Study on the Efficacy and Safety of PERIOGEN in the Treatment of Periodontal Bone Defect - A Double-blind, Controlled, Randomised,Parallel,Multi-centre Study
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- 1.Area under curve (AUC) of clinical attachment level (CAL) gain (0-24 weeks) 2.Extent of linear bone growth (LBG) and percentage of bone fill (%BF) at 6 months.
研究概览
简要总结
PERIOGEN, containing rhPDGF and -beta-TCP, promotes gingival healing and corrects periodontal defects. This study will test the safety and efficacy of PERIOGEN in the treatment of periodontal disease
详细描述
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
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
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 ≥7 mm at baseline
- •Presence of ≥4 mm vertical bone defect with at least 1 bony wall after surgical debridement.
- •Adequate keratinized tissue to permit complete tissue coverage of defect.
- •Radiographic base of defect ≥3 mm coronal to the apex of the tooth.
排除标准
- •Failure to maintain adequate oral hygiene (plaque index>2)
- •Pregnant and lactating women
- •History of oral cancer or HIV
- •Periodontal surgery on treatment-targeted tooth within the last year.
- •Tooth mobility greater than grade II.
- •Study tooth exhibiting a class III furacation defect
- •Localized aggressive periodontitis
- •Radiographic signs of untreated acute infection at the surgical site
- •Recent history of smoking more than 20 cigarettes/day
- •Known allergy to E.coli-derived products
- •Using an investigational therapy within the past 30 days.
研究组 & 干预措施
Drug Group
PERIOGEN
干预措施: PERIOGEN (Drug)
Control group
Beta TCP alone
干预措施: Beta TCP alone (Drug)
结局指标
主要结局
1.Area under curve (AUC) of clinical attachment level (CAL) gain (0-24 weeks) 2.Extent of linear bone growth (LBG) and percentage of bone fill (%BF) at 6 months.
时间窗: 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.(3 and 6 months)