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RECRUITING
NCT06312085
NA

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

Sponsor: Lumendo AG

View on ClinicalTrials.gov

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

Interventions

DEVICE

Endofill

Endofill is intended for the permanent obturation of root canals following root canal preparation and disinfection.

Locations (1)

Medipol University

Istanbul, Turkey (Türkiye)