The Effect of Pre-operative Single Dose Antibiotic Prophylaxis on the Post-operative Implant Success
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Baseline implant stability / osseointegration
研究概览
简要总结
There is no consensus on antibiotic prophylaxis in dental implant applications, and its necessity is controversial. Current reports on antibiotic use are insufficient. Also, other than antibiotic prophylaxis, data that may affect the post-operative situation such as the patient's gender, age, smoking, duration of surgery, length of the operation field, flap design have not been evaluated comprehensively.
This study aims to evaluate post-operative complications, implant success, and implant stability in 50 individuals: preoperative single dose of 2 g amoxicillin + clavulanic acid (25) and placebo (25).
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)
盲法说明
The patients and the surgeon will be masked if antibiotics or placebo were used.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Tooth loss
排除标准
- •Systemic disease
- •Lactation/pregnancy
研究组 & 干预措施
Prophylaxis
2 g amoxicillin+clavulanic acid 1 hour prior to dental implant surgery
干预措施: Dental implant placement (Procedure)
Prophylaxis
2 g amoxicillin+clavulanic acid 1 hour prior to dental implant surgery
干预措施: Antibiotic prophylaxis (Drug)
Placebo
placebo 1 hour prior to dental implant surgery
干预措施: Dental implant placement (Procedure)
Placebo
placebo 1 hour prior to dental implant surgery
干预措施: Placebo (Other)
结局指标
主要结局
Baseline implant stability / osseointegration
时间窗: Baseline
Periotest M
10th day implant stability / osseointegration
时间窗: 10th day
Periotest M
1st month implant stability / osseointegration
时间窗: 1st month
Periotest M
Radiographic bone loss
时间窗: 3rd month
The distance of the bone crest to the implant shoulder
Final implant stability / osseointegration
时间窗: 3rd month
Periotest M
Early healing index (Wachtel et al)
时间窗: 1st month
Complete flap closure (1), fine fibrin line (2), fibrin clot (3), partial necrosis (4), complete necrosis (5)
次要结局
- Painkiller (0-3 days)(Baseline - 3rd day)
- Operation duration(Baseline)
- Painkiller (3-10 days)(3rd day - 10th day)
- Operation zone length(Baseline)
研究者
Mustafa YILMAZ
Assist Prof
Biruni University