JPRN-jRCT1062230093招募中1 期
Evaluation of the efficacy Bio-C Sealer of during endodontic re-treatment.
Saito Noriko0 个研究点目标入组 60 人开始时间: 2024年1月22日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 60
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 18age old 至 ot applicable(—)
- 性别
- All
入选标准
- •1. persons who are at least 18 years of age at the time of obtaining consent
- •2. who have given their written consent to participate in the study
- •3. who are able to visit the clinic for treatment and follow-up
- •4. who have had periapical bone resorption confirmed by dental radiographs prior to treatment
- •5. whose tooth has a single root canal confirmed after the start of infected root canal treatment
- •6. those who have undergone re-root canal treatment
- •7. 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
- •1. those with severe clenching of the teeth (clenching and bruxism)
- •2. those with root fractures.
- •3. those with periodontal-endodontic or endodontic-periodontal lesions.
- •4. those whose teeth under study have undergone perforation
- •5. persons with a history of hypersensitivity, such as rashes or dermatitis, to chemical substances, including raw materials of the material under study
- •6. women who are pregnant or possibly pregnant, lactating or wishing to become pregnant
- •7. who are participating or intend to participate in other clinical research studies during the period of their participation in this study
- •8. is deemed to interfere with, limit or confound the evaluation specific to the clinical research plan
- •9. 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)
- •10. those whose clinical symptoms (spontaneous pain, bruxism, gingival swelling or redness, fistula) have not resolved despite standard root canal treatment
- •11. 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
- •12. who have previously been enrolled in this study
- •13. who have periapical bone resorption contiguous to the root apex of multiple teeth on pre-treatment dental radiographs
研究者
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