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临床试验/NCT05684601
NCT05684601已完成不适用

Analysis Impact of 3D Intraoral Scanning on Postsurgical Evaluation of Mandibular Third Molar Surgery Using Piezosurgery Versus Traditional Rotating Instrumentations

University of Catania1 个研究点 分布在 1 个国家目标入组 56 人开始时间: 2020年9月15日最近更新:
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
56
试验地点
1
主要终点
Visual analogue Scale (VAS), values 1-10

研究概览

简要总结

The aim of this study was to analyze the effectiveness of piezoelectric surgery and traditional rotating device in reducing perioperative sequelae after impacted mandibular third molar surgery in 56 subjects. Ni All subjects were randomly allocated to receive one treatment.

详细描述

The aim of this study was to analyze the effectiveness of piezoelectric surgery and traditional rotating device in reducing perioperative sequelae after impacted mandibular third molar surgery. Fifty-six patients who needed surgical extraction of an impacted mandibular third molar were selected for the study. All subjects were randomly allocated to receive one of the following surgical treatments piezoelectric surgery (n = 28), traditional surgery with rotating device (n = 28). The primary outcome was postoperative pain, evaluated using the visual analogue scale (VAS) score at baseline, 1, 2, 5, 7, 10 and 14 and 28 days following surgery. The secondary outcomes chosen were changes in postoperative swelling and maximum mouth opening values compared to preoperative ones.

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, Care Provider)

盲法说明

Treatment performed with sealed envelopes

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •aged between 18 and 32 years;
  • •good general health;
  • •the presence of one impacted third molar in the mandible with a class II position, type B impaction;
  • •absence of pericoronitis or signs of inflammation during the last 30 days. Panoramic radiographs were used to determine tooth position.

排除标准

  • •the presence of any systemic disease;
  • •consumption of oral contraceptives or other medications;
  • •consumption of any immunosuppressive or anti-inflammatory drugs during the 3 months prior to the study;
  • •status of pregnancy or lactation;
  • •previous history of excessive drinking;
  • •allergy to local anesthetic;
  • •smoking habit.

研究组 & 干预措施

rotating drills device

Placebo Comparator

Third molar surgery performed with traditional rotating devices

干预措施: Third molar surgery (Device)

Piezoelectric device

Active Comparator

Third molar surgery performed with piezoelectric surgery device

干预措施: Third molar surgery (Device)

结局指标

主要结局

Visual analogue Scale (VAS), values 1-10

时间窗: 1- and 3-months

Evaluation of VAS value changes at baseline and follow-up session

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

Gaetano Isola

Researcher

University of Catania

研究点 (1)

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