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A Study to Assess the Clinical Success of Root Canal Treatment Using Novel Obturation Material.
Sponsor: Lumendo AG
Summary
The goal of this study is prospective, single-arm, non-randomized controlled trial to test the effectiveness, safety and performance of a novel dental obturation material. The main question sit answers is 1. To test the effectiveness of the Endofill device for root canal obturation up to 12-month follow-up period. 2. To test the performance of the Endofill device evaluated with periapical radiographs immediately on completion of procedure. The participants requiring root canal treatment will be treated with obturated using Endofill material and post-treatment follow-up vistis will be conducted for 1 year. This is a single-arm study with no comparison groups.
Official title: A Prospective, Single-arm, Non-randomized Controlled Trial to Test the Effectiveness, Safety and Performance of a Novel Dental Obturation Material
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
63
Start Date
2024-06-07
Completion Date
2026-12
Last Updated
2024-07-12
Healthy Volunteers
Yes
Conditions
Interventions
Endofill
Endofill is intended for the permanent obturation of root canals following root canal preparation and disinfection.
Locations (1)
Medipol University
Istanbul, Turkey (Türkiye)