Abbreviated journal title; Date;Vol #
(Issue #):
Page #s

J Am Dent Assoc.
2001 Mar;132
(3):
368-76.

Link(s) to comments

• J Am Dent Assoc. 2001 Jun;132(6):728.

Link to full-text article

Title of the article

Author's names

First author's institutional affiliation

Detailed 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.

Publication Types

• Clinical Trial
• Clinical Trial, Phase I
• Clinical Trial, Phase II
• Multicenter Study
• Randomized Controlled Trial

MeSH Terms

• Administration, Topical
• Adult
• Comparative Study
• Cyanoacrylates/administration & dosage
• Cyanoacrylates/therapeutic use*
• Drugs, Non-Prescription/administration & dosage
• Drugs, Non-Prescription/therapeutic use
• Female
• Human
• Hydrogel/administration & dosage
• Hydrogel/therapeutic use
• Linear Models
• Male
• Pain/prevention & control
• Pain Measurement
• Placebos
• Proportional Hazards Models
• Safety
• Self Administration
• Single-Blind Method
• Statistics, Nonparametric
• Stomatitis, Aphthous/drug therapy*
• Support, Non-U.S. Gov't
• Support, U.S. Gov't, P.H.S.
• Time Factors
• Tissue Adhesives/administration & dosage
• Tissue Adhesives/therapeutic use*
• Wound Healing

Substance terms:

• Cyanoacrylates
• Drugs, Non-Prescription
• Placebos
• Tissue Adhesives
• Hydrogel
• octyl 2-cyanoacrylate

Grant Support

• RR00046/RR/NCRR

Unique PMID #