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. 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.

Intraoral digital imaging documenting recurrent aphthous ulcer healing in 2-octyl cyanoacrylate versus sham-treated lesions.

OBJECTIVE: A device to standardize imaging was coupled with a digital intraoral camera to investigate the efficacy of 2-octyl cyanoacrylate (OC) tissue adhesives on the healing of minor aphthous ulcers. STUDY DESIGN: Forty-two subjects were enrolled in a patient-blinded, sham-controlled study assessing the effects of 2-OC formulations on ulcer size and healing time. Daily images were made until ulcers were healed. Ulcer image outlines were traced by using a mouse, and ulcer areas were automatically calculated. RESULTS: A mean difference of -0.15 mm(2) was seen between baseline and next-day measurements (P =.48). The cumulative ulcer area was meaningfully reduced in one OC group compared with the sham group (P =.04). Time to healing was reduced by 1.9 days in the same group compared with the sham group (P =.02). CONCLUSIONS: The use of digital intraoral images with an integrated measurement reference enhances the accuracy and reproducibility of measurements. 2-OC adhesives hold promise as devices to promote healing of recurrent aphthous ulcers.

Recognition of worrisome facial conditions by the dentist.

We can see that there are a number of conditions that commonly occur on the skin of the face, and that these may be of little or great consequence to our patients. Dentists enjoy an ideal situation for the detection and management or referral of the more worrisome lesions. By paying close attention to the faces of dental patients, asking appropriate questions about the lesions discovered, and following up on the results of advise given to patients, dentists can play an important role as health care advisors concerning dermatologic conditions of the face.

Computer-aided analysis of intraoral ulcerative lesions.

At the present time there is no objective method to evaluate oral ulcerative lesions for degree of inflammation, surface area, or other parameters of healing. The capability of infrared photography to uniquely image the inflammatory process associated with oral lesions and the use of image-processing technology for parameter analysis was investigated. Lesions were compared cross-sectionally and over time for area of tissue degeneration, active inflammation, and intensity of inflammation with respect to adjacent tissue. Eight subjects were available for study. Standard black and white, color, and black and white infrared photographs were taken in accord with study protocols. A reflectance standard was included in each photograph to normalize the background intensity. A video camera was used to enter the data into a microcomputer image processing system. Quantitative data obtained included area of ulceration and erythematous halo, inflammatory intensity changes over time, and intensity with respect to adjacent tissue. This computer-aided photographic technique was able to quantify healing progression and intensity parameters associated with intraoral inflammatory lesions.

Oral considerations for the cancer patient.

An increasing number of patients are undergoing cancer chemotherapy and/or radiotherapy and are experiencing side effects in their mouths. A thorough oral examination is important in the overall pretherapy evaluation of these patients, and, along with a consideration for the patient's disease, treatment, prognosis and laboratory values, allows for realistic planning for dental management prior to, during and following cancer therapy. The early establishment of a good working relationship with the patient and those caring for him or her, and an understanding of the importance of compliance with oral hygiene will eliminate needless therapy-induced morbidity and mortality.

Effect of an antimicrobial mouthrinse on recurrent aphthous ulcerations.

Recurrent aphthous ulceration (RAU) remains a clinical problem for many patients. Efforts in prevention and/or treatment with prescription and nonprescription formulations have to date resulted in minimal success at best. A 6-month double-blind clinical study of 96 adults compared a commercially available antimicrobial mouthrinse (Listerine Antiseptic [LA], Warner-Lambert Co., Morris Plains, N.J.) and a hydroalcoholic control to evaluate the effects of vigorous twice-daily rinsing on the incidence, duration, and severity of RAU in persons prone to this disorder. LA rinse and the hydroalcoholic rinse resulted in a statistically significant reduction in the incidence of RAU occurrences from baseline. The duration of lesions and the severity of pain in subjects with ulcers during the treatment period were also significantly reduced in the LA rinse group of patients when compared with baseline. The hydroalcoholic rinse did not show a significant effect versus baseline for either severity or duration of the lesions. Rinsing therefore can be of clinical value in reducing the occurrence of RAU in susceptible patients, and LA rinse can be of significant additional value in decreasing the duration and severity of RAU.

Identification of genital tract papillomaviruses HPV-6 and HPV-16 in warts of the oral cavity.

Warty lesions of the oral cavity were examined for etiologic association with genital tract papillomaviruses HPV-6, HPV-11, and HPV-16. DNAs extracted from ten oral biopsies were screened for HPV genomic sequences by Southern transfer hybridization with 32P-labeled viral DNA probes. Nonstringent hybridization with an HPV-6 probe revealed papillomavirus DNA sequences in four of seven tissues with histologic evidence of papillomatosis, in none of two tissues without histologic evidence of papillomatosis, and in one tissue that was not examined by histology. Stringent hybridization tests with HPV-6 and HPV-16 probes identified the genome in one tissue as being HPV-16, in a second tissue as being HPV-6 subtype a, and in a third tissue as HPV-6 (subtype unidentified); papillomavirus DNA sequences in two tissues are as yet not identified. An additional case of HPV-6 or HPV-11 related oral cavity lesion was diagnosed by in situ hybridization of paraffin sections with a 35S-labeled, mixed HPV-6 + HPV-11 probe. The hybridization in the positive section was extensive and confined to epithelial nuclei. The oral lesions associated with genital tract papillomaviruses were asymptomatic, multiple or single, and were located in different parts of the oral cavity, for example, on the gingivae, on the tongue, on the lip, on the tonsillar pillar, and on the floor of the mouth.

Blood pressure fluctuations in hypertensive patients during oral surgery.

The lability of blood pressure during oral surgical procedures and the effects of antihypertensive drugs on this lability have not been investigated sufficiently to evaluate potential medical risks. The purpose of this study was to accurately evaluate blood pressure fluctuations during oral surgical procedures in three groups of patients: normotensive patients; stratum I hypertensive patients not taking medication; and stratum I hypertensive patients taking antihypertensive medication. Blood pressure measurements were recorded by an American Heart Association certified technician at baseline, immediately prior to surgery, during administration of the local anesthetic, during the surgical procedure, and 15 minutes after surgery. Analysis of variance indicated that the blood pressure fluctuations (systolic and diastolic) among these five intervals were not statistically significant for any of the groups. The clinical significance of the above findings is that stratum I hypertensive patients experience minimal fluctuations in blood pressure that are no greater than those in normotensive patients and, therefore, may present no greater clinical risk during the dental stress associated with certain oral surgical procedures.