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Behavioural Intervention

DentalVibe turned Off and then turned On for Pain

N/A
Waitlist Available
Led By Christopher H Johnson, DDS
Research Sponsored by University of Nebraska
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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.
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up immediately after local anesthetic delivery
Awards & highlights

Study 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

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~immediately after local anesthetic delivery
This trial's timeline: 3 weeks for screening, Varies for treatment, and immediately after local anesthetic delivery for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Self Reported Pain Rating Using Wong-Baker FACES Scale

Trial Design

2Treatment groups
Experimental Treatment
Group I: DentalVibe turned On then turned OffExperimental Treatment1 Intervention
DentalVibe will be turned on during local anesthetic injection at the first appointment. DentalVibe will be turned off during local anesthetic injection at the second appointment.
Group II: DentalVibe turned Off and then turned OnExperimental Treatment1 Intervention
DentalVibe will be turned off during local anesthetic injection at the first appointment. DentalVibe will be turned on during local anesthetic injection at the second appointment.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
DentalVibe
2018
Completed Phase 2
~90

Find a Location

Who is running the clinical trial?

University of NebraskaLead Sponsor
535 Previous Clinical Trials
1,143,883 Total Patients Enrolled
1 Trials studying Pain
8,100 Patients Enrolled for Pain
Christopher H Johnson, DDSPrincipal InvestigatorUniversity of Nebraska

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
~3 spots leftby Mar 2025