Assessing the Benefits of the Vibraject Attachment (Vibraject)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01227525
Recruitment Status : Completed
First Posted : October 25, 2010
Last Update Posted : August 22, 2017
Information provided by (Responsible Party):
Keith Allen, PhD, University of Nebraska

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.

Condition or disease Intervention/treatment Phase
Pain Device: Vibraject Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Assessing Pain Behaviors of Children Receiving Local Anesthesia Using VibraJect Attachment
Study Start Date : August 2008
Actual Primary Completion Date : June 2009
Actual Study Completion Date : June 2009

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.

Primary Outcome Measures :
  1. Observed disruptive behavior [ Time Frame: 1 Year ]

Secondary Outcome Measures :
  1. Behavior ratings by dentist of cooperative behavior [ Time Frame: 1 Year ]
  2. subjective pain ratings on visual analogue scale [ Time Frame: 1 Year ]

Information from the National Library of Medicine

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Ages Eligible for Study:   4 Years to 8 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01227525

Sponsors and Collaborators
Keith Allen, PhD
Principal Investigator: Brandi Roeber, DDS University of Nebraska

Responsible Party: Keith Allen, PhD, Secondary Investigator, University of Nebraska Identifier: NCT01227525     History of Changes
Other Study ID Numbers: 535-07-FB
First Posted: October 25, 2010    Key Record Dates
Last Update Posted: August 22, 2017
Last Verified: August 2017