Status:
RECRUITING
A Study to Compare Various Root Canal Cleaning Devices Based on Cavitation,Ultrasonic and Conventional Methods.
Lead Sponsor:
Lumendo AG
Conditions:
Apical Periodontitis
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
The goal of this clinical trial is to compare the effectiveness of various root canal cleaning devices based on the principle of cavitation, ultrasonics, and conventional methods in a normal healthy a...
Detailed Description
Study title: "A Comparative Evaluation of Effectiveness in Root Canal Debridement using Inertial Cavitation Device vs Passive Ultrasonic Irrigation and Conventional Preparation: A Randomized Controlle...
Eligibility Criteria
Inclusion
- •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
- 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.
Key Trial Info
Start Date :
October 4 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2026
Estimated Enrollment :
109 Patients enrolled
Trial Details
Trial ID
NCT06005545
Start Date
October 4 2023
End Date
March 1 2026
Last Update
December 6 2023
Active Locations (1)
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1
İstanbul Medipol Universitesi, Faculty of Dentistry, Department of Endodontics
Istanbul, Unkapanı, Fatih, Turkey (Türkiye), 34083