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

This trial accepts healthy volunteers

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

Design model

Single group

Treatments tested in this trial

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

Treatment groups

63 Participants

are divided into 1 treatment group

Group A: Endofill armExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

Effectiveness of root canal treatment using Endofill

To measure effectiveness by assessing overall healing, through rate of reduction in apical periodontitis, from baseline up to 12 months post-procedure by measuring periapical radiolucency size.

Time frame

12 months

Secondary outcomes

Safety of root canal treatment using endofill

To measure safety by measuring postoperative pain from completion of the procedure up to 1 month of follow-up period (24 hours, 48 hours, 72 hours, 7 days, and 1 month). Pain is measured by VAS assessment. It consists of a line, approximately 10 cm in length, with the left side signifying no pain with a smiling face image and the right side signifying the worst pain with a frowning face image. A patient is asked to indicate his/her perceived pain intensity along a 100 mm horizontal line, and this rating is then measured from the left edge. A VAS score of 0 indicates no pain and a score of 10 indicates the highest level of pain experienced.

Time frame

1 month

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Lumendo AG

Lead sponsor

Avania

Collaborator

Source ClinicalTrials.gov

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