A Study to Assess the Clinical Success of Root Canal Treatment Using Novel Obturation Material.
ConditionEndodontic Treatment
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorLumendo AG
About this trial
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.
Eligibility criteria
Qualifiers
Patients who agreed to participate and who have signed the informed consent.
Patients presenting with symptomatic and/or asymptomatic apical periodontitis and radiographic evidence of apical periodontitis in anterior or posterior teeth larger than 1.5 mm in diameter.
Mature tooth with closed apices.
Tooth that has never been treated with root canal therapy.
Disqualifiers
Patients who have pre-existing health or oral conditions that placed them at risk during the trial.
Patients with generalized untreated periodontal disease.
Patients with a history of analgesic intake within the past 3 days or antibiotics in the last 1 month.
Uncooperative patients.
Trial design
Treatments tested in this trial
- Endofill
Treatment groups
63 Participants
are divided into 1 treatment groupSponsors and collaborators
Lumendo AG
Lead sponsor
Avania
Collaborator
Source ClinicalTrials.gov