JPRN-jRCTs072190012已完成1 期
Clinical study on safety to apply the bio-degradable membrane with L-lactide, E-caprolactone copolymers for guided bone regeneration
Asahina Izumi0 个研究点目标入组 5 人开始时间: 2019年7月1日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 5
研究概览
简要总结
The study aimed to investigate the safety and feasibility for clinical application of poly (L Lactic acid e caprolactone; P(LA CL)) membrane, a new bioabsorbable synthetic material used for guiding bone regeneration (GBR).The study comprised five subjects with a mean age of 49 years. The application of P(LA CL) membrane for bone augmentation with GBR made it possible to maintain the augmented bone volume without causing any irreversible adverse events.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 <= 79age old（—）
- 性别
- All
入选标准
- •1. Patients who agreed to have dental implant treatment, but whose alveolar bone height and/or width are insufficient for ideal implant placement, and are required the alveolar ridge augmentation with GBR (guided bone regeneration) technique (judge by CT examination one month more before entry).
- •2. Patients who are diagnosed to be able to obtain the primary fixation when placed the dental implants.
- •3. Patients who had an alveolar bone height of at least 3mm
排除标准
- •1. Patients who have severe hematologic disease.
- •2. Patients who have disorders of organs related to calcium metabolism, such as kidney and digestive organs, and collagen disease.
- •3. Patients who are getting an artificial dialysis.
- •4. Patients who are taking steroid medications.
- •5. Patients who have any cancer, and had got the radiation therapy.
- •6. Patients who are getting the bisphosphonate treatment.
- •7. Patients who are limited to obey the requirements of this study by their severe infectious diseases, immune system abnormalities, heart disease and other uncontrollable disorders such as psychological disorder.
- •8. Patients who are alcohol or drug dependence.
- •9. Patients who are pregnant and lactation period, or planned pregnancy
- •10. Patients who live in a remote place and are difficult to visit Nagasaki University Hospital for follow-ups after treatment.
- •11. Patients who are limited to obey the requirements of this study on the ground of their social or home environment.
- •12. Patients who are smokers.
- •13. Patients who need the legal representative.
- •14. Patients who are judged as improper to join in this study by the principal investigator or co-investigators.
研究者
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