Efficacy of the Dental Vibe Unit for Use of Reduction or Elimination of Pain During Dental Anesthetic Injection
Condition: Dental Pain
MeSH terms: Toothache
Study type: Interventional
Phase: Phase 4

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.
    

Intervention name(s): Generation II Dental Vibe Unit
Intervention type(s): Device
Intervention description(s): . The Dental Vibe emits strong pulsed vibration which is transmitted via a silicone mouth piece to mucosal tissue.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Efficacy; Dental Vibe Unit; Reduction; Elimination; Dental Anesthetic Injection