Evaluation of Passive Fit in Implant-Supported Complete-Arch Prostheses Using Three Digital Workflows, Including an Automated AI-Assisted Protocol: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Multi-assessment global passive fit score of definitive full-arch implant-supported prostheses
研究概览
简要总结
The goal of this clinical trial is to evaluate and compare three digital workflows for the fabrication of definitive implant-supported full-arch prostheses in adult patients requiring fixed implant rehabilitation.
The main questions it aims to answer are:
- Does an automated AI-assisted digital workflow improve the passive fit of definitive full-arch implant-supported prostheses compared with manual and splint-guided alignment workflows?
- Are there differences in marginal, geometric, mechanical, and radiographic passivity among the three digital workflows? Researchers will compare manual CBCT-STL alignment, splint-guided alignment, and automated AI-assisted CBCT-STL alignment to see if the degree of digital workflow automation affects the passive fit of definitive full-arch implant-supported prostheses.
Participants will:
- Be adults (18 years and older) indicated for fixed implant-supported full-arch rehabilitation.
- Receive a definitive, screw-retained, full-arch implant-supported prosthesis fabricated using one of the three assigned digital workflows.
- Undergo standardized clinical and radiographic assessments at the time of definitive prosthesis placement to evaluate prosthesis passive fit.
详细描述
This randomized controlled clinical trial aims to evaluate and compare the passive fit of definitive full-arch implant-supported prostheses fabricated using three different digital workflows with increasing levels of automation for implant position registration and prosthesis fabrication.
Full-arch implant-supported rehabilitations require a high level of precision to ensure passive fit between the prosthetic framework and the implant-abutment connections. Inadequate passive fit may lead to mechanical complications, biological overload, or long-term prosthetic failure. Digital workflows combining intraoral scanning (IOS) and cone-beam computed tomography (CBCT) have been introduced to improve accuracy; however, differences in data acquisition and dataset alignment strategies may influence the final prosthetic fit.
The study will include adult patients (18 years and older) indicated for fixed implant-supported full-arch rehabilitation in the maxilla or mandible. Eligible participants will be recruited from the Faculty of Dentistry of the Complutense University of Madrid and associated clinical centers. After providing written informed consent, participants will be randomly assigned in a 1:1:1 ratio to one of three digital workflows:
- Manual CBCT-STL alignment (MedicalFit 1.0): implant positions are obtained by combining intraoral scans and CBCT data, with dataset registration performed manually by the operator based on visual alignment of scan bodies.
- Splint-guided alignment (MedicalFit 2.0): a calibrated rigid reference splint with metallic cylinders is used to stabilize implant positions and assist manual dataset registration, aiming to reduce operator-dependent variability.
- Automated AI-assisted CBCT-STL alignment (MedicalFit 3.0 - Pdental): dataset registration and passivation are performed automatically by dedicated software using advanced algorithms for implant detection and alignment, without manual intervention.
All participants will receive a definitive, screw-retained, full-arch implant-supported prosthesis fabricated according to the assigned digital workflow. Prosthetic materials and clinical procedures will follow standard clinical practice. No outcome measures will be assessed during provisional prosthetic phases.
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
- 否
入选标准
- •Adults aged 18 years or older.
- •Patients indicated for fixed implant-supported full-arch rehabilitation in the maxilla or mandible.
- •Presence of clinically stable, osteointegrated titanium implants suitable for prosthetic rehabilitation.
- •Absence of clinical or radiographic signs of peri-implant disease.
- •Ability to understand the study procedures and provide written informed consent.
- •Willingness and ability to attend all required clinical visits and evaluations.
排除标准
- •Presence of peri-implant mucositis or peri-implantitis at the time of evaluation.
- •Implant mobility or implant positioning that prevents proper prosthetic rehabilitation.
- •Uncontrolled systemic medical conditions that could interfere with study participation or prosthetic treatment.
- •Cognitive, psychological, or medical conditions that limit the ability to comply with study procedures.
- •Inability to complete the required clinical evaluations or follow the study protocol, as judged by the investigator.
结局指标
主要结局
Multi-assessment global passive fit score of definitive full-arch implant-supported prostheses
时间窗: At definitive prosthesis placement
Passive fit of the definitive full-arch implant-supported prosthesis will be evaluated using a standardized multi-assessment clinical approach. Marginal, geometric (modified Sheffield test), mechanical (passive screw test sensitivity), and radiographic passive fit will be assessed independently at each implant-prosthesis connection. Each assessment will be scored using an ordinal scale (0-2) based on predefined clinical criteria: 0 = no detectable discrepancy, indicating adequate passive fit; 1 = minor discrepancy, indicating a cl To obtain the prosthesis-level outcome, a conservative aggregation rule will be applied: for each assessment dimension, the prosthesis score will be defined as the worst score observed among all implant-prosthesis connections. The global multi-assessment passive fit score (0-2) will then be defined as the worst score observed across all assessment dimensions.
次要结局
- Clinical marginal passive fit (probe assessment)(At definitive prosthesis placement)
- Radiographic marginal gap at the prosthesis-abutment interface(At definitive prosthesis placement)
- Geometric passive fit assessed by the modified Sheffield test(At definitive prosthesis placement)
- Mechanical passive fit assessed by passive screw test sensitivity(At definitive prosthesis placement)
研究者
Miguel Gómez Polo
Associate Professor of Prosthodontics, Department of Conservative Dentistry and Prosthodontics, Faculty of Dentistry, Universidad Complutense de Madrid
Universidad Complutense de Madrid