a study to compare various root canal cleaning devices based on cavitation,ultrasonic and conventional methods.

Conditions: Apical Periodontitis

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 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.

Eligibility 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.

Keywords: root canal treatment endodontic treatment root canal debridement