NCT02382809已完成4 期
Efficacy of DC071 Mouthwash (0.2% Chlorhexidine Digluconate) in Peri-surgical Care for Preventing Alveolar Osteitis After Third Molar Extraction
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 414
- 主要终点
- Occurrence of an alveolar osteitis
研究概览
简要总结
The purpose of this study is to demonstrate the efficacy of 0.2 % digluconate chlorhexidine mouthwash in the prevention of alveolar osteitis following third molar extraction and to evaluate the safety and local tolerability.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female over 18 years old
- •Subject needing to undergo extraction of one impacted mandibular third molar
- •For woman of childbearing potential and woman in post menopausal period under hormonal substitution treatment, she must accept to plan the extraction of the impacted mandibular third molar only during the last week of the menstrual cycle.
- •Affiliated to a social security system, or is a beneficiary (if applicable in the national regulation)
排除标准
- •Existence or history of parotid gland disorders
- •Acute or history of recent acute pericoronitis at any tooth
- •Extraction of more than 1 third molar in the same surgical procedure
- •Subject at high risk of bacterial endocarditis (prosthetic heart valve, history of bacterial endocarditis, congenital cyanogenic heart disease)
- •Coagulation or haemostatic disorder or use of anticoagulants
- •Hypersensitivity to chlorhexidine or any of the excipients;
- •Hypersensitivity to any anesthetic agent;
- •Hypersensitivity to corticosteroids, analgesics including opioid drugs used for post-surgery pain relief
- •Intake of systemic vasodilator or vasoconstrictor
- •Intake of systemic or local (in the mouth) antibiotics within 7 days before Day 1 and/or any pre- or post-operative antibiotic prophylaxis planned to be prescribed during the study;
- •Use of any antiseptic mouthwash within 7 days before Day -1
- •Regular heavy smokers (more than 20 cigarettes per day)
- •Is pregnant or in post-partum period or a nursing mother
研究组 & 干预措施
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
DC071 (0.2% chlorhexidine digluconate)
Experimental
干预措施: DC071 (Drug)
结局指标
主要结局
Occurrence of an alveolar osteitis
时间窗: Within 7 days
The primary Outcome measure will be evaluated based on the absence/presence of an alveolar osteitis within 7 days after the extraction of the third molar.
次要结局
未报告次要终点
研究者
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