Assessing a new material for root canal treatment effectiveness

A Prospective, Single-arm, Non-randomized Controlled Trial to Test the Effectiveness, Safety and Performance of a Novel Dental Obturation Material

This study is testing a new dental material called Endofill to see if it can make root canal treatments more effective and safe for adults aged 18 to 75.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 63 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Lumendo AG (industry)
• Locations: 1 site (Istanbul)
• Trial ID: NCT06312085 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are patients aged 18-75 with symptomatic or asymptomatic apical periodontitis and no prior root canal treatment.

Not a fit: Patients with pre-existing health or oral conditions that pose risks during the trial will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a more effective and efficient option for patients undergoing root canal treatments.

How similar studies have performed: While similar studies have explored novel obturation materials, the specific use of Endofill in this context is relatively novel and has not been extensively tested.

Eligibility criteria

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 this trial is running

Istanbul

• Medipol University — Istanbul, Turkey (Türkiye) (RECRUITING)

Study contacts

• Principal investigator: Tan Firat Eyuboglu, Prof. Dr. — Medipol University
• Study coordinator: Anupama Tripathi

Conditions: Endodontic Treatment, Root Canal Treatment