Multi-Center Phase 3 Trial of Minocycline HCl 1mg Microspheres for the Use in Subjects With Peri-Implantitis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- OraPharma
- 入组人数
- 215
- 试验地点
- 12
- 主要终点
- Change in mean Probing Depth of qualifying implant sites
研究概览
简要总结
The objective of the study is to evaluate the safety and effectiveness of Arestin (minocycline HCl) 1 mg Microspheres in the treatment of subjects with peri-implantitis, when used in combination with mechanical debridement.
The hypothesis of the study is that Arestin in combination with mechanical debridement is more effective in the treatment of peri-implantitis when compared to mechanical debridement alone. The primary efficacy measure will be the reduction of probing depth at Day 180 as measured at qualifying implant sites.
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
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A minimum of one osseointegrated implant with a diagnosis of peri-implantitis
- •Absence of any significant oral soft tissue pathology
- •At least one peri-implant site with an average of 2 probing depth readings between 5mm and 7mm (inclusive) when using a light force and with bleeding on probing within 30 seconds of the probing
- •Confirmed evidence of pathologic bone loss
- •At least 1mm of keratinized gingiva present around the implant
排除标准
- •Pregnancy
- •Allergy to tetracycline-class drug(s)
- •Systemic medical condition(s) requiring antibiotic prophylaxis prior to invasive dental procedures
- •Presence of active systemic infectious disease such as hepatitis, HIV, history of tuberculosis
- •Diagnosis of clinically significant or unstable organic disease, or compromised healing potential
- •Signs of untreated advanced periodontal disease and/or poor oral hygiene
- •Subjects having a probing depth greater than 8mm at time of enrollment
- •Subjects presenting with mobility of any dental implant
- •Subjects having a qualifying implant under occlusal trauma or overloaded (as determined by the investigator)
研究组 & 干预措施
Treatment
Treatment (minocycline HCl microspheres, 1mg) administered at Baseline (following randomization) and Day 90 to qualifying implant sites, plus full-mouth mechanical debridement (deep cleaning) at Baseline and Day 180.
干预措施: Minocycline HCl Microspheres (Drug)
结局指标
主要结局
Change in mean Probing Depth of qualifying implant sites
时间窗: Baseline to Day 180
次要结局
- Change in percentage of qualifying implants with Bleeding on Probing(Baseline to Day 90)
- Change in mean Probing Depth of qualifying implant sites(Baseline to Day 90)