跳至主要内容
临床试验/NCT07826039
NCT07826039已完成不适用

Computer Guided Immediate Implant Placement in Mandibular Molars Using Patient Specific 3D Printed Polylactic Acid Guide Versus Modified Resin Guide

Mohamed Esmail Ahmed Hassan1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2025年11月2日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
20
试验地点
1
主要终点
accuracy of implant position

研究概览

简要总结

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.

详细描述

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 (Participant)

入排标准

年龄范围
20 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

研究组 & 干预措施

patient specific 3d printed PLA guide

Experimental

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.

干预措施: immediate implant placement using PLA guide (Procedure)

Modified Resin guide

Active Comparator

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.

干预措施: Immediate implant placement using Modified resin guide. (Procedure)

结局指标

主要结局

accuracy of implant position

时间窗: 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.

次要结局

  • primary implant stability by osstell(Measured immediately at the time of implant placement during the surgical procedure.)
  • surgical time(Assessed intraoperatively, measured during the surgical appointment, and recorded immediately after surgery)

研究者

发起方
Mohamed Esmail Ahmed Hassan
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Mohamed Esmail Ahmed Hassan

Master's Student, Department of Oral and Maxillofacial Surgery

Future University in Egypt

研究点 (1)

Loading locations...

相似试验