Evaluation of the Efficacy Rate of Endodontic Treatment at 2 Years After Root Canal Filling With a Ready-to-use Root Canal Sealer PA1704 Versus BioRoot™ RCS: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Septodont
- 入组人数
- 160
- 试验地点
- 9
- 主要终点
- Efficacy Rate of Root Canal Obturation
研究概览
简要总结
The study design is a multicentric randomized controlled non-inferiority trial. 160 subjects (teeth) requiring a primary or a secondary root canal treatment will be enrolled in 2 groups (80 in each group). The aim of the study is to assess the efficacy rate and the safety 2 years after root canal obturation undertaken using a ready-to-use calcium silicate sealer (PA1704) compared to the control calcium silicate sealer BioRoot™ RCS.
Procedures of root canal treatment will be conventional and standardized for all investigational centers. The canals will be cleaned, shaped and then obturated using a calcium silicate sealer (the ready to use sealer PA1704 or BioRoot™ RCS) with a single cone technique or cold lateral condensation of gutta-percha. Follow-up assessments will be conducted at 6, 12 and 24 months in both groups. The performance and safety of the sealer PA1704 will also be evaluated at 3.5 and 5 years after surgery. Retroalveolar radiographs will be taken at each study visit. The preoperative, postoperative and follow-up clinical and radiographic data will be analyzed.
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
- Single (Outcomes Assessor)
盲法说明
Blinding will be done to the assessors who analyzed radiographs to reduce bias to healing assessment.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult male or female (age ≥ 18 years)
- •Patient requiring a primary or a secondary root canal obturation on a single or multi-rooted tooth,
- •Patient geographically stable who can be followed by the same investigator site for 2 years,
- •Informed consent signed,
- •Patient with social protection
排除标准
- •Patient with one or more documented contraindication to endodontic treatment,
- •Contraindication to the use of calcium silicate root canal sealer, such as an immature tooth or a known hypersensitivity to one component of the sealer formula,
- •Endodontic treatment on tooth with calcified root canal assessed radiographically,
- •Endodontic treatment on tooth with suspected perforation,
- •Patient with an uncontrolled systemic disease such as diabetes or thyroid disorders, or with an immunocompromised condition or who has undergone radiation therapy to the jaw.
- •Patient suffering from uncontrolled active periodontitis, not supported
- •Participation to another interventional clinical study at the same time,
- •Vulnerable subjects referred to in articles L.1121-5 to 8 and L.1122-1-2 of the Public Health Code and article 66 of Regulation (EU) 2017/745 on medical devices are excluded from the investigation (such as known pregnancy or lactation, patients with legal protection).
研究组 & 干预措施
ready-to-use root canal sealer: PA1704
PA1704 is used in combination with gutta percha points for the permanent obturation of root canals.
干预措施: ready-to-use root canal sealer: PA1704 (Device)
root canal sealer: BioRoot™ RCS
BioRoot™ RCS is used in combination with gutta percha points for the permanent obturation of root canals.
干预措施: root canal sealer: BioRoot™ RCS (Device)
结局指标
主要结局
Efficacy Rate of Root Canal Obturation
时间窗: 24 months post-treatment
Efficacy rate of root canal obturation using clinical and radiological criteria. A successfull treatment is defined in this study, based on some loose criteria, as: a functional tooth with no lesion on the radio, or a functional tooth with a size reduction of the lesion on the radio, or a functional tooth with a lesion size stabilisation.
次要结局
- Efficacy Rate of Root Canal Obturation(6 months post-treatment)
- Radiological Evaluation of the Canal Obturation(24-months post-treatment)
- Postoperative Pain(Before endodontic treatment*; before session#2 initiation**; T0 (after canal obturation); 12; 24; 48; & 72h; 7 days after endodontic treatment. *Evaluation on same day for 1-session treatment; up to 18 days before if 2 sessions needed. **On same day.)
- Use of Oral Pain Treatment(From Day 0 to Day 7)