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 adult population aged between 18 to 75 years requiring root canal treatment.

The main question[s] it aims to answer are:

• Effectiveness of the cleaning mechanism
• Evaluate the safety of use of the device. Participants will be provided root canal treatment. Participants will be asked to record their post-operative pain levels in a Patient Pain diary. The healing rate of the lesion will be examined at follow-up visits using intraoral X-rays. At the end of the study, a statistical analysis of the clinical outcomes of the root canal treatment will be examined and evaluated in every group.

Study 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".

Study Design: This is a prospective, 3-arm randomized, non-blinded, single-center pivotal clinical investigation, performed to evaluate the effectiveness and safety of the Endoclean device with 2 comparator arms.

Primary objective: To test the effectiveness of the Endoclean device for root canal debridement up to 12-month follow-up.

Secondary objective: To test the extended effectiveness and safety of the Endoclean device up to a 24-month follow-up.

Inclusion/Exclusion Criteria:

1. 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.

2. 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.

Number of Participants:

Total number of participants = 109 subjects Arm 1: 40 subjects Arm 2: 40 subjects Arm 3: 29 subjects Test device: Endoclean (Lumendo AG): hydraulic cavitation cleaning device Control device 1: Passive ultrasonic irrigation (PUI) Control device 2: Rotary files with standard NaOCl irrigation Study duration: 2-3 years The results of the Endoclean group shall be compared to data gathered from the comparator device groups and results shall be presented in the clinical investigation report.

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.