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

Primary Purpose

Dental Pain

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Generation II Dental Vibe Unit
Sponsored by
University of the Pacific
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Dental Pain focused on measuring Efficacy, Dental Vibe Unit, Reduction, Elimination, Dental Anesthetic Injection

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Dental Vibe

    Arm Description

    New oscillating device for reduction in pain during dental anesthesia

    Outcomes

    Primary Outcome Measures

    reduction of pain in dental anesthesia

    Secondary Outcome Measures

    Full Information

    First Posted
    April 8, 2015
    Last Updated
    April 10, 2015
    Sponsor
    University of the Pacific
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02414620
    Brief Title
    Efficacy of the Dental Vibe Unit for Use of Reduction or Elimination of Pain During Dental Anesthetic Injection
    Official Title
    Efficacy of the Dental Vibe Unit for Use of Reduction or Elimination of Pain During Dental Anesthetic Injection
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2012
    Overall Recruitment Status
    Completed
    Study Start Date
    August 2012 (undefined)
    Primary Completion Date
    June 2013 (Actual)
    Study Completion Date
    June 2013 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University of the Pacific

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.
    Detailed Description
    Subjects were in groups of 3-4 for 2 ½ hours where 1 subject will be the operator delivering injection, 1 subject will be the assistant, and 1 subject was the patient receiving the injection. It was all be conducted in the pre-clinical local anesthesia rotation in a clinical setting. OSHA regulations will be followed and supplies was provided for subjects. Using standard syringe, the operator assembled a 27 gauge short needle and load a 2% lidocaine 1:100,000 epi cartridge. Gauze was applied to the area of the upper right muccobuccal fold, where the penetration site of the ASA injection was administered. Small amount of topical will be placed at penetration site and left for approximately one minute. The subject posing as the operator obtained a retraction method using a mouth mirror. The ASA injection technique was then be applied and 1/3 cartridge of solution will be administered at the deposition site. Immediately after, using same standard syringe and remaining anesthestic cartridge, the operator replaced the 27 gauge short needle. Gauze was applied to the area of the upper left muccobuccal fold, where the penetration site of the ASA injection was administered. Small amount of topical was placed at penetration site and left for approximately one minute. The subject posing as the operator will obtain a retraction method using the Dental Vibe Unit, turn the device on and kept active for 3-5 seconds prior to, during, and after needle penetration. The ASA injection technique was applied and 1/3 cartridge of solution was administered at the deposition site. The ASA injection technique had a penetration site into the muccobuccal fold above or in between the maxillary canine and maxillary first pre-molar. The depth of penetration was initially 3 mm into soft tissue, and then the needle was slowly advanced an additional 2 mm or until bone was gently reached. Anesthesia was then deposited at a rate of ¼ cartridge / 15 seconds. An aspiration test was given, which then confirmed that anesthesia was not being deposited into a blood vessel. Once 1/3 cartridge was dispensed, needle was then removed from site. An evaluation then was given to the subject posing as the patient. The subjects was carefully observed for appropriate site preparation, injection technique, proper placement of mouth mirror, and proper placement of Dental Vibe Unit.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Dental Pain
    Keywords
    Efficacy, Dental Vibe Unit, Reduction, Elimination, Dental Anesthetic Injection

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Phase 4
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    80 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Dental Vibe
    Arm Type
    Experimental
    Arm Description
    New oscillating device for reduction in pain during dental anesthesia
    Intervention Type
    Device
    Intervention Name(s)
    Generation II Dental Vibe Unit
    Intervention Description
    . The Dental Vibe emits strong pulsed vibration which is transmitted via a silicone mouth piece to mucosal tissue.
    Primary Outcome Measure Information:
    Title
    reduction of pain in dental anesthesia
    Time Frame
    15 min

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: The subjects will be first and second year students giving their injections during their anesthesia rotation. Subjects are not being actively recruited. Exclusion Criteria: Students will be given the option to voluntarily participate in this study during their normally scheduled anesthesia rotation.

    12. IPD Sharing Statement

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