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临床试验/NCT02711501
NCT02711501已完成不适用

Comparison of Post-operative Complications of Bone Augmentation at Anterior of Maxilla After Periosteal Releasing Incision With Two Techniques Diode Laser and Scalpel

Tehran University of Medical Sciences3 个研究点 分布在 1 个国家目标入组 14 人开始时间: 2016年3月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
14
试验地点
3
主要终点
post-operative swelling intensity

研究概览

简要总结

The aim of this study was to investigate if using lasers instead of scalpel for flap advancement in bone augmentation procedures would reduce post-operative swelling and pain.

详细描述

Guided bone regeneration (GBR) is a well established method to augment excessive alveolar bone loss before and at the time of implant placement. Primary closure of soft tissue is a prerequisite for successful bone augmentation procedures. Adequate flap advancement is a key factor for tension free primary wound closure. The tension free flap is usually attained by incising the buccal flap using scalpels. However, this procedure, especially in cases with major flap advancement, results in increased patient morbidity after surgery. Swelling and hemorrhage during the first week after surgery have a negative effect on patient's quality of life.

Currently, lasers are widely used as a tool for soft tissue management and diode laser appears to be an effective tool for incision and excision of the soft tissue. The major advantageous property of lasers is ablation of tissue together with effective hemostasis, minimal swelling and virtually no pain.

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
30 Years 至 45 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • patients with the need for a single-tooth replacement in the maxilla by implant and simultaneous GBR

排除标准

  • general contraindication for bone augmentation or implant surgeries,
  • existence of swelling or pain at the time of surgery,
  • smoking habits, pregnancy, and lactation.

结局指标

主要结局

post-operative swelling intensity

时间窗: Within the first 6 days after surgery

Swelling on the operated side was evaluated as follows: 0 (none: no inflammation), 1 (mild: intraoral swelling confined to the surgical field), 2 (moderate: extra oral swelling in the surgical zone), or 3 (intense: extra oral swelling spreading beyond the surgical zone).

次要结局

  • post-operative pain intensity(Within the first 6 days after surgery)
  • implant success(3 months later)

研究者

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

Neda Moslemi

Associate Professor

Tehran University of Medical Sciences

研究点 (3)

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