The Journal of the American Dental ae
. Association
ELSEVIER Volume 132, Issue 3, March 2001, Pages 368-376
Evaluation of a bioadhesive device for the management of
aphthous ulcers
MARK J. KUTCHER, D.D.S., M.S." @-®4, JOHN B. LUDLOW, D.D.S., M.S, ALLEN D. SAMUELSON,
D.D.S.°, TAMARA CAMPBELL, D.M.D., SUSAN N. PUSEK, M.P_H
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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-OGA, 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 sate 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.