KCT0001731已完成未知
Ability of new bone formation of allogenous graft material(THE Graft) and Bio-oss in sinus augmentation : Multicenter comparative clinical study.
Yonseit University Health System, Dental Hospital0 个研究点目标入组 22 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 22
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 19(Year) 至 o Limit（—）
- 性别
- All
入选标准
- •1) Age 19 or older
- •2) Need maxillary sinuses floor augmentation before implantation operation for single or multiple numbers of tooth
- •3) By result of panorama radiography and computed tomography, whose actual height of residual bone in lateral-posterior segment is 1mm < 6mm
- •4) Nonsmoking or smoking less than 10 cigarette for a day
- •5) Those who can understand and follow the instruction through the clinical trial period
- •6) Those who voluntarily participate to the trial and signed the agreement
排除标准
- •1)Those who has taken for has possibility to take medication that interfere bone formation within 2 weeks from the time of screening (e.g. Adrenocortical hormones, etc.) or throughout trial period.
- •2)Those who has taken oral or injectable rheumatism therapeutics including immunosuppressive within 2 weeks from the time of screening.
- •3)Who has hypersensitivity history with porcine bone and anorganic bovine bone
- •4)Patients with uncontrolled diabetes or hypertension or blood clotting tunes
- •5)Patients with a maxillary sinus or uncontrolled periodontal disease
- •6)Patients with intraoral skin disease or lesions (e.g. erosive lichen planus, erosive lichen planus, ulcer, malignant tumor, mouth ulcer, etc.)
- •7)Who has history of intraoral radiation therapy
- •8)Patients who has history of treatment with oral or injectable bisphosphonate base osteoporosis treatment more than 3 months or who is current under the treatment. (For exception that according to American Association of Oral and Maxillofacial Surgeons(AAOMS) standard, who stopped the treatment within 3 months and who has CTx level 0.150ng/ml can participate the clinical trial)
- •9)Among the control and experimental group, who is applicable of at least one of the following conditions
- •A.Who has experience with bone graft and/or implantation
- •B.Who has removed tumor
- •C.Patients with osteomyelitis
- •D.Patient with vascular diseases
- •10)Person who has significant clinical or radiological signs or symptoms in the maxillary that can affect the clinical trials
- •11)Alcoholic or who have lowered immune system
- •12)Person with severe bruxism or clenching habits
- •13)Person with lack of oral hygiene
- •14)Patient who is currently showing a clinical significant disorders in cardiovascular, digestive system, respiratory, endocrine and central nervous system or mental illness who can significantly impact on the clinical trial.
- •15)Person who participated to other clinical trial within 30 days from screening
- •16)Pregnant or lactating women
- •17)By the judge of test director or staff, person with clinical significant findings that are considered inappropriate other than conditions listed above.
研究者
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