Evaluating the efficacy of 2-octyl cyanoacrylate bioadhesive for treatment of oral ulcerations.
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.
Kutcher
M
M
University of North Carolina School of Dentistry, General Clinical Research Center, University of North Carolina Hospitals, Chapel Hill, North Carolina, USA.
D000700:Analgesics / Q000627:therapeutic use; D002266:Carboxymethylcellulose Sodium / Q000031:analogs & derivatives* / Q000627:therapeutic use*; D003487:Cyanoacrylates / Q000627:therapeutic use*; D018795:Device Approval; D006801:Humans; D004366:Nonprescription Drugs / Q000627:therapeutic use; D010147:Pain Measurement; D020011:Protective Agents / Q000627:therapeutic use*; D016037:Single-Blind Method; D013281:Stomatitis, Aphthous / Q000188:drug therapy*; D014014:Tissue Adhesives / Q000627:therapeutic use*; D014481:United States; D014486:United States Food and Drug Administration
D000700:Analgesics; D003487:Cyanoacrylates; D004366:Nonprescription Drugs; D020011:Protective Agents; D014014:Tissue Adhesives; C100832:octyl 2-cyanoacrylate; C056627:Orabase; D002266:Carboxymethylcellulose Sodium