跳至主要内容
临床试验/NCT04244422
NCT04244422已完成不适用

Clinical And Radiographic Outcomes Of Radicular Cyst Enucleation Using Piezosurgery Versus Conventional Surgery

Alexandria University2 个研究点 分布在 1 个国家目标入组 14 人开始时间: 2018年9月1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
14
试验地点
2
主要终点
Radiographic percentage of change in bone defect volume using cone beam computed tomography

研究概览

简要总结

AIM: The study was intended to evaluate the effectiveness of piezosurgery in enucleation of radicular odontogenic cysts in comparison to the conventional technique from both the clinical and radiographic perspectives.

详细描述

METHODS: Fourteen (8 females and 6 males) patients with age range of 30-55 years who had radicular cysts associated with non-vital teeth, were operated at the Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Alexandria University. The patients were randomly divided into 2 groups;1) the study group (7 patients) in which cyst enucleation using piezosurgery was employed, 2) control group in which the cysts were removed using the conventional technique. The following parameters were assessed; postoperative pain, time of operation, hemorrhage control and field visibility, ease of operation, neurosensory evaluation and radiographic percentage of change in bone defect volume between preoperative and 3-months postoperative values.

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
Double (Participant, Investigator)

入排标准

年龄范围
31 Years 至 52 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Periapical cysts involving more than one tooth in close relation to the maxillary sinus, nasal cavity or inferior alveolar neurovascular bundle,
  • Intact labial/buccal cortical plate with no perforation.

排除标准

  • Patients with systemic diseases contraindicating surgery
  • Cases in suspicion of malignancy

结局指标

主要结局

Radiographic percentage of change in bone defect volume using cone beam computed tomography

时间窗: 3 months

The change between preoperative and 3-months postoperative values of both groups were compared

Time of operation in minutes

时间窗: Intraoperative

Time from start of the incision to the last suture.

Hemorrhage control and ease of operation using a visual analogue scale

时间窗: Intraoperative

To assess the visibility of the field and ease of operation, a visual analogue scale was used. Each parameter constituted a horizontal 100 mm continuous line in which value of zero indicates minimum level of the assessed parameter and 100 indicates the maximum level. Each surgeon marked on the line then the score is determined by measuring in mms from the left end of the line to that marked point. (higher scores mean a better outcome)

Objective assessment of neurosensory function using a probe (to detect nerve injury after the surgeries)

时间窗: 1 month

A probe was used to prick the patient's skin relevant to the area of operation to assess the neurosensory function in comparison to the contralateral side.If the patient states a difference in sensation between the side of operation and the normal side, it was assigned as "Y" and if there was no difference in sensation between the two sides, it was assigned as "N".

次要结局

未报告次要终点

研究者

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

Marwa Gamaleldin Marei Noureldin

Lecturer of oral and maxillofacial surgery

Alexandria University

研究点 (2)

Loading locations...

相似试验