Efficacy of the Dental Vibe Unit for Use of Reduction or Elimination of Pain During Dental Anesthetic Injection

NCT02414620 | Completed Phase 4

• 1 other identifier: 10-40.7
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of the research was to test the efficacy of the Dental Vibe Injection Comfort System. The study was conducted by faculty to have students as subjects to see if there are any differences in the comfort level of an ASA injection given on one side with topical anesthesia and lidocaine 1:100,000 with epinephrine using a standard syringe, and the other side uing the Dental Vibe, topical anesthesia and lidocaine 1:100,000 with epinephrine and a standard syringe. The Dental Vibe emits strong pulsed vibration which is transmitted via a silicone mouth piece to mucosal tissue. This in turn interferes with, blocks or reduces the perception of pain from the injection for the patient. It is stated that this phenomenon is achieved due to the "gate theory" of neuronal activity. There are also likely, distraction and placebo effects that contribute to the devices' efficacy.

Conditions

Dental Pain

Keywords

Efficacy; Dental Vibe Unit; Reduction; Elimination; Dental Anesthetic Injection

Outcome Measures

Primary Outcomes (1)

• reduction of pain in dental anesthesia

  15 min

Study Arms (1)

Dental Vibe

EXPERIMENTAL

New oscillating device for reduction in pain during dental anesthesia

Device: Generation II Dental Vibe Unit

Interventions

Generation II Dental Vibe Unit DEVICE

. The Dental Vibe emits strong pulsed vibration which is transmitted via a silicone mouth piece to mucosal tissue.

Dental Vibe

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The subjects will be first and second year students giving their injections during their anesthesia rotation. Subjects are not being actively recruited.

You may not qualify if:

• Students will be given the option to voluntarily participate in this study during their normally scheduled anesthesia rotation.

Sponsors & Collaborators

• University of the Pacific: lead

MeSH Terms

Conditions

Toothache

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases; Facial Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2015
• First Posted: April 13, 2015
• Study Start: August 1, 2012
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: April 13, 2015

Record last verified: 2012-07