In Vivo Evaluation of the Accuracy of Immediate Screw-Retained Provisional Crowns Prefabricated Using Digital Planning and Fully Guided Surgery
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 27
- 试验地点
- 1
- 主要终点
- Accuracy of Implant and Provisional Crown Placement
研究概览
简要总结
This clinical trial aims to evaluate the in vivo accuracy of a fully digital workflow for the immediate placement of a previously fabricated screw-retained provisional crown using digital planning and guided implant surgery. The study will be conducted in partially edentulous adult patients requiring the replacement of a single tooth with an immediately loaded dental implant.
The main objective of the study is to assess the accuracy (trueness and precision) of the planned digital implant position and provisional restoration by comparing the virtually planned position with the actual clinical outcome after guided surgery. Emphasis will be placed on linear, angular, and rotational deviations at both the implant and provisional restoration levels.
Participants will undergo a fully guided implant placement procedure with rotational control, followed by the immediate placement of a prefabricated screw-retained provisional crown designed during the digital planning phase. Postoperative intraoral scans will be obtained to register the final implant and restoration positions.
The planned and achieved positions will be compared using three-dimensional analysis software to quantify deviations and determine whether the accuracy achieved remains within clinically acceptable limits.
详细描述
Background Computer-guided implant surgery has consolidated a prosthetically driven approach, in which implant positioning is planned according to the definitive or provisional restoration. The integration of cone-beam computed tomography (CBCT) and intraoral scanning allows for virtual planning of implant position, axis, and prosthetic emergence. However, the accurate transfer of the digital plan to the clinical setting remains subject to cumulative errors throughout the digital and surgical workflow.
Accuracy in guided implant surgery is commonly assessed by comparing the planned and postoperative implant positions using linear and angular deviation metrics. From a clinical perspective, the accuracy at the level of the provisional restoration is of particular relevance, as the restoration must seat passively without requiring significant adjustment. This requirement becomes especially critical when an immediate prefabricated screw-retained provisional crown is placed at the time of surgery, as both positional and rotational accuracy are essential for proper seating.
Recent digital workflows have demonstrated the feasibility of designing and fabricating immediate provisional restorations prior to surgery. The use of guided surgical protocols incorporating rotational control aims to reproduce the planned implant orientation and facilitate the immediate placement of prefabricated restorations. However, the accuracy achievable with such workflows has not been sufficiently quantified in clinical settings.
Justification Despite advances in guided surgery and digital manufacturing, limited clinical evidence exists regarding the accuracy of workflows that combine fully guided implant placement with rotational control and the immediate placement of a prefabricated screw-retained provisional crown. Quantifying plan-to-actual deviations at both the implant and restoration levels is essential to determine the clinical feasibility, predictability, and potential optimization of this protocol.
Study Design This is a prospective, single-arm interventional clinical trial with an intraindividual comparison between the digitally planned implant and provisional restoration positions and the actual clinical outcomes obtained after guided surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
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
- •Adults aged 18 years or older.
- •Partially edentulous patients requiring replacement of a single tooth with an immediately loaded dental implant.
- •Patients classified as ASA I or ASA II according to the American Society of Anesthesiologists physical status classification.
- •Patients with clinical conditions allowing immediate implant placement with a minimum primary stability of ≥25 Ncm.
- •Ability to understand the study procedures and provide written informed consent.
- •Willingness to comply with the study protocol and attend required clinical visits.
排除标准
- •Patients classified as ASA III or ASA IV, or with uncontrolled systemic conditions that may interfere with study participation.
- •Presence of psychiatric or cognitive disorders that may compromise informed consent or protocol compliance.
- •Inability to comply with the visit schedule or required evaluations.
- •Any other condition that, in the investigator's judgment, could compromise patient safety, protocol adherence, or data validity.
结局指标
主要结局
Accuracy of Implant and Provisional Crown Placement
时间窗: Immediate postoperative period
Accuracy will be assessed as the combination of trueness and precision by quantifying plan-to-actual deviations between the digitally planned and clinically achieved implant position and provisional crown position. Linear deviations at the coronal and apical implant levels, angular deviation of the implant axis, and linear and angular deviations of the provisional restoration will be calculated using three-dimensional analysis software.
次要结局
未报告次要终点
研究者
Miguel Gómez Polo
Associate Professor of conservative dentistry and prosthodontics
Universidad Complutense de Madrid