JPRN-jRCTs072180075已完成1 期
Keratinized gingival tissue regeneration with micronized-gingival connective tissues: Pilot Study - Keratinized tissue reconstruction with gingival micro-grat.
Asahina Izumi0 个研究点目标入组 4 人开始时间: 2019年3月26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
- 4
研究概览
简要总结
The objective of this clinical study is to assess the safety, and in part the efficacy of micro-graft with MGCTs on keratinized gingival tissue regeneration in dental implant therapy in a pilot study. A total of 4 patients received a transplantation of atelocollagen-matrix with MGCTs micronized by using Rigenera system. For 4 weeks after surgery, this study demonstrated that using micro-graft with MGCTs did not cause any irreversible adverse events, and showed efficacy of micro-graft with MGCTs.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 <= 75age old（—）
- 性别
- All
入选标准
- •Patients who received the dental implant treatment.
- •1. Patients who recognize the keratinized gingival defect or insufficient thickness (<2mm).
- •2. Patients who received the oral health care and maintain the good condition of Plaque Control.
排除标准
- •1. Patients who have serious endocrine metabolic disease or autoimmune disease
- •2. Patients who have malignances, septicemia
- •3. Patients who have disorder of blood coagulation;
- •PT:more than 50 %
- •APTT:23.5 - 42.5seconds
- •4. Patients who have hepatitis function disorders or dysfunction;
- •GOT(AST):10 - 40 IU/L
- •GPT(ALT): 5 - 45 IU/L
- •5. Patients who have metabolic bone disease or skeletal dysplasia.
- •6. Patients who have pregnancy.
- •7. Patients who have dementia.
- •8. All patients are required to be nonsmokers.
研究者
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