jRCT1062230093招募中不适用
Evaluation of the efficacy Bio-C Sealer of during endodontic re-treatment.
未提供0 个研究点目标入组 60 人开始时间: 2024年12月5日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 主要终点
- Percentage of patients with reduced or eliminated periapical bone defect image area
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Single Arm Study
- 干预模型
- Single Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Open(masking Not Used)
入排标准
- 年龄范围
- 18age old over 至 No limit（—）
- 性别
- All
入选标准
- •persons who are at least 18 years of age at the time of obtaining consent
- •who have given their written consent to participate in the study
- •who are able to visit the clinic for treatment and follow-up
- •who have had periapical bone resorption confirmed by dental radiographs prior to treatment
- •those who have undergone re-root canal treatment
- •whose clinical symptoms have resolved after root canal treatment and the results of the root canal bacterial culture test have been confirmed negative.
排除标准
- •those with severe clenching of the teeth (clenching and bruxism)
- •those with root fractures.
- •those with periodontal-endodontic or endodontic-periodontal lesions.
- •those whose teeth under study have undergone perforation
- •persons with a history of hypersensitivity, such as rashes or dermatitis, to chemical substances, including raw materials of the material under study
- •women who are pregnant or possibly pregnant, lactating or wishing to become pregnant
- •who are participating or intend to participate in other clinical research studies during the period of their participation in this study
- •is deemed to interfere with, limit or confound the evaluation specific to the clinical research plan
- •the principal investigator(s) directly involved in this or any other clinical research, or any employee of the implementing healthcare organisation, or any family member of the principal investigator(s)
- •those whose clinical symptoms (spontaneous pain, bruxism, gingival swelling or redness, fistula) have not resolved despite standard root canal treatment
- •those whose clinical symptoms disappear after root canal treatment but the results of the root canal bacterial culture test do not become negative for more than six months
- •who have previously been enrolled in this study
- •who have periapical bone resorption contiguous to the root apex of multiple teeth on pre-treatment dental radiographs
结局指标
主要结局
Percentage of patients with reduced or eliminated periapical bone defect image area
Calculated from dental radiographs images
次要结局
未报告次要终点
研究者
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