Assessing the Benefits of the Vibraject Attachment

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Assessing Pain Behaviors of Children Receiving Local Anesthesia Using VibraJect Attachment

Conditions
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Pain

Intervention / Treatment
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* Device: Vibraject


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 8 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|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.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Observed disruptive behavior |  | 1 Year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Behavior ratings by dentist of cooperative behavior |  | 1 Year | 
| subjective pain ratings on visual analogue scale |  | 1 Year |