Evaluation of a Triple Antibiotic Paste as a Root Canal Obturating Material for Deciduous Teeth: A Study Protocol

Background: Teeth with infected root canals, secondary to endodontic infections are a common problem in primary as well as permanent dentition. The key to successful endodontic treatment is seen only after the complete removal of infection from root canals. Systemic antibiotics have limited reach to endodontic spaces. In pediatric dentistry, difficulties in antimicrobial control require the development of a new root canal obturating paste with broad antimicrobial activity, minimal tissue toxicity, and high safety index. In this experimental study, a new Triple Antibiotic Obturating Paste (TAOP) will be developed and its efficacy will be evaluated. Methods and Design: This is a pre-clinical in-vitro microbiological and in-vivo animal study, utilizing laboratory-grown white Wistar rats aged 2-3 months and weighing 200-300 grams. The antibiotic sensitivity test (AST) will be conducted using 21 standard aerobic and anaerobic microbial strains for determining potency through serial dilution and agar diffusion assay. The systemic and local tissue toxicity will be assessed by inserting the test and control materials into the dorsal connective tissues of the experimental rats. The antimicrobial efficacy of triple antibiotic obturating paste [thermo-modulated in-situ polymeric hydrogel matrix of TAOP, containing chitosan-carbopol and poloxamer blended with clindamycin (5%), metronidazole (5%), and doxycycline (1%)] will be evaluated against Metapex [Ca(OH)2-Iodoform paste] on endodontic microflora. The microbiological study data will be evaluated through One-way ANOVA trailed by ‘Tuckey’s post hoc test’ for intergroup as well as, t-test for intragroup comparison. The animal study data will be evaluated through One-way ANOVA for intergroup and ‘paired t-test’ for intragroup comparison. Results: The newly developed bio-degradable obturating material will be more suitable than the conventionally used one, to eliminate resistant endodontic pathogens from root canal systems, along with good pharmacokinetic and pharmacodynamic responses as well as minimal local and systematic tissue toxicity when used in primary teeth. Conclusion: The application of such novel multi-antibiotic formulation as an obturating material not only will achieve efficient disinfection of the endodontic spaces but also increase chances of therapeutic success due to the elimination of side effects associated with cytotoxicity and material properties as it contains most of the bioresorbable organic ingredients.