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临床试验/NCT06046976
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

University of Belgrade2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2022年6月13日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
2
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

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Bozidar Brkovic, DDS, MSc, PhD, Professor

DDS PhD, Professor

University of Belgrade

研究点 (2)

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