KCT0005545招募中未知
Bone-guided regeneration of NR Line implant peripheral defects: a prospective randomized clinical study
Yonsei University Health System, Dental Hospital0 个研究点目标入组 40 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 发起方
- 入组人数
- 40
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational Study
入排标准
- 年龄范围
- 20(Year) 至 o Limit（—）
- 性别
- All
入选标准
- •1) Over 20 years old
- •2) Implant placement does not have any contraindicated systemic/localized disease or condition
- •3) In the maxilla or mandible, a deterioration defect of 3 mm or more in apex-crown width should be expected to occur around at least one implant.
- •4) The initial stability of the implant is secured
- •5) Implant placement should be done at least 2 months after extraction
- •6) No soft tissue transplantation required after implant placement
- •7) Implant placement should be done at least 2 months after soft tissue transplantation.
- •8) Non-smokers, smokers who smoke less than 10 cigarettes a day
- •9) Those with no possibility of pregnancy
排除标准
- •1) Those who have taken medicines that interfere with bone formation within 2 weeks from the time of screening (e.g., adrenal corticosteroids) or are likely to take them during the clinical trial period
- •2) Those who administered oral or injectable rheumatism treatment including immunosuppressants within 2 weeks from the time of screening
- •3) Patients with uncontrolled diabetes or high blood pressure
- •4) Those with oral skin diseases or lesions (eg, erosive lichen planus, erosive lichen planus, stomatitis, ulcers, malignant tumors)
- •5) Those suffering from osteomyelitis
- •6) In the past, oral or injectable bisphosphonate drugs to treat osteoporosis for more than 3 months
- •Those who have been or are receiving the administration (However, according to the AAOMS standard, discontinuation of the administration for more than 3 months, those with a CTx level of 0.150ng/ml or more may participate in the clinical study)
- •7) A person who meets any of the following items in the area where the test/control medical device is applied
- •i. Those with past bone graft or implant experience
- •ii. Those who have had a tumor removed in the past
- •8) Those who lack oral hygiene management skills
- •9) Those with mental disorders that have a significant impact on this clinical trial
- •10) Pregnant or lactating women
- •11) In addition to the above, a person who has clinically significant findings deemed inappropriate for this test as a result of medical judgment by the person in charge or in charge of the study
研究者
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