NCT01283490

The Effect of Sonophoresis on Topical Anesthesia: a Clinical Trial

Completed Phase 1 Last updated 18 November 2016

What this trial tests

Phase 1 trial testing DASD Group in Topical Anesthetic Applied With Sonophoresis in 50 participants. Completed in 1 December 2012.

Timeline

1 February 2011

Primary endpoint
1 December 2012

1 December 2012

Quick facts

Lead sponsor	Loma Linda University
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	factorial
Masking	double
Primary purpose	basic science
Enrollment	50
Start date	1 February 2011
Primary completion	1 December 2012
Estimated completion	1 December 2012
Sites	1 location across United States

Drugs / interventions tested

• DASD Group
• Sonic Vibration (SV)

Conditions studied

• Topical Anesthetic Applied With Sonophoresis — all drugs for Topical Anesthetic Applied With Sonophoresis →

Sponsor

Loma Linda University

Who can join

Adults 18 to 50, any sex, with Topical Anesthetic Applied With Sonophoresis. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• The Effect of Sonophoresis on Topical Anesthesia: a Clinical Trial
  Time frame: Immediately after needle puncture
  Subjects will rate there perceived pain immediately after needle puncture using the Visual Analog Scale (VAS). This will occur twice once after application of topical anesthetic by a dummy device and another after application of topical anesthetic with the Dental Anesthesia Sonophoresis Device (DASD)

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.