Topical Anesthetic Applied With SonophoresisPhase 1NCT01283490
The Effect of Sonophoresis on Topical Anesthesia: A Pilot Study
A Phase 1 study testing DASD Group and Sonic Vibration (SV) in people with Topical Anesthetic Applied With Sonophoresis, run by Loma Linda University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Topical Anesthetic Applied With Sonophoresis
- What is being tested?
- DASD Group and Sonic Vibration (SV)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2011to Dec 2012
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Good general health as evidenced by the medical history.
- Ages 18 to 50 (male or female).
Who cannot join
- Use of tobacco products.
- A soft or hard tissue tumor of the oral cavity.
- Advanced periodontal disease (characterized by the presence of purulent exudate, tooth mobility, and/or extensive alveolar bone loss).
- Participation in another clinical study or panel test.
- Pregnant women or women who are breast-feeding.
- Diabetic.
- Allergy to benzocaine or ester-type local anesthetic.
- Previous dental treat in experimental area within 30 days
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Sonophoresis on Topical Anesthesia: a Clinical Trial
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.
Read the detailed description
Fifty healthy patients between the ages of 18 and 50 will be used for this clinical trial. The anatomical site used for this clinical trial is the maxillary mucobuccal fold above the canine eminence. This site has been selected because it is an anatomical structure that is easily found for all subjects and is reproducible from one side of the patient to the other. One side of the patient's maxillary mucobuccal canine area will be dried with dental 2x2 sponge gauze, then 20% Benzocaine will be applied with an SV for one minute. The site will then be punctured using a short 27-gauge needle inserted to the depth of 3mm.
Immediately after the removal of the needle, the patients will be asked to rate their pain according to the Visual Analogue Scale (VAS) model. The VAS is a measurement instrument 100mm in length anchored by word descriptors at each end. The subject marks on the line the point that they feel represents their perception of their current state.
On the contralateral side, a 2x2 will be used to dry the mucus, and then 20% benzocaine will be applied using the DASD for one minute, followed by a puncture of the oral mucosa with a 27-gauge needle to the depth of 3mm. Immediately after the removal of the needle, the subject will rate their pain according to the same method described above. The application of the topical anesthetic by the DASD and SV will be administered by a single investigator for all subjects. After administration of topical anesthetic the subjects will be divided randomly among six separate investigators who will insert the needle into the mucosa. Neither the investigator giving the injection nor the subjects will be told whether the DASD or SV was used to administer the topical anesthesia. This will insure a double blind trial. A new 27-gauge needle will be used for each injection site to standardize each injection.
Statistical Analysis
Each patient will be treated prior to injection with a topical anesthetic applied either using the SV device or the DASD device. A paired t-test will be used to determine if a statistically significant difference exists between pain scores recorded for each of the injection sites. For the VAS model, the patient's vertical mark is measured from the left hand side in millimeters. The paired t-test will test if the mean difference between SV treated sites and DASD, treated sites to determine which of the two hypotheses are true. The Null Hypothesis (Ho) is that the mean of the differences in pain scores is zero. The Alternative Hypothesis (Ha) is that the mean of the differences in pain scores is not equal to zero . A probability value of 0.05 will be used to determine if the difference is significant.
- Being tested
- DASD Group, Sonic Vibration (SV)
- Keywords
- topical anesthetic, sonophoresis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DASD GroupDevice
Single application of 20% Benzocaine applied for one minute with the DASD ultrasonic and sonic vibration prior to needle puncture.
Sonic Vibration (SV)Device
Single application of 20% benzocaine applied with SV for one minute prior to needle puncture.
| Study group | Role | What they receive |
|---|---|---|
| DASD Group | Active comparator | Benzocaine 20% will be placed using the DASD for one minute. Immediately after DASD application a needle puncture with a 27 gauge needle to the depth of 3 millimeters will be performed. Receives: Device: DASD Group |
| Sonic Vibration (SV) | Sham comparator | A modified tooth brush which only allows sonic vibration (SV), that has the appearance and sound of the DASD will be used to apply the benzocaine 20% for one minute. Following application with the SV a needle puncture with a 27 gauge needle to the depth of 3millimeters. Receives: Device: Sonic Vibration (SV) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Effect of Sonophoresis on Topical Anesthesia: a Clinical Trial
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)
Measured: Immediately after needle puncture
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2011 (estimated)
- Study startFeb 2011
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (22)Papers the sponsor has linked to this study.
