The Effect of Sonophoresis on Topical Anesthesia: a Clinical Trial

Detailed Summary

The Dental Anesthesia Sonophoresis Device (DASD) is a novel device that is intended to reduce the discomfort associated with puncturing the oral mucosa. DASD is a portable, battery-powered device that simultaneously generates ultrasonic energy and sonic vibration in a small applicator head that can easily reach and adapt to injection sites in the oral cavity. The ultrasonic energy provides a sonophoretic effect on the oral mucosa, generating micro channels through the lipids between the keratinized cells that make up the stratum corneum. Once the benzocaine has permeated the stratum corneum, it is quickly absorbed into the soft tissue desensitizing the area and reducing the perception of pain caused by the trauma of puncturing soft tissue. Methods: A split-mouth model using 50 healthy subjects from the ages of 18 to 50 will undergo needle puncture of the maxillary mucobuccal fold at the canine eminence. Prior to the injection there will be randomized application of 20% Benzocaine with a device which is a modified battery operated tooth brush that in appearance and sound is similar to the DASD which only produces sonic vibration which will be known as (SV) or 20% benzocaine with application of the DASD device, that produces ultrasonic as well as sonic vibration. Subjects will rate their pain according to the Visual Analog Scale (VAS).The purpose of this study is to evaluate whether sonophoresis applied using the DASD will eliminate the pain associated with intraoral injections within one minute of application. Null Hypothesis (Ho): There is no difference in the perception of pain when the DASD is used compared to topical anesthetic applied with sonic vibration. The Alternative Hypothesis (Ha): There is a difference in pain perception when the DASD is used for application of topical anesthetic compared to topical anesthetic applied with sonic vibration.

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