JPRN-jRCTs051190045已完成未知
The clinical study to evaluate the safety and efficacy of combination therapy of REGROTH and Cytrans Granules for periodontitis patients.
Murakami Shinya0 个研究点目标入组 10 人开始时间: 2019年9月5日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 10
研究概览
简要总结
In this study, the safety (the primary endpoint) and the efficacy (the secondary endpoint) of the periodontal tissue regenerative therapy using the test drug (REGROTH) and the test device (CytransGranules) were evaluated in severe periodontitis patients. Regarding the primary endpoint and secondary endpoint, the above outcome measures were observed. These results indicate the safety and efficacy of periodontal tissue regenerative therapy using the test drug and the test device for severe periodontitis.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 ot applicable（—）
- 性别
- All
入选标准
- •Patients aged 20 years old or more who can acquire written consent by themselves for participation in this study and who have teeth that meet all of the following conditions will be selected.
- •1. A tooth diagnosed as marginal periodontitis and judged to require flap surgery judged to require flap operation by the registered dentist.
- •2. A tooth which has a vertical bone defect with a probing pocket depth of 4mm or more and a depth of 3mm or more at the mesial or distal site.
- •3. A tooth with keratinized gingiva, which can be judged as an indication for flap operation and the degree 2 or less.
排除标准
- •The following patients and teeth are excluded from this study.
- •1. Patients who are complicated malignant tumor or have its history
- •2. Patients who have used bisphosphonate drugs or have osteoporosis
- •3. Patients with abnormal gingival overgrowth or its history
- •4. Patients with malignant tumor, precancerous lesions or findings that they are suspected in oral cavity
- •5. Tooth having other complicated diseases except periodontitis (apical periodontitis, tooth root fracture etc.) that may affect the periodontal tissue healing
- •6. Teeth that are expected to undergo treatment that will affect the evaluation of safety or efficacy within 36 weeks after surgery
- •7. Teeth whose restoration etc. interferes with accurate measurement of the clinical attachment level
- •8. Patients who remain affected by the treatment performed in the oral cavity within the past 3 months.
- •9. Patients with severe blood disorder or bone target hormone metabolic disorders
- •10. Patients who suspected collagenosis and the abnormalities of calcium metabolism organs such as
- •kidney and gastrointestinal tract
- •11. Patients under dialysis treatment or steroid use
- •12. Patients with uncontrollable complications that are restricted from observing the requirements of this clinical research, such as severe disease (infection, immunodeficiency, heart disease, etc) or psychiatric disorder.
- •13. Patient with alcohol/drug addiction
- •14. Uncontrolled diabetes mellitus patients who have had not adequate glycemic control (HbA1c less than 6.5%).
- •15. Patients who are pregnant, wishing for pregnancy during this clinical study, under pregnant, or breastfeeding.
- •16. Patients who are considered to be difficult for follow-up visits such as distant place residents
- •17. Patients who are restricted from observing the requirements of clinical research for social or domestic environments
- •18. Patients participated in the clinical studies with interventions for other medical devices or medicines within the past 3 months
- •19. Patients who have participated in this study
- •20. For other reasons, Patients who are considered inappropriate as subjects for this clinical study or combination therapy of REGROTH and Cytrans granules by clinical research director or registered dentist.
研究者
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