Evaluation of the Dental Vibe Injection Comfort System

Study Overview
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Brief Summary
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This study investigated the Dental Vibe Injection Comfort System (DV), developed to lessen anesthesia pain through pulsed vibration, a form of counter-stimulation. The study's aims were to evaluate DV's efficacy in reducing pain/discomfort from intra-oral long buccal (LB) and inferior alveolar nerve (IAN) injections and the time needed to achieve complete anesthesia during an IAN block.

Detailed Description
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Objective: Pain from local anesthesia injections can be reduced by distraction and counter-stimulation techniques. This study investigated the Dental Vibe Injection Comfort System (DV), developed to lessen anesthesia pain through pulsed vibration, a form of counter-stimulation. Design: Our study's aims were to evaluate DV's efficacy in reducing pain/discomfort from intra-oral long buccal (LB) and inferior alveolar nerve (IAN) injections and the time needed to achieve complete anesthesia during an IAN block. Methods: The sixty subjects, equally split by sex, ages 21-32, rated injection pain on a visual analog scale and discomfort, unpleasantness, and difficulty in enduring the injection on a modified symptom severity index. Each subject received bilateral LB injections and an IAN block. Using block design, DV Generation 3 (DV3) was randomly assigned to either the first or second LB injection and to thirty subjects on their third injection, the IAN block. No topical anesthesia was applied.

Official Title
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Evaluation of the Dental Vibe Injection Comfort System

Conditions
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Anesthesia, Local, Pain

Intervention / Treatment
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* Device: Dental Vibe


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Able to volunteer for dental anesthesia - Exclusion Criteria: Non volunteer -

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: DV3 with first LB injection<br>Use of Dental Vibe with first long buccal block | Device: Dental Vibe<br>* Use of Dental Vibe during dental anesthesia intervention<br>|
| Active Comparator: DV3 with first LB and with IAN<br>Dental Vibe with first long buccal injection and inferior alveolar block | Device: Dental Vibe<br>* Use of Dental Vibe during dental anesthesia intervention<br>|
| Experimental: DV3 with 2nd LB<br>Use of DentalVibe with 2nd Long Buccal injection | Device: Dental Vibe<br>* Use of Dental Vibe during dental anesthesia intervention<br>|
| Experimental: DV3 with 2nd LB and IAN<br>Use of DentalVibe with 2nd long buccal and inferior alveolar nerve block | Device: Dental Vibe<br>* Use of Dental Vibe during dental anesthesia intervention<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| VAS | VAS (visual analog scale) measured pain during anesthesia procedure on a scale from 0-10 with 0 being no pain and 10 being the most intense pain. The lowest number is the best outcome. | Measured during anesthesia procedure by the subject and recorded after each individual anesthesia procedure, an average of one minute | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SSI | SSI measured tolerability, intensity, and unpleasantness of anesthesia procedure. Each has a scale from 0-28; with 0 being the least discomfort, least intolerable, and lowest intensity; whereas 28 is the most discomfort, most intolerable, and most intense. | measured by subject during procedure but recorded directly after each procedure | 
| Time in Minutes | Time for complete inferior alveolar nerve block anesthesia with or without use of Dental Vibe measured in minutes. The time was recorded in minutes from when the anesthesia procedure was completed until the subject had a numb lip and could no longer feel cold (ice) applied to their ipsilateral canine tooth | After procedure until lip numbness, an average of four minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Anesthesia, local, Pain