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
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
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
NCT ID
NCT02414620
First Posted
April 8, 2015
Last Updated
April 10, 2015
Sponsor
University of the Pacific
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
Learn more about this trial
Efficacy of the Dental Vibe Unit for Use of Reduction or Elimination of Pain During Dental Anesthetic Injection
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