- Other trials for Topical Anesthetic Applied With SonophoresisStudies of the same condition, open and under way.
- More trials run by Loma Linda UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Loma Linda University
- Sponsor type
- University, hospital or other
- Collaborators
- Innovadontics
- Responsible party
- Sponsor
- Investigators
- Mahmoud Torabinejad, DMD MSD PhD, Principal investigator, Loma Linda University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01283490
- Sponsor's protocol ID
- 5100300
- Status last verified
- Nov 2016
- First submitted
- 24 Jan 2011
- Last updated
- 21 Nov 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Calatayud J, Gonzalez A. History of the development and evolution of local anesthesia since the coca leaf. Anesthesiology. 2003 Jun;98(6):1503-8. doi: 10.1097/00000542-200306000-00031. No abstract available.
PubMed 12766665Giddon DB, Quadland M, Rachwall PC, Springer J, Tursky B. Development of a method for comparing topical anesthetics in different application and dosage forms. J Oral Ther Pharmacol. 1968 Jan;4(4):270-4. No abstract available.
PubMed 4868310Carr MP, Horton JE. Clinical evaluation and comparison of 2 topical anesthetics for pain caused by needle sticks and scaling and root planing. J Periodontol. 2001 Apr;72(4):479-84. doi: 10.1902/jop.2001.72.4.479.
PubMed 11338300Martin MD, Ramsay DS, Whitney C, Fiset L, Weinstein P. Topical anesthesia: differentiating the pharmacological and psychological contributions to efficacy. Anesth Prog. 1994;41(2):40-7.
PubMed 8638859Fukayama H, Suzuki N, Umino M. Comparison of topical anesthesia of 20% benzocaine and 60% lidocaine gel. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2002 Aug;94(2):157-61. doi: 10.1067/moe.2002.124858.
PubMed 12221381Nakanishi O, Haas D, Ishikawa T, Kameyama S, Nishi M. Efficacy of mandibular topical anesthesia varies with the site of administration. Anesth Prog. 1996 Winter;43(1):14-9.
PubMed 10323120Hutchins HS Jr, Young FA, Lackland DT, Fishburne CP. The effectiveness of topical anesthesia and vibration in alleviating the pain of oral injections. Anesth Prog. 1997 Summer;44(3):87-9.
PubMed 9481967Vickers ER, Punnia-Moorthy A. A clinical evaluation of three topical anaesthetic agents. Aust Dent J. 1992 Aug;37(4):267-70.
PubMed 1444945Rosivack RG, Koenigsberg SR, Maxwell KC. An analysis of the effectiveness of two topical anesthetics. Anesth Prog. 1990 Nov-Dec;37(6):290-2.
PubMed 2097909Chung JE, Koh SA, Kim TI, Seol YJ, Lee YM, Ku Y, Rhyu IC, Chung CP, Koo KT. Effect of eutectic mixture of local anesthetics on pain perception during scaling by ultrasonic or hand instruments: a masked randomized controlled trial. J Periodontol. 2011 Feb;82(2):259-66. doi: 10.1902/jop.2010.090748. Epub 2010 Aug 23.
PubMed 20731585Musawi AA, Andersson L. Use of topical as only anesthetic for suturing a traumatic facial laceration. Dent Traumatol. 2010 Jun;26(3):292-3. doi: 10.1111/j.1600-9657.2010.00881.x.
PubMed 20572847Meechan JG. Intra-oral topical anaesthetics: a review. J Dent. 2000 Jan;28(1):3-14. doi: 10.1016/s0300-5712(99)00041-x.
