JPRN-jRCTs032210705招募中未知
The safety and efficacy of Cytrance Granule and Cytrance Elashield in Guided tissue regeneration for periodontal patients with bone defects; A clinical trial.
Iwata Takanori0 个研究点目标入组 10 人开始时间: 2022年3月28日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 发起方
- 入组人数
- 10
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
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 periodontitis and diagnosed to require flap surgery by the registered dentist.
- •2. A tooth which has a intrabony defect with a probing pocket depth of 6 mm or more and a depth of 3mm or more in the dental X-ray image.
- •3. A tooth with class 2 furcation involvement in madible.
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 with malignant tumor, precancerous lesions or findings that they are suspected in oral cavity
- •3. Patients with abnormal gingival overgrowth or its history
- •4. Tooth having other complicated diseases except periodontitis (apical periodontitis, tooth root fracture etc.) that may affect the periodontal tissue healing
- •5. Teeth that are expected to undergo treatment that will affect the evaluation of safety or efficacy within 24 weeks after surgery
- •6. Teeth whose restoration etc. interferes with accurate measurement of the clinical attachment level
- •7. Patients who remain affected by the treatment performed in the oral cavity within the past 3 months.
- •8. Patients who have used bisphosphonate drugs or have osteoporosis
- •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 hepatic impairment or whose liver function is considered abnormal.
- •13. 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.
- •14. Patients undergoing or previously undergoing radiotherapy
- •15. Patients with hypertension and hypotension not adequately controlled
- •16. Uncontrolled diabetes mellitus patients who have had not adequate glycemic control (HbA1c less than 6.5%).
- •17. Patients with asthmatics without adequate control.
- •18. Patients with rheumatic fever
- •19. Patients with hyperthyroidism
- •20. Patients who are pregnant, wishing for pregnancy during this clinical study, under pregnant, or breastfeeding.
- •21.Patients with allergic tendencies and a history of hypersensitivity or allergy to materials containing L-lactide-caprolactone copolymers.
- •22.Patient who has smoking habit of 11 cigarettes/day or more.
- •23.Patient with alcohol/drug addiction
- •24.Patients who are considered to be difficult for follow-up visits such as distant place residents
- •25. Patients who are restricted from observing the requirements of clinical research for social or domestic environments
- •26.Patients participated in the clinical studies with interventions for other medical devices or medicines within the past 3 months
- •27.Patients who have participated in this study
- •28.For other reasons, Patients who are considered inappropriate as subjects for this clinical study or combination therapy of Cytrans granules and Cytrans elashields by clinical research director or registered dentist.
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