
[Time Frame: 0, 5 minutes]
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Width of anesthetic field medial-lateral
[Time Frame: 5 minutes]
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Heart rate at 10 minutes
[Time Frame: 0, 10 minutes]
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Heart rate at baseline
[Time Frame: 0 minutes]
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Heart rate at 20 minutes
[Time Frame: 0, 20 minutes]
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Width of anesthetic field marginal-superior
[Time Frame: 5 minutes]
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Diastolic blood pressure at 10 minutes
[Time Frame: 0, 10 minutes]
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Duration of soft tissue anesthesia palatal
[Time Frame: Up to 120 minutes]
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Diastolic blood pressure at 35 minutes
[Time Frame: 0, 35 minutes]
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Heart rate at 15 minutes
[Time Frame: 0, 15 minutes]
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Onset of pulpal anesthesia
[Time Frame: Up to 8 minutes]
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Systolic blood pressure at 15 minutes
[Time Frame: 0, 15 minutes]
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Diastolic blood pressure at 5 minutes
[Time Frame: 0, 5 minutes]
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Heart rate at 35 minutes
[Time Frame: 0, 35 minutes]
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Diastolic blood pressure at 20 minutes
[Time Frame: 0, 20 minutes]
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Diastolic blood pressure at baseline
[Time Frame: 0 minutes]
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Systolic blood pressure at baseline
[Time Frame: 0 minutes]
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Systolic blood pressure at 10 minutes
[Time Frame: 0, 10 minutes]
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Secondary ID(s)
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175021
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36/5-2015
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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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