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临床试验/NCT03003624
NCT03003624已完成3 期

Comparing the Outcomes Of Incisions Made By Colorado® Microdissection Needle, Electrosurgery Tip And Surgical Blade During Periodontal Surgery

SVS Institute of Dental Sciences2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2015年3月最近更新:
适应症

试验速览

阶段
3 期
状态
已完成
入组人数
30
试验地点
2
主要终点
Quantity of blood loss in ml

研究概览

简要总结

The aim of the present study was to compare the outcomes of incisions made by Colorado® microdissection needle, electrosurgery tip and surgical blade during periodontal surgery.

详细描述

Commercially, many microdissection needle systems are available, such as Stryker Colorado® microdissection needle (CMN) (Stryker-Leibinger, Freiburg, Germany) and optimicro™ microdissection needles. Colorado® microdissection needle (CMN) combine the advantages of scalpel and electrosurgery. CMN® was introduced into clinical practice in 1997, with a wide array of applications in the field of Ophthalmology, Neurosurgery, and others.

The primary feature of the Colorado® microdissection needle is the ultra-sharp tungsten tip that delivers the wave-form from the electrosurgery generator to a very small spot. This allows the use of extremely low wattages, resulting in less tissue necrosis, precision cutting and cautery, and less post-operative pain. The instrument tip is a delicately machined, insulated tungsten diathermy needle that is compatible with any standard cautery hand piece. Tungsten, with its extremely high melting point (>3400°C) provides a heat resistant tip that maintains sharpness compared to stainless steel tips that dull rapidly.

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
Triple (Participant, Care Provider, Investigator)

入排标准

年龄范围
25 Years 至 55 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Systemically healthy individuals within the age group of 25-45 years having at least 20 teeth remaining in the mouth of which at least 4 teeth in each quadrant requiring periodontal surgery, patients with periodontal pockets with ≥5 mm in depth suitable for modified Widman flap were included in the study.

排除标准

  • Patients who underwent periodontal therapy in the past 6 months, medically compromised patients, patients with poorly shielded cardiac pacemakers were excluded from the study.

结局指标

主要结局

Quantity of blood loss in ml

时间窗: Immediate postoperative volume

Quantity of blood loss by swab weighing method.

PPD in mm

时间窗: Baseline to 180 days

Probing pocket depths (PPD) were recorded using a University of North Carolina no. 15 (UNC -15) color-coded periodontal probe at baseline, 120 and 180 days after surgery.

Changes in dimensions of interdental papilla in mm

时间窗: Baseline to 180 days

Changes in dimensions of interdental papilla using a periodontal probe.

次要结局

  • Assessment of postoperative pain:(1 day, 7 & 15 days)
  • Assessment of wound healing:(1 day, 7 & 15 days)

研究者

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

Dr R Viswa Chandra

IEC Secretary

SVS Institute of Dental Sciences

研究点 (2)

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