NCT06046976已完成不适用
Evaluation of Piezosurgical vs Conventional Surgery Approach During Complex Exodontia in Healthy and Patients With Diabetes Mellitus Type 2
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- MicroRNA 21 (Mir-21) expression
研究概览
简要总结
This study will evaluateand compare intraoperative and postoperative clinical parameters related to discomfort and wound heeling, as well as laboratory wound healing parameters after piezosurgical and conventional surgery approach during complex exodontia in healthy and patients with Diabetes Mellitus Type 2
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •multiple multi-rooted teeth indicated for extraction
- •controlled DMT2
排除标准
- •HbA1c >7%
- •chronic orofacial pain and infection in orofacial region
- •alcohol and tobacco consumption
- •pregnant women and nursing mothers
研究组 & 干预措施
Healthy
Active Comparator
干预措施: piesosurgical extraction (Procedure)
Healthy
Active Comparator
干预措施: conventional extraction (Procedure)
Diabetes mellitus type 2
Experimental
干预措施: piesosurgical extraction (Procedure)
Diabetes mellitus type 2
Experimental
干预措施: conventional extraction (Procedure)
结局指标
主要结局
MicroRNA 21 (Mir-21) expression
时间窗: during the first 24 hours after intervention
Duration of osteotomy
时间窗: from the start of procedure to the end of performing osteotomy
次要结局
- Total exodontia time(from the beginning of surgical procedure to the end of tooth extraction)
- First analgesic consumption(within 24 hours after procedure)
- First postoperative pain report(within 24 hours after procedure)
- Pain intensity(during the first 24 hours after intervention)
- Duration of tooth sectioning(from the beginning of tooth sectioning to the end of tooth sectioning)
- Healing Index Score(within 21 days after procedure)
- Clinical appearance of gingival tissue(within 7 days after procedure)
- Vascular Endothelial Growth Factor (VEGF) level(within 24 hours after intervention)
- Phosphatase and Tensin Homolog (PTEN) level(within 24 hours after intervention)
- Superoxide Dismutase(SOD) enzyme activity (%)(within 24 hours after intervention)
- Matrix Metalloproteinase 9 (MMP9) level(within 24 hours after intervention)
- Residual Socket Volume(within 21 days after procedure)
- Postextraction wound epithelization(within 21 days after procedure)
研究者
Bozidar Brkovic, DDS, MSc, PhD, Professor
DDS PhD, Professor
University of Belgrade
研究点 (1)
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