PubMed 10666956Meechan JG. Effective topical anesthetic agents and techniques. Dent Clin North Am. 2002 Oct;46(4):759-66. doi: 10.1016/s0011-8532(02)00035-6.
PubMed 12436830Watanabe IS. Ultrastructures of mechanoreceptors in the oral mucosa. Anat Sci Int. 2004 Jun;79(2):55-61. doi: 10.1111/j.1447-073x.2004.00067.x.
PubMed 15218624Swartzendruber DC. Studies of epidermal lipids using electron microscopy. Semin Dermatol. 1992 Jun;11(2):157-61.
PubMed 1498019
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Sonophoresis on Topical Anesthesia: a Clinical Trial
- ClinicalTrials.gov ID
- NCT01283490
- Acronym / sponsor ID
- 5100300
- Keywords
- topical anesthetic, sonophoresis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Loma Linda UniversityUniversity, hospital or other
- Collaborators
- Innovadontics
- Study start
- Feb 2011
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 26 Jan 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Fifty healthy patients between the ages of 18 and 50 will be used for this clinical trial. The anatomical site used for this clinical trial is the maxillary mucobuccal fold above the canine eminence. This site has been selected because it is an anatomical structure that is easily found for all subjects and is reproducible from one side of the patient to the other. One side of the patient's maxillary mucobuccal canine area will be dried with dental 2x2 sponge gauze, then 20% Benzocaine will be applied with an SV for one minute. The site will then be punctured using a short 27-gauge needle inserted to the depth of 3mm.
Immediately after the removal of the needle, the patients will be asked to rate their pain according to the Visual Analogue Scale (VAS) model. The VAS is a measurement instrument 100mm in length anchored by word descriptors at each end. The subject marks on the line the point that they feel represents their perception of their current state.
On the contralateral side, a 2x2 will be used to dry the mucus, and then 20% benzocaine will be applied using the DASD for one minute, followed by a puncture of the oral mucosa with a 27-gauge needle to the depth of 3mm. Immediately after the removal of the needle, the subject will rate their pain according to the same method described above. The application of the topical anesthetic by the DASD and SV will be administered by a single investigator for all subjects. After administration of topical anesthetic the subjects will be divided randomly among six separate investigators who will insert the needle into the mucosa. Neither the investigator giving the injection nor the subjects will be told whether the DASD or SV was used to administer the topical anesthesia. This will insure a double blind trial. A new 27-gauge needle will be used for each injection site to standardize each injection.
Statistical Analysis
Each patient will be treated prior to injection with a topical anesthetic applied either using the SV device or the DASD device. A paired t-test will be used to determine if a statistically significant difference exists between pain scores recorded for each of the injection sites. For the VAS model, the patient's vertical mark is measured from the left hand side in millimeters. The paired t-test will test if the mean difference between SV treated sites and DASD, treated sites to determine which of the two hypotheses are true. The Null Hypothesis (Ho) is that the mean of the differences in pain scores is zero. The Alternative Hypothesis (Ha) is that the mean of the differences in pain scores is not equal to zero . A probability value of 0.05 will be used to determine if the difference is significant.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DASD Group | Active comparator | Device: DASD GroupBenzocaine 20% will be placed using the DASD for one minute. Immediately after DASD application a needle puncture with a 27 gauge needle to the depth of 3 millimeters will be performed. |
| Sonic Vibration (SV) | Sham comparator | Device: Sonic Vibration (SV)A modified tooth brush which only allows sonic vibration (SV), that has the appearance and sound of the DASD will be used to apply the benzocaine 20% for one minute. Following application with the SV a needle puncture with a 27 gauge needle to the depth of 3millimeters. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Good general health as evidenced by the medical history.
- Ages 18 to 50 (male or female).
Key exclusion criteria (8 listed)
- Use of tobacco products.
- A soft or hard tissue tumor of the oral cavity.
- Advanced periodontal disease (characterized by the presence of purulent exudate, tooth mobility, and/or extensive alveolar bone loss).
