Comparing different methods for cleaning root canals
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
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 109 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Lumendo AG Industry-sponsored |
| Locations | 1 site (Istanbul, Unkapanı, Fatih) |
| Trial ID | NCT06005545 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are healthy adults aged 18 to 75 with symptomatic or asymptomatic apical periodontitis requiring root canal treatment.
Not a fit: Patients with pre-existing health or oral conditions that may pose risks during the trial will not benefit from this study.
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 performed: Other studies have shown promising results with similar approaches in root canal treatment, indicating potential for success.
Eligibility criteria
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 this trial is running
Istanbul, Unkapanı, Fatih
- İstanbul Medipol Universitesi, Faculty of Dentistry, Department of Endodontics — Istanbul, Unkapanı, Fatih, Turkey (Recruiting)
Study contacts
- Study coordinator: Tan Fırat Eyüboglu Assoc. Prof.
- Email: tfeyuboglu@yahoo.com
- Phone: +90 530 463 60 59
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.