Condition or disease | Intervention/treatment | Phase |
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Pediatric Anesthesia Local Anesthesia | Device: Comfort-in injection system Other: conventional injection with dental needle | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 60 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Comparision of Injection Pain Caused by the 'Comfort in' Injection System Versus a Traditional Syringe for Inferior Alveolar Nerve Block Anaesthesia in Primary Teeth |
Actual Study Start Date : | June 1, 2018 |
Actual Primary Completion Date : | May 15, 2019 |
Actual Study Completion Date : | June 15, 2019 |
Arm | Intervention/treatment |
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Experimental: experimental
local anesthesia applyed with Comfort in system
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Device: Comfort-in injection system
local anesthesia during dental treatment
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Active Comparator: conventional injection
local anesthesia applyed with conventional syringe
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Other: conventional injection with dental needle
for local anesthesia during dental treatment
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Ages Eligible for Study: | 6 Years to 12 Years (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
In need of treatment of right and left molar teeth of mandible,
Exclusion Criteria:
Turkey | |
Okan University Faculty of Dentistry | |
Istanbul, Turkey, 34959 |
Tracking Information | |||||
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First Submitted Date ICMJE | July 11, 2019 | ||||
First Posted Date ICMJE | July 22, 2019 | ||||
Last Update Posted Date | July 22, 2019 | ||||
Actual Study Start Date ICMJE | June 1, 2018 | ||||
Actual Primary Completion Date | May 15, 2019 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | No Changes Posted | ||||
Current Secondary Outcome Measures ICMJE | Not Provided | ||||
Original Secondary Outcome Measures ICMJE | Not Provided | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | Local Anesthesia With Needle-free Injection System | ||||
Official Title ICMJE | Comparision of Injection Pain Caused by the 'Comfort in' Injection System Versus a Traditional Syringe for Inferior Alveolar Nerve Block Anaesthesia in Primary Teeth | ||||
Brief Summary | The purpose of this study was to compare the pain during needle insertion and injection in mandibular molars anesthetized with either traditional syringe (control) or Comfort in System (experimental). | ||||
Detailed Description | Not Provided | ||||
Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Not Applicable | ||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Crossover Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Completed | ||||
Actual Enrollment ICMJE |
60 | ||||
Original Actual Enrollment ICMJE | Same as current | ||||
Actual Study Completion Date ICMJE | June 15, 2019 | ||||
Actual Primary Completion Date | May 15, 2019 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 6 Years to 12 Years (Child) | ||||
Accepts Healthy Volunteers ICMJE | Yes | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | Turkey | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT04028271 | ||||
Other Study ID Numbers ICMJE | 2018/201 Marmara universty ( Other Identifier: Ethical Committe ) |
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Has Data Monitoring Committee | Not Provided | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Sinem yildirim, Okan University | ||||
Study Sponsor ICMJE | Sinem yildirim | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE | Not Provided | ||||
PRS Account | Okan University | ||||
Verification Date | July 2019 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |