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

NCT03374982 | Completed Results DMC FDA Device

• 1 other identifier: 0661-17-FB
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

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 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

Pain

Outcome Measures

Primary Outcomes (1)

• Self Reported Pain Rating Using Wong-Baker FACES Scale

  The scale includes pictures of facial expressions with correlating numerical scale of 0-10. 0 being no hurt and 10 being the worst hurt.

  Immediately after local anesthetic delivery

Study Arms (2)

DentalVibe turned On then turned Off

EXPERIMENTAL

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.

Device: DentalVibe

DentalVibe turned Off and then turned On

EXPERIMENTAL

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.

Device: DentalVibe

Interventions

DentalVibe DEVICE

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

DentalVibe turned Off and then turned On; DentalVibe turned On then turned Off

Eligibility Criteria

• Age: 5 Years - 11 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Nebraska: lead

Study Sites (1)

Children's Hospital & Medical Center Specialty Pediatric Center Dental Clinic

Omaha, Nebraska, 68114, United States

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Zachary Houser
• Organization: University of Nebraska Medical Center

zach.houser@unmc.edu

402-980-9633

Study Officials

• Christopher H Johnson, DDS

  University of Nebraska

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The person administering the FACES pain rating scale will be masked
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a randomized cross-over clinical trial wherein the study subject serves as his or her own control.

Study Record Dates

• First Submitted: December 12, 2017
• First Posted: December 15, 2017
• Study Start: February 19, 2018
• Primary Completion: April 3, 2018
• Study Completion: May 20, 2019
• Last Updated: January 3, 2024
• Results First Posted: January 3, 2024

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)