Evaluation of the Dental Vibe Injection Comfort System

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.

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Key information

Conditions

Anesthesia, Local Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Able to volunteer for dental anesthesia -

Exclusion criteria

Non volunteer

Treatment and study plan

Dental Vibe

Device

Use of Dental Vibe during dental anesthesia intervention

Primary outcomes

VAS

Time frame: Measured during anesthesia procedure by the subject and recorded after each individual anesthesia procedure, an average of one minute

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.

Secondary outcomes

SSI

Time frame: measured by subject during procedure but recorded directly after each procedure

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.
Time in Minutes

Time frame: After procedure until lip numbness, an average of four 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

Sponsors and collaborators

Lead sponsor

Harvard Medical School (HMS and HSDM)

Other

Registry information

Acronym: DVRCT

Important dates

Study start: 2015
Primary completion: 2015
Study completion: 2015
First posted: Jul 22, 2021
Registry last updated: Feb 3, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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