N/A N=23 Randomized Single-blind Supportive Care

Effect of the DentalVibe Injection System on Pain During Local Anesthesia Injections in Children

Pain

Bottom Line

View on ClinicalTrials.gov: NCT03374982 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jan 2024

Primary outcome: Primary: Self Reported Pain Rating Using Wong-Baker FACES Scale — 3.57; 5.13 score on a scale

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: DentalVibe (Device)
Age: Pediatric · 5+ yrs
Sex: All
Sponsor: University of Nebraska
Primary completion: Apr 2018

Outcome Measures

Outcome	Result	p-value
PRIMARY Self Reported Pain Rating Using Wong-Baker FACES Scale	3.57; 5.13	—

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 the Wong-Baker FACES pain rating scale from an experimental group (local anesthesia injection with DentalVibe system) and a control group (traditional local anesthesia injection with DentalVibe system turned off) in children. Eligibility: Children age 5-11 years old who require local anesthesia for bilateral dental treatment at University of Nebraska Medical Center (UNMC) pediatric dental clinic. Children must understand and speak English. Interventions and evaluations: Each patient will have two separate restorative appointments where the DentalVibe will be used during local anesthetic injections. One appointment the DentalVibe will be turned on and one appointment the DentalVibe will be turned off. After each injection the child will be shown the Wong Baker FACES Pain Rating Scale and asked to pick a face associated with their level of hurt during the injection. Follow-up: All children will be followed up with any necessary recommended dental treatment.

Eligibility Criteria

Inclusion Criteria

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 Criteria

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.

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Data sourced from ClinicalTrials.gov (NCT03374982). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.