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Local anesthetic administration step is mandatory step for controlling pain before dental procedures. The aim of this study was to compare effectiveness of topical Benzocaine 18% gel patch form and Benzocaine 20% topical gel in reducing pain during injection of local anesthesia in children receiving dental treatment.
A sample of 50 children ranging in age from 6 to 8 years who need a bilateral dental treatment in the same arch participated in this study. They were healthy children rated 3 or 4 according to Frankl behavioral rating scale. They were selected from the clinic of Pediatric Dentistry Department, Faculty of Dentistry, Alexandria University.
A randomized split mouth design was done in which each child received both tested topical anesthetics on each side of the arch. The topical anesthetic gel patch or the topical gel application was randomly used at the first or second visits. Pain or discomfort was evaluated during injection using sound, eye, motor (SEM) scale, and after injection using faces pain scale- revised (FPS-R).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention group | Active Comparator | Topicale® topical anesthetic gel patch (Benzocaine 18%) |
|
| control group | Placebo Comparator | Opahl® topical anesthetic gel (Benzocaine 20%) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Topicale GelPatch (Benzocaine 18%) | Drug | Intervention group |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Comparing the tolerability of oral topical anesthetic Topicale GelPatch (Benzocaine 18%) and Benzocaine oral gel 20% during injection | The aim was to reduce pain and discomfort during injection of local anesthesia in pediatric dental patients. Pain or discomfort was evaluated during injection using sound, eye, motor (SEM) scale Sound, Eye, Motor scale: Grade 1: Comfort
Grade 2: Mild discomfort
Grade 3: Moderate discomfort
Grade 4: Severe discomfort
| 4 months |
| Comparing the tolerability of oral topical anesthetic Topicale GelPatch (Benzocaine 18%) and Benzocaine oral gel 20% after injection | Pain or discomfort was evaluated after injection using faces pain scale-revised (FPS-R). 2- Face Pain Scale- Revised: Scoring the chosen face 0, 2, 4, 6, 8, or 10, counting left to right, so "0" = "no pain" and "10" = "very much pain". | 4 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Huda M Ibrahim, BSc | Alexandria University | Principal Investigator |
| Amina Abdelrahman, PhD | Alexandria University | Study Director |
| Aly Sharaf, PhD | Alexandria University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Dentistry, Alexandria University | Alexandria | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18341564 | Result | Bagesund M, Tabrizi P. Lidocaine 20% patch vs lidocaine 5% gel for topical anaesthesia of oral mucosa. Int J Paediatr Dent. 2008 Nov;18(6):452-60. doi: 10.1111/j.1365-263X.2007.00910.x. Epub 2008 Mar 12. | |
| 12779107 | Result | Stecker SS, Swift JQ, Hodges JS, Erickson PR. Should a mucoadhesive patch (DentiPatch) be used for gingival anesthesia in children? Anesth Prog. 2002 Winter;49(1):3-8. |
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| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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Split mouth randomized clinical trial.
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| Benzocaine oral gel 20% |
| Drug |
control group |
|