Evaluating the Hemostatic Efficacy and Comparing the Clinical Performance of Colibricare; A Newly Devel-oped Dental Sponges on Oral Surgical Procedures/Extraction Wound and Gingiva Retraction to Other Conven-tional Products (Randomized Clinical Trail)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 124
- 试验地点
- 1
- 主要终点
- pain
研究概览
简要总结
In this randomized, three-arm trial, 120 patients undergoing wisdoms' extractions were assigned to control (gauze pressure application), commercial sponge, or Coli-sorb® groups. Outcomes included time to hemostasis, ease of placement, pain (VAS), facial swelling, and wound healing, assessed on days 1, 7, and 6 weeks.
详细描述
Colisorb® is a safe, efficient, and biocompatible hemostatic agent, providing rapid bleeding control, reduced pain, and enhanced healing, outperforming conventional gauze and commercial alternatives.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •require wisdoms removal
排除标准
- •systemic diseases affecting healing
研究组 & 干预措施
Colisorb
study arm
干预措施: wisdoms' surgical extractions (Procedure)
gelatin sponge
study
干预措施: wisdoms' surgical extractions (Procedure)
gauze pressure
control arm
干预措施: wisdoms' surgical extractions (Procedure)
结局指标
主要结局
pain
时间窗: 7 days
VAS visual analogue scale grades (0-10)
次要结局
- closure of the wound(15 days)
研究者
Nahla Mahmoud Awad
associate professor
Cairo University