Clinical trial No longer in our active list Interventional Ages 18 to 75

Comparing different methods for cleaning root canals

Official title: A Comparative Evaluation of Effectiveness in Root Canal Debridement Using Inertial Cavitation Device vs Passive Ultrasonic Irrigation and Conventional Preparation: A Randomized Controlled Clinical Trial

Run by Lumendo AG · NCT06005545 · Data updated 2026-05-14

This study is no longer in our active list. It may have stopped recruiting or finished. The details below are as of 2026-05-14 and are kept for reference. Check ClinicalTrials.gov for its current status, or see similar studies below.

This study is testing different ways to clean root canals to see which method is safest and most effective for adults needing treatment for tooth infections.

Quick facts

Study typeInterventional
Ages18 Years to 75 Years
SexAll
Enrollment109 (estimated)
SponsorLumendo AG
Industry-sponsored
Locations1 site (Istanbul, Unkapanı, Fatih)
Trial IDNCT06005545 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are healthy adults aged 18 to 75 with symptomatic or asymptomatic apical periodontitis requiring root canal treatment.

Probably not a fit

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

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

What this trial studies

This clinical trial aims to evaluate the effectiveness and safety of various root canal cleaning devices, including an inertial cavitation device, passive ultrasonic irrigation, and conventional methods. It involves a prospective, randomized, non-blinded design with three arms, focusing on patients aged 18 to 75 years who require root canal treatment due to apical periodontitis. Participants will record their post-operative pain levels and follow-up visits will include intraoral X-rays to assess healing rates. The study will analyze clinical outcomes over a 12 to 24-month period.

Why it matters

Potential benefit: If successful, this study could lead to improved root canal treatment outcomes and reduced post-operative pain for patients.

How similar studies have gone: Other studies have shown promising results with similar approaches in root canal treatment, indicating potential for success.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

•Patients aged between 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 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

  • İstanbul Medipol Universitesi, Faculty of Dentistry, Department of Endodontics
    Istanbul, Unkapanı, Fatih, Turkey
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.