3D-Printed PLA Guide Versus Resin Guide in Mandibular Molar Implant Placement (CGIIPMM-PLA-MR)
2026年9月12日 更新者：Mohamed Esmail Ahmed Hassan
Computer Guided Immediate Implant Placement in Mandibular Molars Using Patient Specific 3D Printed Polylactic Acid Guide Versus Modified Resin Guide
This randomized clinical trial compares two tooth-supported computer-guided surgical guide systems for immediate implant placement in mandibular molar extraction sockets: a patient-specific 3D-printed PLA guide system and a modified resin guide system.
The study evaluates implant positioning accuracy, primary implant stability, and surgical time.
研究概览
地位
完全的
详细说明
This randomized clinical trial compares two tooth-supported computer-guided surgical guide systems for immediate implant placement in mandibular molar extraction sockets: a patient-specific 3D-printed polylactic acid (PLA) guide system and a modified resin guide system. Preoperative CBCT and digital intraoral scans were used for prosthetically driven virtual implant planning and fabrication of the surgical guides.
Implant positioning accuracy was assessed by comparing the planned and actual implant positions using preoperative and postoperative CBCT datasets. Angular deviation, coronal deviation at the implant platform, and apical deviation were recorded.
Primary implant stability was assessed immediately after implant placement using Implant Stability Quotient (ISQ) measurements obtained with an Osstell device. Surgical time was recorded from seating of the surgical guide and initiation of osteotomy until completion of implant insertion.
The study was designed to compare the performance of the two guide systems in immediate mandibular molar implant placement.
研究类型
介入性
注册 (实际的)
20
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
-
-
New Cairo
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Cairo、New Cairo、埃及、11511
- Future University in Egypt (FUE)
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-
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:
- Age 20-50 years.
- Non-restorable mandibular first molar indicated for extraction.
- Sufficient bony support for implant placement without the need for significant bone augmentation.
- Good oral hygiene and motivation.
- Adequate prosthetic space.
- Ability and willingness to undergo the surgical procedure and follow-up.
- Suitable for computer-guided, tooth-supported implant placement.
Exclusion Criteria:
- Uncontrolled systemic diseases that may impair healing (e.g., uncontrolled diabetes or hypertension).
- Severe periodontal disease.
- Patients undergoing chemotherapy or radiotherapy.
- Insufficient prosthetic space.
- Heavy smokers.
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：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：patient specific 3d printed PLA guide
Immediate implant placement in mandibular molar extraction sockets using a patient-specific tooth-supported 3D-printed PLA surgical guide system.
Preoperative CBCT and digital intraoral scans were used for prosthetically driven virtual implant planning and guide fabrication.
The guide was fabricated from PLA according to the planned implant position.
Following atraumatic tooth extraction and socket preparation, the guide was seated and osteotomy preparation was performed through the guide's guiding channel according to the planned trajectory, followed by immediate implant insertion.
Primary implant stability was assessed using an Osstell device and Implant Stability Quotient (ISQ) measurements.
|
Preoperative virtual planning was performed using CBCT data and digital intraoral scans.
The datasets were used for prosthetically driven implant planning and fabrication of a patient-specific 3D-printed PLA surgical guide.
Following atraumatic tooth extraction and socket preparation, the guide was seated and osteotomy preparation was performed through the guiding channel according to the planned implant position and trajectory.
The implant was then immediately inserted.
Primary implant stability was assessed using an Osstell device and Implant Stability Quotient (ISQ) measurements.
|
|
有源比较器：Modified Resin guide
Immediate implant placement in mandibular molar extraction sockets using a tooth-supported modified resin surgical guide system.
Preoperative CBCT and digital intraoral scans were used for prosthetically driven virtual implant planning and guide fabrication.
The guide was fabricated from light-cured surgical-guide resin according to the planned implant position.
Following atraumatic tooth extraction and socket preparation, the guide was seated and osteotomy preparation was performed through the guide's guiding channel according to the planned trajectory, followed by immediate implant insertion.