- Participation in another clinical study or panel test.
- Pregnant women or women who are breast-feeding.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DASD GroupSingle application of 20% Benzocaine applied for one minute with the DASD ultrasonic and sonic vibration prior to needle puncture. | Device | DASD Group |
| Sonic Vibration (SV)Single application of 20% benzocaine applied with SV for one minute prior to needle puncture. | Device | Sonic Vibration (SV) |
Primary outcome
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2016.
- Background: PubMed 12766665Calatayud J, Gonzalez A. History of the development and evolution of local anesthesia since the coca leaf. Anesthesiology. 2003 Jun;98(6):1503-8. doi: 10.1097/00000542-200306000-00031. No abstract available.
- Background: PubMed 4868310Giddon DB, Quadland M, Rachwall PC, Springer J, Tursky B. Development of a method for comparing topical anesthetics in different application and dosage forms. J Oral Ther Pharmacol. 1968 Jan;4(4):270-4. No abstract available.
- Background: PubMed 11338300Carr MP, Horton JE. Clinical evaluation and comparison of 2 topical anesthetics for pain caused by needle sticks and scaling and root planing. J Periodontol. 2001 Apr;72(4):479-84. doi: 10.1902/jop.2001.72.4.479.
- Background: PubMed 8638859Martin MD, Ramsay DS, Whitney C, Fiset L, Weinstein P. Topical anesthesia: differentiating the pharmacological and psychological contributions to efficacy. Anesth Prog. 1994;41(2):40-7.
- Background: PubMed 12221381Fukayama H, Suzuki N, Umino M. Comparison of topical anesthesia of 20% benzocaine and 60% lidocaine gel. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2002 Aug;94(2):157-61. doi: 10.1067/moe.2002.124858.
- Background: PubMed 10323120Nakanishi O, Haas D, Ishikawa T, Kameyama S, Nishi M. Efficacy of mandibular topical anesthesia varies with the site of administration. Anesth Prog. 1996 Winter;43(1):14-9.
- Background: PubMed 9481967Hutchins HS Jr, Young FA, Lackland DT, Fishburne CP. The effectiveness of topical anesthesia and vibration in alleviating the pain of oral injections. Anesth Prog. 1997 Summer;44(3):87-9.
- Background: PubMed 1444945Vickers ER, Punnia-Moorthy A. A clinical evaluation of three topical anaesthetic agents. Aust Dent J. 1992 Aug;37(4):267-70.
- Background: PubMed 2097909Rosivack RG, Koenigsberg SR, Maxwell KC. An analysis of the effectiveness of two topical anesthetics. Anesth Prog. 1990 Nov-Dec;37(6):290-2.
- Background: PubMed 20731585Chung JE, Koh SA, Kim TI, Seol YJ, Lee YM, Ku Y, Rhyu IC, Chung CP, Koo KT. Effect of eutectic mixture of local anesthetics on pain perception during scaling by ultrasonic or hand instruments: a masked randomized controlled trial. J Periodontol. 2011 Feb;82(2):259-66. doi: 10.1902/jop.2010.090748. Epub 2010 Aug 23.
- Background: PubMed 20572847Musawi AA, Andersson L. Use of topical as only anesthetic for suturing a traumatic facial laceration. Dent Traumatol. 2010 Jun;26(3):292-3. doi: 10.1111/j.1600-9657.2010.00881.x.
- Background: PubMed 10666956Meechan JG. Intra-oral topical anaesthetics: a review. J Dent. 2000 Jan;28(1):3-14. doi: 10.1016/s0300-5712(99)00041-x.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mahmoud Torabinejad, DMD MSD PhD principal investigator
Loma Linda University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing DASD Group and Sonic Vibration (SV) in people with Topical Anesthetic Applied With Sonophoresis, run by Loma Linda University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Effect of Sonophoresis on Topical Anesthesia: a Clinical Trial (time frame: Immediately after needle puncture). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01283490, which also lists 22 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2016.