NCT01972399撤回3 期
Influence of Laser Therapy Upon Surgical Treatment of Peri-implantitis Lesions.
适应症
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Perio Probing Depth
研究概览
简要总结
The primary objective of this study is to compare the clinical outcomes of using Er: YAG laser along with bone graft and barrier membrane to conventional mechanical debridement also with bone graft and barrier membrane in the treatment of peri-implantitis infections.
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
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients, aged 18 - 85 years
- •Physical status according to the American Society of Anesthesiologists (ASA) I or II, which includes patients who are systemically healthy or suffer under mild to moderate, but well controlled systemic diseases.
- •Patients having a minimum of 1 dental implant with peri-implantitis.
- •The dental implant with peri-implantitis has ≥ 3 threads exposed or pocket probing depth (PPD) ≥ 5mm, with bleeding on probing (BOP) and/or suppuration (pus).
- •The implants are in function for at least 6 months
- •No uncontrolled systemic disease or condition known to alter bone metabolism, like Osteoporosis, Osteopenia, Hyperparathyroidism, Paget's disease.
- •Only rough surface implant will be included in this study
排除标准
- •Long-term use of antibiotics > 2 weeks in the past two months
- •No peri-implantitis treatment in the last 2 months
- •Patients taking medications known to modify bone metabolism (such as bisphosphonates, corticosteroids, Hormone replacement therapy for menopausal women, Parathyroid hormone, Denosumab, strontium ranelate).
- •Pregnant females or those planning to become pregnant.
- •Patients with a history of medically diagnosed oral cancer, bisphosphonate usage, Sepsis or those having adverse outcomes to oral procedures in the past, will be excluded
- •Mobility of dental implants
- •History of alcoholism or drug abuse
- •Current smokers or quit smoking less than 6 months
- •Diseases of the immune system or any medical condition that may influence the outcome (uncontrolled diabetes (HbA1c >7)
- •Patients with allergies known to affect one or more of the treatment provided in this study
- •Polish surface implants
- •Implants with trabecular surface
结局指标
主要结局
Perio Probing Depth
时间窗: Change in probing depth from beginning of study to 6 months after intervention
次要结局
- Bleeding on Probing(Change in bleeding on probing from beginning of study to 6 months after intervention)
研究者
Dr Hom-Lay Wang
Principal Investigator
University of Michigan
研究点 (2)
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