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NCT01283490 · ClinicalTrials.gov registry record · Phase 1
The Effect of Sonophoresis on Topical Anesthesia: A Pilot Study
A Phase 1 study, sponsored by Loma Linda University.
- Completed
- Registry status
- Phase 1
- Development phase
- 50
- Enrollment target
NCT01283490: Completed Phase 1 study, sponsored by Loma Linda University.
NCT01283490 is a Phase 1 study that has completed, run by Loma Linda University. The registered enrollment target is 50 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (17% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01283490, a Phase 1 study, has completed, sponsored by Loma Linda University.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 50 participants
- Enrollment target
Study 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.
Primary Outcome
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)
Interventions
- DEVICE DASD Group
- DEVICE Sonic Vibration (SV)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2011-02 |
| Est. Completion | 2012-12 |
| Phase | Phase 1 |
What the finished NCT01283490 record still lists
NCT01283490 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (17% lower).
The record links to 0 conditions, and to 2 interventions - of which DASD Group is the first listed.
NCT01283490 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01283490 about?
NCT01283490 is a clinical study titled "The Effect of Sonophoresis on Topical Anesthesia: A Pilot Study". 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 ...
What is the current status of trial NCT01283490?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 50 participants. The study started on 2011-02. Estimated completion is 2012-12.
What interventions are being tested in trial NCT01283490?
The interventions under investigation include: DASD Group (DEVICE), Sonic Vibration (SV) (DEVICE).
Who is sponsoring clinical trial NCT01283490?
This trial is sponsored by Loma Linda University, which has 237 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01283490's enrollment target sits among peer trials
50 973rd of 2000 higher than 984 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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