NCT01227525

Brief Summary

Behavioral and physiologic observations suggest that the injection of local anesthetic is among the most feared or anxiety producing procedures during dental intervention. Discomfort during the injection is currently reduced by pharmacologic or mechanical methods. No technique has proven to be effective for every patient. The VibraJect LLC (USA) was first introduced in 1995 and was developed under the hypothesis that a vibrating needle would stimulate large diameter nerve fibers and thereby close the gate to smaller nerves carrying the pain signal from the injection site. Studies on adult patients have been promising. The purpose of this study is to investigate the efficacy of the VibraJect dental syringe attachment in reducing injection discomfort and procedural anxiety in the pediatric dental population.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable pain

Timeline
Completed

Started Aug 2008

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2008

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

April 27, 2009

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
1.4 years until next milestone

First Posted

Study publicly available on registry

October 25, 2010

Completed
Last Updated

August 22, 2017

Status Verified

August 1, 2017

Enrollment Period

10 months

First QC Date

April 27, 2009

Last Update Submit

August 17, 2017

Conditions

Pain

Outcome Measures

Primary Outcomes (1)

  • Observed disruptive behavior

    1 Year

Secondary Outcomes (2)

  • Behavior ratings by dentist of cooperative behavior

    1 Year

  • subjective pain ratings on visual analogue scale

    1 Year

Interventions

VibrajectDEVICE

The VibraJect clips onto the barrel of a conventional and intraligamentary dental syringe (and some disposable syringes) and vibrates the needle at a high frequency while injections are administered.

Eligibility Criteria

Age4 Years - 8 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Attending the UNMC pediatric dentistry clinic for dental restorations requiring injection of local anesthetic for restorative procedures with or without use of inhalation anesthesia but without physical restraint
  • age 4 to 8

You may not qualify if:

  • No parent or legal guardian is present
  • Parent does not give consent
  • Non-English speaking participants will be excluded because PI is English speaking and this study needs behavior guidance of children that only the dentist can deliver and not an interpreter.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Brandi Roeber, DDS

    University of Nebraska

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Secondary Investigator

Study Record Dates

First Submitted

April 27, 2009

First Posted

October 25, 2010

Study Start

August 1, 2008

Primary Completion

June 1, 2009

Study Completion

June 1, 2009

Last Updated

August 22, 2017

Record last verified: 2017-08