Postoperative Pain Evaluation After Definitive Root Canal Obturation With Zinc Oxide/Eugenol-type Sealer Containing or Not 1% Prednisolone Acetate - Steroid Anti-inflammatory Agent: a Comparative, Randomized Clinical Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 243
- 试验地点
- 10
- 主要终点
- Post-operative pain assessed by a VAS
研究概览
简要总结
The study design is a multicentric randomized controlled clinical trial. 238 subjects (teeth) requiring a primary or a secondary root canal treatment will be enrolled in 2 groups (119 in each group).
The aim is to assess the effectiveness and utility of the ancillary drug substance, prednisolone acetate (1%) contained in CORTISOMOL SP (Zinc Oxide/Eugenol-type sealer) to help to decrease the possible postoperative painful reactions after root canal treatment. SEALITE REGULAR, which has a similar formulation except it is prednisolone acetate-free, is used as the comparator sealer.
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 Zinc oxide/Eugenol-type sealer (CORTISOMOL SP or SEALITE REGULAR) and gutta-percha.
Patients assess their pain for 7 days after permanent root canal obturation.
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 (Participant)
盲法说明
the participant will be blind from the treatment
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
- •Male or female, age > 18 years old
- •Patient requiring a primary or a secondary root canal treatment on a single or multi-rooted tooth.
- •Informed consent signed
- •Patient with social protection.
排除标准
- •Endodontic treatment on tooth with suspected root perforation, or immature tooth,
- •Known allergy to corticosteroids, local anesthetics, or any component of the medical devices,
- •Patient taking anti-pain or anti-inflammatory treatment regularly for another pathology,
- •Presence of any significant medical finding or significant history such as uncontrolled systemic diseases that may impact the safety, the interpretation of the results and/or the participation of the subject in the study according to the opinion of the investigator,
- •Participation in another intervnetional clinical trial or subject still within the exclusion period of a previous clinical trial,
- •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).
结局指标
主要结局
Post-operative pain assessed by a VAS
时间窗: From the end of the root canal treatment (Day 0) to Day 7
The pain is assessed by patients in a diary using a Visual Analogue Scale (range from 0 (= no pain) to 100 (= the worst pain)) at different times after endodontic treatment from the end of the root canal obturation to Day 7. The maximum pain felt will be compared between the 2 groups.
次要结局
- Use of oral pain treatment(From the end of the root canal treatment (Day 0) to Day 7)
- Number of adverse events(From the end of the root canal treatment (Day 0) to the end of follow-up visit (Day 14))