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临床试验/NCT07112664
NCT07112664进行中(未招募)不适用

Accuracy of Fully Guided Dental Implant Placement: A Comparative Study of Experienced vs. Novice Clinicians Using Unilateral Tooth Supported, Bilateral Tooth Supported, and Soft Tissue Supported Guides

Abdelrahman Khalaf Eldabe1 个研究点 分布在 1 个国家目标入组 54 人开始时间: 2025年5月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
54
试验地点
1
主要终点
Angular Deviation

研究概览

简要总结

The goal of this clinical trial is to learn how accurate fully guided dental implant placement is when performed by experienced versus novice clinicians. It will also study how different types of surgical guides affect the accuracy of implant placement.

The main questions it aims to answer are:

Does the clinician's level of experience affect how closely the dental implant matches the planned position?

Does the type of surgical guide (tooth-supported or mucosa-supported) influence implant placement accuracy?

Researchers will compare the implant accuracy across six groups based on clinician experience and guide type.

Participants will:

Undergo a fully guided dental implant procedure using a 3D-printed surgical guide

Be treated by either an experienced or a novice clinician

Receive follow-up scans to measure how accurately the implant was placed compared to the digital plan

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
Single (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
是

入选标准

  • •Age 18 years or older
  • •Clinical situation suitable for dental implant placement as judged by the examining physician or principal investigator
  • •Adequate soft and hard tissue conditions for implant placement
  • •Adequate occlusion in the implant area
  • •Sufficient bone volume to place the implant without bone augmentation (i.e., at least 2 mm of bone circumferentially around the implant site based on preoperative CBCT)

排除标准

  • •Major systemic diseases (e.g., uncontrolled diabetes, immunosuppressive conditions)
  • •Untreated or uncontrolled dental caries
  • •Active periodontal disease
  • •Requirement for bone augmentation or sinus lift in the implant area
  • •Current pregnancy
  • •Current smoker (defined as >10 cigarettes per day)
  • •Noncompliance or inability to follow study protocols
  • •Known allergies to materials used in the implant system or medications administered

研究组 & 干预措施

Experienced Clinician - Bilateral Tooth-Supported Guide

Experimental

Experienced Clinician - Bilateral Tooth-Supported Guide Participants receive fully guided dental implant placement using a bilateral tooth-supported surgical guide. The procedure is performed by an experienced clinician with over 500 guided implant placements.

干预措施: Fully Guided Dental Implant Placement Using Surgical Guide (Device)

Experienced Clinician - Unilateral Tooth-Supported Guide

Experimental

Experienced Clinician - Unilateral Tooth-Supported Guide Participants receive fully guided dental implant placement using a unilateral tooth-supported surgical guide. The procedure is conducted by an experienced clinician.

干预措施: Fully Guided Dental Implant Placement Using Surgical Guide (Device)

Experienced Clinician - Mucosa-Supported Guide

Experimental

Participants receive fully guided dental implant placement using a mucosa-supported surgical guide. The procedure is performed by an experienced clinician with extensive experience in guided surgery.

干预措施: Fully Guided Dental Implant Placement Using Surgical Guide (Device)

Novice Clinician - Bilateral Tooth-Supported Guide

Experimental

Participants receive fully guided dental implant placement using a bilateral tooth-supported surgical guide. The procedure is performed by a novice clinician with fewer than 20 guided implant cases and at least one year of general implant experience.

干预措施: Fully Guided Dental Implant Placement Using Surgical Guide (Device)

Novice Clinician - Unilateral Tooth-Supported Guide

Experimental

Participants receive fully guided dental implant placement using a unilateral tooth-supported surgical guide, performed by a novice clinician.

干预措施: Fully Guided Dental Implant Placement Using Surgical Guide (Device)

Novice Clinician - Mucosa-Supported Guide

Experimental

Participants receive fully guided dental implant placement using a mucosa-supported surgical guide. The procedure is carried out by a novice clinician under standard protocol.

干预措施: Fully Guided Dental Implant Placement Using Surgical Guide (Device)

结局指标

主要结局

Angular Deviation

时间窗: Immediately postoperative (within 1 day after implant placement)

The angular deviation is defined as the angle (in degrees) between the long axis of the virtually planned implant and the long axis of the actual placed implant. It reflects the angular accuracy of guided implant placement.

次要结局

  • Depth Deviation(Immediately postoperative)
  • Apical Global Deviation (AGD)(Immediately postoperative)
  • Coronal Global Deviation (CGD)(Immediately postoperative)

研究者

发起方
Abdelrahman Khalaf Eldabe
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Abdelrahman Khalaf Eldabe

Lecturer of Oral Medicine and Periodontology , Assiut University

Assiut University

研究点 (1)

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