A Prospective, Single-arm, Non-randomized Controlled Trial to Test the Effectiveness, Safety and Performance of a Novel Dental Obturation Material

What this Trial Is About

Researchers are evaluating the effectiveness, safety, and performance of a new dental obturation material called Endofill in patients undergoing root canal treatment. This prospective, single-arm, non-randomized trial aims to measure how well Endofill seals root canals and supports healing of apical periodontitis over a 12-month follow-up. The study will also assess the device's safety and performance through radiographic evaluation and monitoring of symptoms such as pain or swelling. Participants will receive root canal treatment using the Endofill device after standard preparation steps, including access cavity preparation, cleaning, shaping, and disinfecting the root canal. The obturation with Endofill is evaluated immediately afterward via periapical radiographs to assess seal completeness. Follow-up visits at 3, 6, and 12 months will monitor healing progress, safety, and the need for any retreatment. The study includes a safety check after three months on the first 10 subjects to ensure device performance. During the study, participants will undergo regular assessments including periapical radiographs to measure lesion size, clinical evaluations for symptoms, and pain assessments up to one month after treatment. Data on procedural duration and patient-reported device usability will also be collected. The total participation time is around one year, with planned enrollment lasting 6 to 9 months and study completion expected within 2 to 2.5 years.

A Study to Assess the Clinical Success of Root Canal Treatment Using Novel Obturation Material.