TCTR20181026001已完成2 期
Clinical evaluation of 3D printed nano-bioengineered bone graft for alveolar ridge preservation: A randomized controlled trial
Faculty of Dentistry Thammasat University0 个研究点目标入组 30 人开始时间: 2018年10月26日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
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
- 18 Years 至 0 N/A (No limit)（—）
- 性别
- All
入选标准
- •1.Adult patients (Age > 18 years)
- •2.Good general health (ASA 1, 2) and not contraindication for extraction
- •3.The diagnosis and indications for extracting tooth are including: endodontic failure or complications (e.g. root fracture), unable to restore from severe caries or crown/root fracture, hopeless prognosis from periodontitis and for prosthodontics reasons.
- •4.Controlled periodontitis.
- •5.Smoking history <10 cigarettes per day. For subject who smokes but less than 10 cigarettes per day is requested to stop smoking two weeks before and after extraction and implant placement.
- •6.No history of allergy or hypersensitivity to any of the products to be used in the study such as polyethylene.
- •7.Signed informed consent.
- •8.Only tooth with an intact buccal bone plate (>50%) and No sign of acute inflammation or infection/abscess. The condition of the buccal bone plate will be evaluated intra-surgically immediately after tooth extraction. All extraction sites must present with a minimum width of 2 mm of keratinized gingival tissue.
排除标准
- •1.Age <18 years.
- •2.Presence of relevant medical conditions: Patients with bone disease, diabetes mellitus, unstable or life-threatening conditions, or requiring antibiotic prophylaxis. Patients with medication of drugs influencing the bone metabolism or use of bisphosphonates.
- •3.Smoking status of more than 10 cigarettes/day.
- •4.Pregnancy or lactation.
- •5.Patients who cannot take impression (both conventional and digital) and CBCT.
- •6.Patients who have socket destruction more than 50% after extraction.
- •7.History of malignancy, radiotherapy, or chemotherapy for malignancy in the past 5 years.
- •8.History of autoimmune disease or long-term prescribed of steroid drugs.
- •9.Lack of opposite occluding dentition in the area intended for extraction and subsequent implant placement; absence of adjacent teeth.
- •10.Presence of dehiscence or fenestration on bone wall of the socket.
- •11.Unwillingness to return for the follow-up examination
研究者
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