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Assessing the Benefits of the Vibraject Attachment

This study has been completed.
Sponsor:
Information provided by:
University of Nebraska
ClinicalTrials.gov Identifier:
NCT01227525
First received: April 27, 2009
Last updated: October 25, 2010
Last verified: October 2010
History of Changes
  Purpose

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.


Condition Intervention
Pain
 Device: Vibraject

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Assessing Pain Behaviors of Children Receiving Local Anesthesia Using VibraJect Attachment

Resource links provided by NLM:

MedlinePlus related topics: Anxiety
U.S. FDA Resources

Further study details as provided by University of Nebraska:

Primary Outcome Measures:
  • Observed disruptive behavior [ Time Frame: 1 Year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Behavior ratings by dentist of cooperative behavior [ Time Frame: 1 Year ] [ Designated as safety issue: No ]
  • subjective pain ratings on visual analogue scale [ Time Frame: 1 Year ] [ Designated as safety issue: No ]

Enrollment: 90
Study Start Date: August 2008
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    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.
Detailed Description:

One hundred children will be recruited from the UNMC Pediatric Dentistry clinic. Eligible children will be selected from the 4-6 year group who are scheduled for routine dental restorative treatment and who have or have never received a dental injection. Each patient will randomly participate in either a control or experimental condition. The device will be attached for both conditions. During the control injection, the dentist will perform the dental injection as usual. During the experimental injection, the dentist will activate the attached device and perform the injection. Immediately following each injection, the patient will rate the pain on a visual analog scale and a trained observer will rate the child's behavior on a Frankl behavior scale. A videotape of the procedure will be reviewed by an independent dentist who will evaluate the child's response and any perceived disruptive behavior. This observer will be blind to whether the instrument is functioning.

  Eligibility

Ages Eligible for Study:   4 Years to 8 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 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
  2. age 4 to 8

Exclusion Criteria:

  1. No parent or legal guardian is present
  2. Parent does not give consent
  3. 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01227525

Sponsors and Collaborators
University of Nebraska
Investigators
Principal Investigator: Brandi Roeber, DDS University of Nebraska
  More Information

No publications provided

Responsible Party: Brandi Roeber, University of Nebraska Medical Center
ClinicalTrials.gov Identifier: NCT01227525     History of Changes
Other Study ID Numbers: 535-07-FB
Study First Received: April 27, 2009
Last Updated: October 25, 2010
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on May 23, 2013