Assessing the Benefits of the Vibraject Attachment
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.
|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|
- Observed disruptive behavior [ Time Frame: 1 Year ] [ Designated as safety issue: No ]
- 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 ]
|Study Start Date:||August 2008|
|Study Completion Date:||June 2009|
|Primary Completion Date:||June 2009 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01227525
|Principal Investigator:||Brandi Roeber, DDS||University of Nebraska|