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临床试验/NCT07061418
NCT07061418已完成不适用

3D Evaluation the Accuracy of Free-Handed-Countersink Guided and Fully-Guided Implant Surgery in Partially Edentulous Patients: A Clinical Trial With Quasi-experimental Study

Islamic University of Caza, Gaza, Palestine2 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2023年2月23日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
15
试验地点
2
主要终点
Angular deviation

研究概览

简要总结

This clinical trial with a quasi-experimental design investigates the accuracy of dental implant placement using three different surgical approaches: free-handed countersink guided, fully-guided, and traditional freehand techniques in partially edentulous patients. Dental implant therapy not only requires successful osseointegration but also a precise three-dimensional placement to ensure functional and esthetic outcomes. Accurate implant positioning is vital to prevent complications and ensure long-term stability. The evolution of digital technology has led to the development of computer-assisted implant surgery, enhancing surgical precision and minimizing the chances of deviation from planned positions.

In this study, implants were placed in the same patients on both sides of the jaw using two techniques for comparison - one side received a free-handed countersink guided implant, while the other used a fully-guided surgical guide. Patients included in this research were partially dentate adults with adequate oral health, bone volume, and no systemic conditions or habits that could interfere with healing. Pre-operative and post-operative cone-beam computed tomography (CBCT) scans were used to evaluate the positional accuracy of the implants.

The three-dimensional evaluation method utilized Blue Sky Plan 4 and 3D Slicer software to superimpose and analyze implant placements. Parameters such as angular deviation, crestal global deviation, apical global deviation, vertical linear deviation, lateral linear deviation, apical vertical deviation, apical lateral deviation, and distances from anatomical structures like the inferior alveolar nerve and the maxillary sinus were measured to assess placement accuracy. Measurements were taken using automatic image registration and STL superimposition of planned versus actual implant locations.

Data collected was analyzed using SPSS software. Both descriptive and inferential statistical analyses were conducted. The results aimed to determine the accuracy differences between countersink-guided and fully-guided implant techniques. The findings of this study contribute to evidence-based clinical decisions in implant dentistry by exploring if countersink-guided approaches offer comparable accuracy to fully-guided methods, thus supporting safer and more effective dental implant procedures in clinical practice.

详细描述

This clinical trial with a quasi-experimental study design explores the comparative accuracy of dental implant placement using three different surgical protocols in partially edentulous patients: free-handed countersink guided, fully-guided, and traditional freehand methods. The precision of implant positioning plays a pivotal role in the long-term success and aesthetics of dental implant therapy. Although osseointegration is fundamental, optimal functional and esthetic outcomes are contingent upon the precise three-dimensional positioning of the implant within the jawbone. The rationale behind this study stems from the clinical observation that improper implant placement can result in technical and biological complications, leading to treatment failure or compromised prosthetic outcomes.

The advent of digital imaging and surgical planning has revolutionized implant dentistry. Traditional radiographic stents and manual implant placement methods have been increasingly replaced by static computer-assisted implant surgery (s-CAIS), allowing for improved preoperative visualization and enhanced implant positioning accuracy. In the digital workflow, combining intraoral scans with cone-beam computed tomography (CBCT) enables clinicians to plan implant positions based on bone quality, soft tissue contours, and the spatial relationship with adjacent teeth or anatomical landmarks.

Despite these advancements, there remains a lack of clinical evidence on the performance of countersink guided protocols specifically. Countersink guided placement involves using drills designed to widen the crestal cortical bone, especially in cases of dense bone, facilitating a passive fit of the implant at the neck. This approach is typically categorized under the freehand technique but is believed to offer enhanced stability during insertion. Fully-guided surgery, in contrast, utilizes a prefabricated guide that controls each step of the drilling and implant placement process, theoretically minimizing deviation.

The study involved the recruitment of partially dentate adults who fulfilled strict inclusion criteria such as having at least six remaining teeth, good oral hygiene, sufficient bone volume for implant placement without the need for grafting, and the ability to maintain mouth opening of at least 40 mm. Patients with parafunctional habits, heavy smoking, psychiatric or systemic conditions that contraindicate implant surgery, a history of radiotherapy in the head and neck region, or younger than 18 years of age were excluded.

Each patient received two implants-one placed with the countersink guided freehand method, and the other placed using a fully-guided surgical protocol. Both procedures were performed by the same surgeon using a parallel surgical kit (Dentsply®, MIS, M4, Germany), ensuring consistency in technique and instrumentation. The implants were placed on the same day and with identical preoperative planning to eliminate inter-operator and time-related variability.

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
None

入排标准

年龄范围
18 Years 至 53 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Partially dentate adults with at least 6 remaining teeth
  • The anticipated presence of sufficient bone volume allowing for implant placement with no simultaneous bone grafting
  • Extractions within 2 months of welding.
  • Want the missing tooth to be replaced by an implant
  • Adequate related attached mucosa was found
  • Mouth opening ≥ 40 mm
  • Good oral hygiene
  • Good general health

排除标准

  • Heavy smoking
  • Physical or psychiatric disorders preventing the implant treatment.
  • Previous radiotherapy of the head-neck region
  • Younger than 18 years

结局指标

主要结局

Angular deviation

时间窗: 3 months

The primary outcome was angular deviation defined as the angle closed by the principal axis of the planned implant and the principal axis of the inserted implant in degrees.

次要结局

  • Apical global deviation(3 months)
  • Apical Endpoint Deviation and Vertical Deviation(3 months)
  • Apical Lateral Deviation(3 months)
  • Crestal global deviation(3 months)
  • Coronal Center Deviation(3 months)
  • Hexagonal Lateral Deviation(3 months)
  • Long Axis Lateral Deviation(3 months)
  • Anatomical Safety Distances (IAN and MS)(3 months)

研究者

发起方
Islamic University of Caza, Gaza, Palestine
申办方类型
Other
责任方
Principal Investigator
主要研究者

Tayseer Afifi

Dr.

Islamic University of Caza, Gaza, Palestine

研究点 (2)

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