CTRI/2008/091/000152已完成3 期
Study on the efficacy and safety of PERIOGEN (rhPDGF-beta-TCP) in the treatment of periodontal bone defect - A double-blind, controlled, randomized, parallel multi-centre study
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 3
- 主要终点
- Area under curve (AUC) of clinical attachment level (CAL) gain (0-24 weeks);
研究概览
简要总结
This is a double-blind, controlled, randomised, parallel, multi-centre study. Sixty eligible patients with periodontal defect will randomly receive either beta-TCP implantation (control group) or PERIOGEN implantation, containing beta-TCP and rhPDGF (drug group). The specified primary and secondary end points related to efficacy and safety will be assessed during 6 months study period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 25.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Probing depth greater than or equal to 7 mm at baseline 2.Presence of greater than or equal to4 mm vertical bone defect with at least 1 bony wall after surgical debridement.
- •3.Adequate keratinized tissue to permit complete tissue coverage of defect.
- •4.Radiographic base of defect greater than or equal to 3 mm coronal to the apex of the tooth.
排除标准
- •1.Failure to maintain adequate oral hygiene (plaque index>2) 2.Pregnant and lactating women 3.History of oral cancer or HIV 4.Periodontal surgery on treatment-targeted tooth within the last year.
- •5.Tooth mobility greater than grade II.
- •6.Study tooth exhibiting a class III furacation defect 7.Localized aggressive periodontitis 8.Radiographic signs of untreated acute infection at the surgical site 9.Recent history of smoking more than 20 cigarettes/day 10.Known allergy to E.coli-derived products 11.Using an investigational therapy within the past 30 days.
结局指标
主要结局
Area under curve (AUC) of clinical attachment level (CAL) gain (0-24 weeks);
时间窗: 1. AUC from 0 to 24 weeks | 2. LBG at 6 months
2. Extent of linear bone growth (LBG) and percentage of bone fill (%BF) at 6 months.
时间窗: 1. AUC from 0 to 24 weeks | 2. LBG at 6 months
次要结局
- 1. Changes in CAL gain, probing depth and gingival recession at 3 and 6 months; 2.Incidence of adverse events(1. CAL gain, probing depth and gingival recession at 3 and 6 months)
研究者
研究点 (3)
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