Randomized Clinical Evaluation of the Effectiveness of Biomimetic Hemostatic Sponges ColiSorB Following Dental Extraction
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Time of placement
研究概览
简要总结
This study tested three different treatment groups in a fair and organized way. It included people who came to Cairo University's Dental Department to have a back tooth (molar) removed and who qualified to join.
Out of 40 people who were checked, 8 did not meet the requirements, and 2 others did not return for check-up visits.
The study followed all ethical rules and was approved by the Research Ethics Committee at Cairo University's Faculty of Oral and Dental Medicine.
详细描述
ColiSorB® is a novel biomimetic adhesive, coagulant-free hemostatic sponge engineered for dental and surgical applications. Unlike conventional hemostatic methods that rely on mechanical compression or exogenous coagulation agents, ColiSorB® mimics the body's natural adhesive and clot-stabilization mechanisms. Its architecture replicates the fibrin mesh, forming a bio-adhesive matrix at the application site to achieve rapid hemostasis, minimize patient discomfort, and reduce postoperative complications such as persistent bleeding and alveolar osteitis (dry socket).
The material is composed of a gelatin-based, non-pyrogenic, absorbable polysaccharide that is both cost-effective and adaptable. By eliminating the need for coagulants, ColiSorB® offers a simplified, biocompatible approach to bleeding control in dental extractions.
This study aimed to evaluate the safety and effectiveness of ColiSorB® sponges in patients undergoing molar extraction, with direct comparison to both a widely used commercial reference product (Cutanplast®) and the conventional method of gauze or cotton under pressure. The primary endpoint was the achievement of post-extraction hemostasis, while secondary endpoints included assessment of postoperative pain and wound healing.
Study Groups
Participants were randomized into three equal groups (n = 10 per arm):
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
- 14 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients seeking removal of a wisdom tooth due to:
- •Severe decay
- •Malposition/misalignment
- •Pressure caries affecting adjacent teeth
- •Indication for future orthodontic treatment
- •Age ≥ 14 years
- •Available for at least one postoperative evaluation (scheduled approximately 7 days post-surgery)
- •Willing and able to provide informed consent for participation
排除标准
- •Unwillingness to provide informed consent
- •Current use of anticoagulant medications (e.g., Aspirin, Coumadin, Plavix) or discontinuation of such medications < 3 days prior to surgery
- •Pregnant, planning pregnancy during the follow-up period, or actively breastfeeding
- •Active or suspected infection at the surgical site
- •Known sensitivity or allergy to any component of the hemostatic gelatin sponge
- •Severe congenital or acquired immunodeficiency
- •Undergoing bisphosphonate therapy
- •Diabetes with unstable blood glucose levels
研究组 & 干预措施
Control
Conventional cotton and gauze were applied with firm pressure on the extraction site
Experimental Group
A newly developed hemostatic gelatin sponge called Colisorb was used
干预措施: Hemostatic gelatin sponge (Combination Product)
Experimental Comparator Group
A commercially available hemostatic sponge was used, namely Cutanplast.
干预措施: Hemostatic Agent (Combination Product)
结局指标
主要结局
Time of placement
时间窗: Assessed at baseline (time of dressing application immediately after tooth extraction).
Duration (in minutes) required at baseline to apply the assigned dressing (sponge or standard gauze) at the extraction site, including any pre-wetting step if applicable.
Time to achieve full absorption and hemostasis
时间窗: Assessed from baseline until hemostasis is achieved (within 1 day).
Time (in minutes) from baseline (application of the assigned dressing immediately after tooth extraction) until complete hemostasis is achieved, defined as cessation of visible bleeding at the extraction site.
次要结局
- Pain and Healing Scale(Up to 7 days)
研究者
Sara Omar
Clinical Researcher
The American University in Cairo