Outcome of Endodontic Treatment with Heated-Activated Sodium Hypochlorite and Minimal Instrumentation versus Conventional Instrumentation: A Pilot Clinical Trial

Aim This pilot clinical trial aims to preliminarily evaluate and compare radiographic healing outcomes of a minimally instrumentation technique using a novel device capable of both heating and activating 5.25% of intracanal sodium hypochlorite (NaOCl) versus conventional reciprocating instrumentation with sonic activation on single rooted teeth with apical periodontitis. Material and Methods Thirty-two single rooted teeth with pre-operative periapical radiolucency and PAI score ≥ 3 were randomly divided into: (1) Conventional reciprocating instrumentation using Reciproc Blue files and sonic activation, (2) Minimal instrumentation technique using ProGlider 16.02 to the foramen along with a novel device capable of heating and activating NaOCl. Follow up was scheduled at 3,6 and 12 months and a periapical index (PAI) was recorded at T0, T3, T6 and T12 to evaluate the treatment outcome. Once a PAI score was assigned, each tooth was classified into: healed, healing and diseased, based on loose criteria healed and healing cases were considered successful, while the strict criteria consider only healed cases as successful. Data analysis was performed using IBM SPSS Statistics 27, quantitative data were summarized as means ± SD, qualitative as frequencies (percentages), PAI’s normality was confirmed by Shapiro-Wilk test and Chi-square tested categorical variables; significance set at p < 0.05. Results Both groups had a 100% success rate under loose criteria. Stricter criteria, however, caused a modest decline in the success rate, especially in the Minimal instrumentation group. The Conventional approach had a greater success rate of 93.8%, whereas the Minimal technique demonstrated an 80.0% success rate with no significant difference (p = 0.333). Conclusion Both techniques exhibited predictable outcomes regarding radiographic healing with no significant difference between the two methods. Future studies should employ CBCT analysis and larger sample size to validate long-term efficacy of this novel device.