[Clinical evaluation of mucoadhesive film on gingiva among healthy volunteers]

ABSTRACT

The term bioadhesion refers to the attachment of a natural or systhetic polymer to a biological substrate when this substrate is mucus, mucodhesion is the term used. The aim of this study was formulation and clinical evaluation of the first mucoadhesive film in Iran. In this clinical trial four mucoadhesive films [A, B, C, D] were formulated based on theoretical knowledge of adhesive polymers and physical properties of a mucoadhesive layer. For this, Hydroxy Propyle Metyle Cellulose [HPMC] polyvinyl povolidion [PVP] and carbapol [C], were used as adhesive layer and nitrocellulose [NC] and Ethylcellulose [EC] were used as hydrophobe layer. Films were assessed in a double-blind clinical trial study among 20 healthy volunteers on attached gingiva of maxillary canine. Maximum duration of attachment of films and effects of related factors were evaluated. Data were analysed using SPSS and by chi-square, t-test and repeated measurements. There was a significant difference among four films according to mean duration of adhesion [P<0.001] so as film A showed maximum adhesion time [13 hours] and film D showed minimum adhesion time [5.15 hours]. Mucosal compatibility of the adhesive films was good and eating and drinking had no effects on seperation of films from gingiva. It seems that film A is appropriate for mucosal adhesion. Further studies with different dimensions on this film are needed prior to its use as a mucoadhesive film in oral mucosa