Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
40 participants
INTERVENTIONAL
2013-01-31
2014-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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2
Topical Anesthetic, 2% Tetracaine oral gel - Group A Topical Anesthetic, 20% Benzocaine oral gel - Group B
Analgesic effect of topical tetracaine 2 %
The patient will be held by the parents and comforted after local anesthesia is applied by a research investigator. Then, he will be placed on procedure's board repositioned for clipping, restrained by the parent/nurse (holding both head and arms, keeping with conventional practice). Exactly 5 minutes after the topical anesthetic was applied, the pediatric dentist will press down the chin gently straddling the frenulum while and holding it in place with visualization of tongue base. Then the frenulum will be snipped along the underside of the tongue to its base. The area will be checked to ensure complete release. Bleeding will be controlled by pressuring with a 2x2 gauze pad under the tongue. A study investigator will film the procedure using GO PRO Video Camera mounted on the forehead of the pediatric dentist
Interventions
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Analgesic effect of topical tetracaine 2 %
The patient will be held by the parents and comforted after local anesthesia is applied by a research investigator. Then, he will be placed on procedure's board repositioned for clipping, restrained by the parent/nurse (holding both head and arms, keeping with conventional practice). Exactly 5 minutes after the topical anesthetic was applied, the pediatric dentist will press down the chin gently straddling the frenulum while and holding it in place with visualization of tongue base. Then the frenulum will be snipped along the underside of the tongue to its base. The area will be checked to ensure complete release. Bleeding will be controlled by pressuring with a 2x2 gauze pad under the tongue. A study investigator will film the procedure using GO PRO Video Camera mounted on the forehead of the pediatric dentist
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Any known congenital malformations
* Ankyloglossia type 3 or 4
\-
8 Weeks
ALL
No
Sponsors
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Rambam Health Care Campus
OTHER
Responsible Party
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Principal Investigators
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Dror - Aizenbud, Professor
Role: PRINCIPAL_INVESTIGATOR
Chairman Craniofecial Department, Rambam Medical Center
Locations
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Rambam HealthCare Campus
Haifa, , Israel
Countries
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References
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Shavit I, Peri-Front Y, Rosen-Walther A, Grunau RE, Neuman G, Nachmani O, Koren G, Aizenbud D. A Randomized Trial to Evaluate the Effect of Two Topical Anesthetics on Pain Response During Frenotomy in Young Infants. Pain Med. 2017 Feb 1;18(2):356-362. doi: 10.1093/pm/pnw097.
Other Identifiers
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01 Dated 01 August 2012
Identifier Type: -
Identifier Source: org_study_id