OBJECTIVE: The aim of this study was to determine the feasibility of a novel saliva-activated bioadhesive drug delivery system of lidocaine hydrochloride as a viable alternative to infiltration anesthesia in dentistry. STUDY DESIGN: The study was carried out in three stages. First, the drug delivery system (DDS) was subjectively evaluated for adherence to the gingival mucosa and peak effect of anesthesia. In the second stage, a comparative subjective and objective evaluation of the DDS with a marketed topical gel preparation was carried out. Finally an open label, nonblinded clinical trial was carried out using the exodontia model. A total of 49 extractions were attempted in 41 patients. The effect of the following variables was investigated in the study: (1) jaw (maxillary and mandibular), (2) overall mobility, (3) position-notation of tooth (1, 2, 3, 4 ...). The positive extractions were statistically analyzed by the t test comparison of means of two independent variables. RESULTS: Subjective evaluation revealed that the DDS adheres to the gingiva within a minute and produces peak effect in 15 minutes. Comparative study revealed that the DDS produces greater depth of anesthesia than the marketed topical gel. Of 49 extractions attempted with the DDS, 40 were successful, giving an efficacy of 81.63%. CONCLUSION: The novel saliva-activated bioadhesive drug delivery system of lidocaine hydrochloride exhibits potential as a feasible alternative to infiltration anesthesia in dentistry.
OBJECTIVE: The aim of this study was to determine the feasibility of a novel saliva-activated bioadhesive drug delivery system of lidocaine hydrochloride as a viable alternative to infiltration anesthesia in dentistry. STUDY DESIGN: The study was carried out in three stages. First, the drug delivery system (DDS) was subjectively evaluated for adherence to the gingival mucosa and peak effect of anesthesia. In the second stage, a comparative subjective and objective evaluation of the DDS with a marketed topical gel preparation was carried out. Finally an open label, nonblinded clinical trial was carried out using the exodontia model. A total of 49 extractions were attempted in 41 patients. The effect of the following variables was investigated in the study: (1) jaw (maxillary and mandibular), (2) overall mobility, (3) position-notation of tooth (1, 2, 3, 4 ...). The positive extractions were statistically analyzed by the t test comparison of means of two independent variables. RESULTS: Subjective evaluation revealed that the DDS adheres to the gingiva within a minute and produces peak effect in 15 minutes. Comparative study revealed that the DDS produces greater depth of anesthesia than the marketed topical gel. Of 49 extractions attempted with the DDS, 40 were successful, giving an efficacy of 81.63%. CONCLUSION: The novel saliva-activated bioadhesive drug delivery system of lidocaine hydrochloride exhibits potential as a feasible alternative to infiltration anesthesia in dentistry.
Authors: Gaurav Tiwari; Ruchi Tiwari; Birendra Sriwastawa; L Bhati; S Pandey; P Pandey; Saurabh K Bannerjee Journal: Int J Pharm Investig Date: 2012-01