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临床试验/NCT06542562
NCT06542562已完成不适用

Accuracy of Fully Guided Versus Half Guided Implant Placement in Patients With Edentulous Maxilla: A Split-mouth Randomized Clinical Trial

October University for Modern Sciences and Arts1 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2024年8月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
16
试验地点
1
主要终点
Rate of Angle Deviation in Implant Placement: Fully Guided vs. Half-Guided Approaches

研究概览

简要总结

six implants will be placed in edentulous maxilla to rehabilitate patients with implant prosthesis.The primary outcome measure will be the accuracy of implant placement, which will be evaluated using cone-beam computed tomography (CBCT) scans

详细描述

Study Design:

This will be a Split mouth randomized controlled trial (RCT) study. 16 patients missing teeth in the maxillary (upper) jaw and eligible for dental implant treatment will be recruited.

Interventions will be randomly assigned to the right or the left side of the arch :

Group 1 will undergo fully guided dental implant surgery. Group 2 will undergo partially guided dental implant surgery.

Study Duration:

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, Outcomes Assessor)

入排标准

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

入选标准

  • Patients aged 18 years or older
  • Complete edentulism
  • Adequate bone volume to accommodate six standard implant fixtures (3.7 mm diameter and 10 mm length)
  • All patients underwent a panoramic X-ray and an oral examination
  • Written consent provided prior to participation

排除标准

  • Patients with partial edentulism
  • Insufficient bone volume for a 3.7 mm diameter and 10 mm length implant fixture
  • Local or systemic conditions that could impede dental implant surgery
  • Patients who smoke more than five cigarettes per day

结局指标

主要结局

Rate of Angle Deviation in Implant Placement: Fully Guided vs. Half-Guided Approaches

时间窗: at the day of implant placement

Post-surgery, 16 patients will be scanned using the same CBCT machine and exposure settings. Preoperative and postoperative CBCT scans will be imported into the In2Guide™ software, where an overlay of the preoperative plane onto the postoperative scan allowed for precise evaluation of implant positioning. Implant deviations will be measured in three directions: angular deviation, deviation at the coronal platform (entry deviation), and deviation at the apical portion (Figure 2). The software generated coordinates for the necessary calculations, with coronal and apical deviations reported in millimeters and angular deviation in degrees.

次要结局

未报告次要终点

研究者

发起方
October University for Modern Sciences and Arts
申办方类型
Other
责任方
Sponsor

研究点 (1)

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Accuracy of Fully Guided Versus Half Guided Implant | 临床试验