M J Kutcher1, J B Ludlow, A D Samuelson, T Campbell, S N Pusek. 1. Department of Diagnostic Sciences and General Dentistry, University of North Carolina School of Dentistry, CB 7450 Brauer Hall, Chapel Hill, N.C. 27599-7450, USA. MJKUTCHE@email.unc.edu
Abstract
BACKGROUND:Aphthous ulcers are common and painful. Current treatments are palliative and focused on pain reduction. This article reports on the clinical trials of a novel, bioadhesive treatment modality. METHODS: Formulations of 2-octyl cyanoacrylate, or 2-OCA, tissue adhesive were tested in two blinded, sham-controlled studies. A total of 200 patients with a single, painful aphthous ulcer were entered. In the first study, the investigators applied the tissue adhesive to the aphthous ulcers; in the second trial, the subjects themselves applied the tissue adhesive to their ulcers. The authors evaluated the safety, pain reduction and healing times associated with the bioadhesive. RESULTS: The bioadhesives were found to be safe with no significant adverse events. The short- and long-term pain reduction achieved with an investigator-applied adhesive was significant compared with that achieved with a sham device (P = .024 and P = .036, respectively). The investigator-applied adhesive also demonstrated a significant reduction in healing time over the sham device (P = .021). In the definitive trial, in which the subjects themselves applied the tissue adhesive, pain reduction with a predicate device approved by the U.S. Food and Drug Administration and with the bioadhesive was significantly better than with a sham application (P < .05). The active devices were not statistically different from each other (P = .37). No difference in healing time was evident between devices and the sham. CONCLUSIONS: The formulations of 2-OCA tissue adhesives tested were safe and demonstrated statistically significant pain reduction when applied by either the investigators or the subjects. CLINICAL IMPLICATIONS: Our clinical trials indicate that these novel tissue adhesives could be used as nonprescription, over-the-counter devices to provide significant pain relief for patients suffering from aphthous ulcers.
RCT Entities:
BACKGROUND:Aphthous ulcers are common and painful. Current treatments are palliative and focused on pain reduction. This article reports on the clinical trials of a novel, bioadhesive treatment modality. METHODS: Formulations of 2-octyl cyanoacrylate, or 2-OCA, tissue adhesive were tested in two blinded, sham-controlled studies. A total of 200 patients with a single, painful aphthous ulcer were entered. In the first study, the investigators applied the tissue adhesive to the aphthous ulcers; in the second trial, the subjects themselves applied the tissue adhesive to their ulcers. The authors evaluated the safety, pain reduction and healing times associated with the bioadhesive. RESULTS: The bioadhesives were found to be safe with no significant adverse events. The short- and long-term pain reduction achieved with an investigator-applied adhesive was significant compared with that achieved with a sham device (P = .024 and P = .036, respectively). The investigator-applied adhesive also demonstrated a significant reduction in healing time over the sham device (P = .021). In the definitive trial, in which the subjects themselves applied the tissue adhesive, pain reduction with a predicate device approved by the U.S. Food and Drug Administration and with the bioadhesive was significantly better than with a sham application (P < .05). The active devices were not statistically different from each other (P = .37). No difference in healing time was evident between devices and the sham. CONCLUSIONS: The formulations of 2-OCA tissue adhesives tested were safe and demonstrated statistically significant pain reduction when applied by either the investigators or the subjects. CLINICAL IMPLICATIONS: Our clinical trials indicate that these novel tissue adhesives could be used as nonprescription, over-the-counter devices to provide significant pain relief for patients suffering from aphthous ulcers.
Authors: Gail Cherry-Peppers; Christine O Daniels; Valli Meeks; Charles F Sanders; David Reznik Journal: J Natl Med Assoc Date: 2003-02 Impact factor: 1.798