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ORGANOTYPIC HUMAN ORAL TISSUE MODELS FOR EVALUATION OF ORAL CARE PRODUCTS.

Bachelor, M., Breyfogle, B. and Klausner, M. MatTek Corporation, Ashland, MA 01721 – USA.
Abstract

Oral irritation can result from exposure of the soft tissue to dentifrice and oral rinse formulations. In vitro tissue models (MatTek Corporation) produced from normal human oral keratinocytes were exposed to common oral care excipients, dentifrice supernatants and mouth rinses to determine the potential irritation of oral care excipients/formulations, including SLS, poloxamer, NaF dentifrice, and pyrophosphate (PPi)/NaF dentifrices. As a measure of mucosal irritation, cell viability levels were monitored for up to 24 hours using the MTT assay. The expression of pro-inflammatory cytokines, IL-1β and IL-1α, were also monitored via ELISA. In addition, a novel oral sloughing assay was developed to quantitate the level of physical damage to the oral tissue when exposed to mouth rinses containing various levels of surfactant. Tissues treated with SLS solutions (0.2%-0.6%) provided a clear dose response with ET-50 values ranging from 10.5 to < 2 hrs. A dose response was also observed for expressed levels of IL-1α and IL-1β in SLS-treated tissues. The addition of poloxamer to SLS solutions increased overall tissue viability and decreased levels of expressed cytokines. Treatment of tissues with NaF and PPi/NaF dentifrices (10% supernatants) exhibited differences in both ET-50 values and cytokine expression levels. In addition, the cell viability results strongly correlated to cytokine expression levels. Differences in the total level of sloughed protein were observed following application of various oral rinse formulations to the organotypic oral epithelium. Findings from the oral sloughing assay were highly correlated to overall tissue thickness. The oral tissue models represent highly reproducible, non-animal means to screen newly developed oral care products and should be useful to study the innate immunity, biology, and pathology of the oral mucosa.

Keywords

Dentifrice, GIN-100, IL-1α, IL-1β, mouth rinse, Mouthwash, oral care excipients, oral irritation, oral rinse, Oral slough assay, ORL-200, Sloughing

Materials Tested

Dentifrice, GIN-100, IL-1α, IL-1β, mouth rinse, Mouthwash, oral care excipients, oral irritation, oral rinse, Oral slough assay, ORL-200, Sloughing

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