Design, Characterization and Clinical Evaluation of Curcumin Dental Film for the Treatment of Periodontitis

Background:: Periodontitis is one of the most widespread oral diseases. Curcumin, a hydrophobic polyphenolic compound derived from the rhizomes of Curcuma longa has a great potential for biological and pharmacological activities. The introduction of local controlled delivery of curcumin directly into the periodontal pocket is a promising approach for the treatment of periodontitis. Objective:: The study has been designed to formulate intrapocket dental film loaded with curcumin to be used for insertion into the periodontal pockets and evaluate its clinical efficacy. Methods:: Curcumin dental films were prepared by the solvent casting technique using polymers such as Ethylcellulose, HPMC K4M, Eudragit RL 100, Chitosan with Dibutyl Phthalate and Poly Ethylene Glycol 400 as the plasticizer. The prepared films (CDF1-CDF16) were evaluated for various physicochemical parameters employing established pharmaceutical procedures such as surface pH, folding endurance, tensile strength, swelling index, drug content, in-vitro drug release, antibacterial efficacy, stability studies, and clinical efficacy. Results:: Experimental parameters of the obtained film exhibited results within the desired limit. Fourier Transform Infrared Spectroscopy and Differential Scanning Calorimetry studies revealed the formulated film to be stable during drug stability and compatible between drugs and excipients. The surface morphology of the formulation using Scanning Electron Microscope images showed the presence of free drug particles on the surface, causing a burst effect at the desired site. In-vitro dissolution studies showed an initial burst release to achieve an immediate therapeutic level of drug in the periodontal pocket followed by a progressive fall and extended-release of the drug for 10 days. The therapeutics effects, such as antibacterial activity of films on P. gingivalis, were also observed. Furthermore, the clinical trials of formulation CDF16 on affected patients proved the therapeutic efficacy of the dental films showing a statistically significant (p < 0.05) decrease in the clinical markers of periodontitis, i.e. periodontal probing depth, plaque index, and sulcular bleeding index. Conclusion:: The experimental results suggest that Curcumin dental film can be experimentally identified as a potential drug delivery device. Hence, curcumin dental film can be used for topical treatment of periodontal diseases and to achieve optimum therapeutic efficacy.