A Prospective, Single-arm, Non-randomized Controlled Trial to Test the Effectiveness, Safety and Performance of a Novel Dental Obturation Material
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 63
- 试验地点
- 2
- 主要终点
- Effectiveness of root canal treatment using Endofill
研究概览
简要总结
The goal of this study is prospective, single-arm, non-randomized controlled trial to test the effectiveness, safety and performance of a novel dental obturation material. The main question sit answers is
- To test the effectiveness of the Endofill device for root canal obturation up to 12-month follow-up period.
- To test the performance of the Endofill device evaluated with periapical radiographs immediately on completion of procedure.
The participants requiring root canal treatment will be treated with obturated using Endofill material and post-treatment follow-up vistis will be conducted for 1 year. This is a single-arm study with no comparison groups.
详细描述
Study Title:
"A prospective, single-arm, non-randomized controlled trial to test the effectiveness, safety and performance of a novel dental obturation material."
Protocol Version and Date: Version 1.0 25 May 2023
Device Risk Category: Risk category: Class IIa, Rule 8 - medium risk device (according to EU MDR).
Background and Rationale:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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 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 root canal treatment, 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
Effectiveness of root canal treatment using Endofill
时间窗: 12 months
To measure effectiveness by assessing overall healing, through rate of reduction in apical periodontitis, from baseline up to 12 months post-procedure by measuring periapical radiolucency size.
次要结局
- Safety of root canal treatment using endofill(1 month)