Assessing a new material for root canal treatment effectiveness

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the effectiveness, safety, and performance of a novel dental obturation material called Endofill for root canal treatments. It is a prospective, single-arm, non-randomized controlled trial involving patients aged 18-75 who require root canal therapy. Participants will receive treatment with Endofill and will be followed up for 12 months to assess outcomes using periapical radiographs. The study aims to demonstrate that Endofill can improve treatment efficiency while maintaining high clinical outcomes.

Why it matters

Who can join: the full rules

Inclusion Criteria:

• Patients aged 18-75 years with ASA (American Society of Anesthesiologists) classification 1 and 2.

ASA 1: A normal healthy patient. Example: Fit, non-obese BMI (Body Mass Index) under 30, a non-smoking patient with good exercise tolerance.

ASA 2: A patient with mild systemic disease. Example: Patient with no functional limitations and a well-controlled disease (e.g., treated hypertension, obesity with BMI under 35, frequent social drinker, or cigarette smoker).

* 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.

Exclusion Criteria:

* 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.
* Teeth with immature apices, root resorption, or requiring extensive prosthetic rehabilitation.
* Teeth that cannot be made functional nor restored or difficult to access teeth with no importance (wisdom teeth).
* Teeth with insufficient periodontal support.
* Teeth with poor prognosis for root canal treatment, for example due to deep root caries, large root resorption or open apex cases.
* Fractured teeth
* Local anatomical factors such as an inaccessible root end
* Presence of fractured instrument in the root canal
* Pregnant women
* Patients unable to understand the study procedure.

Where it's running

• Medipol University
  Istanbul, Turkey (Türkiye) Recruiting

Study contacts

• Principal investigator: Tan Firat Eyuboglu, Prof. Dr. — Medipol University
• Study coordinator: Anupama Tripathi
• Email: anupama.tripathi@odne.co
• Phone: +4144 589 68 03

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.