Status:
COMPLETED
Effect of the DentalVibe Injection System on Pain During Local Anesthesia Injections in Children
Lead Sponsor:
University of Nebraska
Conditions:
Pain
Eligibility:
All Genders
5-11 years
Phase:
NA
Brief Summary
Title: Effect of the DentalVibe injection system on pain during local anesthesia injections in children. Purpose: The purpose of this study is to compare self-reported pain scale measurements using t...
Detailed Description
Up to 50 children between the ages of 5-11 years will participate in this randomized, controlled, cross-over, split-mouth study. There will be no gender restrictions used in this study. Participants w...
Eligibility Criteria
Inclusion
- Children between the ages of 5-11 who require dental treatment that requires bilateral local anesthesia on the maxilla or mandible. Subjects must understand and speak English.
Exclusion
- No children with presence of medically or developmentally compromising conditions (autism, cerebral palsy, moderate/severe asthma); history of chronic disease (seizure disorder, cardiac disorder, hematological disease, endocrine disorder, liver disease, renal disease). Non-English speakers will be excluded. Subject who require oral sedation or general anesthesia for treatment due to behavior or medical history will be excluded.
Key Trial Info
Start Date :
February 19 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 20 2019
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT03374982
Start Date
February 19 2018
End Date
May 20 2019
Last Update
January 3 2024
Active Locations (1)
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1
Children's Hospital & Medical Center Specialty Pediatric Center Dental Clinic
Omaha, Nebraska, United States, 68114