Evaluation of Occlusal Contact Distribution in Digitally Fabricated Implant-Retained Fixed Partial Dentures in Mandibular Kennedy Class II Patients Following Artificial Intelligence Bite Optimization: A Quasi-Experimental Study (Quasi)
2026年6月14日 更新者：Noha Waleed Fathalla Moustafa Barakat、Cairo University
The aim of the study is to evaluate the occlusal contact distribution in digitally fabricated implant-retained fixed partial dentures in mandibular Kennedy Class II patients before and after artificial intelligence bite optimization.
研究概览
详细说明
The recruited patients will be screened for proper bone architecture and CBCTs will be taken for proper virtual implant planning.
Two implants will be placed in the edentulous span in all participants.
All surgical steps will be held according to standard protocol.
After the implant osseointegration period, the prosthetic phase will start with implant exposure and placement of multiunit abutments.
After gingival healing, intraoral scans for the implants timing using abutment level scan bodies will be taken.
Then, the fabrication of implant-retained fixed partial denture will be done with a fully digital workflow.
The data acquisition will take place by scanning the patients using Medit intraoral scanner.
Then, the scanned stls will be imported in 3shape software version 2024 and bite optimization module in it will be run.
It automatically recalculates the position of the bite relation using its integrated AI.
After that, the resulted STLs will be exported and re-imported to ExoCAD software to design the prostheses.
研究类型
介入性
注册 (估计的)
15
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。
学习联系方式
- 姓名：Noha Walid Barakat, Masters degree
- 电话号码：002 +201149902334
- 邮箱：noha.barakat@dentistry.cu.edu.eg
研究联系人备份
- 姓名：Ahmed Mustafa Kotb, Lecturer
- 电话号码：002 01006697790
- 邮箱：ahmed.kotb@dentistry.cu.edu.eg
学习地点
-
-
-
Giza、埃及、12511
- Faculty of Dentistry - Cairo University
-
接触：
- Noha Barakat, Masters degree
- 电话号码：002 01149902334
- 邮箱：noha.barakat@dentistry.cu.edu.eg
-
-
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
- 年长者
接受健康志愿者
是的
描述
Inclusion Criteria:
- Patients with a unilateral mandibular distal extension area (Kennedy Class II partially edentulous mandibular arch) and who are indicated for the insertion of 2 implants.
- Fully dentate opposing maxillary arch or restored with a suitable, well constructed fixed prosthesis.
- The remaining teeth should be in good periodontal health, with no signs of inflammation or movement.
- The edentulous area should be covered by a healthy, firm mucoperiosteum, with no or minimal tissue undercut.
- Patient should be with class I occlusion.
- No occlusal disorder; stable jaw relation.
- No TMD signs or symptoms.
- Patients should be in generally good health and free of systemic conditions that can affect the implant treatment, such as diabetes mellitus.
Exclusion Criteria:
- Patients with psychological or mental disorders.
- Patients with insufficient interarch space.
- Patients with parafunctional habits, such as bruxism.
- After the healing phase and exactly before the prosthetic phase, if the inserted implants showed any signs of peri-implantitis or aggressive crestal bone resorption, then this case will be excluded and replaced with another case.
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：非随机化
- 介入模型：顺序分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Before
The recruited patients will be screened for proper bone architecture and CBCTs will be taken for proper virtual implant planning.
Two implants will be placed in the edentulous span in all participants.
All surgical steps will be held according to standard protocol.
After the implant osseointegration period, the prosthetic phase will start with implant exposure and placement of multiunit abutments.
After gingival healing, intraoral scans for the implants timing using abutment level scan bodies will be taken.
Then, the fabrication of implant-retained fixed partial denture will be done with a fully digital workflow.
|
The recruited patients will be screened for proper bone architecture and CBCTs will be taken for proper virtual implant planning.
Two implants will be placed in the edentulous span in all participants.
All surgical steps will be held according to standard protocol.
After the implant osseointegration period, the prosthetic phase will start with implant exposure and placement of multiunit abutments.
After gingival healing, intraoral scans for the implants timing using abutment level scan bodies will be taken.
Then, the fabrication of implant-retained fixed partial denture will be done with a fully digital workflow.
|
|
有源比较器：After
The data acquisition will take place by scanning the patients using Medit intraoral scanner.
Then, the scanned stls will be imported in 3shape software version 2024 and bite optimization module in it will be run.
It automatically recalculates the position of the bite relation using its integrated AI.
After that, the resulted STLs will be exported and re-imported to ExoCAD software to design the prostheses.
|
The data acquisition will take place by scanning the patients using Medit intraoral scanner.
Then, the scanned stls will be imported in 3shape software version 2024 and bite optimization module in it will be run.
It automatically recalculates the position of the bite relation using its integrated AI.
After that, the resulted STLs will be exported and re-imported to ExoCAD software to design the prostheses.
|
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 |
|---|---|---|
|
Occlusal contact distribution
大体时间：From enrollment till the end of the study 17 weeks
|
The 1ry outcome will be assessed on the day of the prosthesis delivery. First, the reading of the occlusal contact distribution will be taken by using the T-scan device before seating the prosthesis intraorally. Then, the retained fixed prosthesis will be seated on the implant abutment, and the prosthetic screw will be screwed to the optimum torque. Another reading of the occlusal contact distribution will be taken by using the T-scan device after seating and torquing the prosthesis intraorally. Finally, the screw access channels will be closed by flowable resin composite material. |
From enrollment till the end of the study 17 weeks
|
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 (估计的)
2026年6月1日
初级完成 (估计的)
2026年9月1日
研究完成 (估计的)
2026年9月1日
研究注册日期
首次提交
2026年6月14日
首先提交符合 QC 标准的
2026年6月14日
首次发布 (实际的)
2026年6月18日
研究记录更新
最后更新发布 (实际的)
2026年6月18日
上次提交的符合 QC 标准的更新
2026年6月14日
最后验证
2026年6月1日
更多信息
与本研究相关的术语
其他研究编号
- 24226
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研究美国 FDA 监管的设备产品
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在美国制造并从美国出口的产品
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