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

NCT03374982 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 23

Last updated 2024-01-03

Study results available
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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.

Conditions

Interventions

DEVICE

DentalVibe

The DentalVibe is a handheld device that delivers vibration to the tissue during local anesthetic administration.

Sponsors & Collaborators

  • University of Nebraska

    lead OTHER

Principal Investigators

  • Christopher H Johnson, DDS · University of Nebraska

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
5 Years
Max Age
11 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-02-19
Primary Completion
2018-04-03
Completion
2019-05-20
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03374982 on ClinicalTrials.gov