Primary implant stability was assessed using an Osstell device and Implant Stability Quotient (ISQ) measurements.
|
Preoperative virtual planning was performed using CBCT data and digital intraoral scans.
The datasets were used for prosthetically driven implant planning and fabrication of a tooth-supported modified resin surgical guide.
Following atraumatic tooth extraction and socket preparation, the guide was seated and osteotomy preparation was performed through the guiding channel according to the planned implant position and trajectory.
The implant was then immediately inserted.
Primary implant stability was assessed using an Osstell device and Implant Stability Quotient (ISQ) measurements.
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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 |
|---|---|---|
|
accuracy of implant position
大体时间：Assessed within 1 week postoperatively, following acquisition of the postoperative CBCT scan.
|
Accuracy of implant placement will be evaluated by comparing the planned implant position from the preoperative digital plan with the actual implant position obtained from the postoperative CBCT scan.
Deviations will be assessed in three dimensions, including angular deviation (degrees), coronal deviation (platform) (mm), and apical deviation (mm).
Measurements will be performed using specialized implant-planning software by superimposing the preoperative and postoperative datasets.
Lower deviation values indicate greater agreement between the planned and actual implant positions.
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Assessed within 1 week postoperatively, following acquisition of the postoperative CBCT scan.
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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primary implant stability by osstell
大体时间：Measured immediately at the time of implant placement during the surgical procedure.
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Primary implant stability will be assessed using an Osstell device, which measures Implant Stability Quotient (ISQ) values through resonance frequency analysis.
A SmartPeg will be attached to the implant, and ISQ readings will be taken in two perpendicular directions (buccolingual and mesiodistal).
Higher ISQ values indicate greater mechanical stability.
The mean ISQ value for each implant will be recorded and used for analysis
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Measured immediately at the time of implant placement during the surgical procedure.
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surgical time
大体时间：Assessed intraoperatively, measured during the surgical appointment, and recorded immediately after surgery
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Surgical time will be recorded to evaluate the procedural efficiency of guided immediate implant placement.
Time will be measured from seating of the surgical guide and initiation of osteotomy until completion of implant insertion.
The total duration will be recorded in minutes.
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Assessed intraoperatively, measured during the surgical appointment, and recorded immediately after surgery
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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。
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Shi Y, Wang J, Ma C, Shen J, Dong X, Lin D. A systematic review of the accuracy of digital surgical guides for dental implantation. Int J Implant Dent. 2023 Oct 25;9(1):38. doi: 10.1186/s40729-023-00507-w.
- Ragucci GM, Elnayef B, Criado-Camara E, Del Amo FS, Hernandez-Alfaro F. Immediate implant placement in molar extraction sockets: a systematic review and meta-analysis. Int J Implant Dent. 2020 Oct 13;6(1):40. doi: 10.1186/s40729-020-00235-5.
- Ku JK, Lee J, Lee HJ, Yun PY, Kim YK. Accuracy of dental implant placement with computer-guided surgery: a retrospective cohort study. BMC Oral Health. 2022 Jan 16;22(1):8. doi: 10.1186/s12903-022-02046-z.
- Pieralli S, Spies BC, Hromadnik V, Nicic R, Beuer F, Wesemann C. How Accurate Is Oral Implant Installation Using Surgical Guides Printed from a Degradable and Steam-Sterilized Biopolymer? J Clin Med. 2020 Jul 22;9(8):2322. doi: 10.3390/jcm9082322.
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11月2日
初级完成 (实际的)
2026年8月10日
研究完成 (实际的)
2026年9月10日
研究注册日期
首次提交
2026年9月12日
首先提交符合 QC 标准的
2026年9月12日
首次发布 (实际的)
2026年9月17日
研究记录更新
最后更新发布 (实际的)
2026年9月17日
上次提交的符合 QC 标准的更新
2026年9月12日
最后验证
2026年9月1日
更多信息
与本研究相关的术语
关键字
其他研究编号
- FUE.REC(78)/10-2025
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
不
IPD 计划说明
Individual participant data will not be shared because of participant privacy and confidentiality considerations.
Only aggregate study results will be reported.
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.