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临床试验/NCT06204692
NCT06204692已完成不适用

Computer Guided Versus Freehand Dental Implant Surgery: Randomized Controlled Clinical Trial

October 6 University2 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2022年6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
12
试验地点
2
主要终点
marginal bone loss

研究概览

简要总结

This study's goal is to evaluate the efficacy of traditional rehabilitation with freehand implant implantation of partly or totally edentulous patients utilizing flapless or mini-flap procedures vs. 3D implant design software and specialized surgical templates.

详细描述

Patients with at least 7 mm of height and 4 mm of breadth in their bones, who needed at least two implants to be restored with a single prosthesis, were recruited one after the other. Patients were randomly assigned to two groups in a parallel group trial design. : Group I: consisted of 6 patients where computer guided dental implant placement and Group II: included six people who had dental implants placed manually. A temporary prosthesis was inserted into the implants right away, and four to six months later, a permanent prosthesis took its place.

Implant failures, marginal bone loss, number of therapy sessions, length of treatment, post-surgical pain and swelling, use of painkillers, surgical time, time needed to resolve problems, and patient satisfaction were among the outcome variables evaluated by a blinded, independent assessor. Patients were tracked for a full year.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

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

入选标准

  • totally edentulous in one or both arches,
  • with at least 7 mm of height and 4 mm of breadth in their bones as assessed by preoperative CBCT scans.
  • patients between the ages of 35 and 65 who could give informed permission,
  • Implants next to each other required to be positioned at least 3 mm apart from each other and 1.5 mm apart from the tooth.

排除标准

  • Patients who have received radiation therapy to the head and neck region within the year prior to implantation,
  • those who are receiving intravenous amino bisphosphonates,
  • those who have untreated periodontitis,
  • those with uncontrolled diabetes,
  • pregnant women, or nursing mothers are among the general contraindications to implant surgery.

结局指标

主要结局

marginal bone loss

时间窗: 6 months postoperative

Cone Beam Computed Tomography

次要结局

  • post-surgical pain and swelling(7 days prior to implant placement)

研究者

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

Nermine Ramadan Mahmoud

Associated Professor, faculty of Dentistry, October 6 University

October 6 University

研究点 (2)

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