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Assessing the Benefits of the Vibraject Attachment

NCT01227525 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2017-08-22

No results posted yet for this study

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.

Conditions

Interventions

DEVICE

Vibraject

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.

Sponsors & Collaborators

  • Keith Allen, PhD

    lead OTHER

Principal Investigators

  • Brandi Roeber, DDS · University of Nebraska

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
4 Years
Max Age
8 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-08-31
Primary Completion
2009-06-30
Completion
2009-06-30

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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 NCT01227525 on ClinicalTrials.gov