Comparison of Postoperative Pain After Root Canal Obturation With Sealer Containing or Not 1% Enoxolone: a Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 95
- 试验地点
- 2
- 主要终点
- Postoperative pain
研究概览
简要总结
This study aims to assess the efficacy of a zinc oxide eugenol sealer containing Enoxolone, a non-steroidal anti inflammatory drug (NSAID) on the pain relief after endodontic treatment.
The study design is a multicenter, doubled blinded randomized controlled trial. The comparator is the equivalent zinc oxide eugenol sealer without NSAID (allocation ratio is 1:1). The conventional endodontic treatment, using gutta percha and sealer, is done. Patients assess their pain for 7 days after permanent root 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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •male or female aged from 18 to 70 years,
- •patient requiring root canal treatment on permanent mature teeth (single rooted teeth, premolar or molar),
- •Informed consent signed,
- •Patient with social protection.
排除标准
- •root canal retreatment,
- •root canal treatment on an immature tooth,
- •calcified root canal assessed radiographically,
- •Patient with one or more documented contraindication to endodontic treatment,
- •Patient who takes regular analgesic or anti-inflammatory therapy for another pathology,
- •Known allergy to NSAID or to one component of the sealer formula,
- •Participation to another clinical trial at the same time,
- •known pregnancy or lactation,
- •Patients with legal protection.
结局指标
主要结局
Postoperative pain
时间窗: 24 hours
To assess the efficacy of Enoxolone contained in the SEALITE Ultra formula compared to the SEALITE Regular formula, the pain is assessed by patients on a diary using a Visual Analogue Scale (VAS : 0-100 mm) 24 hours after the root canal obturation.
次要结局
- Adverse events(7 days)
- Use of oral pain treatment(7 days)
- Pain response profil(0 hour, 6 hours, 12 hours, 24 hours, Day 2, Day 3, Day 7)