The outcome of combined use of iRoot BP Plus and iRoot SP for root-end filling in endodontic microsurgery: a randomized controlled trial

Objectives Root-end filling is important for the clinical outcome of endodontic microsurgery. Our previous study showed that combined application of iRoot BP Plus Root Repair Material (BP-RRM) and iRoot SP Injectable Root Canal Sealer (SP-RCS) in root-end filling exhibited better apical sealing as compared to the application of BP-RRM alone. The aim of this randomized controlled clinical trial was to evaluate the effect of the combined use of BP-RRM and SP-RCS on the prognosis of teeth with refractory periapical diseases after endodontic microsurgery. Materials and methods 240 teeth with refractory periapical diseases scheduled for endodontic microsurgery were randomly divided into BP-RRM/SP-RCS group ( n = 120) and BP-RRM group ( n = 120). The patients were followed up at 3 months, 6 months, and 12 months after endodontic microsurgery. Pre- and post-operative clinical and radiographic examinations were performed to evaluate the treatment outcome. The 1-year success rate of endodontic microsurgery in BP-RRM/SP-RCS and BP-RRM groups was compared by Chi-square test. Factors that might impact the prognosis were further analyzed using Chi-square test or Fisher's exact test. Results A total of 221 teeth completed the 12-month follow-up. The 1-year success rates of the BP-RRM/SP-RCS and BP-RRM groups were 94.5% (104/110) and 92.8% (103/111), respectively. The combined use of BP-RRM and SP-RCS achieved a clinical outcome comparable to BP-RRM alone ( P = 0.784). Tooth type ( P = 0.002), through-and-through/apico-marginal lesion ( P = 0.049), periodontal status ( P < 0.0001), and Kim’s lesion classification ( P < 0.0001) were critical factors associated with the 1-year success of endodontic microsurgery. Conclusions The combined use of BP-RRM and SP-RCS is a practicable method for root-end filling in endodontic microsurgery with a satisfactory 1-year clinical outcome. Clinical relevance The combined application of BP-RRM and SP-RCS in EMS is an effective root-end filling method with a satisfactory 1-year clinical outcome. Trial registration This study was registered in the Chinese Clinical Trial Registry (ChiCTR2100052174).