Comparison of Three Types of Sutures in Oral Surgery. Study of Bacterial Colonization, Tissue Reaction and Clinical Characteristics: Randomized Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 24
- 主要终点
- Bacterial colonization
研究概览
简要总结
Considering the wide variety of surgical sutures currently marketed in the field of Dentistry, it was decided to conduct a study comparing the microbial adhesion and antibacterial activity of three different types of sutures used in Oral Surgery (Silk, non-absorbable polyamide monofilament and non-absorbable expanded polytetrafluoroethylene).
详细描述
The general or primary objective is:
• To compare 3 non-absorbable suture materials used in oral surgery: silk, polyamide monofilament and expanded polytetrafluoroethylene.
The specific or secondary objectives are:
- To evaluate how each type of suture influences wound healing and the patient's postoperative period.
- To study bacterial colonization in each type of suture.
- To determine the tissue reaction and clinical characteristics of each suture.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Patients with indication for extraction of a third lower molar retained in an unfavorable position that requires a bayonet incision in the surgical procedure.
- •Age: patients aged 18 years or older.
- •ASA I patients (Classification of the American Society of Anesthesiology, 1979): healthy patients who tolerate stress well, without systemic pathology, no anxiety and in whom a therapeutic modification is not necessary.
排除标准
- •Pregnant or breastfeeding women.
- •Smoking patients.
研究组 & 干预措施
Suture 1: Silk.
Silk suture.
干预措施: To Compare 3 different suture materials used in oral surgery (Other)
Suture 2: Non-absorbable polyamide monofilament.
Non-absorbable polyamide monofilament.
干预措施: To Compare 3 different suture materials used in oral surgery (Other)
Suture 3: Non-resorbable expanded polytetrafluoroethylene.
Non-resorbable expanded polytetrafluoroethylene.
干预措施: To Compare 3 different suture materials used in oral surgery (Other)
结局指标
主要结局
Bacterial colonization
时间窗: 7 days.
Microbiological analysis: CFU and qPCR bacterial count.
Level of inflammation
时间窗: 7 days.
The degree of soft tissue inflammation was assessed using Visual Analogue Scale (VAS).
次要结局
未报告次要终点
研究者
Jose Manuel Alarcón Cordovilla
DDS (University of Granada), MSc (Oral Surgery)
Universidad de Granada