Computer Guided Immediate Implant Placement in Mandibular Molars Using Patient Specific 3D Printed Polylactic Acid Graft Versus Conventional Immediate Implant Placement With Xenograft
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 17
- 试验地点
- 1
- 主要终点
- Implant primary stability (IST)
研究概览
简要总结
This randomized controlled clinical trial will evaluate a computer-guided immediate implant placement technique in non-restorable mandibular molars using a patient-specific 3D-printed polylactic acid (PLA) graft and implant position guide, compared with conventional immediate implant placement using xenograft for grafting of the jumping gap.
Eligible patients requiring extraction and immediate implant placement in mandibular molars will be randomly allocated to either the PLA-guided intervention group or the conventional treatment group. In the intervention group, a patient-specific 3D-printed PLA graft and guide will be designed from preoperative CBCT data and used to guide implant placement in the digitally planned position. In the control group, immediate implant placement will be performed using the conventional protocol with xenograft grafting.
The study will assess the primary stability of the dental implant and the accuracy of implant placement compared with the digitally planned position. Implant stability will be measured using the Osstell device, while implant position will be evaluated by superimposing the immediate postoperative CBCT scan on the preoperative CBCT using Blue-Sky Plan software.
Patients will be followed clinically after surgery, with follow-up visits during the healing period and a six-month postoperative CBCT evaluation before implant loading.
详细描述
This is a prospective randomized controlled clinical trial designed to evaluate computer-guided immediate implant placement in mandibular molar extraction sockets using a patient-specific 3D-printed polylactic acid (PLA) socket guide and customized root-form PLA graft, compared with conventional freehand immediate implant placement using xenograft.
Immediate implant placement in mandibular molar extraction sockets can be challenging because of the wide socket morphology and the limited amount of bone available for achieving primary implant stability. The interradicular septum and apical bone are important for implant anchorage, while the irregular shape of the extraction socket may make conventional freehand osteotomy preparation and implant positioning difficult.
In the experimental group, preoperative cone-beam computed tomography (CBCT) data will be used for three-dimensional digital planning of the implant position. The implant position, angulation, diameter, and length will be planned using Blue Sky Plan 4 software. A patient-specific socket-supported PLA surgical guide will then be designed according to the planned implant position. A customized root-form PLA graft will also be designed to fit the peri-implant gap within the extraction socket.
The PLA socket guide and customized PLA graft will be fabricated using additive manufacturing. The patient-specific guide will be used during osteotomy preparation to control the drilling trajectory and facilitate placement of the implant according to the digitally planned position. The customized PLA graft will be positioned within the residual gap between the implant and extraction socket walls.
Participants allocated to the control group will undergo conventional immediate implant placement using a freehand surgical technique. Xenograft will be used for grafting of the peri-implant gap according to the conventional treatment protocol.
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
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients requiring immediate implant placement in mandibular molar extraction sockets.
- •Patients with adequate bone volume to accommodate the planned implant.
- •Patients willing to undergo immediate implant placement and follow-up for 6 months.
- •Patients who provided informed consent.
排除标准
- •Uncontrolled systemic diseases or medical conditions contraindicating implant surgery.
- •Patients receiving medications or treatments that may adversely affect bone healing.
- •Poor oral hygiene or uncontrolled periodontal disease.
- •Acute uncontrolled infection at the surgical site.
- •Conditions requiring additional bone augmentation beyond the study protocol.
- •Patients unable or unwilling to attend the required follow-up visits.
结局指标
主要结局
Implant primary stability (IST)
时间窗: Immediately after implant placement
Primary implant stability was measured using resonance frequency analysis and expressed as an Implant Stability Quotient (IST) value.
次要结局
- Implant stability at 6 months (IST)(6 months after implant placement)
- Implant positional accuracy(Immediately after implant placement)
研究者
Mahmoud Fawzy Mahmoud Mohamed
Oral and Maxillofacial Resident
Future University in Egypt