NCT06250907尚未招募不适用
Evaluation of Accuracy of Implant Placement for Patients With Mandibular Reconstruction Using Dynamic Navigation Compared to Static Guides: a Parallel, Randomized Controlled Clinical Trial
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University0 个研究点目标入组 20 人开始时间: 2024年2月29日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 20
- 主要终点
- Three-dimensional implant placement accuracy of apical point
研究概览
简要总结
To evaluate and compare the accuracy of implant placement using dynamic navigation technique versus static template technique in patients with bone tissue flap reconstruction of mandibular defects, thus further guiding the clinical application of dynamic navigation systems to assist in conventional implant placement in patients with mandibular defects.
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female patients between the ages of 18 and 70 (inclusive)
- •Mandibular defects (including Class I defects, limited to the body of the mandible; Class II defects, muscular-mandibular region defects and Class III defects, chin protrusion-muscular-mandibular region defects), which have been reconstructed by mandibular vascularization of free iliac bone, and fibular composite muscular flap grafts for greater than 3 months
- •Normal mouth opening (≥ 40 mm)
- •Trialists voluntarily signed an informed consent form before performing any research-related experimental steps.
排除标准
- •Presence of localized inflammation in adjacent teeth, including uncontrolled periodontitis (periodontal probing to a depth of >4 mm)
- •Presence of untreated acute and chronic apical periodontitis in adjacent teeth
- •Oral mucosal lesions (e.g., lichen planus)
- •Adjacent teeth with space-occupying lesions (including cysts, tumors, etc.)
- •Systemic diseases affecting bone healing, wound healing and dental implant treatment (e.g., uncontrolled diabetes mellitus, fasting blood glucose ≥ 8.8 mmol/L despite medication)
- •Uncontrolled and unstabilized severe hypertension
- •Contraindications to routine implant surgery and oral surgery
- •Heart disease (Class II or above)
- •Patients with liver or kidney insufficiency or abnormality
- •Obese patients with body mass index (BMI) > 28 kg/m2
- •Patients with a history of full-dose radiotherapy, localized radiotherapy to the head or neck
- •Patients requiring long-term high-dose steroid therapy
- •Patients who are receiving or have received in the last 3 months medications (e.g., bisphosphonates) that may affect or promote bone metabolism
- •Consecutive antibiotic therapy or chronic anti-inflammatory therapy (≥3 times per week) within the first 4 weeks of starting the procedure
- •Alcohol or chronic substance abuse
- •Immunocompromised patients
- •Smoking/tobacco equivalents/chewing tobacco >10 cigarettes per day
- •Physical or mental impairment that interferes with the performance of oral hygiene care
- •Female patients who are pregnant or breastfeeding
- •Patients who, in the opinion of the investigator, have poor compliance and cannot participate in the trial
- •Patients who have participated in a clinical trial of another drug or device within 30 days prior to the start of the procedure (Study Day 0)
结局指标
主要结局
Three-dimensional implant placement accuracy of apical point
时间窗: Postoperative day 2±1
The postoperative cone beam computed tomography (CBCT) was aligned to the preoperative plan in specific software, and the three-dimensional coordinates of the preoperatively planned and actual postoperative implant placement positions were measured separately, from which the three-dimensional distance (in mm) between the apical point of the actual implant and the apical point of the virtual implant was calculated.
次要结局
- Failure rate during implant healing period(Postoperative day 90±7)
- Three-dimensional implant placement angular accuracy(Postoperative day 2±1)
- Operation time(Intraoperative)
- Patient subjective satisfaction(Postoperative day 14±1)
- Three-dimensional implant placement accuracy of coronal point(Postoperative day 2±1)
研究者
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