Evaluation of the Dental Vibe Injection Comfort System (DVRCT)

Harvard Medical School (HMS and HSDM)

Status: Completed

Conditions: Anesthesia, Local; Pain

Treatments: Device: Dental Vibe

Study type: Interventional

Funder types: Other

Identifiers

NCT04971941

IRB14-2778

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria: Able to volunteer for dental anesthesia -

Exclusion Criteria: Non volunteer

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 4 patient groups

DV3 with first LB injection

Active Comparator group

Description:

Use of Dental Vibe with first long buccal block

Treatment:

Device: Dental Vibe

DV3 with first LB and with IAN

Active Comparator group

Description:

Dental Vibe with first long buccal injection and inferior alveolar block

Treatment:

Device: Dental Vibe

DV3 with 2nd LB

Experimental group

Description:

Use of DentalVibe with 2nd Long Buccal injection

Treatment:

Device: Dental Vibe

DV3 with 2nd LB and IAN

Experimental group

Description:

Use of DentalVibe with 2nd long buccal and inferior alveolar nerve block

Treatment:

Device: Dental Vibe