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Influence of Provisional Restoration Type on Outcomes of Immediate Implant Placement and Loading (PRODIGI)

2026年7月21日 更新者:Mansoura University

Influence of Provisional Restoration Type on Clinical Outcomes of Fully Digital Single-Visit Immediate Implant Placement and Loading: A Randomized Clinical Trial

A randomized clinical trial comparing 3D-printed resin and CAD/CAM-milled PMMA provisional restorations used for immediate loading of fully digitally guided immediate implants.

研究概览

详细说明

Sixty patients were randomly allocated to receive either a 3D-printed resin or a CAD/CAM-milled PMMA provisional crown used for immediate loading after fully digitally guided immediate implant placement in the maxillary esthetic zone. Clinical and peri-implant soft tissue outcomes will be evaluated.

研究类型

介入性

注册 (实际的)

60

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Dakahlia Governorate
      • Al Mansurah、Dakahlia Governorate、埃及
        • Faculty of Dentistry Mansoura University

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人

接受健康志愿者

不

描述

Inclusion Criteria:

  • Patients presenting with non-restorable teeth in the maxillary esthetic zone indicated for extraction and immediate implant placement.
  • Age ranging from 18 to 50 years.
  • Adequate interarch relationship and interocclusal space to accommodate the planned prosthetic restoration.
  • Intact extraction socket walls with a jumping gap not exceeding 4 mm, as measured on preoperative CBCT images. The jumping gap will be defined as the horizontal distance between the implant surface and the inner aspect of the buccal socket wall and will be grafted in all cases.
  • Good oral hygiene and periodontal health.
  • Willingness to attend all follow-up visits and comply with study requirements.

Exclusion Criteria:

  • Presence of acute infection, pathological lesions, or severe periodontal disease at the planned implant site.
  • Smokers.
  • Alcohol or drug abuse.
  • Patients with systemic conditions contraindicating implant surgery (e.g., uncontrolled diabetes mellitus, bleeding disorders, immunosuppression, recent radiotherapy to the head and neck region).
  • Pregnancy or lactation.
  • Patients with parafunctional habits such as bruxism or clenching.
  • Inability to maintain adequate oral hygiene or attend follow-up visits.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:双倍的

武器和干预

参与者组/臂
干预/治疗
实验性的:Study Group 2 (CAD/CAM-Milled PMMA Group)
Thirty patients received a digitally designed CAD/CAM-milled PMMA immediate provisional crown for immediate loading, serving as a customized healing abutment following fully guided immediate implant placement in the maxillary esthetic zone.
A digitally designed CAD/CAM-milled PMMA immediate provisional crown was delivered immediately after fully guided implant placement in the maxillary esthetic zone and served as a customized healing abutment.
实验性的:Study Group 1 (3D-Printed resin Group)
Thirty patients received a digitally designed 3D-printed resin immediate provisional crown for immediate loading, serving as a customized healing abutment following fully guided immediate implant placement in the maxillary esthetic zone.
A digitally designed and 3D-printed resin immediate provisional crown was delivered immediately after fully guided implant placement in the maxillary esthetic zone and served as a customized healing abutment.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Peri-implant soft tissue changes
大体时间:Baseline (immediately after provisionalization), 1 month, 3 months, and 6 months postoperatively.
Soft tissue contour and peri-implant tissue condition will be assessed using digital intraoral scanning (STL files) using superimposition.
Baseline (immediately after provisionalization), 1 month, 3 months, and 6 months postoperatively.

次要结果测量

结果测量
措施说明
大体时间
Pink Esthetic Score (PES)
大体时间:After 3 and 6 months postoperatively.
Peri-implant soft tissue esthetics were assessed using the Pink Esthetic Score (0-14). Higher scores indicated better esthetic outcomes.
After 3 and 6 months postoperatively.
Implant stability
大体时间:Immediate post-operative and at 3 months.
Implant stability will be evaluated using Osstell device based on resonance frequency analysis (ISQ values).
Immediate post-operative and at 3 months.

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2025年12月1日

初级完成 (实际的)

2026年6月30日

研究完成 (估计的)

2026年7月1日

研究注册日期

首次提交

2026年7月8日

首先提交符合 QC 标准的

2026年7月8日

首次发布 (实际的)

2026年7月14日

研究记录更新

最后更新发布 (实际的)

2026年7月22日

上次提交的符合 QC 标准的更新

2026年7月21日

最后验证

2026年7月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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