Evaluation of the Dental Vibe Injection Comfort System

Not Applicable

Completed

• Conditions: Pain; Anesthesia, Local
• Interventions: Device: Dental Vibe

• Registration Number: NCT04971941
• Lead Sponsor: Harvard Medical School (HMS and HSDM)

Brief Summary

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

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.

Study Timeline

• Study Start: 2015-04
• Primary Completion: 2015-11
• Study Completion: 2015-11
• Study First Submitted: 2021-02-28
• Study First Submitted QC: 2021-07-12
• Study First Posted: 2021-07-22
• Results First Submitted: 2021-08-26
• Status Verified: 2023-01
• Results First Submitted QC: 2023-01-07
• Last Update Submitted: 2023-01-07
• Results First Posted: 2023-02-03
• Last Update Posted: 2023-02-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Able to volunteer for dental anesthesia -

Exclusion Criteria

Non volunteer

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
DV3 with first LB injection	Dental Vibe	Use of Dental Vibe with first long buccal block
DV3 with first LB and with IAN	Dental Vibe	Dental Vibe with first long buccal injection and inferior alveolar block
DV3 with 2nd LB	Dental Vibe	Use of DentalVibe with 2nd Long Buccal injection
DV3 with 2nd LB and IAN	Dental Vibe	Use of DentalVibe with 2nd long buccal and inferior alveolar nerve block

Primary Outcome Measures

Name	Time	Method
VAS	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 Outcome Measures

Name	Time	Method
Time in Minutes	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
SSI	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.