orabase and octyl-2-cyanoacrylate

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.

Topics: Analgesics; Carboxymethylcellulose Sodium; Cyanoacrylates; Device Approval; Humans; Nonprescription Drugs; Pain Measurement; Protective Agents; Single-Blind Method; Stomatitis, Aphthous; Tissue Adhesives; United States; United States Food and Drug Administration

Clinical symptoms of viral infections, such as herpes labialis (cold sores) and oral ulcers (canker sores), are common in adulthood, affecting approximately 19% of adults aged 25 to 44 years. For some patients, lesions last longer, are more painful, and are more difficult to treat, requiring medications that allow the affected area to heal but do little to alleviate pain. Conventionally, pain caused by oral ulcerations has been addressed with either topical analgesics or systemic pain medications. However, a recently introduced over-the-counter topical medication (ORABASE Soothe.N.Seal) has been shown to be an effective pain-relieving adjunct to healing therapies. This article reviews the characteristics of painful oral ulcerations and details the research findings of a clinical trial of the use of this new medication.

Topics: Adult; Carboxymethylcellulose Sodium; Cyanoacrylates; Humans; Oral Ulcer; Patient Satisfaction; Protective Agents; Stomatitis, Aphthous; Stomatitis, Herpetic; Surveys and Questionnaires; Tissue Adhesives

Cyanoacrylate, a synthetic adhesive, is a fast polymerizable liquid monomer. Serendipity led to the discovery of cyanoacrylate adhesives in 1951. Today, a specific cyanoacrylate monomer, 2-octyl cyanoacrylate, is being used in a topical medical adhesive formulation. The only over-the-counter cyanoacrylate-based product cleared by the Food and Drug Administration is Colgate ORABASE Soothe.N. Seal Liquid Protectant. Upon application, this liquid monomer formulation polymerizes instantly into a thin, flexible polymer film that adheres tenaciously to mucosal tissue. This polymer film creates a mechanical barrier that provides immediate and long-term pain relief of oral ulcerations and irritations, and maintains a natural healing environment for the area to heal.

Topics: Analgesics; Carboxymethylcellulose Sodium; Cyanoacrylates; Dermatologic Agents; Humans; Lacerations; Protective Agents; Stomatitis, Aphthous; Tissue Adhesives