The Effect of Sonophoresis on Topical Anesthesia: A Pilot Study
NCT ID: NCT01283490
Last Updated: 2016-11-21
Study Results
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Basic Information
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COMPLETED
PHASE1
50 participants
INTERVENTIONAL
2011-02-28
2012-12-31
Brief Summary
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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
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
FACTORIAL
BASIC_SCIENCE
DOUBLE
Study Groups
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DASD Group
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.
DASD Group
Single application of 20% Benzocaine applied for one minute with the DASD ultrasonic and sonic vibration prior to needle puncture.
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.
Sonic Vibration (SV)
Single application of 20% benzocaine applied with SV for one minute prior to needle puncture.
Interventions
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DASD Group
Single application of 20% Benzocaine applied for one minute with the DASD ultrasonic and sonic vibration prior to needle puncture.
Sonic Vibration (SV)
Single application of 20% benzocaine applied with SV for one minute prior to needle puncture.
Eligibility Criteria
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Inclusion Criteria
2. Ages 18 to 50 (male or female).
Exclusion Criteria
2. A soft or hard tissue tumor of the oral cavity.
3. Advanced periodontal disease (characterized by the presence of purulent exudate, tooth mobility, and/or extensive alveolar bone loss).
4. Participation in another clinical study or panel test.
5. Pregnant women or women who are breast-feeding.
6. Diabetic.
7. Allergy to benzocaine or ester-type local anesthetic.
8. Previous dental treat in experimental area within 30 days
18 Years
50 Years
ALL
Yes
Sponsors
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Innovadontics
UNKNOWN
Loma Linda University
OTHER
Responsible Party
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Principal Investigators
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Mahmoud Torabinejad, DMD MSD PhD
Role: PRINCIPAL_INVESTIGATOR
Loma Linda University
Locations
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Loma Linda University
Loma Linda, California, United States
Countries
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References
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Giddon 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.
Carr 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.
Martin 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.
Fukayama 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.
Nakanishi 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.
Hutchins 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.
Vickers ER, Punnia-Moorthy A. A clinical evaluation of three topical anaesthetic agents. Aust Dent J. 1992 Aug;37(4):267-70.
Rosivack RG, Koenigsberg SR, Maxwell KC. An analysis of the effectiveness of two topical anesthetics. Anesth Prog. 1990 Nov-Dec;37(6):290-2.
Chung 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.
Musawi 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.
Meechan JG. Intra-oral topical anaesthetics: a review. J Dent. 2000 Jan;28(1):3-14. doi: 10.1016/s0300-5712(99)00041-x.
Meechan 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.
Watanabe 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.
Swartzendruber DC. Studies of epidermal lipids using electron microscopy. Semin Dermatol. 1992 Jun;11(2):157-61.
Squier CA. The permeability of keratinized and nonkeratinized oral epithelium to horseradish peroxidase. J Ultrastruct Res. 1973 Apr;43(1):160-77. doi: 10.1016/s0022-5320(73)90076-2. No abstract available.
Gangarosa LP Sr. Newer local anesthetics and techniques for administration. J Dent Res. 1981 Aug;60(8):1471-80. doi: 10.1177/00220345810600080906. No abstract available.
Malamed SF. What's new in local anesthesia? Anesth Prog. 1992;39(4-5):125-31. No abstract available.
Mitragotri S, Kost J. Low-frequency sonophoresis: a review. Adv Drug Deliv Rev. 2004 Mar 27;56(5):589-601. doi: 10.1016/j.addr.2003.10.024.
Benson HA, McElnay JC, Harland R, Hadgraft J. Influence of ultrasound on the percutaneous absorption of nicotinate esters. Pharm Res. 1991 Feb;8(2):204-9. doi: 10.1023/a:1015892020468.
Tachibana K, Tachibana S. Use of ultrasound to enhance the local anesthetic effect of topically applied aqueous lidocaine. Anesthesiology. 1993 Jun;78(6):1091-6. doi: 10.1097/00000542-199306000-00011.
Mitragotri S, Blankschtein D, Langer R. Ultrasound-mediated transdermal protein delivery. Science. 1995 Aug 11;269(5225):850-3. doi: 10.1126/science.7638603.
Other Identifiers
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5100300
Identifier Type: -
Identifier Source: org_study_id