Evaluation of a bioadhesive device for the management of aphthous ulcers.
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.


CONCLUSIONS
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.
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
M J
MJ
Kutcher
J B
JB
Ludlow
A D
AD
Samuelson
T
T
Campbell
S N
SN
Pusek
D000287:Administration, Topical; D000328:Adult; D003487:Cyanoacrylates / Q000008:administration & dosage / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D020136:Hydrogel, Polyethylene Glycol Dimethacrylate / Q000008:administration & dosage / Q000627:therapeutic use; D016014:Linear Models; D008297:Male; D004366:Nonprescription Drugs / Q000008:administration & dosage / Q000627:therapeutic use; D010146:Pain / Q000517:prevention & control; D010147:Pain Measurement; D010919:Placebos; D016016:Proportional Hazards Models; D012449:Safety; D012646:Self Administration; D016037:Single-Blind Method; D018709:Statistics, Nonparametric; D013281:Stomatitis, Aphthous / Q000188:drug therapy*; D013997:Time Factors; D014014:Tissue Adhesives / Q000008:administration & dosage / Q000627:therapeutic use*; D014945:Wound Healing
D003487:Cyanoacrylates; D004366:Nonprescription Drugs; D010919:Placebos; D014014:Tissue Adhesives; D020136:Hydrogel, Polyethylene Glycol Dimethacrylate; C100832:octyl 2-cyanoacrylate