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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 109
- 试验地点
- 2
- 主要终点
- Primary effectiveness endpoint
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients aged between 18-75 years with ASA (American Society of Anesthesiologists) classification 1 and
- •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.
排除标准
- •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.
结局指标
主要结局
Primary effectiveness endpoint
时间窗: 12 months
Successful healing of periapical lesion up to 12 months post-procedure where success is defined as completely healed or healing lesion with absence of clinical symptoms. Healing is assessed by measuring the reduction in periapical lesion radiolucency, up to 12 months post-procedure, using the PAI (periapical index score). The absence of clinical symptoms is defined as: 1. The patient had no discomfort in treated tooth 2. The patient had no percussive pain during the examination in treated tooth
次要结局
- Safety endpoint(1 month)
- Secondary effectiveness endpoints(24 months)