NCT01530126已完成不适用
Platelet Derived Growth Factor Stimulates Bone Fill and Rate of Attachment Level Gain
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 180
- 试验地点
- 2
- 主要终点
- Rate of CAL Gain
研究概览
简要总结
The aim of the study was to evaluate the safety and effectiveness of Platelet Derived Growth Factor (PDGF) mixed with b tricalcium phosphate (BTCP) for the treatment of advanced periodontal osseous defects at 6 months of healing.
详细描述
This triple blind, prospective and parallel arm trial was conducted in subjects requiring surgical treatment of a periodontal osseous defect.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 25 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •probing depth of 7mm or greater at baseline
- •following debridement, 4mm or greater vertical bone defect depth with at least one intact bony wall
- •sufficient keratinized tissue to allow complete tissue coverage of the defect
- •a radiographic base of the defect at least 3mm coronal to the apex of the tooth
- •no evidence of localized aggressive periodontitis
- •smoke less than 1 pack of cigarettes per day
排除标准
- •failure to maintain adequate oral hygiene
- •pregnant women or women intending to become pregnant
- •history of oral cancer within last 6 months or HIV
- •history within last year of periodontal surgery on study tooth
- •study tooth mobility greater than 2
- •study tooth exhibiting a class 3 furcation defect
- •signs of untreated acute infection at the surgical site, apical pathology, root fracture, severe root irregularities, cemental pearls, cementoenamel junction (CEJ) projections not easily removed, untreated carious lesions at the CEJ or on the root surface, subgingival restorations or restorations with open margins at or below CEJ
- •history within 6 months of weekly or more frequent use of smokeless chewing tobacco, pipe or cigar smoking, or more than 20 cigarettes a day
- •allergy to yeast derived products
- •investigational therapy within 30 days of surgery
结局指标
主要结局
Rate of CAL Gain
时间窗: Baseline to 6 months
Measurements for the rate of clinical attachment levels (CAL)
次要结局
- Change in Gingival Recession (GR)(Baseline to 6 months)
研究者
William Giannobile
Principal Investigator
University of Michigan
研究点 (2)
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