Clinical efficacy of root canal treatment at 2 years using a new ready‐to‐use injectable calcium silicate‐based sealer: A multicentric randomised controlled trial

Aim Calcium silicate‐based sealers (CSSs) have gained popularity in endodontic applications primarily due to their biological properties and ease of use. This study aimed to assess the 24‐month efficacy and safety of root canal treatment using a new injectable CSS, BioRoot ™ Flow, and to demonstrate the non‐inferiority compared to the established hand‐mixed BioRoot ™ RCS. Methodology This was a multicentric, prospective, randomised, assessor‐blinded, controlled, non‐inferiority trial ( ClinicalTrials.gov : NCT04757753). Patients requiring a primary or a secondary root canal treatment on a single or multi‐rooted tooth were block randomly assigned to BioRoot Flow or BioRoot RCS groups. The primary outcome was the 24‐month success rate based on clinical and radiological criteria. Secondary outcomes included the 6‐ and 12‐month success rates based on similar radiological and clinical criteria, quality of obturation, resorption of extruded material in case of overfilling assessed at 6, 12 and 24 months, post‐operative pain measured using the Visual Analog Scale (VAS) at baseline, 12 h, 24 h, 48 h, 72 h and 7 days, and occurrence of adverse events. A subgroup analysis was also performed based on the type of treatment and on the presence or absence of apical periodontitis (AP) at baseline. Non‐inferiority between materials was assessed using Dunnett and Gent's Chi‐squared (χ 2 ) test, based on an initial hypothesis with a non‐inferiority margin set at 13%, an 80% power and a 5% one‐sided alpha risk. Investigators and patients were not blinded to the assigned medical device. Two qualified evaluators performed a blinded independent central review of the retro‐alveolar radiographs. Results A total of 160 patients with a mean age of 48 years were treated (77 in BioRoot Flow and 83 in BioRoot RCS). The 24‐month follow‐up rate was 85.6%. The overall 24‐month success rates were 86.6% and 87.7% ( p = .0195), respectively. No significant differences were observed between the groups regarding any of the considered secondary outcomes. No adverse events were reported. Conclusion This study demonstrated the non‐inferiority of the new injectable CSS (BioRoot Flow) compared to the previous hand‐mixed version (BioRoot RCS) in terms of efficacy and safety, supporting the implementation of the new material in clinical practice.