Endodontic Post-operative Pain Evaluation of Patients After Using Endomethasone N or Endomethasone SP Root Canal Sealer: a Prospective, Comparative Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Septodont
- 入组人数
- 300
- 试验地点
- 19
- 主要终点
- Maximum post-operative pain using a visual analogue scale (VAS : 0-100)
研究概览
简要总结
The study is a post-marketing performance and safety study, designed as a comparative, prospective, multicenter, simple-blind, randomized clinical trial. 300 subjects requiring a primary or a secondary root canal treatment will be enrolled in 2 groups (150 in each group). The aim of the study is to demonstrate the superiority of the hydrocortisone-containing root canal sealer Endomethasone N RCS, compared to the hydrocortisone-free root canal sealer Endomethasone SP RCS, with regard to reduction of the maximum post-operative spontaneous pain during the 7 days following the root canal treatment.
Root canal treatment procedures will be in accordance with the allocation by randomisation of Endomethasone N RCS or Endomethasone SP RCS. The spontaneous and the Masticatory pain will be record at predefined times, a phone call will be done at 48h and a visit will be realized at day 7 (max Day 14).
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 color of the two powders are not the same. The dentist will not be blinded to the treatment, but the patient will. The study is simple-blinded.
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 root canal treatment or retreatment;
- •Patient who will need a single visit for the root canal therapy, for a mature molar or second premolar, with or without pre-operative pain
- •Patient who received information and gave written consent (signed informed consent form);
- •Subject affiliated to a health insurance system, or is a beneficiary (art. L.1121-11, Code of Public Health, France).
排除标准
- •Pulpotomy or pulpectomy performed at a prior visit;
- •Tooth with apical calcification (sealer unable to reach the root apex);
- •Tooth with suspected root perforation;
- •Immature tooth (too wide root apex requiring an apexification);
- •Other dental treatment ongoing or scheduled within the study period;
- •At least one symptomatic tooth among those that are not included in this study
- •Known hypersensitivity to steroids, local anesthetics, or any component of study medical devices;
- •Subject using long term anti-inflammatory drugs;
- •Use of illicit substances during the 48h before the first visit (cannabis, cocaine…);
- •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;
- •Subject who cannot be contacted in case of emergency (phone number);
- •Simultaneous participation in another clinical trial or subject still within the exclusion period of a previous clinical trial;
- •Vulnerable subjects (art. L.1121-5 and L.1122-1-2, Code of Public Health, France; art. 66 of the Regulation (EU) 2017/745 on medical devices)
研究组 & 干预措施
Endomethasone N RCS
Endomethasone N RCS is used in combination with gutta percha points for the permanent obturation of root canals.
干预措施: Endomethasone N RCS (Device)
Endomethasone SP RCS
Endomethasone SP RCS is used in combination with gutta percha points for the permanent obturation of root canals.
干预措施: Endomethasone SP RCS (Device)
结局指标
主要结局
Maximum post-operative pain using a visual analogue scale (VAS : 0-100)
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 (VAS: 0-100 mm; 0 no pain - 100 maximum pain) at different times after endodontic treatment (at the end of the root canal obturation, 3h, 6h 12h, 24h, Day 2, Day 3, Day 4 Day 5, Day 5, Day 7). The maximum pain felt will be compared between the 2 groups.
次要结局
- Spontaneous pain intensity(from the end of the root canal treatment (Day 0) to Day 7)
- Occurrence of spontaneous pain flare-ups(From Day 3 to Day7)
- Masticatory pain intensity(from the end of the root canal treatment (Day 0) to Day 7)
- Maximum Masticatory pain intensity using a visual analogue scale (VAS : 0-100mm)(from the end of the root canal treatment (Day 0) to Day 7)
- Use of oral pain treatment(from the end of the root canal treatment (Day 0) to Day 7)
- Quality of life with the OHIP-17 questionnaire (score 0-68)(baseline and from 48 to 72 hours)
- Adverse events(from the inclusion (Day 0) to Day 7)