NCT05536115已完成不适用
Prospective, Multicentre Clinical Trial Measuring the Impact of Treatment With ALVEOGYL in Patients With Post-extraction Dry Socket
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Septodont
- 入组人数
- 120
- 试验地点
- 16
- 主要终点
- Pain Using a Visual Analog Scale (VAS : 0-10)
研究概览
简要总结
Alveogyl (Septodont, Saint-Maur-des-Fossés - France) is a Medical Device used as dressing in case of dry socket.
ALVE study is a clinical investigation measuring Alveogyl performance and safety in patients with post-extraction dry socket.
The study takes place in India and in France where Alveogyl is already marketed, since 2010 in France and since 2014 in India .
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 5 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patient, adult or child
- •Positive diagnosis of dry socket occurring after the extraction of a permanent tooth (mature or immature)
- •Signed informed consent
- •In France only :Patient affiliated to a Health Insurance Scheme ("sécurité sociale")
排除标准
- •Spreading infection in the alveolar socket
- •Placement of Alveogyl done immediately after tooth extraction
- •Multiple post-extraction dry sockets
- •Patient treated with cervico-facial radiotherapy
- •Immunodeficiency related to any diseases or current treatments
- •Psychiatric patient or patient unable to assess his/her pain via the study Pain VAS
- •Patient with history of hypersensitivity to one of the components
- •Patient on post extraction of deciduous teeth
- •Participation in another clinical investigation
研究组 & 干预措施
Study population
Study patients are patients with post-extraction dry socket.
干预措施: Alveogyl (Device)
结局指标
主要结局
Pain Using a Visual Analog Scale (VAS : 0-10)
时间窗: 7 days post-treatment
Patients with no pain or mild pain at Day7 The pain is measured by patients in a diary using a Visual Analogue Scale (VAS: 0-10 mm; 0 no pain - 10 maximum pain) 7 days after treatment with Alveogyl.
次要结局
- Analgesic Use(3 and 5 days post-treatment)
- Signs of Local Inflammation(7 days post-treatment)
- Healing of the Alveolar Mucosa(7 days post-treatment)
- Antiseptic Effect(7 days post-treatment)
- Hemostasis(Immediately after Alveogyl placement and Day 7 after treatment)
- Complication Rate(From Alveogyl placement to 7 days post-treatment)
研究者
研究点 (16)
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