{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,2]],"date-time":"2026-10-02T06:27:46Z","timestamp":1790922466923,"version":"4.1.0"},"reference-count":41,"publisher":"Wiley","issue":"9","license":[{"start":{"date-parts":[[2025,6,10]],"date-time":"2025-06-10T00:00:00Z","timestamp":1749513600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Int Endodontic J"],"published-print":{"date-parts":[[2025,9]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Aim<\/jats:title>\n                    <jats:p>\n                      Calcium silicate\u2010based 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\u2010month efficacy and safety of root canal treatment using a new injectable CSS, BioRoot\n                      <jats:italic>\u2122<\/jats:italic>\n                      Flow, and to demonstrate the non\u2010inferiority compared to the established hand\u2010mixed BioRoot\n                      <jats:italic>\u2122<\/jats:italic>\n                      RCS.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methodology<\/jats:title>\n                    <jats:p>\n                      This was a multicentric, prospective, randomised, assessor\u2010blinded, controlled, non\u2010inferiority trial (\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" xlink:href=\"http:\/\/clinicaltrials.gov\">ClinicalTrials.gov<\/jats:ext-link>\n                      : NCT04757753). Patients requiring a primary or a secondary root canal treatment on a single or multi\u2010rooted tooth were block randomly assigned to BioRoot Flow or BioRoot RCS groups. The primary outcome was the 24\u2010month success rate based on clinical and radiological criteria. Secondary outcomes included the 6\u2010 and 12\u2010month 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\u2009months, post\u2010operative pain measured using the Visual Analog Scale (VAS) at baseline, 12\u2009h, 24\u2009h, 48\u2009h, 72\u2009h and 7\u2009days, 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\u2010inferiority between materials was assessed using Dunnett and Gent's Chi\u2010squared (\u03c7\n                      <jats:sup>2<\/jats:sup>\n                      ) test, based on an initial hypothesis with a non\u2010inferiority margin set at 13%, an 80% power and a 5% one\u2010sided 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\u2010alveolar radiographs.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      A total of 160 patients with a mean age of 48\u2009years were treated (77 in BioRoot Flow and 83 in BioRoot RCS). The 24\u2010month follow\u2010up rate was 85.6%. The overall 24\u2010month success rates were 86.6% and 87.7% (\n                      <jats:italic>p<\/jats:italic>\n                      \u2009=\u2009.0195), respectively. No significant differences were observed between the groups regarding any of the considered secondary outcomes. No adverse events were reported.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>This study demonstrated the non\u2010inferiority of the new injectable CSS (BioRoot Flow) compared to the previous hand\u2010mixed version (BioRoot RCS) in terms of efficacy and safety, supporting the implementation of the new material in clinical practice.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1111\/iej.14265","type":"journal-article","created":{"date-parts":[[2025,6,10]],"date-time":"2025-06-10T03:44:09Z","timestamp":1749527049000},"page":"1420-1432","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":13,"title":["Clinical efficacy of root canal treatment at 2\u2009years using a new ready\u2010to\u2010use injectable calcium silicate\u2010based sealer: A multicentric randomised controlled 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