Abstract
Studies were recently completed that evaluated a novel bioadhesive device for use in treating oral ulcerations. This article reviews the research protocols and results of these studies on the bioadhesive's safety, ability to decrease immediate and long-term pain, effects on ulcer healing, and equivalence to a predicate device in providing pain relief for oral ulcers.
Publication types
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Clinical Trial
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Randomized Controlled Trial
MeSH terms
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Analgesics / therapeutic use
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Carboxymethylcellulose Sodium / analogs & derivatives*
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Carboxymethylcellulose Sodium / therapeutic use*
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Cyanoacrylates / therapeutic use*
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Device Approval
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Humans
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Nonprescription Drugs / therapeutic use
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Pain Measurement
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Protective Agents / therapeutic use*
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Single-Blind Method
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Stomatitis, Aphthous / drug therapy*
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Tissue Adhesives / therapeutic use*
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United States
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United States Food and Drug Administration
Substances
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Analgesics
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Cyanoacrylates
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Nonprescription Drugs
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Protective Agents
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Tissue Adhesives
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octyl 2-cyanoacrylate
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Orabase
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Carboxymethylcellulose Sodium