- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02414620
Efficacy of the Dental Vibe Unit for Use of Reduction or Elimination of Pain During Dental Anesthetic Injection
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 4
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Dental Vibe
New oscillating device for reduction in pain during dental anesthesia
|
. The Dental Vibe emits strong pulsed vibration which is transmitted via a silicone mouth piece to mucosal tissue.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
reduction of pain in dental anesthesia
Time Frame: 15 min
|
15 min
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 10-40.7
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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